SEP+OCT 2011 by POSITIVELY AWARE

Understanding the immune system Opportunistic infections

Positively Aware SE P T EM B ER + OC T O B ER 2 0 1 1

HIV 101

A practical guide to living healthier with HIV

The HIV Treatment & Health Journal of

Test Positive Aware Network

CONFERENCE UPDATE: IAS Rome 2011

ATRIPLA Important Safety Information and Indication INDICATION ATRIPLA (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate [DF] 300 mg) is a prescription medication used alone as a complete regimen or with other medicines to treat HIV-1 infection in adults. ATRIPLA does not cure HIV-1 and has not been shown to prevent passing HIV-1 to others. The long-term effects of ATRIPLA are not known at this time. People taking ATRIPLA may still get infections that develop because the immune system is weak or other conditions that happen with HIV-1 infection. Do not stop taking ATRIPLA unless directed by your healthcare provider. See your healthcare provider regularly. ®

IMPORTANT SAFETY INFORMATION Contact your healthcare provider right away if you get the following side effects or conditions associated with ATRIPLA: • Nausea, vomiting, unusual muscle pain, and/or weakness. These may be signs of a buildup of acid in the blood (lactic acidosis), which is a serious medical condition. • Light-colored stools, dark-colored urine, and/or if your skin or the whites of your eyes turn yellow. These may be signs of serious liver problems. • If you have HIV-1 and hepatitis B virus (HBV), your liver disease may suddenly get worse if you stop taking ATRIPLA. Do not take ATRIPLA if you are taking the following medicines because serious and life-threatening side effects may occur when taken together: Vascor® (bepridil), Propulsid® (cisapride), Versed® (midazolam), Orap® (pimozide), Halcion® (triazolam), or ergot medications (for example, Wigraine® and Cafergot®). In addition, ATRIPLA should not be taken with: Combivir® (lamivudine/zidovudine), EMTRIVA® (emtricitabine), Epivir® or Epivir-HBV® (lamivudine), Epzicom® (abacavir sulfate/lamivudine), SUSTIVA® (efavirenz), Trizivir® (abacavir sulfate/lamivudine/zidovudine), TRUVADA® (emtricitabine/tenofovir DF), or VIREAD® (tenofovir DF), because they contain the same or similar active ingredients as ATRIPLA. ATRIPLA should not be used with HEPSERA® (adefovir dipivoxil). Vfend® (voriconazole) or REYATAZ® (atazanavir sulfate) with or without Norvir® (ritonavir) should not be taken with ATRIPLA since they may lose their effect and may also increase the chance of having side effects from ATRIPLA. Fortovase® or Invirase® (saquinavir) should not be used as the only protease inhibitor in combination with ATRIPLA. Taking ATRIPLA with St. John’s wort or products containing St. John’s wort is not recommended as it may cause decreased levels of ATRIPLA, increased viral load, and possible resistance to ATRIPLA or cross-resistance to other anti-HIV drugs. This list of medicines is not complete. Discuss with your healthcare provider all prescription and nonprescription medicines, vitamins, or herbal supplements you are taking or plan to take. Tell your healthcare provider if you: • Are pregnant: Women should not become pregnant while taking ATRIPLA and for 12 weeks after stopping ATRIPLA. Serious birth defects have been seen in children of women treated during pregnancy with one of the medicines in ATRIPLA. Women must use a reliable form of barrier contraception, such as a condom or diaphragm, even if they also use other methods of birth control, while on ATRIPLA and for 12 weeks after stopping ATRIPLA. • Are breastfeeding: Women with HIV should not breastfeed because they can pass HIV through their milk to the baby. Also, ATRIPLA may pass through breast milk and cause serious harm to the baby. • Have liver problems, including hepatitis B or C virus infection. • Have ever had seizures: Seizures have occurred in patients taking a © 2011 Bristol-Myers Squibb. All rights reserved. ATRIPLA is a registered trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. EMTRIVA, VIREAD, and TRUVADA are registered trademarks of Gilead Sciences, Inc. SUSTIVA and REYATAZ are registered trademarks of Bristol-Myers Squibb. All other trademarks are the property of their respective owners.

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component of ATRIPLA, usually in those with a history of seizures. If you have ever had seizures, or take medicine for seizures, your healthcare provider may want to switch you to another medicine or monitor you. • Have ever had mental illness or use drugs or alcohol. Contact your healthcare provider right away if you experience any of the following serious or common side effects: Serious side effects associated with ATRIPLA: • Severe depression, strange thoughts, or angry behavior have been reported by a small number of patients. Some patients have had thoughts of suicide, and a few have actually committed suicide. These problems may occur more often in patients who have had mental illness. • Kidney problems (including decline or failure of kidney function). If you have had kidney problems, or take other medicines that may cause kidney problems, your healthcare provider should do regular blood tests. Symptoms that may be related to kidney problems include a high volume of urine, thirst, muscle pain, and muscle weakness. • Other serious liver problems. Some patients have experienced serious liver problems, including liver failure resulting in transplantation or death. Most of these serious side effects occurred in patients with a chronic liver disease such as hepatitis infection, but there have also been a few reports in patients without any existing liver disease. • Bone changes. Lab tests show changes in the bones of patients treated with tenofovir DF, a component of ATRIPLA. Some HIV patients treated with tenofovir DF developed thinning of the bones (osteopenia), which could lead to fractures. Also, bone pain and softening of the bone (which may lead to fractures) may occur as a consequence of kidney problems. If you have had bone problems in the past, your healthcare provider may want to check your bones. Common side effects: • Dizziness, headache, trouble sleeping, drowsiness, trouble concentrating, and/or unusual dreams. These side effects tend to go away after taking ATRIPLA for a few weeks. These symptoms may be more severe with the use of alcohol and/or mood-altering (street) drugs. If you are dizzy, have trouble concentrating, and/or are drowsy, avoid activities that may be dangerous, such as driving or operating machinery. • Rash is a common side effect that usually goes away without any change in treatment, but may be serious in a small number of patients. • Other common side effects include: tiredness, upset stomach, vomiting, gas, and diarrhea. Other possible side effects: • Changes in body fat have been seen in some people taking anti-HIV-1 medicines. The cause and long-term health effects are not known. • Skin discoloration (small spots or freckles) may also happen. • If you notice any symptoms of infection, contact your healthcare provider right away. • Additional side effects are inflammation of the pancreas, allergic reaction (including swelling of the face, lips, tongue, or throat), shortness of breath, pain, stomach pain, weakness, and indigestion. You should take ATRIPLA once daily on an empty stomach. Taking ATRIPLA at bedtime may make some side effects less bothersome. ATRIPLA is one of several treatment options your doctor may consider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see Patient Information on the following pages.

With ATRIPLA,

You’re in good company Most doctors choose ATRIPLA — with nearly 3.8 million prescriptions written in the US since 2006, ATRIPLA is the #1 prescribed HIV regimen*

Alone or with other HIV medications.

Real ATRIPLA patients. ATRIPLA: • The first to combine 3 HIV meds in 1 pill daily • The only DHHS† guidelines-preferred HIV regimen available as one pill daily for patients new to therapy • Proven to lower viral load to undetectable‡ in approximately 7 out of 10 patients new to therapy, with high or low viral load§ when starting treatment, through 3 years of a clinical study.ll ATRIPLA does not cure HIV-1 and has not been shown to prevent passing HIV-1 to others.

Selected Important Safety Information: Some people who have taken medicine like ATRIPLA have developed the following: a serious condition of acid buildup in the blood (lactic acidosis), and serious liver problems (hepatotoxicity). For patients with both HIV-1 and hepatitis B virus (HBV), hepatitis may suddenly worsen if ATRIPLA is discontinued. Please see detailed and additional Important Safety Information, including the bolded information to the left. * Wolters Kluwer prescription data, March 2011; † Department of Health and Human Services January 10, 2011; ‡ Undetectable was defined as a viral load of less than 400 copies/mL; § High viral load is defined as greater than 100,000 copies/mL. Low viral load is defined as less than or equal to 100,000 copies/mL; ll In this study, 227 patients took the meds in ATRIPLA.

Ask your doctor about ATRIPLA — the #1 prescribed HIV regimen. To learn more, visit www.ATRIPLA.com

FDA-Approved Patient Labeling Patient Information ATRIPLA® (uh TRIP luh) Tablets ALERT: Find out about medicines that should NOT be taken with ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate). Please also read the section “MEDICINES YOU SHOULD NOT TAKE WITH ATRIPLA.” Generic name: efavirenz, emtricitabine and tenofovir disoproxil fumarate (eh FAH vih renz, em tri SIT uh bean and te NOE’ fo veer dye soe PROX il FYOU mar ate) Read the Patient Information that comes with ATRIPLA before you start taking it and each time you get a refill since there may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. You should stay under a healthcare provider’s care when taking ATRIPLA. Do not change or stop your medicine without first talking with your healthcare provider. Talk to your healthcare provider or pharmacist if you have any questions about ATRIPLA. What is the most important information I should know about ATRIPLA? • Some people who have taken medicine like ATRIPLA (which contains nucleoside analogs) have developed a serious condition called lactic acidosis (build up of an acid in the blood). Lactic acidosis can be a medical emergency and may need to be treated in the hospital. Call your healthcare provider right away if you get the following signs or symptoms of lactic acidosis: • You feel very weak or tired. • You have unusual (not normal) muscle pain. • You have trouble breathing. • You have stomach pain with nausea and vomiting. • You feel cold, especially in your arms and legs. • You feel dizzy or lightheaded. • You have a fast or irregular heartbeat. • Some people who have taken medicines like ATRIPLA have developed serious liver problems called hepatotoxicity, with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Call your healthcare provider right away if you get the following signs or symptoms of liver problems: • Your skin or the white part of your eyes turns yellow (jaundice). • Your urine turns dark. • Your bowel movements (stools) turn light in color. • You don’t feel like eating food for several days or longer. • You feel sick to your stomach (nausea). • You have lower stomach area (abdominal) pain. • You may be more likely to get lactic acidosis or liver problems if you are female, very overweight (obese), or have been taking nucleoside analog-containing medicines, like ATRIPLA, for a long time. • If you also have hepatitis B virus (HBV) infection and you stop taking ATRIPLA, you may get a “flare-up” of your hepatitis. A “flare-up” is when the disease suddenly returns in a worse way than before. Patients with HBV who stop taking ATRIPLA need close medical follow-up for several months, including medical exams and blood tests to check for hepatitis that could be getting worse. ATRIPLA is not approved for the treatment of HBV, so you must discuss your HBV therapy with your healthcare provider. What is ATRIPLA? ATRIPLA contains 3 medicines, SUSTIVA® (efavirenz), EMTRIVA® (emtricitabine) and VIREAD® (tenofovir disoproxil fumarate also called tenofovir DF) combined in one pill. EMTRIVA and VIREAD are HIV-1 (human immunodeficiency virus) nucleoside analog reverse transcriptase inhibitors (NRTIs) and SUSTIVA is an HIV-1 non-nucleoside analog reverse transcriptase inhibitor (NNRTI). VIREAD and EMTRIVA are the components of TRUVADA®. ATRIPLA can be used alone as a complete regimen, or in combination with other anti-HIV-1 medicines to treat people with HIV-1 infection. ATRIPLA is for adults age 18 and over. ATRIPLA has not been studied in children under age 18 or adults over age 65. HIV infection destroys CD4+ T cells, which are important to the immune system. The immune system helps fight infection. After a large number of T cells are destroyed, acquired immune deficiency syndrome (AIDS) develops. ATRIPLA helps block HIV-1 reverse transcriptase, a viral chemical in your body (enzyme) that is needed for HIV-1 to multiply. ATRIPLA lowers the amount of HIV-1 in the blood (viral load). ATRIPLA may also help to increase the number of T cells (CD4+ cells), allowing your immune system to improve. Lowering the amount of HIV-1 in the blood lowers the chance of death or infections that happen when your immune system is weak (opportunistic infections). Does ATRIPLA cure HIV-1 or AIDS? ATRIPLA does not cure HIV-1 infection or AIDS. The long-term effects of ATRIPLA are not known at this time. People taking ATRIPLA may still get opportunistic infections or other conditions that happen with HIV-1 infection. Opportunistic infections are infections that develop because the immune system is weak. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infection. It is very important that you see your healthcare provider regularly while taking ATRIPLA. Does ATRIPLA reduce the risk of passing HIV-1 to others? ATRIPLA has not been shown to lower your chance of passing HIV-1 to other people through sexual contact, sharing needles, or being exposed to your blood. • Do not share needles or other injection equipment.

ATRIPLA® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) •

Do not share personal items that can have blood or body fluids on them, like toothbrushes or razor blades. • Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom or other barrier to reduce the chance of sexual contact with semen, vaginal secretions, or blood. Who should not take ATRIPLA? Together with your healthcare provider, you need to decide whether ATRIPLA is right for you. Do not take ATRIPLA if you are allergic to ATRIPLA or any of its ingredients. The active ingredients of ATRIPLA are efavirenz, emtricitabine, and tenofovir DF. See the end of this leaflet for a complete list of ingredients. What should I tell my healthcare provider before taking ATRIPLA? Tell your healthcare provider if you: • Are pregnant or planning to become pregnant (see “What should I avoid while taking ATRIPLA?”). • Are breastfeeding (see “What should I avoid while taking ATRIPLA?”). • Have kidney problems or are undergoing kidney dialysis treatment. • Have bone problems. • Have liver problems, including hepatitis B virus infection. Your healthcare provider may want to do tests to check your liver while you take ATRIPLA or may switch you to another medicine. • Have ever had mental illness or are using drugs or alcohol. • Have ever had seizures or are taking medicine for seizures. What important information should I know about taking other medicines with ATRIPLA? ATRIPLA may change the effect of other medicines, including the ones for HIV-1, and may cause serious side effects. Your healthcare provider may change your other medicines or change their doses. Other medicines, including herbal products, may affect ATRIPLA. For this reason, it is very important to let all your healthcare providers and pharmacists know what medications, herbal supplements, or vitamins you are taking. MEDICINES YOU SHOULD NOT TAKE WITH ATRIPLA • The following medicines may cause serious and life-threatening side effects when taken with ATRIPLA. You should not take any of these medicines while taking ATRIPLA: Vascor (bepridil), Propulsid (cisapride), Versed (midazolam), Orap (pimozide), Halcion (triazolam), ergot medications (for example, Wigraine and Cafergot). • ATRIPLA also should not be used with Combivir (lamivudine/zidovudine), EMTRIVA, Epivir, Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine), Trizivir (abacavir sulfate/lamivudine/zidovudine), SUSTIVA, TRUVADA, or VIREAD. • Vfend (voriconazole) should not be taken with ATRIPLA since it may lose its effect or may increase the chance of having side effects from ATRIPLA. • Do not take St. John’s wort (Hypericum perforatum), or products containing St. John’s wort with ATRIPLA. St. John’s wort is an herbal product sold as a dietary supplement. Talk with your healthcare provider if you are taking or are planning to take St. John’s wort. Taking St. John’s wort may decrease ATRIPLA levels and lead to increased viral load and possible resistance to ATRIPLA or cross-resistance to other anti-HIV-1 drugs. • ATRIPLA should not be used with HEPSERA® (adefovir dipivoxil). It is also important to tell your healthcare provider if you are taking any of the following: • Fortovase, Invirase (saquinavir), Biaxin (clarithromycin), Noxafil (posaconazole), or Sporanox (itraconazole); these medicines may need to be replaced with another medicine when taken with ATRIPLA. • Calcium channel blockers such as Cardizem or Tiazac (diltiazem), Covera HS or Isoptin (verapamil) and others; Crixivan (indinavir), Selzentry (maraviroc); the immunosuppressant medicines cyclosporine (Gengraf, Neoral, Sandimmune, and others), Prograf (tacrolimus), or Rapamune (sirolimus); Methadone; Mycobutin (rifabutin); Rifampin; cholesterol-lowering medicines such as Lipitor (atorvastatin), Pravachol (pravastatin sodium), and Zocor (simvastatin); or Zoloft (sertraline); these medicines may need to have their dose changed when taken with ATRIPLA. • Videx, Videx EC (didanosine); tenofovir DF (a component of ATRIPLA) may increase the amount of didanosine in your blood, which could result in more side effects. You may need to be monitored more carefully if you are taking ATRIPLA and didanosine together. Also, the dose of didanosine may need to be changed. • Reyataz (atazanavir sulfate) or Kaletra (lopinavir/ritonavir); these medicines may increase the amount of tenofovir DF (a component of ATRIPLA) in your blood, which could result in more side effects. Reyataz is not recommended with ATRIPLA. You may need to be monitored more carefully if you are taking ATRIPLA and Kaletra together. Also, the dose of Kaletra may need to be changed. • Medicine for seizures [for example, Dilantin (phenytoin), Tegretol (carbamazepine), or phenobarbital]; your healthcare provider may want to switch you to another medicine or check drug levels in your blood from time to time. These are not all the medicines that may cause problems if you take ATRIPLA. Be sure to tell your healthcare provider about all medicines that you take. Keep a complete list of all the prescription and nonprescription medicines as well as any herbal remedies that you are taking, how much you take, and how often you take them. Make a new list when medicines or herbal remedies are added or stopped, or if the dose changes. Give copies of this list to all of your healthcare providers and pharmacists every time you visit your healthcare

ATRIPLA® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) provider or fill a prescription. This will give your healthcare provider a complete picture of the medicines you use. Then he or she can decide the best approach for your situation. How should I take ATRIPLA? • Take the exact amount of ATRIPLA your healthcare provider prescribes. Never change the dose on your own. Do not stop this medicine unless your healthcare provider tells you to stop. • You should take ATRIPLA on an empty stomach. • Swallow ATRIPLA with water. • Taking ATRIPLA at bedtime may make some side effects less bothersome. • Do not miss a dose of ATRIPLA. If you forget to take ATRIPLA, take the missed dose right away, unless it is almost time for your next dose. Do not double the next dose. Carry on with your regular dosing schedule. If you need help in planning the best times to take your medicine, ask your healthcare provider or pharmacist. • If you believe you took more than the prescribed amount of ATRIPLA, contact your local poison control center or emergency room right away. • Tell your healthcare provider if you start any new medicine or change how you take old ones. Your doses may need adjustment. • When your ATRIPLA supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to ATRIPLA and become harder to treat. • Your healthcare provider may want to do blood tests to check for certain side effects while you take ATRIPLA. What should I avoid while taking ATRIPLA? • Women should not become pregnant while taking ATRIPLA and for 12 weeks after stopping it. Serious birth defects have been seen in the babies of animals and women treated with efavirenz (a component of ATRIPLA) during pregnancy. It is not known whether efavirenz caused these defects. Tell your healthcare provider right away if you are pregnant. Also talk with your healthcare provider if you want to become pregnant. • Women should not rely only on hormone-based birth control, such as pills, injections, or implants, because ATRIPLA may make these contraceptives ineffective. Women must use a reliable form of barrier contraception, such as a condom or diaphragm, even if they also use other methods of birth control. Efavirenz, a component of ATRIPLA, may remain in your blood for a time after therapy is stopped. Therefore, you should continue to use contraceptive measures for 12 weeks after you stop taking ATRIPLA. • Do not breast-feed if you are taking ATRIPLA. The Centers for Disease Control and Prevention recommend that mothers with HIV not breast-feed because they can pass the HIV through their milk to the baby. Also, ATRIPLA may pass through breast milk and cause serious harm to the baby. Talk with your healthcare provider if you are breast-feeding. You should stop breast-feeding or may need to use a different medicine. • Taking ATRIPLA with alcohol or other medicines causing similar side effects as ATRIPLA, such as drowsiness, may increase those side effects. • Do not take any other medicines, including prescription and nonprescription medicines and herbal products, without checking with your healthcare provider. • Avoid doing things that can spread HIV-1 infection since ATRIPLA does not stop you from passing the HIV-1 infection to others. What are the possible side effects of ATRIPLA? ATRIPLA may cause the following serious side effects: • Lactic acidosis (buildup of an acid in the blood). Lactic acidosis can be a medical emergency and may need to be treated in the hospital. Call your healthcare provider right away if you get signs of lactic acidosis. (See “What is the most important information I should know about ATRIPLA?”) • Serious liver problems (hepatotoxicity), with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Call your healthcare provider right away if you get any signs of liver problems. (See “What is the most important information I should know about ATRIPLA?”) • “Flare-ups” of hepatitis B virus (HBV) infection, in which the disease suddenly returns in a worse way than before, can occur if you have HBV and you stop taking ATRIPLA. Your healthcare provider will monitor your condition for several months after stopping ATRIPLA if you have both HIV-1 and HBV infection and may recommend treatment for your HBV. ATRIPLA is not approved for the treatment of hepatitis B virus infection. If you have advanced liver disease and stop treatment with ATRIPLA, the “flare-up” of hepatitis B may cause your liver function to decline. • Serious psychiatric problems. A small number of patients may experience severe depression, strange thoughts, or angry behavior while taking ATRIPLA. Some patients have thoughts of suicide and a few have actually committed suicide. These problems may occur more often in patients who have had mental illness. Contact your healthcare provider right away if you think you are having these psychiatric symptoms, so your healthcare provider can decide if you should continue to take ATRIPLA. • Kidney problems (including decline or failure of kidney function). If you have had kidney problems in the past or take other medicines that can cause kidney problems, your healthcare provider should do regular blood tests to check your kidneys. Symptoms that may be related to kidney problems include a high volume of urine, thirst, muscle pain, and muscle weakness. • Other serious liver problems. Some patients have experienced serious liver problems including liver failure resulting in transplantation or death. Most of these serious side effects

ATRIPLA® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) occurred in patients with a chronic liver disease such as hepatitis infection, but there have also been a few reports in patients without any existing liver disease. • Changes in bone mineral density (thinning bones). Laboratory tests show changes in the bones of patients treated with tenofovir DF, a component of ATRIPLA. Some HIV patients treated with tenofovir DF developed thinning of the bones (osteopenia) which could lead to fractures. If you have had bone problems in the past, your healthcare provider may need to do tests to check your bone mineral density or may prescribe medicines to help your bone mineral density. Additionally, bone pain and softening of the bone (which may contribute to fractures) may occur as a consequence of kidney problems. Common side effects: Patients may have dizziness, headache, trouble sleeping, drowsiness, trouble concentrating, and/or unusual dreams during treatment with ATRIPLA. These side effects may be reduced if you take ATRIPLA at bedtime on an empty stomach. They also tend to go away after you have taken the medicine for a few weeks. If you have these common side effects, such as dizziness, it does not mean that you will also have serious psychiatric problems, such as severe depression, strange thoughts, or angry behavior. Tell your healthcare provider right away if any of these side effects continue or if they bother you. It is possible that these symptoms may be more severe if ATRIPLA is used with alcohol or mood altering (street) drugs. If you are dizzy, have trouble concentrating, or are drowsy, avoid activities that may be dangerous, such as driving or operating machinery. Rash may be common. Rashes usually go away without any change in treatment. In a small number of patients, rash may be serious. If you develop a rash, call your healthcare provider right away. Other common side effects include tiredness, upset stomach, vomiting, gas, and diarrhea. Other possible side effects with ATRIPLA: • Changes in body fat. Changes in body fat develop in some patients taking anti-HIV-1 medicine. These changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), in the breasts, and around the trunk. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these fat changes are not known. • Skin discoloration (small spots or freckles) may also happen with ATRIPLA. • In some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately. • Additional side effects are inflammation of the pancreas, allergic reaction (including swelling of the face, lips, tongue, or throat), shortness of breath, pain, stomach pain, weakness and indigestion. Tell your healthcare provider or pharmacist if you notice any side effects while taking ATRIPLA. Contact your healthcare provider before stopping ATRIPLA because of side effects or for any other reason. This is not a complete list of side effects possible with ATRIPLA. Ask your healthcare provider or pharmacist for a more complete list of side effects of ATRIPLA and all the medicines you will take. How do I store ATRIPLA? • Keep ATRIPLA and all other medicines out of reach of children. • Store ATRIPLA at room temperature 77 °F (25 °C). • Keep ATRIPLA in its original container and keep the container tightly closed. • Do not keep medicine that is out of date or that you no longer need. If you throw any medicines away make sure that children will not find them. General information about ATRIPLA: Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use ATRIPLA for a condition for which it was not prescribed. Do not give ATRIPLA to other people, even if they have the same symptoms you have. It may harm them. This leaflet summarizes the most important information about ATRIPLA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ATRIPLA that is written for health professionals. Do not use ATRIPLA if the seal over bottle opening is broken or missing. What are the ingredients of ATRIPLA? Active Ingredients: efavirenz, emtricitabine, and tenofovir disoproxil fumarate Inactive Ingredients: croscarmellose sodium, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, sodium lauryl sulfate. The film coating contains black iron oxide, polyethylene glycol, polyvinyl alcohol, red iron oxide, talc, and titanium dioxide. March 2011 ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. EMTRIVA, TRUVADA, HEPSERA and VIREAD are trademarks of Gilead Sciences, Inc. SUSTIVA is a trademark of Bristol-Myers Squibb Pharma Company. Reyataz and Videx are trademarks of Bristol-Myers Squibb Company. Pravachol is a trademark of ER Squibb & Sons, LLC. Other brands listed are the trademarks of their respective owners.

SF-B0001B-03-11

21-937-GS-008

TR9171

March 2011

SEP+OCT 2011 V O L U M E

2 3

N U M B E R

INSIDE D e pa r t m e n t s

c o n f e r e n c e u pda t e

6 | editor’s Note

17 | IAS 2011 Rome

Back to the drawing board—making the case for the return of treatment education.

Prevention as treatment dominates the 2011 International AIDS Society conference in Rome. An international effort works, “Towards an HIV Cure.”

7 | In Box F e at u r e s

11 | Briefly Janssen Therapeutics launches awareness campaign with HGTV star David Bromstad. Drug-resistant gonorrhea may hit the U.S. Prezista getting new non-Norvir booster. Kidney problems for infants on Kaletra?

26 | Unfolding picture

38 | HIV WELLNESS SERIES

42 | Lighting the way

Opportunistic infections.

How a case manager can help you find the services you need.

52 | Ask the HIV specialist

44 | Legal rights and wrongs

Matters of the heart.

Newly diagnosed or long-term survivor—what everyone should know about HIV and their legal rights.

53 | Salient Ramblings What’s so funny ’bout peace, love, and understanding?

Understanding the puzzle that is our immune system.

34 | It’s in your blood Some of the most important lab tests and what they mean.

48 | To your health Practically everything you ever wanted to know about HIV meds.

50 | Resources: Know where to look A list of reliable sources of HIV information you can find online.

SEPTEMBER+OCTOBER 2011

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Conference Update:

E d it o r i a l

Report from the 2011 International AIDS Society conference in Rome.

associate editor Enid Vázquez

page

editor Jeff Berry copy Editor Sue Saltmarsh Web Master Joshua Thorne art director Rick Guasco

ONLINE

proofreaders Jason Lancaster, David Perez

P o s i t i v e lyawa r e . c o m

contributing writers

ADAP advocacy is alive and well

Sal Iacopelli, Laura Jones,

A report from the ADAP Advocacy Association’s annual conference. www.positivelyaware.com/11_06/ole.shtml

Jim Pickett, Matt Sharp

Coming to terms—An HIV glossary

Chris Knight, Joshua Thorne

Keith R. Green, L iz Highleyman,

photographers

www.positivelyaware.com/11_06/glossary.shtml

What makes the HPTN 052 study so significant?

M e d i c a l a d vi s o r s

PA sits down with Myron Cohen, the study’s lead author. www.positivelyaware.com/11_06/cohen.shtml

Daniel S. Berger, MD Gary Bucher, MD Michael Cristofano, PA

D i g i ta l e d i t i o n Read the print version of Positively Aware on your computer. http://issuu.com/positivelyaware READ it on POSITIVELYAWARE.COM, then comment online

Joel Gallant, MD Swarup Mehta, Pharm D

A d v e r ti s i n g & Di s t r ib u ti o n advertising inquiries LORRAINE HAYES

© 2011. Positively Aware (ISSN: 1523-2883) is published bi-monthly by Test Positive Aware Network (TPAN), 5537 N. Broadway St, Chicago, IL 60640. TPAN is an Illinois not-for-profit corporation, providing information and support to anyone concerned with HIV and AIDS issues. Positively Aware is a registered trademark of TPAN. All rights reserved. Circulation: 85,000. For reprint permission, contact Sue Saltmarsh. Six issues mailed bulk rate for $30 donation; mailed free to TPAN members or those unable to contribute. We encourage contribution of articles covering medical or personal aspects of HIV/AIDS. We reserve the right to edit or decline submitted articles. When published, the articles become the property of TPAN and its assigns. You may use your actual name or a pseudonym for publication, but please include your name and phone number. Although Positively Aware takes great care to ensure the accuracy of all the information that it presents, Positively Aware staff and volunteers, TPAN, or the institutions and personnel who provide us with information cannot be held responsible for any damages, direct or consequential, that arise from use of this material or due to errors contained herein. Opinions expressed in Positively Aware are not necessarily those of staff or membership or TPAN, its supporters and sponsors, or distributing agencies. Information, resources, and advertising in Positively Aware do not constitute endorsement or recommendation of any medical treatment or product. TPAN recommends that all medical treatments or products be discussed thoroughly and frankly with a licensed and fully HIV-informed medical practitioner, preferably a personal physician. A model, photographer, or author’s HIV status should not be assumed based on their appearance in Positively Aware, membership in TPAN, or contributions to this journal. Distribution of Positively Aware is supported in part through an unrestricted grant from ViiV Healthcare.

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l.hayes@tpan.com distribution coordinator Brad Mazzie distribution@tpan.com

POSITIVELY AWARE IS PUBLISHED BY TEST POSITIVE AWARE NETWORK

S E P T E M B E R + O C TO B E R 2 01 1

Editor’s NOTE Jeff Berry

Back to the drawing board

At the end of lead investigator Myron Cohen’s presentation on the landmark HPTN 052 study, he received a long, standing ovation from the 3,000-plus crowd. During an interview with him immediately following his presentation, I asked what the enthusiastic response meant to him personally. “Quite remarkable,” he said. “Everybody has been saying, ‘Yeah, treatment is prevention—but what about 052? It isn’t done yet.’ This audience has been waiting for these results for a long time, and they appreciated the tenacity of all of the investigators and the support of the NIH.” “I didn’t discover anything,” said Cohen, “I proved an idea. I’m happy about that, but I don’t hold myself out as Galileo.” HPTN 052 found a 96% reduction in HIV transmission among serodiscordant couples when the positive partner was on suppressive therapy. But treatment is not for everyone. It’s an individual choice that each person must make on their own, once they are ready and fully informed about the ramifications of life-long treatment for HIV. And there are still issues like toxicity, side effects, drug interactions, stigma, and treatment adherence that all need to be factored into the equation, not to mention access. HIV advocate Sean Strub said it best recently: “I’m alive because of ART, but I’m also alive because of knowing when not to take it.” One of the statistics I heard in Rome which shouldn’t have surprised me is that only 19% of people on antiretroviral 6

S EPTEMBER+OCTOBER 2011

treatment have a suppressed viral load— 19%. That calls for some major treatment education. As International AIDS Society president Elly Katabira stated, it’s the messaging that’s going to be important, we’ll need to put “relative risk” and “confidence interval” into simpler language in order to be understood. In recent years, it has become more and more difficult to fund and maintain programs that are created and staffed by HIV-positive survivors to educate their peers. These programs are being replaced with a trend towards more traditional core medical services, and outcomes that can be easily measured and quantified. The irony is that it is only because of those rapidly disappearing treatment education programs that many of us are still alive. I can’t tell you how important it was to me when I first tested positive to find Test Positive Aware Network (which publishes Positively Aware), to which I turned for information and support. To discover that there were so many others like me who were HIV-positive, to learn from them about what they were doing to cope and to survive—it was extremely empowering to me. There is no way that we can expect to scale-up treatment without the education that is so vital to its very success. As programs continue to get slashed, doors closed, and positions eliminated, disaster awaits us all if we don’t start now to insist on increased funding for treatment education. Recently I was invited to Washington,

D.C. to take part in the Department of Health and Human Services’ Consultation with People Living with HIV/AIDS on the National HIV/AIDS Strategy (NHAS). The two-day meeting brought together federal partners and individuals from around the country to discuss the NHAS implementation. During the meeting, I brought up the importance of treatment education, and how we need to continue to make it a high priority as we move forward with the president’s strategy. While no one in the room seemed to disagree with my point, we all need to be reminded that the NHAS doesn’t have any new funding attached to it. It’s up to us to continue to stress the importance of treatment education with our federal partners, legislators, and policy makers as funding priorities are set and shifted over the next few months and years. This issue of Positively Aware is all about education. Whether you have been living with HIV for years, are newly diagnosed, or are caring for someone with HIV, this issue will touch on some of the basics that we all need to know. From an immune system overview and legal issues for people with HIV, to opportunistic infections and all those lab tests, there is something for everyone who wants to learn more and become empowered. Of course, treatment education is not the answer to everything. But it is the solid foundation that we all need in order to build a better and more fulfilling life with HIV. Even Galileo had to start somewhere. Take care of yourself, and each other.

publications@tpan.com P os it i v e lyAware .com

Photo: Chris Knight

“Watershed moment.” “Turning point.” “A prevention revolution.” These are just a few of the phrases that were used to describe the excitement over data generated from several important prevention studies presented at this year’s 6th IAS Conference on Pathogenesis, Treatment, and Prevention in Rome.

In Box

Readers’ poll

Positive and negative

Do you support the use of PrEP?

Though I don’t have HIV, my partner of two years has been HIV-positive since 2008. People assume I have it because I’m with someone who does. I’m aware of the constant stares and people talking about him and how ignorant and arrogant people are. I was reading your special issue (Spring 2011). The three questions you asked HIV-positive people helped me to understand even more. The first question (What helped get you tested and into care?) didn’t apply to me, but my partner would say he did it for me. He’s told me many times that because of me, he kept pushing forward. The second question (How do you cope with the stigma surrounding HIV/AIDS?) I can answer. It’s not easy coping with the judgment from others. It’s very stressful and bothers me a lot. My partner and I support each other, because no one else understands. The third question (What uncensored advice would you give to health care providers about what does/doesn’t work to get people tested and into care?), I don’t know—I would probably tell them not to push the issue, but to let their patients know there are people who care and are willing to help. Your magazine has helped me in many ways. To all those who are HIV-negative and with someone who is positive, never give up and always let your loved one know you’re with them through it all. I thank you and all those who have shared their stories. —JR Pennsylvania

Never enough Drug Guides I work in the Department of Corrections system here in New York and would love to pass out the Drug Guide to prisoners and peer educators. This is just the information P osi t i v elyAware .com

Results from the Readers’ poll in the July+August issue:

that they crave. Could I get another 150 or more copies? Thank you for any help that you can give. —Derek Villnave Syracuse, NY Thank you and TPAN for all you do for the HIV-positive community. Your magazine is a wealth of information that is hard to come by. It offers in-depth medical explanations in simple language. Your Drug Guide is much better reading than trying to understand the patient information inserts that come with the medication. Once again, thank you so very much for all that TPAN does for us! —Benjamin C. Ashland, KY

Charting assistance I wanted to start by telling you how much I love your very handy HIV Co-Pay and Patient Assistance Programs Chart. As a social worker and case manager I am using and printing this chart constantly. My clients love it too. Now that Edurant has been approved and Tibotec is now Janssen Therapeutics, I am wondering when you’re going to update the online version. I have called to find out whether Edurant had a patient assistance program and was told applications were available at their website, www.jjpaf.com, and that the assistance programs were the same as Prezista and Intelence, both of which you show on your chart already. I was hoping that you’d be updating the information online for all of us who really love that handy chart. Thank you. —Michael Columbus, OH Thanks for your e-mail, Michael, we’ve recently updated the co-pay and patient assistance chart as well as the PA 2011 HIV Drug Chart. —Jeff Berry

No: 36% YES: 64%

Your comments:

Anything that can help should be used. I am cautious in my support—I don’t want people to think that they no longer have to be responsible for their health. Prevention messages are now becoming confusing. For example, if you are undetectable with no other infections (like STIs), is it OK to have unsafe sex? I feel safer sex is still vital for all people including people living with HIV. this issue’s poll question:

When you were first diagnosed, what influenced you more—fear, hope, or the will to live? cast your vote at

positivelyaware.com

Do the write thing

Positively Aware treats all communications (letters, faxes, e-mail, etc.) as letters to the editor unless otherwise instructed. We reserve the right to edit for length, style, or clarity. Unless you tell us not to, we will use your name and city. Positively aware

5537 N. Broadway St. Chicago, IL 60640 E-Mail: readersforum@tpan.com S E P T E M B E R + O C TO B E R 2 01 1

www.egrifta.com

Actual patient living with HIV since 2000

You HAVE YouR HIV unDER ConTRoL. noW, on To

HIV-RELATED EXCESS BELLY FAT. In two separate clinical trials of HIV-infected people with lipodystrophy, each lasting 6 months, EGRIFTA® reduced HIV-related excess belly fat by an average of 18% in the first trial, and 14% in the second trial. This reduction in excess belly fat resulted in an approximate 1-inch reduction in waist size. Individual results may vary. On average, patients on EGRIFTA® did not lose weight. Like HIV, HIV-related excess belly fat is a chronic condition. In clinical studies: • People who used EGRIFTA® continuously for 1 year maintained their results over this time period • People who stopped taking EGRIFTA® after 6 months had their HIV-related excess belly fat come back EGRIFTA® is believed to work with your own body to produce natural growth hormone to reduce your excess belly fat. Indication: EGRIFTA® is a daily injectable prescription medicine to reduce the excess in abdominal fat in HIV-infected patients with lipodystrophy. Limitations of use: • The impact and safety of EGRIFTA® on cardiovascular health has not been studied • EGRIFTA® is not indicated for weight-loss management • It’s not known whether taking EGRIFTA® helps improve compliance with antiretroviral medications • EGRIFTA® is not recommended to be used in children Important Risk Information: Do not use EGRIFTA® if you: • Have pituitary gland tumor, pituitary gland surgery or other problems related to your pituitary gland • Have or had a history of active cancer (either newly diagnosed or recurrent) • Are allergic to tesamorelin or any of the ingredients in EGRIFTA®, including mannitol or sterile water • Are pregnant or become pregnant Before using EGRIFTA®, tell your healthcare provider if you: • Have or have had cancer • Have diabetes • Are breastfeeding or plan to breastfeed • Have kidney or liver problems • Have any other medical condition • Take prescription or non-prescription medicines, vitamins, or herbal supplements EGRIFTA® may cause serious side effects, including: • Serious allergic reaction. Stop using EGRIFTA® and get emergency help right away if you have any of the following symptoms: rash over your body, hives, swelling of your face or throat, shortness of breath or trouble breathing, fast heartbeat, feeling of faintness or fainting • Swelling (fluid retention). EGRIFTA® can cause swelling in some parts of your body. Call your healthcare provider if you have an increase in joint pain, or pain or numbness in your hands or wrist (carpal tunnel syndrome) • Increase in glucose (blood sugar) intolerance and diabetes 110628-115709 7/11

• Injection-site reactions, such as redness, itching, pain, irritation, bleeding, rash, and swelling. Change (rotate) your injection site to help lower your risk for injection-site reactions The most common side effects of EGRIFTA® include: • joint pain • numbness and pricking • pain in legs and arms • nausea • swelling in your legs • vomiting • muscle soreness • rash • tingling • itching EGRIFTA® will NOT cure HIV or lower your chance of passing HIV to others. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see Consumer Brief Summary of EGRIFTA® on following page.

Ask your healthcare provider if EGRIFTA®, the first and only FDA-approved medicine for HIV-related excess belly fat, may be right for you. For more information, visit www.egrifta.com or call the AXIS Center at 1-877-714-AXIS (2947).

Consumer Brief Summary for EGRIFTA® (tesamorelin for injection) EGRIFTA® (eh-GRIF-tuh) (tesamorelin for injection) for subcutaneous use Read the Patient Information that comes with EGRIFTA® before you start to take it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or your treatment. What is EGRIFTA®? • EGRIFTA® is an injectable prescription medicine to reduce the excess in abdominal fat in HIV-infected patients with lipodystrophy. EGRIFTA® contains a growth hormonereleasing factor (GRF). • The impact and safety of EGRIFTA® on cardiovascular health has not been studied. • EGRIFTA® is not indicated for weight loss management. • It is not known whether taking EGRIFTA® helps improve compliance with antiretroviral medications. • It is not known if EGRIFTA® is safe and effective in children. EGRIFTA® is not recommended to be used in children. Who should not use EGRIFTA®? Do not use EGRIFTA® if you: • have pituitary gland tumor, pituitary gland surgery or other problems related to your pituitary gland • have or had a history of active cancer (either newly diagnosed or recurrent) • are allergic to tesamorelin or any of the ingredients in EGRIFTA®. See the end of this leaflet for a complete list of ingredients in EGRIFTA® • are pregnant or become pregnant. If you become pregnant, stop using EGRIFTA® and talk with your healthcare provider. See “What should I tell my healthcare provider before using EGRIFTA®?” What should I tell my healthcare provider before using EGRIFTA®? Before using EGRIFTA®, tell your healthcare provider if you: • have or have had cancer • have diabetes • are breastfeeding or plan to breastfeed. It is not known if EGRIFTA® passes into your breast milk. The Centers for Disease Control and Prevention (CDC) recommends that HIV-infected mothers not breastfeed to avoid the risk of passing HIV infection to your baby. Talk with your healthcare provider about the best way to feed your baby if you are taking EGRIFTA® • have kidney or liver problems • have any other medical condition Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. EGRIFTA® may affect the way other medicines work, and other medicines may affect how EGRIFTA® works. Know the medicines you take. Keep a list with you to show your healthcare provider and pharmacist when you get a new medicine. How should I use EGRIFTA®? • Read the detailed “Instructions for Use” that comes with EGRIFTA® before you start using EGRIFTA®. Your healthcare provider will show you how to inject EGRIFTA®. • Use EGRIFTA® exactly as prescribed by your healthcare provider. • Inject EGRIFTA® under the skin (subcutaneously) of your stomach area (abdomen). • Change (rotate) the injection site on your stomach area (abdomen) with each dose. Do not inject EGRIFTA® into scar tissue, bruises or your navel. • Do not share needles or syringes with other people. Sharing of needles can result in the transmission of infectious diseases, such as HIV. What are the possible side effects of EGRIFTA®? EGRIFTA® may cause serious side effects including: • Serious allergic reaction. Some people taking EGRIFTA® may have an allergic reaction. Stop using EGRIFTA® and get emergency help right away if you have any of the following symptoms: – a rash over your body

– hives – swelling of your face or throat – shortness of breath or trouble breathing – fast heartbeat – feeling of faintness or fainting • Swelling (fluid retention). EGRIFTA® can cause swelling in some parts of your body. Call your healthcare provider if you have an increase in joint pain, or pain or numbness in your hands or wrist (carpal tunnel syndrome). • Increase in glucose (blood sugar) intolerance and diabetes. Your healthcare provider

will measure your blood sugar periodically. • Injection-site reactions. Change (rotate) your injection site to help lower your risk for

injection-site reactions. Call your healthcare provider for medical advice if you have the following symptoms around the area of the injection site: – bleeding – redness – rash – itching – swelling – pain – irritation The most common side effects of EGRIFTA® include: – joint pain – nausea – vomiting – pain in legs and arms – rash – swelling in your legs – itching – muscle soreness – tingling, numbness and pricking Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of EGRIFTA®. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. To report side effects, contact EMD Serono toll-free at 1-800-283-8088 ext. 5563. You may report side effects to FDA at 1-800-FDA-1088. Keep EGRIFTA® and all medicines out of the reach of children. General information about the safe and effective use of EGRIFTA®: Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use EGRIFTA® for a condition for which it was not prescribed. Do not give EGRIFTA® to other people, even if they have the same symptoms you have. It may harm them. Do not share your EGRIFTA® syringe with another person, even if the needle is changed. Do not share your EGRIFTA® needles with another person. This Patient Information leaflet summarizes the most important information about EGRIFTA®. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about EGRIFTA® that is written for healthcare professionals. For more information about EGRIFTA®, go to www.EGRIFTA.com or contact the AXIS Center toll-free at 1-877-714-2947. What are the ingredients in EGRIFTA®? Active ingredient: tesamorelin Inactive ingredients: mannitol and Sterile Water for Injection

BRIEFLY

Reported by ENid VÁZQUEz

Raising awareness to an art form

Photo: Vikram Pathak

As soon as he came out at the age of 22, artist and designer David Bromstad began meeting people with HIV. The winner of HGTV’s first Design Star competition, in 2006, and now host of his own show on HGTV, Color Splash, Bromstad says the issue of HIV is “very dear to my heart. Being in the gay community, you’re around HIV a lot,” he told Positively Aware. And so, he says it’s his honor to promote HIV testing, by teaming up with Janssen Therapeutics for the “Know Yourself: Get Tested” initiative. On September 27, for Gay Men’s HIV/AIDS Awareness Day, Bromstad will unveil a mural in Manhattan promoting testing and awareness. Bromstad said people older than 30 have heard a lot about HIV, but he doesn’t see a true understanding of risk in younger people. He called the lack of fear both a good thing and a bad thing. Having seen many of his close friends deal with their HIV infection, Bromstad, who is HIVnegative, gets it. “It’s a lifelong disease with no cure, and it’s something that has to be managed and that’s no fun. It’s still medicine. It’s still side effects.” “It’s heartbreaking,” Bromstad continued. “People don’t understand the nuances.” At the same time, he hopes people will overcome their fear of dealing with all that, since so many people do not test for HIV until their disease has progressed. According to the Centers for Disease Control and Prevention (CDC), one out of five people with HIV in this country don’t know that they have it, and furthermore, gay and bisexual men are the only group with a rising rate of infection. “If you’re afraid to get tested, get tested anyway, so you can make it more manageable [rather] than waiting until it’s [too] late,” Bromstad said. In a half-hour video promoting HIV awareness, “Simple HIV Facts Everyone P osi t i v elyAware .com

Should Know,” face time with HIV-positive people, their medical providers, and a support group is alternated with shots of Bromstad in his studio, beautiful, colorful works and supplies lining the shelves behind him. “It’s a break from the seriousness,” he says with a laugh. That mix makes for an awareness video that is very different from the usual (it can be viewed at www.acpfoundation.org/videos.htm). In a press release, Bromstad said,

“Knowledge is one of the most powerful tools in fighting HIV, and you have to get tested to know your status. I am especially passionate about HIV testing and education because it particularly affects the community to which I’m proud to belong. I want to raise awareness of the importance of testing by using something I know well and am also passionate about: art and design. Join me by getting tested and encouraging others to do the same.”

Is drug-resistant gonorrhea on the way? The Centers for Disease Control and Prevention (CDC) warns that “although there have been no documented treatment failures yet, untreatable gonorrhea may become a reality in the U.S.” The sexually transmitted disease is common and can cause painful urination, infertility, and increased risk of acquiring HIV. In its July 8 issue of Morbidity and Mortality Weekly Report (MMWR), the CDC said that drug-resistant gonorrhea has been seen in men who have sex with men (MSM) in the past and then spread to the heterosexual population. However, findings from a recent analysis signal the potential for resistance to cephalosporins, the last line of defense for gonorrhea. At a conference in Canada held in July, it was reported that a strain of gonorrhea found in Japan did not respond to any medication. The CDC says that medical providers should check to see that gonorrhea treatment is successful and report cases that do not respond to therapy.

S E P T E M B E R + O C TO B E R 2 01 1

BRIEFLY

Reported by ENid VÁZQUEz

Prezista to get new, non-Norvir booster Tibotec Therapeutics (now known as Janssen Therapeutics), maker of the widely used HIV drug Prezista, entered into a licensing agreement in June with Gilead Sciences to develop a co-formulation of Prezista with Gilead’s experimental booster drug cobicistat. Prezista is currently taken with a booster dose of Norvir, a drug which comes with tolerability issues (such as diarrhea, stomach distress, and taste disturbance). Prezista is one of the two HIV protease inhibitor drugs recommended by U.S. guidelines for use when beginning antiviral treatment and, despite the Norvir, is considered to be generally tolerable. Cobicistat has no activity against HIV and is used only to increase blood levels of HIV protease inhibitor drugs like Prezista. This allows for smaller or less frequent doses (such as once daily), often with fewer side effects. However, cobicistat may have a negative impact on kidney function—further research will look at this potential effect. Tibotec also announced that the two companies are negotiating for the development and commercialization of a future single-tablet regimen (STR) combining Prezista with Gilead’s Emtriva, and its experimental drugs GS 7340 and cobicistat. Gilead is also developing a fixed-dose “Quad” formula consisting of cobicistat, another experimental medication called elvitegravir, an integrase inhibitor, and the company’s best-selling Truvada.

61%

of all new HIV infections are among MSM. Young, black MSM are hardest hit, with new HIV infections increasing 48%, according to the CDC’s most recent statistics.

SEPTEMBER+OCTOBER 2011

Cenicriviroc begins Phase 2b trial Tobira Therapeutics has initiated a Phase 2b clinical trial for its experimental CCR5/ CCR2 inhibitor cenicriviroc (TBR-652). In addition to potent antiviral activity, cenicriviroc also has a potential anti-inflammatory effect, important for possibly controlling heart disease, dementia, and other problems. CCR5 inhibitors work by blocking HIV from entering the CCR5 receptor on immune system cells. According to the Tobira press release, “The multi-center, double-blind, doubledummy, 48-week comparative study is designed to evaluate the efficacy, safety, and tolerability of cenicriviroc in 150 HIV 1-infected, antiretroviral treatment-naïve patients with only CCR5-tropic virus. The trial is actively enrolling patients in more than 50 sites across the United States and Puerto Rico.” Several sub-studies will assess changes in biomarkers associated with inflammation, cardiovascular function, metabolic indicators of glucose control, and immune function. For details, go to www.clinicaltrials.gov.

Serious relationships don’t lead to safer sex Long-running research on young men who have sex with men (MSM) found an eighttimes higher rate of unprotected sex in those who were in a serious relationship compared to those engaging in casual sex. Brian Mustanski, associate professor in medical social sciences at Northwestern University’s Feinberg School of Medicine, and colleagues studied 122 gay men who were between the ages of 16 and 20 when they joined the study. In a university press release, Mustanski said, “Being in a serious relationship provides a number of mental and physical health benefits, but it also increases behaviors that put you at risk for HIV transmission. Men who believe a relationship is serious mistakenly think they don’t need to protect themselves.” The study echoes recent findings from the CDC showing the majority of HIV transmissions occur in serious relationships. Moreover, Mustanski said that 80% of young MSM who are HIV-positive don’t know it because they don’t test frequently enough. “It isn’t enough to ask your partner his HIV status,” he noted. “Instead, both people in a serious, monogamous couple relationship should receive at least two HIV tests before deciding to stop using condoms.” According to the study, partners met online were not associated with significantly more sexual risk. The study results were published May 23 online in Health Psychology. For articles and videos, go to www.impactprogram.org. P os it i v e lyAware .com

Tropism access for uninsured patients

RFAC PHOTO: BETH D eMARS

Kidney concerns for infants on Kaletra? French researchers found evidence of adrenal dysfunction in newborns and preemies who were given the antiviral medication Kaletra after birth to avoid contracting HIV from their mothers. Adrenal dysfunction may interfere with blood sugar levels, among other things. The French researchers conducted the study after a warning was issued about intolerance to Kaletra in premature infants and the finding of a high level of an adrenal hormone in two French newborns who had been given the medication. The study looked at 50 infants who were born uninfected and were given Kaletra. They were compared to a control group of 108 infants who were given other HIV medications. None of the full-term infants had symptoms, and the hormone elevation was transient. In three premature infants, however, there were life-threatening symptoms, with one experiencing cardiogenic shock (inadequate blood supply to the heart). All symptoms resolved after finishing the temporary Kaletra treatment. The researchers wrote that the finding “suggests that [Kaletra] and more generally [Norvir] boosting should be used with caution, if at all, in premature infants, and if this drug regimen is administered to full-term infants, it should be used under electrolyte monitoring.” The study was published in the July 6 issue of JAMA (Journal of the American Medical Association). P osi t i v elyAware .com

ViiV Healthcare, in collaboration with Monogram Biosciences, has developed the Tropism Access Program (TAP) to facilitate access to tropism testing with Trofile for uninsured ADAP-eligible patients. A tropism test must be performed prior to initiating therapy with any CCR5 inhibitor such as Selzentry (maraviroc). However, the $1,800 price tag is often prohibitive. A TAP certificate, which can be obtained through a ViiV Healthcare Clinical Specialist, must be completed and presented to the health care provider at the time the blood is drawn, and the blood sample and certificate are then sent to Monogram. The provider will not be billed, but ViiV will reimburse Monogram directly, and test results will be sent to the health care provider or to a third-party laboratory when applicable. To find out if you are ADAP-eligible, talk to a case manager or contact your state AIDS Drug Assistance Program. For a directory of state HIV/AIDS programs go to http://www. nastad.org/about/res_state_Directory.aspx. Monogram also has its own patient assistance program to help cover the cost of the Trofile test for uninsured and underinsured individuals who qualify; call 877-436-6243 or go to www.monogramvirology.com. —Jeff Berry

Ride for AIDS Chicago passes $500K The Ride for AIDS Chicago (RFAC) raised a record-breaking sum of more than $500,000 in much-needed funds for nearly one dozen HIV/AIDS service organizations. This is the eighth year that Test Positive Aware Network (TPAN) has produced the ride, which was held July 9-10. More than 375 riders and crew members, also a new record, converged at Northwestern University to begin a 200-mile bike ride to raise both money and awareness of HIV. The ride was the culmination of nearly six months of training and fundraising to provide lifesaving services to those living with or affected by HIV, and to continue prevention work in communities at highest risk. To become a partner of TPAN in continuing its mission to empower people living with HIV through peer-led programming, support services, information dissemination, and advocacy, go to www.tpan.com or www.rideforaids.org. The 2012 RFAC is scheduled for July 14 and 15. Registration opens Dec. 1.

S E P T E M B E R + O C TO B E R 2 01 1

Model

INDICATIONS ISENTRESS is an anti-HIV medicine used for the treatment of HIV. ISENTRESS must be used with other anti-HIV medicines, which may increase the likelihood of response to treatment. The safety and effectiveness of ISENTRESS in children has not been studied. It is important that you remain under your doctorâ&#x20AC;&#x2122;s care. ISENTRESS will NOT cure HIV infection or reduce your chance of passing HIV to others through sexual contact, sharing needles, or being exposed to your blood.

IMPORTANT RISK INFORMATION A condition called Immune Reconstitution Syndrome can happen in some patients with advanced HIV infection (AIDS) when anti-HIV treatment is started. Signs and symptoms of inflammation from opportunistic infections may occur as the medicines work to treat the HIV infection and strengthen the immune system. Call your doctor right away if you notice any signs or symptoms of an infection after starting ISENTRESS. Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness while taking ISENTRESS. This is because on rare occasions muscle problems can be serious and can lead to kidney damage. When ISENTRESS has been given with other anti-HIV drugs, side effects included nausea, headache, tiredness, weakness, trouble sleeping, stomach pain, dizziness, depression, and suicidal thoughts and actions. Mild rash occurred more often in patients taking ISENTRESS plus Prezista than with either drug alone.

I am a go-getter. I am romantic. I am a world traveler. I am HIV positive. You are special, unique, and different from anyone else. And so is your path to managing HIV. When you’re ready to start HIV therapy, talk to your doctor about a medication that may fit your needs and lifestyle. In clinical studies lasting 96 weeks, patients being treated with HIV medication for the first time who took ISENTRESS plus Truvada: Had a low rate of side effects — The most common side effect of moderate to severe intensity (that interfered with or kept patients from performing daily activities) was trouble sleeping — This side effect occurred more often in patients taking ISENTRESS plus Truvada (4%) versus Sustiva plus Truvada (3%) Experienced less effect on LDL cholesterol (“bad” cholesterol) — Cholesterol increased an average of 7 mg/dL with ISENTRESS plus Truvada versus 21 mg/dL with Sustiva plus Truvada — When they began the study, the average LDL cholesterol of patients on ISENTRESS plus Truvada was 96 mg/dL versus 93 mg/dL for those on Sustiva plus Truvada

Ask your doctor about ISeNTReSS. Not sure where to start? Visit isentress.com/questions People taking ISENTRESS may still develop infections, including opportunistic infections or other conditions that occur with HIV infection. Tell your doctor about all of your medical conditions, including if you have any allergies, are pregnant or plan to become pregnant, or are breast-feeding or plan to breast-feed. ISENTRESS is not recommended for use during pregnancy. Women with HIV should not breast-feed because their babies could be infected with HIV through their breast milk. Tell your doctor about all the medicines you take, including prescription medicines like rifampin (a medicine used to treat infections such as tuberculosis), non-prescription medicines, vitamins, and herbal supplements. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. For more information about ISENTRESS, please read the Patient Information on the following page.

Need help paying for ISENTRESS? Call 1-866-350-9232 Copyright © 2011 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. IMMU-1001562-0002-06/11(111) Sustiva is a registered trademark of Bristol-Myers Squibb Truvada is a registered trademark of Gilead Sciences, Inc. Prezista is a registered trademark of Tibotec,Inc.

Patient Information ISENTRESS ® (eye sen tris) (raltegravir) Tablets Read the patient information that comes with ISENTRESS1 before you start taking it and each time you get a refill. There may be new information. This leaflet is a summary of the information for patients. Your doctor or pharmacist can give you additional information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment. What is ISENTRESS? • ISENTRESS is an anti-HIV (antiretroviral) medicine used for the treatment of HIV. The term HIV stands for Human Immunodeficiency Virus. It is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). ISENTRESS is used along with other anti-HIV medicines. ISENTRESS will NOT cure HIV infection. • People taking ISENTRESS may still develop infections, including opportunistic infections or other conditions that happen with HIV infection. • Stay under the care of your doctor during treatment with ISENTRESS. • The safety and effectiveness of ISENTRESS in children has not been studied. ISENTRESS must be used with other anti-HIV medicines. How does ISENTRESS work? • ISENTRESS blocks an enzyme which the virus (HIV) needs in order to make more virus. The enzyme that ISENTRESS blocks is called HIV integrase. • When used with other anti-HIV medicines, ISENTRESS may do two things: 1. Reduce the amount of HIV in your blood. This is called your “viral load”. 2. Increase the number of white blood cells called CD4 (T) cells. • ISENTRESS may not have these effects in all patients. Does ISENTRESS lower the chance of passing HIV to other people? No. ISENTRESS does not reduce the chance of passing HIV to others through sexual contact, sharing needles, or being exposed to your blood. • Continue to practice safer sex. • Use latex or polyurethane condoms or other barrier methods to lower the chance of sexual contact with any body fluids. This includes semen from a man, vaginal secretions from a woman, or blood. • Never re-use or share needles. Ask your doctor if you have any questions about safer sex or how to prevent passing HIV to other people. What should I tell my doctor before and during treatment with ISENTRESS? Tell your doctor about all of your medical conditions. Include any of the following that applies to you: • You have any allergies. • You are pregnant or plan to become pregnant. - ISENTRESS is not recommended for use during pregnancy. ISENTRESS has not been studied in pregnant women. If you take ISENTRESS while you are pregnant, talk to your doctor about how you can be included in the Antiretroviral Pregnancy Registry. • You are breast-feeding or plan to breast-feed. - It is recommended that HIV-infected women should not breast-feed their infants. This is because their babies could be infected with HIV through their breast milk. - Talk with your doctor about the best way to feed your baby. Tell your doctor about all the medicines you take. Include the following: • prescription medicines, including rifampin (a medicine used to treat some infections such as tuberculosis) • non-prescription medicines • vitamins • herbal supplements Know the medicines you take. • Keep a list of your medicines. Show the list to your doctor and pharmacist when you get a new medicine. How should I take ISENTRESS? Take ISENTRESS exactly as your doctor has prescribed. The recommended dose is as follows: • Take only one 400-mg tablet at a time. • Take it twice a day. • Take it by mouth. • Take it with or without food. Do not change your dose or stop taking ISENTRESS or your other anti-HIV medicines without first talking with your doctor. IMPORTANT: Take ISENTRESS exactly as your doctor prescribed and at the right times of day because if you don’t: • The amount of virus (HIV) in your blood may increase if the medicine is stopped for even a short period of time. • The virus may develop resistance to ISENTRESS and become harder to treat. • Your medicines may stop working to fight HIV. • The activity of ISENTRESS may be reduced (due to resistance). 1 Registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Copyright © 2007, 2009 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved.

If you fail to take ISENTRESS the way you should, here’s what to do: • If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do NOT take two tablets of ISENTRESS at the same time. In other words, do NOT take a double dose. • If you take too much ISENTRESS, call your doctor or local Poison Control Center. Be sure to keep a supply of your anti-HIV medicines. • When your ISENTRESS supply starts to run low, get more from your doctor or pharmacy. • Do not wait until your medicine runs out to get more. What are the possible side effects of ISENTRESS? When ISENTRESS has been given with other anti-HIV drugs, side effects included: • nausea • headache • tiredness • weakness • trouble sleeping • stomach pain • dizziness • depression • suicidal thoughts and actions Other side effects include: rash, severe skin reactions, feeling anxious, paranoia, low blood platelet count, diarrhea, liver failure. A condition called Immune Reconstitution Syndrome can happen in some patients with advanced HIV infection (AIDS) when combination antiretroviral treatment is started. Signs and symptoms of inflammation from opportunistic infections that a person has or had may occur as the medicines work to treat the HIV infection and help to strengthen the immune system. Call your doctor right away if you notice any signs or symptoms of an infection after starting ISENTRESS with other anti-HIV medicines. Contact your doctor promptly if you experience unexplained muscle pain, tenderness, or weakness while taking ISENTRESS. This is because on rare occasions, muscle problems can be serious and can lead to kidney damage. Rash occurred more often in patients taking ISENTRESS and darunavir together than with either drug separately, but was generally mild. Tell your doctor if you have any side effects that bother you. These are not all the side effects of ISENTRESS. For more information, ask your doctor or pharmacist. How should I store ISENTRESS? • Store ISENTRESS at room temperature (68 to 77°F). • Keep ISENTRESS and all medicines out of the reach of children. General information about the use of ISENTRESS Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. • Do not use ISENTRESS for a condition for which it was not prescribed. • Do not give ISENTRESS to other people, even if they have the same symptoms you have. It may harm them. This leaflet gives you the most important information about ISENTRESS. • If you would like to know more, talk with your doctor. • You can ask your doctor or pharmacist for additional information about ISENTRESS that is written for health professionals. • For more information go to www.ISENTRESS.com or call 1-800-622-4477. What are the ingredients in ISENTRESS? Active ingredient: Each film-coated tablet contains 400 mg of raltegravir. Inactive ingredients: Microcrystalline cellulose, lactose monohydrate, calcium phosphate dibasic anhydrous, hypromellose 2208, poloxamer 407 (contains 0.01% butylated hydroxytoluene as antioxidant), sodium stearyl fumarate, magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, red iron oxide and black iron oxide. Distributed by: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, USA

Revised February 2011 9795112 U.S. Patent Nos. US 7,169,780 IMMU-1001562-0004-08/11(112)

CONFERENCE UPDATE

IAS 2011 ROME Rome was hot and humid, but the air was ablaze with excitement at this year’s 6th IAS Conference on Pathogenesis, Treatment and Prevention. Following are highlights of this year’s conference. Go to www.positivelyaware.com for additional online-only coverage; for a complete listing of conference webcasts and slides, go to www.ias2011.org.

Eric Verdin addressed issues surrounding the search for a cure.

Towards a cure Photo: ©IAS-Marcus Rose-Worker’s Photo

While research progresses, challenges persist By Jeff Berry While news on treatment as prevention (TasP) and preexposure prophylaxis (PrEP) was highlighted at this year’s conference and made most of the headlines, the other topic that garnered quite a bit of attention was progress that’s being made “Towards an HIV Cure,” which is also the name of an ongoing international initiative to develop a global scientific agenda for an HIV cure. P osi t i v elyAware .com

At a Wednesday morning plenary session, Eric Verdin of the University of California, San Francisco gave a great overview presentation which sought to provide some answers to four basic questions: Why do we need a cure? Is a cure feasible? Why does HAART fail to cure, and what are the mechanisms of persistence? And how can we cure HIV?

Verdin laid out the two areas of cure research currently being studied: non-sterilizing cure (functional cure), which is exemplified by elite controllers, or those individuals whose immune systems are able to control HIV in the absence of treatment; and sterilizing cure (eradication), like what we saw with the recent success in the “Berlin patient,” which proved that eradication of HIV is

possible. But that was only one patient, he cautioned, and you have to repeat an experiment before you can claim victory. However, it’s generally widely accepted that this proof-ofconcept has quickly revitalized and helped focus interest in the area of cure research. There are theroetically three mechanisms for persistent HIV production in patients on HAART—CD4+ T-cell latency, persistent infection, and sanctuary sites. It is estimated that 1 in 100,000 to 1,000,000 resting CD4+ T-cells are latently infected, which means cells that are not normally producing virus but from which it can be reactivated. While CD4+ T-cell latency is very rare, the hope is that we could somehow purge those latent reservoirs, reactivate the virus, and those cells would then be eliminated by the immune system in the presence of highly active antiretroviral therapy (HAART). The potential role of treating these latently infected cells with compounds called HDAC inhibitors, such as SAHA and valproic acid, as well as other compounds such as prostratin and disulfiram (Antabuse), are now being studied. The second mechanism, persistent infection, is less studied and likely to be much more complicated. The third mechanism would be in the area of sanctuary sites such as S E P T E M B E R + O C TO B E R 2 01 1

CONFERENCE UPDATE

IAS 2011 ROME the brain, testes, or the gut. Verdin suggests that we might be able to achieve either a functional cure or eradication, using intensification (treating early and treating strong); a therapeutic vaccine; purging and eliminating latently infected cells; or some type of stem cell or gene therapy, although the latter he feels may not be feasible but is still an area that deserves research. During a Wednesday morning session entitled “Towards an HIV Cure: New Strategies for an Old Challenge,” Daria Hazuda of Merck and Co. gave an excellent presentation which looked at drug development and the area of cure research. Hazuda pointed out that in studies thus far, intensification has not been shown to have much of an effect in blood plasma. However, when looking at other markers, such as tissue reservoirs, it seems that intensification does impact the level of immune activation, and HIV medications from different drug classes affect various reservoirs in different ways. The approach originally termed “shock and kill” is also known as the induction/elimination method, though many of the targets identified so far would not be useful when it comes to drug development because of the potential for toxicity.

An important and fundamental point she brought up toward the end of her presentation is whether induction—even “very robust” induction using combination approaches—will ultimately lead to eradication in the face of suppressive antiretroviral therapy. Hazuda says that in people whose virus has been suppressed on HIV therapy for years, we can still detect persistent viremia, so it’s not clear why the immune system would be able to clear latently infected cells that are induced. That is why she believes it will require multiple approaches in combination, and not only will we have to address the latent reservoir, but ongoing immune dysfunction as well, in order to achieve eradication. During the conference, the Towards an HIV Cure working group issued The Rome Statement for an HIV Cure in support of increased funding and research towards a cure. To sign on to the statement go to www.iasociety.org/ Default.aspx?pageId=583. There were many, many other posters and presentations related to HIV cure research, including work by Nicholas Chomant, Peter Hunt, Stephen Deeks, Sharon Lewin, and others. To find out more, go to www.ias2011.org.

To help you navigate cure research at IAS, visit Treatment Action Group’s Richard Jefferys’ comprehensive list at http://tagbasicscienceproject.typepad.com/ tags_basic_science_vaccin/conferences_meetings/.

SEPTEMBER+OCTOBER 2011

By Enid VÁzquez

Once again, prevention—not treatment—dominated an HIV conference. The latest in the string of prevention bonanzas over the past year: two separate research teams reported that the use of HIV drugs when taken by uninfected people greatly reduced the risk of getting HIV through heterosexual sex.

Prevention Dominates International Conference First, before the conference, the University of Washington released findings from its Partners PrEP (“PrEP” stands for pre-exposure prophylaxis or prevention) study conducted in Kenya and Uganda. Because its interim data clearly showed a benefit to using HIV medications to prevent transmission, the study’s independent Data Safety and Monitoring Board (DSMB) recommended that the placebo (fake pill) part of the trial be stopped. Instead, the study participants who had been given a placebo would now be offered one of the two medications being studied for prevention, Viread (tenofovir) or Truvada (tenofovir combined with Emtriva). The DSMB also recommended that these results, which came years before they were expected, be made public. In response to the early announcement from Partners PrEP, the CDC released the findings of its TDF2 study on the use of Truvada in heterosexual men and women in Botswana. TDF2 also found

significant drops in the risk of HIV infection with the use of Truvada PrEP. “These are exciting results for global HIV prevention. We now have findings from two studies showing that PrEP can work for heterosexuals, the population hardest hit by HIV worldwide,” said Kevin Fenton, MD, director of the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. Another prevention study presented at IAS was HPTN 052. This research showed that treatment of an HIVpositive partner in a serodiscordant couple (in which one partner has HIV and the other doesn’t) not only improves that person’s health, but reduces the risk of transmission by 96%. “There are now so many potential weapons at our disposal—to combat HIV and to prevent its transmission—it isn’t surprising there is a palpable sense of optimism and excitement here,” wrote Caspar Thomson, executive director of National AIDS Map (NAM) in Great Britain, in his blog from Rome. NAM is the official online partner for scientific reporting at IAS. All of these results came on the 2010 coattails P os it i v elyAware .com

of CAPRISA 004, a South African study which found that a gel formulation of tenofovir applied vaginally before and after sex greatly reduced the risk of becoming infected with HIV; and iPrEx, which showed that daily PrEP with Truvada reduces the risk of HIV in men who have sex with men, as well as transgender women, by 42% to 93%. “We have witnessed two years of significant biomedical advances, the likes of which we have not seen since the antiretroviral breakthroughs of the mid-1990s,” said Elly Katabira, president of the International AIDS Society, in his speech opening the conference.

Partners PrEP “This study is the largest study to date looking at the effectiveness of PrEP,” said Dr. Connie Celum, a UW professor and principal investigator of the Partners PrEP Study. The study was funded by the Bill & Melinda Gates Foundation, and the CDC co-managed two of the study’s nine sites. The study enrolled nearly 5,000 serodiscordant couples. All received safer sex counseling along with free condoms. The positive partners were not eligible for HIV treatment based on their country’s criteria. Study co-chair Jared Baeten, MD, PhD, also with UW, presented the results at IAS. There was a decreased risk of acquiring HIV of between 62% and 73%, with P osi t i v elyAware .com

no statistically significant difference in whether participants used Viread or Truvada. Both medications involve taking one pill once daily.

HPTN 052 In a conference session titled “Treatment is Prevention: The Proof is Here,” Myron Cohen, MD, of the University of North Carolina at Chapel Hill, presented results of HPTN 052, opening exuberantly with, “We hope that you will be as excited as we are about the results.” The audience was, and Dr. Cohen received a standing ovation when his presentation was done. HPTN 052 (conducted by the HIV Prevention Trials Network, of the U.S.), sought to learn whether treating positive people with HIV medications would help prevent transmission to their HIVnegative partners, as had been seen in observational studies, just looking at patients’ medical charts. HPTN 052 instead used the gold standard of research: a prospective, randomized, controlled clinical trial. In other words, they set out to answer the question, enrolled participants, and used a control group not given medication to see if meds really made a difference. The results were, as stated in the title of the session, proof that HIV treatment is also HIV prevention. HPTN 052 looked at more than 1,700 serodiscordant couples around the world. There were 13 sites in nine

countries. Of 28 infections that were genetically connected to the positive partner, only one transmission occurred among the 886 participants put immediately on HIV treatment, compared to 27 in the 877 who were given delayed therapy. This represented a 96% decreased risk of infection when positive people take HIV therapy.

PrEP guidelines The CDC, which has already issued interim guidelines on the use of PrEP in men who have sex with men, urged health care providers and sexually active heterosexuals to wait for guidance on the use of PrEP in the straight population. The CDC pointed out that PrEP can only be used if an individual has been confirmed to be HIV-negative, that only daily PrEP use has been shown to be effective to date, and that “PrEP should never be seen as the first line of defense against HIV. It was only shown to be effective in clinical trials when provided in combination with regular HIV testing, condoms, and other proven prevention methods.”

TDF2 Risk reduction of 63% overall was seen with Truvada in the TDF2 study. With a separate analysis that excluded HIV infections which occurred more than 30 days after a participant’s last Truvada dose, an even higher

reduction in risk of 78% was seen. More analyses on factors such as adherence and detectable levels of medicine in the blood are underway. A group of 1,200 heterosexual men and women participated in TDF2. All of them received free male and female condoms, screening and treatment of sexually transmitted infections, and individualized counseling for adherence and HIV risk reduction. Truvada side effects included dizziness, nausea, and vomiting, but usually went away after a month. The Viread in Truvada has been associated with the potential for kidney problems, and one participant experienced an elevated creatinine level, a sign of renal malfunction. The elevation went away with discontinuation of Truvada.

WhAT now? The good results from these and other prevention studies did not come without criticism and even outright condemnation. For example, critics note that a daily Truvada tablet costs more than a daily condom (or two or three condoms). With all the struggles surrounding the new breakthroughs in prevention, the executive director of UNAIDS, Michel Sidibé, declared in his opening speech: “We have to remember that history will judge us not by our scientific breakthroughs, but how we apply them.” S E P T E M B E R + O C TO B E R 2 01 1

CONFERENCE UPDATE

IAS 2011 ROME By Enid VÁzquez

Among the usual conference suspects were drugs, drugs, and drugs! Here are some of the findings on how HIV drugs compare to one another.

Experimental elvitegravir stacks up against Isentress In an advanced Phase 3 study, elvitegravir was found to be non-inferior to Isentress. Isentress (generic name raltegravir) has been known for its combination of power and tolerability and is one of four drugs recommended by U.S. treatment guidelines for people taking HIV therapy for the first time, as well as being FDA approved for treatment-experienced people. Isentress, from Merck & Co., is currently the only HIV integrase inhibitor. Gilead Sciences is developing elvitegravir, an HIV integrase inhibitor that is taken once a day, unlike twice-daily Isentress. The caveat is that it must be boosted with a small dose of another drug, either Norvir or the company’s experimental booster cobicistat. At 48 weeks, 59% of the 351 participants given elvitegravir vs. 58% of the 351 individuals given Isentress achieved undetectable viral loads of less than 50 copies/ mL. T-cell count increases were also similar (138 for elvitegravir and 147 for Isentress). Side effects included diarrhea, nausea, and 20

SEPTEMBER+OCTOBER 2011

bronchitis, and did not differ between the two drugs. These study participants were highly treatment-experienced, and the majority had HIV with drug resistance to at least two classes of antiviral medication. This group experiences less treatment success than people starting anti-HIV therapy for the first time. All the participants also received a fully active boosted protease inhibitor drug (meaning that their virus was not resistant to it). Still, one in five participants in both groups experienced virologic failure (detectable viral load). Only a minority of those, however, had drug resistance to the integrase inhibitor drug class (approximately 20%). The study is continuing out to 96 weeks. Elvitegravir is also being studied in two other Phase 3 studies in treatment-naïve people (taking therapy for the first time), as part of a complete regimenin-one-pill known as the Quad. The four medications in the Quad are Truvada (made up of Viread and Emtriva) and elvitegravir boosted with cobicistat.

new Edurant, at 96 weeks Edurant (generic name rilpivirine) was approved

by the FDA in May. At IAS, Janssen Therapeutics presented 96-week data from two of its Phase 3 studies with Edurant (ECHO and THRIVE). Edurant and Sustiva (both from the drug class non-nucleoside reverse transcriptase inhibitors, NNRTIs or non-nukes) had similar viral load decreases out to 96 weeks: 78% of participants taking either drug had undetectable viral loads. People taking Edurant, however, had twice the virologic failure rate of those taking Sustiva, 14% vs. 8%. They also had a higher rate of never having achieved undetectable viral load to begin with, 7% of the Edurant group vs. 3% of the Sustiva group. On the other hand, participants given Sustiva had a higher rate of side effects, including discontinuation due to a drug-related adverse event (9% of the Sustiva group vs. 4% of the Edurant group).

Isentress holds its own against Sustiva Merck & Co. reported on nearly five years of data with Isentress. At 240 weeks, 69% of the 160 study participants taking an Isentress regimen had an undetectable viral load, compared to 63% of the 38 individuals taking a Sustiva regimen. T-cell increases were also similar, 302 cells for the Isentress group and 276 for the Sustiva group. Drugrelated adverse events were

higher in the Sustiva group— 76% vs. 55% for those taking Isentress. All participants were taking HIV therapy for the first time.

Selzentry update An HIV drug therapy backbone usually consists of nucleoside medications, the oldest HIV drug class. Although the nukes have come a long way, there’s interest in moving on to regimens that don’t depend on them. Two studies looked at whether the CCR5 inhibitor Selzentry (maraviroc) could replace the popular nuke backbone of Truvada. Of note, Selzentry was given only once daily, at a dose of 150, rather than its FDA approved dose of 150 mg twice daily. That’s because the studies combined it with a boosted protease inhibitor (PI) medication (one taken with a small dose of Norvir). Most boosted PIs allow once-daily Selzentry to reach the plasma concentration that it shows with twicedaily dosing. Italian researchers conducted a small proof-ofconcept study comparing an established combination of Kaletra/Truvada against a novel regimen consisting of Kaletra with Selzentry in treatment-naïve patients. They reported more effective immune and virologic response with Selzentry. The Selzentry group had a greater increase in T-cell count (226 vs. 125 for the Truvada group). P os it i v elyAware .com

The Selzentry group also had a faster time to undetectable viral load (at 24 weeks) in 79% of participants vs. 14% of those in the Truvada group. However, of the 37 patients who reached 48 weeks, there was no statistically significant difference in undetectable viral load, which was achieved by 94.7% of the 19 persons taking Kaletra/Selzentry vs. 83% of the 18 individuals given Kaletra/Truvada. More research is needed to confirm

the studyâ&#x20AC;&#x2122;s results. In an early Phase 2b study, Pfizer compared Selzentry in combination with boosted Reyataz (generic name atazanavir and a small dose of Norvir) to boosted Reyataz/ Truvada. Again, Selzentry was taken once daily. At 48 weeks, 75% of the Selzentry group vs. 84% of the Truvada group had undetectable viral loads. These are from small numbers of participants, 59 in the Selzentry group and

61 in the Truvada group. The study will go into Phase 3 later this year, enrolling more participants. Pfizer also reported pooled results from its MOTIVATE studies looking at Selzentry with boosted PIs. The retrospective analysis found that, as expected, the efficacy of a once-daily Selzentry dose of 150 mg was similar to that of 150 mg taken twice daily. At 48 weeks, 46% of the once-daily group vs.

48% of the twice-daily group had undetectable viral loads. Selzentry, however, cannot be taken once daily with Aptivus and if taken once daily with Lexiva, must be a 300 mg dose. The study reported that once-daily Selzentry worked for these treatment-experienced participants even when they had high viral load or low T-cell counts at the beginning of the study.

Fifteenth Annual

United States Conference on AIDS November 10-13, 2011

Sheraton Chicago Hotel & Towers * Chicago, IL

P osi t i v elyAware .com

S E P T E M B E R + O C TO B E R 2 01 1

INDICATION: REYATAZ® (atazanavir sulfate) is a prescription medicine used in combination with other medicines to treat people 6 years of age and older who are infected with the human immunodeficiency virus (HIV). REYATAZ has been studied in a 48-week trial in patients who have taken anti-HIV medicines and a 96-week trial in patients who have never taken anti-HIV medicines. REYATAZ does not cure HIV or lower your chance of passing HIV to others. People taking REYATAZ may still get opportunistic infections or other conditions that happen with HIV infection. IMPORTANT SAFETY INFORMATION: Do not take REYATAZ if you are allergic to REYATAZ or to any of its ingredients. Do not take REYATAZ if you are taking the following medicines due to potential for serious, life-threatening side effects or death: Versed® (midazolam) when taken by mouth, Halcion® (triazolam), ergot medicines (dihydroergotamine, ergonovine, ergotamine, and methylergonovine such as Cafergot®, Migranal®, D.H.E. 45®, ergotrate maleate, Methergine®, and others), Propulsid® (cisapride), or Orap® (pimozide). Do not take REYATAZ with the following medicines due to potential for serious side effects: Camptosar® (irinotecan), Crixivan® (indinavir), Mevacor® (lovastatin), Zocor® (simvastatin), Uroxatral® (alfuzosin), or Revatio® (sildenafil). Do not take REYATAZ with the following medicines as they may lower the amount of REYATAZ in your blood, which may lead to increased HIV viral load and resistance to REYATAZ or other anti-HIV medicines: rifampin (also known as Rimactane®, Rifadin®, Rifater®, or Rifamate®), St. John’s wort (Hypericum perforatum)containing products, or Viramune® (nevirapine). Serevent Diskus® (salmeterol) and Advair® (salmeterol with fluticasone) are not recommended with REYATAZ. Do not take Vfend® (voriconazole) if you are taking REYATAZ and Norvir® (ritonavir). The above lists of medicines are not complete. Taking REYATAZ with some other medicines may require your therapy to be monitored more closely or may require a change in dose or dose schedule of REYATAZ or the other medicine. Discuss with your healthcare provider all prescription and non-prescription medicines, vitamin and herbal supplements, or other health preparations you are taking or plan to take. Tell your healthcare provider if you are pregnant or plan to become pregnant. REYATAZ use during pregnancy has not been associated with an increase in birth defects. Pregnant women have experienced serious side effects when taking REYATAZ with other HIV medicines called nucleoside analogues. After your baby is born, tell your healthcare provider if your baby’s skin or the white part of his/her eyes turns yellow. You should not breast-feed if you are HIV-positive. Also tell your healthcare provider if you have end-stage kidney disease managed with hemodialysis or severe liver dysfunction. Tell your healthcare provider right away if you have any side effects, symptoms, or conditions, including the following: • Mild rash (redness and itching) without other symptoms sometimes occurs in patients taking REYATAZ, most often in the first few weeks after the medicine is started, and usually goes away within 2 weeks with no change in treatment.

IMPORTANT SAFETY INFORMATION (cont’d): • Severe rash may develop with other symptoms that could be serious and potentially cause death. If you develop a rash with any of the following symptoms, stop using REYATAZ and call your healthcare provider right away: — Shortness of breath – General ill-feeling or “flu-like” symptoms – Fever – Muscle or joint aches – Conjunctivitis (red or inflamed eyes, like “pink eye”) – Blisters – Mouth sores – Swelling of your face • Yellowing of the skin and/or eyes may occur due to increases in bilirubin levels in the blood (bilirubin is made by the liver). • A change in the way your heart beats may occur. You may feel dizzy or lightheaded. These could be symptoms of a heart problem. • Diabetes and high blood sugar may occur in patients taking protease inhibitor medicines like REYATAZ. Some patients may need changes in their diabetes medicine. • If you have liver disease, including hepatitis B or C, it may get worse when you take anti-HIV medicines like REYATAZ. • Kidney stones have been reported in patients taking REYATAZ. Signs or symptoms of kidney stones include pain in your side, blood in your urine, and pain when you urinate. • Some patients with hemophilia have increased bleeding problems with protease inhibitor medicines like REYATAZ. • Changes in body fat have been seen in some patients taking anti-HIV medicines. The cause and long-term effects are not known at this time. • Immune reconstitution syndrome has been seen in some patients with advanced HIV infection (AIDS) and a history of opportunistic infection. Signs and symptoms of inflammation from previous infections may occur soon after starting anti-HIV treatment, including REYATAZ. • Gallbladder disorders (including gallstones and gallbladder inflammation) have been reported in patients taking REYATAZ. Other common side effects of REYATAZ taken with other anti-HIV medicines include: nausea; headache; stomach pain; vomiting; diarrhea; depression; fever; dizziness; trouble sleeping; numbness, tingling, or burning of hands or feet; and muscle pain. You should take REYATAZ once daily with food (a meal or snack). Swallow the capsules whole; do not open the capsules. You should take REYATAZ and your other anti-HIV medicines exactly as instructed by your healthcare provider. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. REYATAZ is one of several treatment options your doctor may consider.

Please see Important Patient Information about REYATAZ on the adjacent pages. REYATAZ is a registered trademark of Bristol-Myers Squibb. All other trademarks are the property of their respective owners and not of Bristol-Myers Squibb.

DETERMINED + UNDETECTABLE

REYATAZ CAN HELP GET YOU TO UNDETECTABLE, SO YOU CAN FIGHT HIV YOUR WAY. ONCE-DAILY REYATAZ IN HIV COMBINATION THERAPY: • Can help lower your viral load to undetectable* and help raise your T-cell (CD4+ cell) count • Has been prescribed by physicians for more than 200,000 HIV patients since 2003 † • Can be taken by adults who are starting HIV treatment for the first time and adults who have already been on HIV treatment

Do not take REYATAZ if you are allergic to REYATAZ or to any of its ingredients. REYATAZ does not cure HIV and has not been shown to reduce the risk of passing HIV to others. Individual results may vary.

Ask your healthcare team how REYATAZ in combination therapy can help get you to undetectable.

Fight HIV your way.

www.REYATAZ.com * Undetectable was defined as a viral load of less than 400 copies/mL.

† Wolters Kluwer. SDI Product Brand Report.

Total Patient Tracker; November 2010.

FDA-Approved Patient Labeling Patient Information

REYATAZ® (RAY-ah-taz) (generic name = atazanavir sulfate) Capsules ALERT: Find out about medicines that should NOT be taken with REYATAZ (atazanavir sulfate). Read the section “What important information should I know about taking REYATAZ with other medicines?” Read the Patient Information that comes with REYATAZ before you start using it and each time you get a refill. There may be new information. This leaflet provides a summary about REYATAZ and does not include everything there is to know about your medicine. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. What is REYATAZ? REYATAZ is a prescription medicine used with other anti-HIV medicines to treat people 6 years of age and older who are infected with the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS). REYATAZ is a type of anti-HIV medicine called a protease inhibitor. HIV infection destroys CD4+ (T) cells, which are important to the immune system. The immune system helps fight infection. After a large number of (T) cells are destroyed, AIDS develops. REYATAZ helps to block HIV protease, an enzyme that is needed for the HIV virus to multiply. REYATAZ may lower the amount of HIV in your blood, help your body keep its supply of CD4+ (T) cells, and reduce the risk of death and illness associated with HIV. Does REYATAZ cure HIV or AIDS? REYATAZ does not cure HIV infection or AIDS. At present there is no cure for HIV infection. People taking REYATAZ may still get opportunistic infections or other conditions that happen with HIV infection. Opportunistic infections are infections that develop because the immune system is weak. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infections. It is very important that you see your healthcare provider regularly while taking REYATAZ. REYATAZ does not lower your chance of passing HIV to other people through sexual contact, sharing needles, or being exposed to your blood. For your health and the health of others, it is important to always practice safer sex by using a latex or polyurethane condom or other barrier to lower the chance of sexual contact with semen, vaginal secretions, or blood. Never use or share dirty needles. Who should not take REYATAZ? Do not take REYATAZ if you: • are taking certain medicines. (See “What important information should I know about taking REYATAZ with other medicines?”) Serious life-threatening side effects or death may happen. Before you take REYATAZ, tell your healthcare provider about all medicines you are taking or planning to take. These include other prescription and nonprescription medicines, vitamins, and herbal supplements. • are allergic to REYATAZ or to any of its ingredients. The active ingredient is atazanavir sulfate. See the end of this leaflet for a complete list of ingredients in REYATAZ. Tell your healthcare provider if you think you have had an allergic reaction to any of these ingredients. What should I tell my healthcare provider before I take REYATAZ? Tell your healthcare provider: • If you are pregnant or plan to become pregnant. REYATAZ use during pregnancy has not been associated with an increase in birth defects. Pregnant women have experienced serious side effects when taking REYATAZ with other HIV medicines called nucleoside analogues. You and your healthcare provider will need to decide if REYATAZ is right for you. If you use REYATAZ while you are pregnant, talk to your healthcare provider about the Antiretroviral Pregnancy Registry. • After your baby is born, tell your healthcare provider if your baby’s skin or the white part of his/her eyes turns yellow. • If you are breast-feeding. You should not breast-feed if you are HIV-positive because of the chance of passing HIV to your baby. Also, it is not known if REYATAZ can pass into your breast milk and if it can harm your baby. If you are a woman who has or will have a baby, talk with your healthcare provider about the best way to feed your baby. • If you have liver problems or are infected with the hepatitis B or C virus. See “What are the possible side effects of REYATAZ?” • If you have end stage kidney disease managed with hemodialysis. • If you have diabetes. See “What are the possible side effects of REYATAZ?” • If you have hemophilia. See “What are the possible side effects of REYATAZ?”

REYATAZ® (atazanavir sulfate) About all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Keep a list of your medicines with you to show your healthcare provider. For more information, see “What important information should I know about taking REYATAZ with other medicines?” and “Who should not take REYATAZ?” Some medicines can cause serious side effects if taken with REYATAZ. How should I take REYATAZ? • Take REYATAZ once every day exactly as instructed by your healthcare provider. Your healthcare provider will prescribe the amount of REYATAZ that is right for you. • Always take REYATAZ with food (a meal or snack) to help it work better. Swallow the capsules whole. Do not open the capsules. Take REYATAZ at the same time each day. • If you are taking antacids or didanosine (VIDEX® or VIDEX® EC), take REYATAZ 2 hours before or 1 hour after these medicines. • If you are taking medicines for indigestion, heartburn, or ulcers such as AXID® (nizatidine), PEPCID AC® (famotidine), TAGAMET® (cimetidine), ZANTAC® (ranitidine), AcipHex® (rabeprazole), NEXIUM® (esomeprazole), PREVACID® (lansoprazole), PRILOSEC® (omeprazole), or PROTONIX® (pantoprazole), talk to your healthcare provider. • Do not change your dose or stop taking REYATAZ without first talking with your healthcare provider. It is important to stay under a healthcare provider’s care while taking REYATAZ. • When your supply of REYATAZ starts to run low, get more from your healthcare provider or pharmacy. It is important not to run out of REYATAZ. The amount of HIV in your blood may increase if the medicine is stopped for even a short time. • If you miss a dose of REYATAZ, take it as soon as possible and then take your next scheduled dose at its regular time. If, however, it is within 6 hours of your next dose, do not take the missed dose. Wait and take the next dose at the regular time. Do not double the next dose. It is important that you do not miss any doses of REYATAZ or your other anti-HIV medicines. • If you take more than the prescribed dose of REYATAZ, call your healthcare provider or poison control center right away. What are the possible side effects of REYATAZ? The following list of side effects is not complete. Report any new or continuing symptoms to your healthcare provider. If you have questions about side effects, ask your healthcare provider. Your healthcare provider may be able to help you manage these side effects. The following side effects have been reported with REYATAZ: • mild rash (redness and itching) without other symptoms sometimes occurs in patients taking REYATAZ, most often in the first few weeks after the medicine is started. Rashes usually go away within 2 weeks with no change in treatment. Tell your healthcare provider if rash occurs. • severe rash: Rash may develop in association with other symptoms which could be serious and potentially cause death. If you develop a rash with any of the following symptoms stop using REYATAZ and call your healthcare provider right away: • shortness of breath • general ill feeling or “flu-like” symptoms • fever • muscle or joint aches • conjunctivitis (red or inflamed eyes, like “pink eye”) • blisters • mouth sores • swelling of your face • yellowing of the skin or eyes. These effects may be due to increases in bilirubin levels in the blood (bilirubin is made by the liver). Although these effects may not be damaging to your liver, skin, or eyes, call your healthcare provider promptly if your skin or the white part of your eyes turn yellow. • a change in the way your heart beats (heart rhythm change). Call your healthcare provider right away if you get dizzy or lightheaded. These could be symptoms of a heart problem. • diabetes and high blood sugar (hyperglycemia) sometimes happen in patients taking protease inhibitor medicines like REYATAZ. Some patients had diabetes before taking protease inhibitors while others did not. Some patients may need changes in their diabetes medicine. • if you have liver disease including hepatitis B or C, your liver disease may get worse when you take anti-HIV medicines like REYATAZ. • kidney stones have been reported in patients taking REYATAZ. If you develop signs or symptoms of kidney stones (pain in your side, blood in your urine, pain when you urinate) tell your healthcare provider promptly. •

REYATAZ® (atazanavir sulfate) some patients with hemophilia have increased bleeding problems with protease inhibitors like REYATAZ. • changes in body fat. These changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the trunk. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these conditions are not known at this time. • immune reconstitution syndrome. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment, including REYATAZ, is started. Other common side effects of REYATAZ taken with other anti-HIV medicines include nausea; headache; stomach pain; vomiting; diarrhea; depression; fever; dizziness; trouble sleeping; numbness, tingling, or burning of hands or feet; and muscle pain. Gallbladder disorders (which may include gallstones and gallbladder inflammation) have been reported in patients taking REYATAZ. What important information should I know about taking REYATAZ with other medicines? •

Do not take REYATAZ if you take the following medicines (not all brands may be listed; tell your healthcare provider about all the medicines you take). REYATAZ may cause serious, life-threatening side effects or death when used with these medicines. • Ergot medicines: dihydroergotamine, ergonovine, ergotamine, and methylergonovine such as CAFERGOT®, MIGRANAL®, D.H.E. 45®, ergotrate maleate, METHERGINE®, and others (used for migraine headaches). • ORAP® (pimozide, used for Tourette’s disorder). • PROPULSID® (cisapride, used for certain stomach problems). • Triazolam, also known as HALCION® (used for insomnia). • Midazolam, also known as VERSED® (used for sedation), when taken by mouth. Do not take the following medicines with REYATAZ because of possible serious side effects: • CAMPTOSAR® (irinotecan, used for cancer). • CRIXIVAN® (indinavir, used for HIV infection). Both REYATAZ and CRIXIVAN sometimes cause increased levels of bilirubin in the blood. • Cholesterol-lowering medicines MEVACOR® (lovastatin) or ZOCOR® (simvastatin). • UROXATRAL® (alfuzosin, used to treat benign enlargement of the prostate). • REVATIO® (sildenafil, used to treat pulmonary arterial hypertension). Do not take the following medicines with REYATAZ because they may lower the amount of REYATAZ in your blood. This may lead to an increased HIV viral load. Resistance to REYATAZ or cross-resistance to other HIV medicines may develop: • Rifampin (also known as RIMACTANE®, RIFADIN®, RIFATER®, or RIFAMATE®, used for tuberculosis). • St. John’s wort (Hypericum perforatum), an herbal product sold as a dietary supplement, or products containing St. John’s wort. • VIRAMUNE® (nevirapine, used for HIV infection). The following medicines are not recommended with REYATAZ: • SEREVENT DISKUS® (salmeterol) and ADVAIR® (salmeterol with fluticasone), used to treat asthma, emphysema/chronic obstructive pulmonary disease also known as COPD. Do not take the following medicine if you are taking REYATAZ and NORVIR® together: • VFEND® (voriconazole). The following medicines may require your healthcare provider to monitor your therapy more closely (for some medicines a change in the dose or dose schedule may be needed): • CIALIS® (tadalafil), LEVITRA® (vardenafil), or VIAGRA® (sildenafil), used to treat erectile dysfunction. REYATAZ may increase the chances of serious side effects that can happen with CIALIS, LEVITRA, or VIAGRA. Do not use CIALIS, LEVITRA, or VIAGRA while you are taking REYATAZ unless your healthcare provider tells you it is okay. • ADCIRCA® (tadalafil) or TRACLEER® (bosentan), used to treat pulmonary arterial hypertension. • LIPITOR® (atorvastatin) or CRESTOR® (rosuvastatin). There is an increased chance of serious side effects if you take REYATAZ with this cholesterollowering medicine. • Medicines for abnormal heart rhythm: CORDARONE® (amiodarone), lidocaine, quinidine (also known as CARDIOQUIN®, QUINIDEX®, and others). • MYCOBUTIN® (rifabutin, an antibiotic used to treat tuberculosis).

REYATAZ® (atazanavir sulfate) •

BUPRENEX®, SUBUTEX®, SUBOXONE®, (buprenorphine or buprenorphine/ naloxone, used to treat pain and addiction to narcotic painkillers). • VASCOR® (bepridil, used for chest pain). • COUMADIN® (warfarin). • Tricyclic antidepressants such as ELAVIL® (amitriptyline), NORPRAMIN® (desipramine), SINEQUAN® (doxepin), SURMONTIL® (trimipramine), TOFRANIL® (imipramine), or VIVACTIL® (protriptyline). • Medicines to prevent organ transplant rejection: SANDIMMUNE® or NEORAL® (cyclosporin), RAPAMUNE® (sirolimus), or PROGRAF® (tacrolimus). • The antidepressant trazodone (DESYREL® and others). • Fluticasone propionate (FLONASE®, FLOVENT®), given by nose or inhaled to treat allergic symptoms or asthma. Your doctor may choose not to keep you on fluticasone, especially if you are also taking NORVIR®. • Colchicine (COLCRYS®), used to prevent or treat gout or treat familial Mediterranean fever. The following medicines may require a change in the dose or dose schedule of either REYATAZ or the other medicine: • INVIRASE® (saquinavir). • NORVIR® (ritonavir). • SUSTIVA® (efavirenz). • Antacids or buffered medicines. • VIDEX® (didanosine). • VIREAD® (tenofovir disoproxil fumarate). • MYCOBUTIN® (rifabutin). • Calcium channel blockers such as CARDIZEM® or TIAZAC® (diltiazem), COVERA-HS® or ISOPTIN SR® (verapamil) and others. • BIAXIN® (clarithromycin). • Medicines for indigestion, heartburn, or ulcers such as AXID® (nizatidine), PEPCID AC® (famotidine), TAGAMET® (cimetidine), or ZANTAC® (ranitidine). Talk to your healthcare provider about choosing an effective method of contraception. REYATAZ may affect the safety and effectiveness of hormonal contraceptives such as birth control pills or the contraceptive patch. Hormonal contraceptives do not prevent the spread of HIV to others. Remember: 1. Know all the medicines you take. 2. Tell your healthcare provider about all the medicines you take. 3. Do not start a new medicine without talking to your healthcare provider. How should I store REYATAZ? • Store REYATAZ Capsules at room temperature, 59° to 86° F (15° to 30° C). Do not store this medicine in a damp place such as a bathroom medicine cabinet or near the kitchen sink. • Keep your medicine in a tightly closed container. • Keep all medicines out of the reach of children and pets at all times. Do not keep medicine that is out of date or that you no longer need. Dispose of unused medicines through community take-back disposal programs when available or place REYATAZ in an unrecognizable, closed container in the household trash. General information about REYATAZ This medicine was prescribed for your particular condition. Do not use REYATAZ for another condition. Do not give REYATAZ to other people, even if they have the same symptoms you have. It may harm them. Keep REYATAZ and all medicines out of the reach of children and pets. This summary does not include everything there is to know about REYATAZ. Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Remember no written summary can replace careful discussion with your healthcare provider. If you would like more information, talk with your healthcare provider or you can call 1-800-321-1335. What are the ingredients in REYATAZ? Active Ingredient: atazanavir sulfate Inactive Ingredients: Crospovidone, lactose monohydrate (milk sugar), magnesium stearate, gelatin, FD&C Blue #2, and titanium dioxide. VIDEX® and REYATAZ® are registered trademarks of Bristol-Myers Squibb Company. COUMADIN® and SUSTIVA® are registered trademarks of Bristol-Myers Squibb Pharma Company. DESYREL® is a registered trademark of Mead Johnson and Company. Other brands listed are the trademarks of their respective owners and are not trademarks of Bristol-Myers Squibb Company. Princeton, NJ 08543 USA 1246226A9

F1-B0001B-02-11

Rev February 2011

Unfolding Picture Understanding the puzzle that is our immune system by Matt Sharp images by Mike Tyka

f ever there was a silver lining to the AIDS pandemic, it might be the scientific contribution HIV has brought to understanding the immune system. Only a few decades ago, not much was understood about our chameleon-like, self-protective immune system because of its enigmatic complexity. Yet today, more is known about the immune system than ever before, although harnessing the knowledge to create immune-based treatments will continue to be challenging. Surviving the roller coaster ride of HIV with its ups and downs, I have personally witnessed a remarkable attribute of the immune system: its resiliency—or ability to maintain a balance, especially with a longterm condition such as HIV. HIV disrupts this balance, yet overcoming a broken immune system is entirely possible with improvements in treatment, and a further understanding of how to “correct” the disruption made by HIV.

What is the immune system?

HIV begins its life cycle when it binds to a CD4 receptor and one of two co-receptors on the surface of a CD4+ T-lymphocyte (pictured). The virus then fuses with the host cell and releases RNA, its genetic material, into the host cell.

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Simply put, the immune system is composed of organs, tissues, cells, and chemicals that work in a specific, coordinated response to fight foreign invaders such as bacteria, viruses, parasites, and proteins. You might consider our immune system to be like computer software or an “app” on your phone that, through a complex series of biological processes and cellular signaling, works collectively to keep us healthy. Despite the immune system’s remarkable ability to fight infections and heal, it has taken thousands of years to evolve to where it is today. Yet it is not perfect. Allergies, for example, are overreactive immune responses to things that are not necessarily harmful. The immune system also has a weaker response to certain Pos i t i ve lyAware .com

Reverse transcription: An HIV enzyme called reverse transcriptase (pictured) converts the singlestranded HIV RNA to double-stranded HIV DNA.

infections that can lead to diseases such as cancer

The pieces of the puzzle Understanding the immune system is like putting together one of those jigsaw puzzles with thousands of pieces. For the sake of this review, I will attempt to deconstruct that puzzle piece by piece, then put it back together by explaining how the immune system works. Finally, I will explain what we currently know about how HIV impacts the immune system and our hopes for the future.

IMAGES: © MIKE TYKA

Blood Cells All cells in the body come from the bone marrow and eventually divide and expand to provide the cellular make-up of bones, tissues, organs, and blood. Blood cells take on their individual roles, separating into white and red blood cells in a process called “hematopoesis.” Lymphoid cells form that are the major immune white blood cells known as T-cells, B-cells and natural killer cells. CD4 and CD8 cells are types of T-cells. APCs, or antigen presenting cells, such as macrophages and dendritic cells, are also immune cells. They sweep and gobble up invaders, digesting them into antigens P osi t i v elyAware .com

that are presented to the T-cells in the lymph nodes. CD4 T-cells (also known as CD4s) are known as the generals of the immune system, as they coordinate signals and responses. When the CD4 T-cell becomes activated, it signals to the CD8 T-cell to kill the infected cell. These two types of cells work as partners to eliminate pathogens. CD4s are also the main target of HIV and over time, without treatment, the total pool of CD4 cells in the body will die. Different kinds of CD8 T-cells have different functions. Cytotoxic lymphocytes, or CTLs, kill infected cells—the cells release cytokines that have their own immune functions, but they also inject a chemical called perforin that is like a killing potion. Without a CD4 T-cell signaling to a CD8 T-cell, this potion would never be released and a critical moment of immune protection would be lost. Suppression of overreactive immune responses is the job of CD8 suppressor cells. These are the most important white blood cells that carry out the bulk of the infection fighting that occurs in our bodies. But there are many other types of cells that help fend off invaders that, for the sake of this review, are smaller, less significant pieces of the puzzle.

Getting the full picture There are several other pieces of our immune system puzzle that are necessary for understanding how it all fits together.

Thymus Another major player in the immune system is the thymus. This organ lies directly under our breastbone and covers almost the entire top portion of the chest when we are born, then shrinks and even disappears with age. The thymus can be thought of as a “school” for CD4 and CD8 T-cells. In the thymus, cells go through a process called “thymopoesis,” that instructs the T-cells on how to carry out their function. Studies have shown that there can still be thymopesis even in older folks or people with HIV who have a shrunken thymus. This is critical to maintaining the large pool of T-cells that are ready to encounter a new pathogen. In the thymus, CD8 T-cells are developed in a similar way as the CD4s. Memory CD8 T-cells will also be made after an encounter with a pathogen.

Lymphatic system The lymphatic system is comprised of an interconnected system of vessels and nodes where much of the immune action takes S E P T E M B E R + O C TO B E R 2 01 1

place. The lymph nodes are small peanutsized glands located at particular places throughout the body where antigens meet up with CD4 cells, sort of like train stations or coffee houses. The CD4 cells then mobilize the rest of the immune system cells to fight the infection. Other secondary lymph tissues involved are the spleen, mucosal tissue in the gut, and tonsils.

to antigen-presenting cells. The receptors help to recognize the cell type.

system a complex yet comprehensive protection for our bodies.

Putting the puzzle together

From Birth to Death: The Life of a CD4 Cell

There are two “arms” or divisions in our immune system puzzle that incorporate separate cells and immune functions to deliver a team approach in fighting infections. One arm is known as the innate Antibodies immune system that can also be referred Antibodies are made by B-cells when you to as “non-specific” and is the first line are exposed to a pathogen. They are small of defense. Key sites of innate immune Y-shaped proteins that stick to and redactivity are the skin and the lining of the respiratory, intestinal, urinary, and reproductive systems that are The Life Cycle of HIV: natural barriers to outside germs. APCs—macrophages and den1. Binding and Fusion dritic cells—and certain antibodies 2. Reverse Transcription patrol these key sites and react to 3. Integration anything they do not recognize, 4. Transcription anything different or foreign to the 5. Assembly body. APCs make antigens to the 6. Budding invader and either gobble them up and destroy them, or deliver them Go to www.PositivelyAware.com for a to a CD4 cell. In our puzzle analdetailed explanation of HIV’s life cycle. ogy, you might think of the innate immune system as the first pieces you lay out on the table, like the flag pathogens for immune system recogborder of the jigsaw puzzle. nition that leads to their destruction. The more advanced second arm is known as adaptive or “acquired” immune Cytokines and Chemokines response. Once the body has been exposed Similar to data being sent over the wire, to a pathogen, a phenomenon known as these are immune system signaling chemiimmunologic memory occurs. This is where cals that either tell the immune system to T-cells, B-cells, macrophages, dendritic start, slow down, or stop, as well as where cells, and antibodies remember a specific to target. They also employ the body’s pathogen and prevent it from invading mucous, saliva, tears, and pus to help rid again. Some cells such as macrophages fall the body of the foreign invader. These into both arms of the immune system, actchemicals are responsible for many of ing as links between the two divisions. the symptoms of an infection, including There are also two different strategies inflammation. that are employed to get the job done in ridding the immune system of pathoMucosal Immunity gens. One is called the humoral immune Mucosal immunity includes a one-inch response that uses antibodies to help barrier of mucous membrane cells which identify and destroy invaders. The cellular is often the first line of defense. Gutimmune response involves cell-to-cell killassociated lymph tissue is a lining in the ing using T-cells. Both are essential for the gut where a lot of HIV is found and is a big most effective immune response. area of current research efforts. Without one of these immune system divisions or strategies you would be like T-cell receptors a knight wearing only your suit of amour T-cell receptors are on the surface of every without the helmet. These mechanisms T-cell and ”introduce” a foreign invader work collectively to make the immune 28

SEPTEMBER+OCTOBER 2011

People with HIV and their care providers discuss CD4s for life, as they are an important measurement of the status of the immune system. It is part of the language of HIV to understand the function of these cells and the significance of their number. An AIDS diagnosis is based on having 200 or fewer CD4s. Treatment guidelines currently recommend starting antiretroviral therapy at 350-500 CD4s, or earlier. As mentioned above, CD4s are responsible for the coordination of the immune response. They are born in the bone marrow as “progenitor” white blood cells. If the destiny of the immature cell is to become a T-cell, it goes to school in the thymus. It is here where the cell will be made a CD4 T-cell (or CD8) for the span of its life. The T-cell receptor or TCR is randomly determined in the thymus. TCRs are like keys that enable the baby cells to enter their target, therefore starting an immune response. When roaming in key lymphatic organs, the new, or “naïve,” CD4s will eventually encounter an invader and begin the process of the immune response. Here is where the cell is activated and proliferation begins. Many duplicate cells are made, sort of like adding new troops to an invasion. As in a battle, some of the cells die, but some survive to become “memory” CD4s. The cells have graduated and are now equipped to protect the body from pathogens they have met before if they ever encounter them again. After they do their jobs, they will either divide and make more of themselves, or die in a process known as apoptosis. Certain memory cells go into hiding or what is called a “quiet” state. These elite cells are a growing area of interest in HIV cure research since they can harbor what is known as “latent” HIV. If scientists can figure out a way to activate these quiet memory cells, new HIV virions (baby viruses) would be unleashed into the plasma where effective antiretroviral therapy could functionally rid the body of HIV.

How HIV Dislodges the Puzzle Now that our puzzle is nearly completed, P os it i velyAware .com

IMAGE: © MIKE TYKA

ASSEMBLY: An HIV enzyme called protease (pictured) cuts the long chains of HIV proteins into smaller individual proteins, which come together with copies of HIV’s RNA genetic material and a new virus particle is assembled.

think about how upset you’d be if the table it was on was upended. This is what happens when HIV invades the immune system, dislodging and even destroying pieces of the puzzle. HIV enters the body, most often in the mucosa, and interacts with the dendritic cell that does its job in sweeping up the virus and presenting it to the CD4 cell. Once inside the lymph node, if the HIV antigen on the dendritic cell fits into the CD4 T-cell’s receptor, it will begin its invasion. HIV has already hitchhiked its way into the CD4 T-cell just because the immune system is doing what it’s supposed to do. At this point, naive CD4s are becoming infected as they are recruited by the entry of HIV into the body. HIV will multiply and many virions will be produced by the activated CD4s. It’s like a copy machine gone wild. This is the point of acute infection where viral load skyrockets. We also know that some HIV-specific memory cells die, but some go off and rest in what are known as reservoirs. Still others remain defective. Some of these cells remain infected after they are activated and return to a resting state, hiding out for years until they are awakened again with the HIV inside of them. CD8 T-cells go about their normal P osi t i v elyAware .com

About these images: Mike Tyka is a Research Fellow at the University of Washington. Using molecular visualized software called PyMOL, Tyka created these images. He is also author of the Beautiful Proteins blog (http://beautifulproteins. blogspot.com).

response to HIV as they are employed by the CD4 cell to kill. Yet because of HIV, the infected CD4 cells don’t properly grow up, so they give weak or ineffective helper signals to the CD8 cells. This process is called anergy. Helpless CD8 T-cells are also ineffective, all caused by HIV in the first place. Now that HIV has messed up the memory T-cell component, it will also duplicate itself, adding new fuel for the over 700 million naïve T-cells being produced in the thymus every day. The entire cycle repeats itself, over and over, again and again, day after day, until the immune system loses much of its work force. In most cases, HIV will eventually win if treatment is not initiated, employing its insidious and underhanded ability to upend the immune system puzzle.

inflammation caused by the immune response, which would hopefully prevent some of the longer-term non-AIDS conditions now experienced by many people living with HIV into their golden years. It is also exciting that research into a cure is gaining momentum, especially after Timothy Brown—the Berlin Patient—was cured of HIV. His case is providing the needed push, evidence that a cure for HIV is possible. Now, four years after his cure, more research is entering into clinical trials, including treatment vaccines, gene therapy, and other immune-based therapies such as IL-7. The possibility of a cure has opened the door for fitting the pieces of the immune system puzzle together once and for all. e

Ending HIV once and for all?

Diagnosed with HIV in 1988, Matt Sharp’s long history as an AIDS advocate includes belonging to ACT UP Golden Gate; directing the education programs at Test Positive Aware Network in Chicago and Project Inform in San Francisco; and helping to found the AIDS Treatment Activists Coalition. Currently, he acts as an international consultant, providing training services to HIV service providers, non-profit organizations, and the pharmaceutical industry.

There has been great success with antiretroviral therapy in turning around the devastation of the early days of the epidemic when sickness and death were common. But with many unknowns as to how to mend the immune system, even when people are successfully treated, there still remains smoldering HIV hiding in those resting cells. Yet there is new hope in controlling

S E P T E M B E R + O C TO B E R 2 01 1

PREZISTA IMPORTANT SAFETY INFORMATION AND INDICATION Talk to your healthcare ABOUT PREZISTA professional about the ® PREZISTA (darunavir) is a signs and symptoms of liver prescription medicine. It is one problems. These may include treatment option in the class of yellowing of your skin or whites HIV (human immunodeficiency of your eyes, dark (tea-colored) virus) medicines known as urine, pale-colored stools protease inhibitors. (bowel movements), nausea, PREZISTA is always taken with vomiting, loss of appetite, and at the same time as ritonavir or pain, aching or sensitivity on (Norvir®), in combination with other your right side below your ribs HIV medicines for the treatment of • In a small number of patients, HIV infection in adults. PREZISTA PREZISTA has been reported should also be taken with food. to cause a severe or life• The use of other medicines active threatening rash. Contact against HIV in combination with your healthcare professional PREZISTA/ritonavir (Norvir®) may immediately if you develop increase your ability to fight HIV. a rash. Your healthcare professional will Can PREZISTA be taken with work with you to find the right other medications? combination of HIV medicines • Taking PREZISTA with • It is important that you remain certain medicines could under the care of your healthcare cause serious and/or lifeprofessional during treatment with threatening side effects PREZISTA or may result in loss of its effectiveness. Do not take PREZISTA does not cure HIV PREZISTA if you are taking infection or AIDS, and does not the following medicines: prevent passing HIV to others. alfuzosin (Uroxatral®), dihydroergotamine (D.H.E.45®, Please read Important Safety ® ), ergonovine, Migranal Information below, and talk to ergotamine (Wigraine®, your healthcare professional Ergostat®, Cafergot®, Ergomar®), to learn if PREZISTA is right methylergonovine, cisapride for you. (Propulsid®), pimozide (Orap®), oral midazolam, triazolam IMPORTANT SAFETY (Halcion®), rifampin (Rifadin®, INFORMATION Rifater®, Rifamate®), sildenafil ® (Revatio ) when used to treat What is the most important pulmonary arterial hypertension, information I should know indinavir (Crixivan®), lopinavir/ about PREZISTA? ritonavir (Kaletra®), saquinavir • PREZISTA, together with (Invirase®), lovastatin (Mevacor®, Norvir®, has been observed Altoprev®, Advicor®), pravastatin in a small number of (Pravachol®), simvastatin (Zocor®, patients to cause liver Simcor®, Vytorin®), salmeterol problems which may be life(Serevent®), or products threatening. Your healthcare containing St. John’s wort professional should do • Before taking PREZISTA, tell your blood tests prior to starting healthcare professional if you combination treatment are taking sildenafil (Viagra®), including PREZISTA. If you vardenafil (Levitra®), tadalafil have chronic hepatitis B or (Cialis®, Adcirca®), atorvastatin C infection, your healthcare ® (Lipitor ), atorvastatin/amlodipine professional should check (Caduet®), rosuvastatin (Crestor®), your blood tests more or colchicine (Colcrys®). This often because you have is not a complete list of an increased chance of medicines. Be sure to tell developing liver problems

your healthcare professional about all the medicines you are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements

• As with other protease inhibitors, taking PREZISTA may strengthen the body’s immune response, enabling it to begin to fight infections that have been hidden. Patients may experience signs and symptoms of inflammation that can include swelling, tenderness, or redness • Tell your healthcare professional if you are taking estrogen-based • The most common side effects contraceptives (birth control). related to taking PREZISTA include PREZISTA might reduce the diarrhea, nausea, rash, headache, effectiveness of estrogen-based stomach pain, and vomiting. Other contraceptives. You must take important severe side effects additional precautions for birth include inflammation of the liver control, such as condoms or pancreas and increased blood fat levels. What should I tell my • This is not a complete list of healthcare professional all possible side effects. If you experience these or other side before I take PREZISTA? effects, talk to your healthcare • Before taking PREZISTA, tell your professional. Do not stop taking healthcare professional if you PREZISTA or any other medicines have any medical conditions, without first talking to your including allergy to sulfa medicines, healthcare professional diabetes, liver problems (including You are encouraged to report hepatitis B or C), or hemophilia negative side effects of • Tell your healthcare professional prescription drugs to the FDA. if you are pregnant or planning Visit www.fda.gov/medwatch, to become pregnant, or are or call 1-800-FDA-1088 breastfeeding Please refer to the ritonavir (Norvir®) - The effects of PREZISTA on Product Information (PI and PPI) pregnant women or their unborn for additional information on babies are not known. You and precautionary measures. your healthcare professional Dosing Information: will need to decide if taking PREZISTA is right for you For adults taking HIV meds for the first time and for many - Do not breastfeed if you are adults who have taken HIV meds taking PREZISTA. You should in the past: PREZISTA 800 mg not breastfeed if you have (two 400-mg tablets) must be taken HIV because of the chance of at the same time with 100 mg passing HIV to your baby Norvir® once daily every day. PREZISTA must be taken with food. What are the possible side For some adults who have taken effects of PREZISTA? HIV meds in the past: • High blood sugar, diabetes or PREZISTA 600 mg/Norvir® 100 mg worsening of diabetes, and must be taken twice daily at the increased bleeding in people with same time every day with food. hemophilia have been reported in Your healthcare professional can patients taking protease inhibitor determine which dose is right for you. medicines, including PREZISTA Please see Important Patient • Changes in body fat have been Information on the next page for seen in some patients taking HIV more information, or visit www. medicines, including PREZISTA. PREZISTA.com. The cause and long-term health effects of these conditions are not If you or someone you know needs help paying for medicine, call known at this time 1-888-4PPA-NOW (1-888-4772669) or go to www.pparx.org.

www.PREZISTA.com Distributed by: Tibotec Therapeutics/Division of Centocor Ortho Biotech Products, L.P., Titusville, NJ 08560

05/11

28PRZDTC10035R

ONCEDAILY PREZISTA

EXPANDED ONCE-DAILY DOSING FOR PREZISTA For adults who have not taken HIV medications before and ALSO for many adults who have taken HIV medications in the past Once-Daily PREZISTA 800 mg (two 400-mg tablets) must be taken with Norvir速 100 mg and food at the same time every day, as part of combination HIV therapy. Talk to your healthcare professional about your HIV treatment options and ask if Once-Daily PREZISTA is right for you. Please read Important Safety Information and dosing information on adjacent page.

www.PREZISTA.com Registered trademarks are the property of their respective owners.

IMPORTANT PATIENT INFORMATION PREZISTA (pre-ZIS-ta) Darunavir ALERT: Find out about medicines that should Not be taken with PREZISTA. Please also read the section “Who should not take PREZISTA?”. Read this Patient Information before you start taking PREZISTA and each time you get a refill. There may be new information.This information does not take the place of talking to your doctor or healthcare provider about your medical condition or your treatment. What is the most important information I should know about PREZISTA? PREZISTA, together with NORVIR® (ritonavir), has been observed in a small number of patients to cause liver problems which may be life-threatening. Your healthcare provider should do blood tests prior to initiating combination treatment including PREZISTA. If you have chronic hepatitis B or C infection, your healthcare provider should check your blood tests more often because you have an increased chance of developing liver problems. Talk to your healthcare provider about the signs and symptoms of liver problems. These may include yellowing of your skin or whites of your eyes, dark (tea colored) urine, pale colored stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching or sensitivity on your right side below your ribs. In a small number of patients, PREZISTA has been reported to cause a severe or life-threatening rash. Contact your healthcare provider immediately if you develop a rash. Please also read the section “What are the possible side effects of PREZISTA?” What is PREZISTA? PREZISTA is a prescription anti-HIV medicine used with other anti-HIV medicines used to treat adults. PREZISTA is a type of anti-HIV medicine called a protease (PRO-tee-ase) inhibitor. PREZISTA is used with ritonavir and other anti-HIV medicines to treat people with human immunodeficiency virus (HIV-1) infection. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). How does PREZISTA work? PREZISTA blocks HIV protease, an enzyme which is needed for HIV to multiply. When used with other anti-HIV medicines, PREZISTA can help to reduce the amount of HIV in your blood (called “viral load”) and increase your CD4 (T) cell count. HIV infection destroys CD4 (T) cells, which are important to the immune system. The immune system helps fight infection. Reducing the amount of HIV and increasing the CD4 (T) cell count may improve your immune system and, thus, reduce the risk of death or infections that can happen when your immune system is weak (opportunistic infections). PREZISTA is always taken with and at the same time as ritonavir (NORVIR®), in combination with other anti-HIV medicines. PREZISTA should also be taken with food. Does PREZISTA cure HIV or AIDS? PREZISTA does not cure HIV infection or AIDS. At present, there is no cure for HIV infection. People taking PREZISTA may still develop infections or other conditions associated with HIV infection. Some of these conditions are pneumonia, herpes virus infection, and Mycobacterium avium complex (MAC) infections. Because of this, it is very important for you to remain under the care of a healthcare provider. Although PREZISTA is not a cure for HIV or AIDS, PREZISTA can help reduce your risks of getting illnesses associated with HIV infection (AIDS and opportunistic infection) and eventually dying from these conditions. Does PREZISTA reduce the risk of passing HIV to others? PREZISTA does not reduce the risk of passing HIV to others through sexual contact, sharing needles, or being exposed to your blood. For your health and the health of others, it is important to always practice safer sex by using a latex or polyurethane condom or other barrier method to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood. Never re-use or share needles. Ask your healthcare provider if you have any questions on how to prevent passing HIV to other people. What should I tell my doctor before I take PREZISTA? PREZISTA may not be right for you. Before taking PREZISTA, tell your doctor or healthcare provider if you: • are allergic to sulfa medicines.

• h ave diabetes. Anti-HIV medicines, such as PREZISTA, might increase sugar levels in the blood. • have liver problems, including hepatitis B and/or C. • have hemophilia. Anti-HIV medicines, such as PREZISTA, might increase the risk of bleeding. • are pregnant or planning to become pregnant. The effects of PREZISTA on pregnant women or their unborn babies are not known. You and your healthcare provider will need to decide if taking PREZISTA is right for you. If you take PREZISTA while you are pregnant, talk to your healthcare provider about how you can be included in the Antiretroviral Pregnancy Registry. • are breastfeeding. Do not breastfeed if you are taking PREZISTA. You should not breastfeed if you have HIV because of the chance of passing HIV to your baby. Talk with your healthcare provider about the best way to feed your baby. The Centers for Disease Control and Prevention (CDC) recommends that HIV-infected mothers not breastfeed to avoid the risk of passing HIV infection to your baby. Who should not take PREZISTA?** Together with your healthcare provider, you need to decide whether taking PREZISTA is right for you. Do not take PREZISTA if you: • are allergic to darunavir or any of the other ingredients in PREZISTA • are allergic to ritonavir (NORVIR®) • take any of the following types of medicines because you could experience serious side effects: – alfuzosin (Uroxatral®) – dihydroergotamine (D.H.E. 45®, Migranal®), ergonovine, ergotamine (Cafergot®, Ergomar®), methylergonovine – cisapride – pimozide (Orap®) – oral midazolam, triazolam (Halcion®) – St. John’s wort (Hypericum perforatum) – lovastatin (Mevacor®, Altoprev®, Advicor®), simvastatin (Zocor®, Simcor®, Vytorin®) – rifampin (Rifadin®, Rifater®, Rifamate®, Rimactane®) – sildenafil (Revatio®) when used to treat pulmonary arterial hypertension Can PREZISTA be taken with other medications?** Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. PREZISTA and many other medicines can interact. Sometimes serious side effects will happen if PREZISTA is taken with certain other medicines (see “Who should not take PREZISTA?”). Tell your healthcare provider if you are taking estrogen-based contraceptives (birth control). PREZISTA might reduce the effectiveness of estrogen-based contraceptives. You must take additional precautions for birth control such as a condom. Tell your healthcare provider if you take other anti-HIV medicines. PREZISTA can be combined with some other anti-HIV medicines while other combinations are not recommended. Tell your healthcare provider if you are taking any of the following medicines: – bepridil, lidocaine, quinidine, amiodarone (Cordarone®), digoxin (Lanoxin®), flecainide (Tambocor®), propafenone (Rythmol®) – warfarin (Coumadin®) – carbamazepine (Tegretol®, Carbatrol®), phenobarbital, phenytoin (Dilantin®, Phenytek®) – trazodone (Desyrel®), desipramine (Norpramin®) – colchicine (Colcrys®) – clarithromycin (Biaxin®) – ketoconazole (Nizoral®), itraconazole (Sporanox®), voriconazole (Vfend®) – rifabutin (Mycobutin®), – metoprolol (Lopressor®, Toprol-XL®), timolol (Betimol®, Combigan®, Istalol®, Cosopt®, Timoptic®) – midazolam administered by injection – felodipine (Plendil®), nifedipine (Adalat®), nicardipine (Cardene®)

IMPORTANT PATIENT INFORMATION – dexamethasone, fluticasone (Advair Diskus®, Cutivate®, Flonase®, Flovent Diskus®) – bosentan (Tracleer®) – atorvastatin (Lipitor®), pravastatin (Pravachol®), rosuvastatin (Crestor®) – cyclosporine (Sandimmune®, Neoral®), tacrolimus (Prograf®), sirolimus (Rapamune®) – salmeterol (Serevent®) – Methadone, buprenorphine, buprenorphine/naloxone – risperidone (Risperdal®, Risperdal® Consta®, Risperdal® M-TAB®), thioridazine – sildenafil (Viagra®), vardenafil (Levitra®), tadalafil (Cialis®) – tadalafil (Adcirca®) – paroxetine (Paxil®), sertraline (Zoloft®) Tell your healthcare provider if you are taking any medicines that you obtained without a prescription. This is not a complete list of medicines that you should tell your healthcare provider that you are taking. Know and keep track of all the medicines you take and have a list of them with you. Show this list to all of your healthcare providers and pharmacists any time you get a new medicine. Both your healthcare provider and your pharmacist can tell you if you can take these other medicines with PREZISTA. Do not start any new medicines while you are taking PREZISTA without first talking with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for a list of medicines that can interact with PREZISTA. How should I take PREZISTA? Take PREZISTA tablets every day exactly as prescribed by your healthcare provider. You must take ritonavir (NORVIR®) at the same time as PREZISTA. • Do not change your dose of PREZISTA or stop treatment without talking to your healthcare provider first. • Take PREZISTA and ritonavir (NORVIR®) with food. • Swallow PREZISTA tablets whole with a drink. What should I do if I miss a dose? People who take PREZISTA one time a day: • If you miss a dose of PREZISTA or ritonavir (NORVIR®) by more than 12 hours, wait and then take the next dose of PREZISTA and ritonavir (NORVIR®) at your regularly scheduled time. If you miss a dose of PREZISTA or ritonavir (NORVIR®) by less than 12 hours, take your missed dose of PREZISTA and ritonavir (NORVIR®) right away. Then take your next dose of PREZISTA and ritonavir (NORVIR®) at your regularly scheduled time. People who take PREZISTA two times a day • If you miss a dose of PREZISTA or ritonavir (NORVIR®) by more than 6 hours, wait and then take the next dose of PREZISTA and ritonavir (NORVIR®) at your regularly scheduled time. • If you miss a dose of PREZISTA or ritonavir (NORVIR®) by less than 6 hours, take your missed dose of PREZISTA and ritonavir (NORVIR®) right away. Then take your next dose of PREZISTA and ritonavir (NORVIR®) at your regularly scheduled time. If a dose of PREZISTA or ritonavir (NORVIR®) is skipped, do not double the next dose. Do not take more or less than your prescribed dose of PREZISTA or ritonavir (NORVIR®) at any one time. What are the possible side effects of PREZISTA? PREZISTA can cause side effects. The following is not a complete list of side effects reported with PREZISTA when taken either alone or with other antiHIV medicines. Do not rely on this leaflet alone for information about side effects. Your healthcare provider can discuss with you a more complete list of side effects. PREZISTA, together with NORVIR® (ritonavir), has been observed in a small number of patients to cause liver problems which may be life-threatening. Your healthcare provider should do blood tests prior to initiating combination treatment including PREZISTA. If you have chronic hepatitis B or C infection, your healthcare provider should check your blood tests more often because you have an increased chance of developing liver problems. Talk to your healthcare provider about the signs and symptoms of liver problems. These may include yellowing of your skin or whites of your eyes, dark (tea colored) urine, pale colored stools (bowel movements), nausea,

vomiting, loss of appetite, or pain, aching or sensitivity on your right side below your ribs. Rash has been reported in 10.3% of patients receiving PREZISTA. In a small number of patients, PREZISTA has been reported to cause a severe or life-threatening rash. Contact your healthcare provider immediately if you develop a rash. Other relevant severe side effects were inflammation of the liver or pancreas, increased blood fat levels, diabetes, and changes in body fat. The most common side effects include diarrhea, nausea, rash, headache, abdominal pain and vomiting. Other side effects of PREZISTA include the following: • high blood sugar (hyperglycemia) and diabetes. This can happen in patients taking PREZISTA or other protease inhibitor medicines. Some patients have diabetes before starting treatment with PREZISTA which gets worse. Some patients get diabetes during treatment with PREZISTA. Some patients will need changes in their diabetes medicine. Some patients may need new diabetes medicine. • increased bleeding in patients with hemophilia. • changes in body fat. These changes can happen in patients taking anti-HIV medicines, including PREZISTA. The changes may include an increased amount of fat in the upper back and neck, breast, and around the back, chest, and stomach area. Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions are not known. • immune reconstitution syndrome. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment, including PREZISTA, is started. Tell your healthcare provider promptly about these or any other unusual symptoms. If the condition persists or worsens, seek medical attention. This medication is prescribed for your particular condition. Do not use it for any other condition or give it to anybody else. Keep PREZISTA and all of your medicines out of the reach of children. If you suspect that more than the prescribed dose of this medicine has been taken, contact your local poison control center or emergency room immediately. This is a brief summary of information about PREZISTA for adult patients with HIV. If you have any questions or concerns about either PREZISTA or HIV, talk to your healthcare provider. For additional information, you may also call Tibotec Therapeutics at 1-877-REACH-TT or 1-877-732-2488. ** The brands listed are the registered trademarks of their respective owners and are not trademarks of Tibotec Pharmaceuticals

Manufactured for Tibotec, Inc. by: JOLLC, Gurabo, Puerto Rico Distributed by: Tibotec Therapeutics, Division of Centocor Ortho Biotech Products, L.P., Raritan NJ 08869 NORVIR® is a registered trademark of its respective owner. PREZISTA® is a registered trademark of Tibotec Pharmaceuticals © Tibotec, Inc. 2006

Revised: December 2010

10101712P

It’s in Your blood Some of the most important lab tests and what they mean by Judith Feinberg, MD

In many parts of the world, medical providers care for their patients who have HIV/AIDS without the benefit of laboratory tests—sometimes even the most basic ones. Fortunately, in the United States (and various other countries), medical providers almost always have available to them a wide range of diagnostic tools. Below are some of the most important ones. Complete blood count (CBC)

CD4 cell count

This tells you whether you are anemic (too few red blood cells), neutropenic (too few of the white blood cells called neutrophils that fight bacterial infections), or thrombocytopenic (too few platelets, or thrombocytes, for your blood to clot normally)—all of which occur commonly in people with HIV. The CBC also gives you something called the “differential,” which is an individual count of all the different kinds of white blood cells: neutrophils, monocytes, lymphocytes, basophils, and eosinophils. It is also crucial in determining your total CD4+ T-cell (or CD4) count, a critical measure of immune function.

The FACS (not “fax,” although pronounced the same way) or Fluorescence Activated Cell Sorter machine identifies CD4 cells and directly measures what their proportion (percent) is of all your lymphocytes (white blood cells) when your blood was drawn. So, the CD4 percent is what the machine actually measures, and the total (or “absolute”) CD4 cell count is derived from multiplying the percentage of CD4s by the total lymphocyte count. That is why the differential from the CBC is necessary—in order to obtain your CD4 cell count. Over time, the CD4 percent is a more stable measure of your immune system

SEPTEMBER+OCTOBER 2011

function because the total CD4 count is influenced by your white blood cell count at the moment your blood was drawn, a number that varies constantly. Nonetheless, by habit and tradition, health care providers have used the total CD4 cell count for key decisions, such as when to start HIV meds or preventive therapy for opportunistic infections, like PCP (pneumocystis pneumonia).

Viral load, or HIV RNA PCR (HIV ribonucleic acid polymerase chain reaction) This key test tells us how much virus is in a milliliter (abbreviation: mL) of your blood, one-fifth of a teaspoon. Note that it does not tell us how much HIV is in your entire body, where most of the virus is—in tissues, such as your lymph glands or nodes. Even though this test uses a tiny quantity of blood, it has proven to be a very good indicator of response to antiretroviral therapy. The most commonly used test is made by Roche, and has established cut-off P os it i v elyAware .com

The type of syphillis test is less important than the fact that everyone with HIV should have one upon entering HIV care.

values for the upper limit of how much virus can be detected and the lower limit, which is referred to as “undetectable” virus, a shorthand way of saying “below the limit of detection.” Note that “undetectable” means the amount of HIV is less than the technical ability of the test to detect it and does not mean that HIV is not there. The Ultrasensitive test has a low-end cut-off of less than 20 copies of HIV RNA/mL. There are other types of viral load tests (see Positively Aware July+August 2011, Undetectable—Says Who?), such as the branched DNA (bDNA) assay, that are sometimes used. There are various technologies, but the measurement principles, with cut-offs for the upper and lower limits, are similar to the RNA PCR tests above.

Serum Chemistries—liver and kidney function tests Liver Function Tests (LFTs): These tests measure some key functions of the liver, a complex organ that performs many important tasks in the body. The liver P osi t i v elyAware .com

manufactures proteins that are essential to blood-clotting and to keeping fluid in your bloodstream instead of leaking out into your tissues and causing swelling (edema). The liver breaks down most environmental poisons (toxins) and drugs to rid the body of them. It also forms bile, which is important for digestion. Amino aspartate transaminase (AST) and alanine aspartate transaminase (ALT) are key enzymes that indicate how well liver cells (hepatocytes) are functioning. The levels of an enzyme called alkaline phosphatase and a protein by-product called bilirubin indicate how well the liver is producing and excreting bile, which is then stored in the gall bladder. Albumin, a protein made in the liver, is critical for keeping fluid in the bloodstream and is an overall measure of nutritional status. Liver function can be damaged by alcohol abuse, environmental toxins (including street drugs), viral infection of the liver (viral hepatitis), and a long list of diseases and prescription medications. Since people with HIV sometimes also have chronic hepatitis B or C, drink too much, or experience liver damage (hepatotoxicity) from medications, LFTs are important to monitor. Kidney (renal) function tests: These tests measure how well your kidneys are doing their primary job, which is to rid the body of protein waste (blood urea nitrogen, or BUN) and regulate blood volume by filtering out the waste and extra water to form urine. The two main kidney function tests look at the level of waste as a way to measure how efficiently your kidneys are operating. These tests can provide clues that someone might have HIV-associated nephropathy (HIVAN) or kidney malfunction due to other causes, such as dehydration, diabetes, or drug toxicity. Since some drugs are excreted from the body by the kidneys, dose adjustments need to be made when a person develops altered kidney function. Awareness of kidney dysfunction is also important when selecting an ARV regimen because some

medications, like Viread (tenofovir), are not preferred for someone with underlying kidney disease. Kidney function should be checked when someone enters HIV care. Thereafter, people at high risk of developing kidney disease (primarily African Americans and diabetics or people with a family history of diabetes) should have their kidney function checked at regular intervals. Routine checks at least annually are also recommended for people on ARV therapy.

Syphilis blood test Syphilis, like HIV, is a sexually transmitted infection that may have no symptoms at all. If left untreated, it can cause—years later—significant disease and death due to damage to blood vessels and the brain. There are a number of blood tests for syphilis (RPR, FTA, syphilis IgG), but the type of test is less important than the fact that everyone with HIV should have one upon entering HIV care; women who become pregnant should also have one to prevent transmission to their unborn baby. After that, screening depends on risk— people who are at higher risk of exposure through unprotected sex, especially those with multiple partners, may need to be screened regularly. Several outbreaks around the country among men who have sex with men have occurred over the past several years. Sex workers, incarcerated individuals, and people with other sexually transmitted infections are also at high risk. Otherwise, annual re-testing is appropriate.

Tests for viral hepatitis Many HIV-positive people are also infected (“co-infected”) with chronic hepatitis B virus (HBV) and/or hepatitis C virus (HCV). It is very important to find this out because, if left untreated, both conditions can ultimately lead to severe scarring of the liver (cirrhosis), liver failure, and liver cancer (hepatocellular carcinoma, or HCC for short). S E P T E M B E R + O C TO B E R 2 01 1

Genotype and phenotype tests are used to help choose a new combination of meds for people who are not responding to their current HIV therapy.

Some HIV medicines are active against hepatitis B, so it is important to craft an ARV regimen that will adequately treat both HIV and HBV at the same time. Hepatitis C currently requires treatment with two drugs—peginterferon and ribavirin—that do not control HIV, and this therapy can be pretty challenging. The use of newly approved drugs for HCV used in addition to the standard combination of peginterferon and ribavirin can markedly improve response to therapy, as well as possibly shortening the treatment period. In addition to HBV and HCV, it is also important to test blood for proteins that are protective (called antibodies) to hepatitis A (HAV). There is no chronic form of hepatitis A, but if you already have chronic liver disease from hepatitis B and/or C, you can get much sicker from hepatitis A than someone who doesn’t have HBV or HCV, because you may already have some liver damage. Since there are vaccines available for hepatitis A and B (but not, unfortunately, for hepatitis C), these should be offered to every HIV-positive person whose blood tests show no immunity to these viruses.

Resistance tests (genotype and phenotype) These tests tell us whether your virus is resistant to certain HIV drugs (in other words, a given medication will not be effective against your virus). Testing for transmitted resistance is now recommended before starting HIV meds, as up to 12% of people have a virus that is resistant to one or more antiretrovirals. These tests are also used to help choose a new combination of meds for people who are not responding to their current HIV therapy. Both genotypes and phenotypes are done on a blood sample. Genotypes, which are simpler, faster, and cheaper to perform, identify changes in particular viral genes that are associated with reduced or no response to specific drugs. 36

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Phenotypes, which are more complicated, time-consuming, and expensive, test how well your HIV grows in the presence of different concentrations of HIV drugs. Genotypes may be more than adequate for early resistance because they look at how much resistance the virus has compared to virus with no resistance; phenotypes have some advantages for people with extensive resistance because they can indicate how well the virus responds to various amounts of individual drugs. The phenotype results can be especially useful when there are no “new” drugs available to someone and the only option is a “salvage” regimen of drugs to which the virus is at least partially, if not fully, susceptible. In the most difficult cases, both tests add information of value. Cost can limit the availability of these tests, especially the phenotype.

Serum lipids Diet, exercise, cigarette smoking, and your genetic heritage (the genes you inherited from your parents and ancestors) all influence your risk for heart disease. Since we now expect HIV-positive people to live a long time, we have to pay attention to the fact that both HIV itself and some of the medications used to treat it have been associated with abnormal lipid levels (cholesterol and triglycerides, which are fats in the blood). This makes it important to obtain fasting lipids when you first enter HIV care, and to have them repeated at least once a year. Repeating them more often will depend on whether they are normal or not to begin with and what other heart disease risks you have—are you overweight? Do you smoke? Do you have diabetes or high blood pressure? Do you exercise? Do you have a family history of high cholesterol or heart disease? To be accurate, lipid testing must be done in the “fasted” state—no food (or drink, except water or diet soda or plain tea or black coffee—any drink without

calories) for a minimum of eight hours, ideally 10 to 12. Fasting lipids include four separate measurements of different forms of fats that circulate in your blood: total cholesterol, high-density lipoprotein (HDL, or “good cholesterol”), low-density lipoprotein (LDL, or “bad cholesterol”), and triglycerides. High levels of HDL protect you against heart disease caused by clogged arteries in your heart (atherosclerotic heart disease). Unfortunately, high levels of the other fats are associated with an increased risk for heart disease. Lipid levels can be lowered with lifestyle changes, but some people may also have to take lipid-lowering drugs in addition to a diet change and other interventions.

Pap smear A Pap smear involves scraping cells from the cervix or anus (usually with a tiny cotton swab), preparing them on a slide, and viewing them through a microscope. Every HIV-negative woman should be screened once a year for cell changes on the cervix that could lead to cervical cancer, but women who are HIV-positive should be screened twice in the first year of care, and then annually after that if their initial tests are negative. Cervical cancer is caused by infection with certain strains of human papillomavirus (HPV). Cervical cancer is a real threat to HIV-positive women, especially at lower CD4 counts, and it became part of the case definition of AIDS in 1993. If caught early, it can be cured. Anal Pap smears are still not standard of care due to limitations of the test and because an expert is needed to accurately analyze the results. The wealth of data that exists for cervical Pap smears does not exist for anal Paps, so questions remain about their reliability and predictability as a screening tool. In some centers, anal Paps have been an effective way to screen for anal carcinoma, but many centers lack P os it i v elyAware .com

Now that HIV-positive people have the prospect of living out a normal lifespan, it is important to provide cancer screening tests.

health care providers and pathologists (the doctors who interpret Pap smears) who can perform this test reliably. There is also as yet no clearly-defined guidance about when the anal Pap shows abnormalities that have not yet become cancerous. Although the anal Pap was developed initially for men who have sex with men who are thought to be susceptible to anal carcinoma because of sexually transmitted HPV infection, women can also benefit from such a test, even if they have not had anal sex, because of something called the “field effect.” This refers to the fact that it is easier to spread HPV around the anogenital region than some other sexually transmitted infections.

Screening tests for cancer Now that HIV-positive people have the prospect of living out a normal lifespan, it is important to provide cancer screening tests because most cancers are age-related. Also, there is some evidence that people who are HIV-positive may be at higher risk for a broader range of cancers than the ones that have long been HIVassociated, like Kaposi’s sarcoma and B cell lymphoma. The guidelines for performing these screening tests are the same as those for HIV-negative individuals. n

For men aged 40 and older: an annual prostate-specific antigen (PSA) blood test to look for prostate cancer is recommended, but controversial because this test is not very precise.

For women aged 40 and older: a baseline mammogram (type of x-ray) to detect breast cancer, with subsequent mammograms based on age and family history.

For all people aged 50 and older: a baseline colonoscopy to detect colon

P osi t i v elyAware .com

cancer that is repeated in 10 years, unless abnormalities are found or there is a strong family history of colon cancer. n

For smokers: QUIT! A chest X-ray may be prudent for smokers with symptoms, but there is no clear interval for subsequent screening.

Additional tests, when a closer inspection is warranted Testosterone level. Among other key functions, testosterone is the hormone that drives sexual interest (libido) in both men and women, though normal levels for women are much lower than for men. Symptoms of low testosterone (hypogonadism) in men include: depression, lack of energy, reduced muscle mass, and decreased sex drive or arousal. Much less is known about women and testosterone, but low testosterone levels in women can also cause decreased sex drive. Hypogonadism seems to be common in HIV-positive men, though it is not known why. Testosterone levels in men normally decline with age, so the level has to be interpreted with your age in mind. Testosterone replacement can be done by injection every few weeks or by gels or patches that are applied to the skin every morning. It is difficult to replace testosterone in women because the amount needed is so small, and current doses of various testosterone preparations are geared for treating men. Thyroid hormone level. Low levels of thyroid hormone (hypothyroidism) are fairly common in women, HIV-positive or not. Low thyroid levels can cause weight gain, lack of energy, depression, and skin changes. A thyroid stimulating hormone (TSH) level can screen for an underactive, as well as overactive, thyroid gland. Both

underactive and overactive thyroid conditions can be treated. DEXA (dual X-ray absorptometry) scan. This scan tells us about the composition of the various body compartments—bone, fat, muscle—and is particularly useful in determining whether you have lost a modest amount (osteopenia) or too much (osteoporosis) of your bone mineral content. Osteopenia and osteoporosis weaken your bones and make them prone to fractures or breaking. Bone mineral loss can occur in men with low testosterone levels and women who have stopped having periods (menopause). It can also run in families. This problem can largely be avoided with a good intake of calcium (at least 500 mg per day in dairy foods and leafy greens or as a supplement) and vitamin D (from exposure to sunshine, in fortified milk, or as a daily supplement of 1,000 IU [international units]). It is important to do the kind of exercise that makes your muscles tug on your bones, such as resistance exercises that use weights or elastic bands. Walking briskly several times a week is also helpful because you are bearing your own weight, which helps keep your bones strong. In addition to calcium, vitamin D, and exercise, you can treat severe bone mineral loss with a medication you take once a week or once a month to help reverse bone loss. DEXA scans can also measure how much fat you have inside your body (visceral fat) and under your skin (subcutaneous fat), although this is more of a tool in studies of fat gain and loss (lipodystrophy) than a test used in the clinic to help with treatment of your HIV disease. e

Judith Feinberg, MD, is a clinician and Professor of Medicine at the University of Cincinnati, where she is also the Co-Director of the AIDS Clinical Trials Unit. S E P T E M B E R + O C TO B E R 2 01 1

HIV WELLNESS SERIEs David AlaIn Wohl, MD

Windows of opportunity Opportunistic infections in 2011

There was a time when living with HIV meant having to dodge one opportunistic infection bullet after another. In the absence of potent and durable HIV therapy, it was not a question of when, but rather, which nasty, weirdo bug would rear up to put you down. Before AIDS, words like pneumocystis and toxoplasmosis would have been gibberish to a medical student but, with the epidemic, these and the names of other opportunistic infections, or OIs, became part of a lexicon of dread spoken in San Francisco, New York, and other HIV hot zones. If we now live in the era of highly active antiretroviral therapy (HAART), then it was the era of OIs. To understand OIs and why they happen, one must appreciate the fortress that is our immune system, built over millennia of natural selection. There are gazillions of germs around and, indeed, inside us that need to stay out of areas of our body that must remain sterile. Those with immune defenses that could keep pathogens in their rightful place and protect the body when attacked from without or within lived to see another day (and also make babies). Those who did not, well, they did not have much fun. The upside of evolutionâ&#x20AC;&#x2122;s weeding out the weak is that those who went on to be fruitful and multiply were strong and we, their daughters and sons, are the inheritors of their rich immune systems. However, all bets are off when a novel virus like HIV attacks the very immune cells responsible for keeping the barbarian bugs outside the walls of our bodily sanctuaries. As the CD4 cell count falls, new infections that come along may fester and spread, rather than being dealt a swift blow by a valiant white blood cell; dormant infections, acquired in some sandbox as a toddler, can emerge as if from some spell 38

SEPTEMBER+OCTOBER 2011

and multiply, wreaking their own havoc. With HAART, however, the empire strikes back and OIs have become endangered in places where potent HIV therapy is a reality. CD4 cells rally in response to durable suppression of the virus and the opportunistic infections that preyed on weak immune systems may have fewer opportunities. Today, OIs are probably the least of your concerns, unless you are one of the millions of people for whom HAART is not available. In fact, in some resourcerich nations, people living with HIV and their health care providers are now preoccupied with the possible consequences of long-term survival and not the maladies that first made us take notice of a new disease 30 years ago. Tellingly, once again medical students know little of pneumocystis and other OIs of yore, as they do not see them often. Yet, more remains of OIs than a dark legacy. They are down but not out. Sometimes, those who are unaware they are HIV-positive, those who are HIVpositive but not on HIV therapy, or those who are not ready to take their HIV medications correctly present with OIs, some of which are life-threatening. Furthermore, itâ&#x20AC;&#x2122;s bad enough that these OIs can directly cause trouble, but they also may complicate HIV therapy. The rebuilding of the immune system that accompanies successful HAART can trigger an inflammatory response to opportunistic pathogens. It is as if a long-sleeping immune system groggily awakes only to find OIs running

amok and then overreacts. These immune reconstitution syndromes can be as damaging and dangerous as the infections themselves. Despite this risk, several studies indicate that starting HIV therapy soon after the diagnosis of an OI can be lifesaving compared to waiting until weeks later when control of the OI is achieved. The main study to look at this in the U.S. was conducted by the federally funded AIDS Clinical Trials Group (ACTG) and enrolled patients with a variety of OIs, but most had pneumocystis pneumonia and bacterial infections (those with tuberculosis were excluded).1 Immune reconstitutions happened but were not common in this study, and the benefits of HIV therapy led to more aggressive use of antiretrovirals in those with pneumocystis and some other OIs.

Mostly gone but not forgotten Below is a brief rundown of five OIs. For most readers, this is a catalogue of diseases you will never develop. For all, these diseases are a frightening reminder of what life can be like without potent HIV therapy.

Pneumocystis pneumonia This is the sine qua non of OIs and was the sentinel infection seen among gay men three decades ago that signaled the emergence of a new syndrome, later called AIDS. Long identified as pneumocystis carinii, it causes a devastating pneumonia, hence its shorthand is PCP, the last P for pneumonia. In 1999, the germ was renamed pneumocystis jiroveci in honor of Otto Jirovec, who in the 1950s was first to describe the organism in humans. (So, officially, we should be calling this PJP but many of us, especially those of us long in P os it i v e lyAware .com

Starting HIV therapy soon after the diagnosis of an OI can be lifesaving compared to waiting until weeks later when control of the OI is achieved. the tooth and gray in the hair, can’t stop saying PCP.) This organism is found in the environment and is essentially harmless to those with intact immune systems. However, when inhaled by someone with HIV disease and a weakened immune system, it can cause a pneumonia that can spread across the lungs, and trigger inflammation and swelling of the lung tissue. In some cases, cysts in the lungs form and pop, leading to collapse of the lung. As fluid accumulates in the lungs, oxygen levels in the body fall. Infected patients develop progressive shortness of breath, especially when walking or exerting themselves. Over the course of days, this can worsen. While cases of pneumocystis in other parts of the body outside the lungs have been reported, this is unusual. The diagnosis is often suspected when someone with AIDS presents with shortness of breath. A chest x-ray may show involvement across the lungs or only a part of the lung. In some cases, the chest films can be mysteriously normal in appearance, despite extensive infection. Sampling of deep down sputum can lead to the diagnosis by laboratory tests that can identify the germ quickly. A fiberoptic scope, called a bronchoscope, may be needed to get such material, as many people with PCP have a dry cough or produce only scant, pearl-colored sputum. Given the severity and high attack rate of PCP, it was an early target for intervention and some of the earliest HIV clinical research studies were directed at prevention and treatment of PCP. Today, doctors can treat PCP effectively. Most importantly, PCP may be almost completely prevented with prophylaxis. PCP prophylaxis made a huge and immediate dent in AIDS mortality, even before HAART. It is recommended that those with a CD4 cell count below 200/mm3 take some form of PCP prophylaxis. For people who start PCP prophylaxis at low CD4 cell counts who then start HAART, prophylaxis can be safely stopped once the counts rise and stay above 200/mm3. 2 You can speak P osi t i v elyAware .com

to your doctor about your risk and prophylaxis, as well as treatment options.

Toxoplasma encephalitis If pneumocystis is an unwelcome visitor, toxoplasma is a guest that stays, refuses to leave, and then messes with your head. Unlike pneumocystis and other OIs that people catch and get sick from, this parasite is an opportunist that is present in the body long before HIV disease weakens the immune system. Only then, when the remnants of the immune system can no longer contain the dormant infection, does the parasite emerge. Toxoplasma is ingested in raw or undercooked meat or, inadvertently, cat feces. It is not uncommon in places where meat is preferred on the rare side. In France, the land of steak tartare and goose liver pate, antibodies to toxoplasma that indicate prior exposure and infection are found in the majority of adults. In the U.S., where we tend to like our food charbroiled, fried, or steamed, fewer people are infected. Upon initial infection with toxoplasma, illness can develop, but then the immune system contains the parasite, which lays low, trouble free. When the immune system is profoundly weakened, like during AIDS, toxoplasma can reactivate and spread. The brain is a favorite site for toxoplasma to take up shop and there it can mass into large tumor-like lesions. Patients present with changes in their thinking and can have a headache and neurological deficits, depending on where the parasite lesions are located. Seizures are not uncommon. The disease can sometimes strike beyond the brain and involvement of the spinal cord and the lungs has been recognized. This is a tough disease, almost always occurring in people with very advanced AIDS, typically in those with CD4 cell counts below 50/mm3. The diagnosis can be a difficult one to make, since on brain scans like MRI and CT, the brain lesions can look a lot like other infections or cancers, such as brain lymphoma. In the early days of the HIV epidemic, a practical approach

to the diagnosis was established as a sort of gentleman’s agreement between HIV clinicians and their brain surgeon colleagues, who were often called on to perform a diagnostic brain biopsy. Aggressive treatment for toxoplasma was started in patients with AIDS and suspicious brain lesions and response would indicate the diagnosis of toxoplasmosis to be correct. However, after two weeks, if the lesions remained unchanged or worsened despite toxoplasma therapy, the surgeon would then attempt a brain biopsy to obtain tissue for a diagnosis. Bets are hedged that brain lesions are toxoplasma if the patient has no evidence of antibodies to the parasite in the blood. However, some people with toxoplasma may even lose the ability to make these antibodies, although this is not common. Treatment for toxoplasma can be effective, but recovery can take time. Prevention of toxoplasma is usually covered by the same medications used for PCP prophylaxis. Use of medications to prevent toxoplasma may need to be added for those with profoundly low CD4 cell counts (50 to 75/mm3 or less). Patients with AIDS should not handle cat litter, although most cases of toxoplasma in AIDS are from reactivation of disease and not newly acquired infection. As with most OIs, treatment and prevention of toxoplasma is not required once an individual’s CD4 count increases to above 100.

Cryptococcal meningitis Cryptococcus is a type of yeast that is found throughout the world, especially in certain trees, like the eucalyptus, and the air and soil beneath them. The fungus can concentrate in bird feces, although birds themselves are not infected, and therefore antibodies to the germ are more commonly found in pigeon handlers. Until the HIV epidemic, it was a rare infection of humans. With AIDS, cases of meningitis due to Cryptococcus dramatically increased. It is a particularly brutal infection. The organism is first inhaled, causing a mild to moderate lung infection, then slowly spreads, S E P T E M B E R + O C TO B E R 2 01 1

One day, people with CMV were walking into clinics with white flashes and blind spots and the next day they weren’t. It was amazing. typically to the meninges, the lining of the brain. The meninges do not like this at all. They swell in response. Yeasts multiply with abandon and start to clog up the parts of the brain that drain spinal fluid. Pressure can build in the head, squeezing nerves and the brain itself. Untreated, this results in death, as the soft brain is pushed down into the small opening at the base of the skull where the brainstem and spinal cord connect. Like most types of meningitis, that caused by Cryptococcus is heralded by headache. The brain is initially not involved; therefore, unlike in toxoplasma encephalitis, thinking is usually unaffected. Neck pain may or may not be present. Cranial nerves that control eye movement course along the skull and, with a buildup of pressure, may be squeezed against the bone, producing an inability to move an eye in one or more directions. The diagnosis is often made rapidly and that is essential. Tests of the blood and spinal fluid can identify the yeast within hours. Cryptococus can be effectively treated, though it may include challenging side effects. Repeated spinal taps may also help control the pressure around the brain and in some recalcitrant cases, a shunt that drains the fluid from the head into the belly must be inserted and tethered down in the neck and through the chest. If caught early, recovery may be expected and with eventual improvement of CD4 cell count, treatment can be discontinued. However, the optimal timing of HAART in those with cryptococcal meningitis is unclear. Immune reconstitution reactions to Cryptococcus triggered by HAART can further increase pressure inside the head with devastating consequences. Some data suggest this is more likely early in infection, while other studies indicate that such reactions can occur even if HAART is delayed for weeks. 3, 4 At present, cautious introduction of HAART is considered after about two weeks of treatment for Cryptococcus. For those with more severe meningitis, some wait longer, until the infection and intracranial pressure are under better control. 40

SEPTEMBER+OCTOBER 2011

Mycobacterium avium Complex (MAC) MAC may be one of the most misunderstood of the AIDS OIs. The whole “mycobacterium” thing confuses people into thinking this is a form of tuberculosis (Mycobacterium tuberculosis) and that it is contagious or is responsible for causing pneumonia. It isn’t and generally does not. MAC refers to a group of related organisms that cause similar disease, although most all of these infections are due to one type, called Mycobacterium avium. This OI is subtle. It eschews the bravado of its OI kin and their showy entrances of air hunger, seizures, and brain squeezing. After being breathed in or ingested, MAC disseminates and slowly starts to wear the body down. Fevers start. Weight drops. The patient tires easily. Much of what we picture in advanced AIDS is a product of MAC. Over time, internal lymph nodes, in a last effort at some response, can swell to contain the germ, only to start pressing on nearby organs, causing pain in the abdomen or obstruction of the intestines. The symptoms of MAC are tell-tale and a blood culture usually detects the bacteria. Treatment response is the rule, rather than the exception. MAC can be treated and prevented. Prophylaxis is recommended for those with CD4 cell counts below 50/mm3. Immune reconstitution to MAC may occur, but can also be treated.

Cytomegalovirus (CMV) CMV is in a family of virus we all know and hate, herpes. The herpes viruses include HSV (types 1 and 2), VZV (responsible for chickenpox and shingles), EBV (causes mononucleosis and certain types of cancers), HHV-8 (leads to Kaposi’s sarcoma), and CMV. A shared family trait is that these viruses are common in humans and once they enter the body, they never leave. All herpes viruses can cause disease and then hide away in the body only to return another day. CMV is found in most adults. The virus can be caught as a child from the mother or other children. It is also transmitted sexually. Acute infection in neonates can

be serious. In adults, infection may cause a mononucleosis-type illness or be completely unnoticed. CMV can cause a variety of diseases, but in people with profound AIDS, its major role on the OI stage is as an infection of the retina of the eye. CMV retinitis was a major scourge of the 1980s and early 1990s when regular eye examinations were an integral part of routine HIV care. Caught early, vision might be able to be controlled with treatment. Found late, vision loss and blindness were common. The virus also caused trouble elsewhere, including the colon, brain, spinal cord, adrenal glands, pancreas, and other organs. In transplant recipients, with immune systems dialed down by medications to prevent organ rejection, CMV is a major problem but more often causes pneumonia and, much less commonly, retinitis. Treatment for CMV disease was onerous and required indwelling central intravenous catheters and hours of hook ups to medications. Eye surgery was often done to correct the damage or implant devices to leak drugs into the eye to control the wildfire of CMV retinal disease. However, CMV disease was one of the OIs to retreat the quickest with the first antiretroviral cocktails. One day, people were walking into clinics with white flashes and blind spots and the next day they weren’t. It was amazing. There were bad cases of immune reconstitution to CMV, most notably, clouding of the fluid of the eye that led to loss of vision. This is almost unheard of nowadays. CMV may continue to do some dirty work in people living with HIV. There is some tantalizing evidence that a component of the inflammation associated with HIV may be due to co-infection with CMV. 5 The theory is that a relative inability of those with HIV, even at higher CD4 cell counts, to keep the virus in check allows it to replicate and trigger immune activation and subsequent inflammatory chemical release. More work is being done to follow up on this and to determine if treating CMV has a role in reducing risk of inflammation-related diseases in people with HIV. P os it i v e lyAware .com

Other OIs There are many other important OIs. In the middle of the country, people with HIV are at increased risk of histoplasmosis, a fungus that behaves a lot like TB in its presentation. TB itself is an opportunist that preys on those with HIV, especially when CD4 cell counts starts to dwindle, and is the leading OI of consequence in the developing world. Candida causes thrush, and may be an early sign of HIV; varicella virus (VZV) re-emerges as shingles; a germ called JC virus leads to progressive multifocal leukoencephalopathy (PML), an often fatal brain infection that can leave patients bewildered and debilitated; and bugs that cause diarrhea, like cryptosporidia, can always ruin someone’s day. The good news is that these, like the classic OIs described above, are on the run. The bad news, they are not completely gone. OIs are often geographic and other pathogens predominate in different parts of the world, an issue for the traveler with HIV and low CD4 cell counts. Other infections have become the new OIs. Human Papilloma Virus (HPV) is at

the root of cancerous and pre-cancerous lesions on the cervix, anus, and mouth. These cancers can happen in those with intact immune systems and, therefore, in those living with HIV, infection may be seen across the CD4 cell count spectrum. In some ways, syphilis has become an HIV opportunist, not by dint of a waning immunity, but because of behavior and the opportunities to spread among those with HIV and their partners. Mini-epidemics of the disease among men who have sex with men are occurring all over the country.

Conclusion OIs are no longer the plague on top of the plague that they once were, at least in the U.S. and other places where HAART is widely available. That means that the people most at risk for serious OIs are those unaware of their HIV infection, those without access to or not ready to start antiretroviral therapy, and those who are not able to adhere to HIV treatment. In addition, there are the people who are veterans of the HIV battle and have exhausted all treatment options or whose

CD4 cell counts remain stuck below 200/ mm3 even though their HIV is controlled. The concentration of risk of OIs in these groups remains a challenge for the HIV treatment community. For most of those living with HIV, however, OIs should be a back-burner issue. HAART, earlier diagnosis of HIV infection, and increased access to quality HIV care means it is much more likely a person with HIV will live a healthier life. And that is the way it should be. e David Alain Wohl, MD, is an Associate Professor of Infectious Diseases and Co-Director of the AIDS Clinical Trials Unit at the University of North Carolina. Metabolic complications associated with HIV infection and the nexus between HIV and incarceration are his major areas of research interest. His e-mail address is wohl@med.unc.edu. This article is supported by funding from Merck. Go to PosItivelyAware.com for references.

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Lighting the Way How a case manager can help you find the services you need

Finding out that you’re HIV-positive can be traumatic and scary enough, but if you feel clueless and alone about what to do, where to go, or who to trust, it can be even worse. That’s when finding a case manager may be exactly what you need. PA sat down with Kevin Bernal and Lorraine Hayes to get the inside story. Kevin is currently the Case Management Supervisor/Total Care Portal Coordinator and Lorraine was, until most recently, a Medical Case Manager at Test Positive Aware Network (TPAN) in Chicago. Starting the process The AIDS Foundation of Chicago (AFC) oversees case management at all the AIDS service organizations in the city. For anyone in Chicago who’s interested in finding a case manager, contacting AFC is the first step. If you live elsewhere, contact your local AIDS service organization or a state HIV/ AIDS hotline for information on how you can find a case manager. Based on information gathered during a phone intake, AFC considers the needs and location of the client, and the availability of case managers at agencies in their area, and then assigns the client to the appropriate agency.

What you don’t know It’s a well known fact that many newly diagnosed people react to the news by 42

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diving into denial, avoiding medical care and treatment, hiding their status from everyone, including themselves. But by the time most seek out a case manager, they’ve gotten to the point where they recognize they need some help. In Bernal’s experience, there are also clients who may have known they were positive for awhile, but for whom barriers to seeking help included lack of insurance, low or no income, or fear that they’d be turned away for inability to pay for services or treatment. “They weren’t aware that there are programs that would help them pay for their drugs, that there are Ryan White programs that will help them see their doctor and get their lab work every three months,” says Bernal. “A lot of people don’t know that there are programs like CHIC [COBRA Health Insurance Continuation]

that will help them pay their COBRA insurance premium if they become unemployed. If they don’t know that, they usually let that COBRA expire and then have no insurance at all. We can help people get connected to those kinds of programs.” Hayes also points out that there are many other community resources that clients may not know about either, where care is provided on a sliding-scale fee basis. This is usually more manageable for most people and case managers can refer their clients to those places. Perhaps a harbinger of things getting worse, both Hayes and Bernal have seen clients who tested positive but didn’t seek care or treatment because they’d heard about ADAP funding being cut and just assumed they wouldn’t be able to get the drugs that would keep their HIV under control. “Those clients have put getting treatment on the back burner until something happens and they’re having trouble getting around,” says Bernal, “or their CD4 count is so low and they’re in bad shape by the time they find out that other programs were out there.”

The first meeting So what happens at the first meeting between a client and their case manager? There is an extensive intake form and P os it i v e lyAware .com

Photo: Joshua Thorne

By Sue Saltmarsh

several other forms that must be filled out and signed (confidentiality, release of information, etc.). Clients are asked to bring with them proof of identity, residency, income, and HIV status. During the intake, case managers gather information that will help them to understand where the client is and what their needs are—medical history (including substance abuse and mental health); medication adherence; criminal history; employment and housing situation; contact information for the client and whoever they want to be notified in case of emergency; nutritional realities; transportation needs; and family and childcare needs. Given the extent and occasional sensitivity of all this information, it was good to hear that both Bernal and Hayes feel their clients, recognize that in order to get the help they need, a true picture of the issues they’re dealing with is necessary. Substance abuse answers are the ones most frequently “fudged.” But according to Bernal, they try to make it clear to the clients that answering the substance abuse questions is to help them, and it’s not going to disqualify them from any services, unless it’s a program where there’s a requirement that they have to be sober for the last 30 or 60 days. Since case managers frequently refer clients to other providers, could a concept like the “medical home” model be applied to case management? Do the medical providers and other agencies report back to the case manager who referred a client to them? Bernal explains that rule number one is that the client must sign a release of information (ROI) form for every provider so that they have the legal right to communicate to each other about the client. Without that, confidentiality laws prohibit the exchange of information. Usually, information sharing is instigated by the TPAN case manager, according to Hayes, though Bernal points out that when a client misses an appointment, that’s when he’s likely to hear from the provider, which he appreciates, and he can then follow up with the client. Once a client has found a case manager, gone through the intake, and been referred to services, how frequent are their visits to the case manager? P osi t i v elyAware .com

“It really depends on the level of need,” says Hayes. “Some clients are very selfsustaining. They may only need case management for specific referrals. Some clients have a higher level of need—they have other issues going on. With those, we can see them as often as they need to be seen.”

Goals Is there an ultimate goal for case managers or does it vary client to client? Bernal says the first goal is to make sure the client has access to the services from which he or she will benefit the most. But “the end goal, in an ideal situation, would be that the client reaches a sort of ‘graduation’ point where they’re self-sufficient and they pre tty much know how to handle all of this on their own.”

files, half-empty coffee cups, and bottles of Pepto-Bismol, but is it really like that? Hayes laughs briefly and then says, “Yes. For me it’s a balance between engaging with a client so that they really feel comfortable enough to open up and let me into their world and also doing the paperwork that needs to be done. It’s a matter of balance and it’s a challenge to maintain that.” A common frustration, says Bernal, is dealing with the effects of funding cuts. “There’s such a need for housing and other services and you see them all being cut. Our ability to refer people or to get them the services they need is diminishing while the need is getting greater.” With demand going up, there is obviously a need for good case managers.

A common frustration is dealing with the effects of funding cuts. The epidemic is not stopping, people are still getting infected, and yet the funding is just dropping away. For public health institutions, like the Illinois Department of Public Health (IDPH), success in self-sufficiency is quantified by medical standards—is the client in care, adherent with their treatment, staying in care, educated about their disease, practicing safe sex, and addressing addictions? Case management has changed over the years, Hayes explains. “It used to be an open-ended relationship, but now the idea is to make it much more time-limited.” The case manager now helps clients reach a level of stability and then they move out of the system, whereas before, they might have had five- or 10-year relationships with their case manager. “You can always come back into the system if your needs change,“ Bernal is quick to point out. “Somebody can graduate and then a year later, their needs are completely different and they can come back into the system and work on those new issues.”

Burn out and payoff It’s a fairly familiar picture—the overworked, underpaid case manager with never enough time to do what needs to be done, surrounded by piles of paper and

What advice would they give an aspiring case manager? Bernal says, “It’s very rewarding. There are so many success stories where the clients have so much to be proud of because they do a lot of work for themselves and it’s rewarding to see someone go from point A to point B.” Hayes agrees and adds that, though she’s not always good at it herself, selfcare is important in helping a case manager to be more balanced. “It also makes you better for your clients,” she says. Giving clients the tools they need to gain access to the things they need in order to go forward and stay healthy is the foundation of case management. Both Hayes and Bernal say seeing their clients do that is the most fulfilling part of their work. Hayes, who now serves as TPAN’s advertising and grants coordinator, says, “You get to see someone progress from ‘All is lost, I hate my life’ to being actually stable and happy, re-engaging with the world, getting the mental health help that they need, seeing their viral load go down and their CD4s go up and knowing that they had a part in that, that they took care of themselves—they were able to change their lives.” e S E P T E M B E R + O C TO B E R 2 01 1

Legal Rights and Wrongs Newly diagnosed or long-term survivor—what everyone should know about HIV and their rights By Roger V. McCaffrey-Boss

Confidentiality Rights— the AIDS Confidentiality Act First, your HIV status should not be disclosed by you to anyone except those people who absolutely need to know (doctors, health care providers, etc.), close friends, most-trusted confidants, and family members. Fellow co-workers are not people who need to know your HIV status. They could betray your confidence and if they told others you were positive, they would be breaking the law. As laws differ from state to state, you may need to seek legal advice or check the laws regarding confidentiality of HIV disclosure in your state. Section 9 of the Illinois AIDS Confidentiality Act prohibits disclosure of the identity of any person upon whom an HIV-antibody test is performed, or the results of the test, except to a list of certain medical professionals. And the confidentiality act provides for civil and 44

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criminal sanctions for disclosure of another’s HIV status to unauthorized persons.

Employment and Job Rights— Should You Tell your Employer? There is no definitive answer as to whether or when you should tell your employer of your HIV status. It is a case-by-case decision, as there are strong arguments against disclosure—it’s none of their business and can often cause you harm. But there are also arguments that the employer should be told in order to afford the employee some of the protections the law offers to people with HIV. Two times when it is appropriate to tell your employer are: when you are making HIV-related insurance claims or when your job performance is being impaired by HIV. If you are submitting medical bills for treatment of HIV, your employer is going

to find out. It’s best for your boss to hear it from you rather than through gossip or from the person in charge of benefits. Your HIV-positive condition is protected as a handicap under the Americans with Disabilities Act (ADA), now in effect, provided your employer has 25 or more employees. In Illinois, the Illinois Human Rights Act, the Cook County Human Rights Ordinance and the Chicago Human Rights Ordinance protect you against discrimination. If your job performance is being affected, you will need to request that your employer provide reasonable accommodation to your handicap, as required under these federal, state, and municipal discrimination laws. The form of the “reasonable accommodation” you may request is the ability to take short periods of time off from work if you need to do so. You may need to visit a doctor, undergo blood Pos i t i ve lyAware .com

If you are fired or laid off without disclosing your HIV status, you lose your legal right to claim that you were discriminated against because of your HIV status. testing to monitor your health, or you may need to rest and otherwise care for and maintain your fitness, energy, and strength. You should request that your employer instruct your immediate supervisor to permit you to take sick days off, but not to inform him or her as to the reasons for this permission. Although your employer may need to know your HIV status, your immediate supervisor and other employees do not. You don’t want to be fired or laid off because you couldn’t perform your job without your employer knowing the reason. If you are fired or laid off without disclosing your HIV status, you lose your legal right to claim that you were discriminated against because of your HIV status—which might be a violation of the law in your state. You may also want to apply for employerprovided short- or long-term disability benefits. These are only provided while you are an employee. Whatever you do, do not voluntarily quit your job if HIV is impairing your job performance. Instead, a medical or disability leave of absence should be requested. Otherwise, your right to long-term disability benefits and life insurance may be jeopardized. If you believe that you have been discriminated against in the City of Chicago or in Illinois, your remedy is to file a complaint with the Chicago Commission on Human Relations, the Cook County Commission on Human Rights, and/or the Illinois Department of Human Rights. Contact information is provided below.

Obligation to Disclose to Sexual Partners— Is it a crime to have sex? Reflecting a growing fear about HIV, legislatures around the country are passing laws attempting to protect the public from AIDS. More than 30 states now make it a crime to knowingly transmit or expose others to HIV, and some states are mandating HIV testing for specific segments of the population such as prisoners and pregnant women. More and more, the trend has been P osi t i v elyAware .com

for lawmakers to get tough on people with HIV. The legislative trend has been moving from a period when civil rights and civil liberties for a person with HIV prevailed, to a compulsory and punitive approach. Unfortunately, state legislatures, in their attempt to gain political points by passing laws which make transmission of HIV a crime, only serve to increase the atmosphere of fear that already surrounds HIV/AIDS, inhibiting people from coming forward to seek education, testing, counseling, and treatment. In addition to potential criminal penalties, there is also the possibility of civil liability for having sex if positive, depending on your state. Again, because the laws differ from state to state, it’s best to seek legal advice or check the laws in your own state. However, in Illinois, the state Supreme Court has unanimously upheld Illinois’ HIV Criminal Transmission of HIV Act. The case concerned alleged conduct involving vaginal intercourse. The defendant was charged with violation of the law that states, “knowing that he... is infected with HIV, [he] engaged in intimate contact with another.” And that intimate contact exposed one person to the bodily fluid of another person in a manner that could result in the transmission of HIV. Yes, you should disclose. The law does create an affirmative defense if the person who was exposed knew, or should have known, that they were at risk of being infected and consented to having sex with that knowledge. Anyone who is positive

and has sex should disclose their HIV status to their partner. The law in Illinois does not include other defenses which should be considered in a criminal prosecution, such as safe sex precautions with the use of a condom. Illinois law also does not require the sexual partner(s) to have actually been infected and the prosecution does not have to show that the accused had the criminal intent to infect someone else with HIV. Merely having sex (“intimate contact”) would be sufficient. Note that there have been very few Illinois prosecutions under this law other than actions involving prisoners who spit on guards.

Keeping Your Medical Insurance When You Change Jobs Employees have felt locked into their jobs to keep insurance coverage for preexisting conditions. To avoid “job-lock,” it is important to know and understand your rights under the Health Insurance Portability and Accountability Act (HIPAA). Under HIPAA, employers’ health care plans cannot exclude a new worker’s pre-existing condition from coverage for more than 12 months. If you are HIV-positive and it was known by the insurance company from your old employer, and you have been covered by them for more than 12 months, your HIV status will not be considered a pre-existing condition for your new insurance company. You will have health insurance on the first

Online resources Ending and Defending Against HIV Criminalization: State and Federal Laws and Prosecutions; go to http://hivlawandpolicy.org/resources/view/564. “Don’t always reveal your status—here’s why,” article by Justin Hayford in the May/June 2000 issue of Positively Aware; go to www.tpan.com/publications/ positively_aware/mar_april_00/DontAlwaysRevealMA00.html. The Safer Sex and HIV Prevention Expert Forum at TheBody.com, answered by Bob Frascino, MD, who is living with HIV himself; go to www.thebody.com/ Forums/AIDS/SafeSex/index.html.

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More than 30 states now make it a crime to knowingly transmit or expose others to HIV. day of your new job or whenever your new employer’s probationary period ends. When you leave your old job, employers with two or more employees that offer health insurance must notify former workers that they are eligible for certificates of coverage that would verify previous health coverage for new employers. New insurers can only exclude coverage for medical conditions that have been newly diagnosed or treated within the six-month period before the employee enrolled in the health care plan at the new job. However, the exclusion from coverage cannot be for more than 12 months.

Have a Rainy Day Plan— Putting Things in Order Everyone should plan for incapacity, regardless of their status. Life is unpredictable. Carry a wallet card with you with contact information for emergency caretakers. If you have a pet at home, carry a pet card to inform emergency care providers that there is a pet in your house that needs care and include information on

who should be contacted in case you are ill or injured while away from home. I also recommend having an ICE (In Case of Emergency) entry in the address book of your cell phone. That listing can help the paramedics call a family member, friend, or partner while you are riding to the hospital in the ambulance. Also, make sure your landlord or apartment building has updated contact information for you, including who can enter your apartment and have access to the important documents you will need.

they can borrow money from their pension or profit-sharing plan), or annuities. Contact current and former employers to see if there are any pension or survivor benefits available to you. Make sure you still favor the beneficiaries named for those benefits. Review all life insurance policies to make sure the primary and contingent beneficiaries reflect current intentions. Exercise any rights to purchase additional life insurance on existing policies.

Three Essential Documents

Keep in Control of your Health Care— Your Rights as a Patient

Everyone should make a will, power of attorney for property, and power of attorney for health care and share the details of their financial affairs with their agents. This should include the location of all assets and vital documents such as insurance policies, passbooks, deeds, etc. Double check your IRA accounts and their beneficiaries, pension funds and profit-sharing plans (employees should find out the circumstances under which

Each person should decide for themselves their choices regarding medical treatment. A health care power of attorney (HCPA) is the legal document in which you choose someone and give them the power to make medical decisions at a time when you cannot. Your doctor can rely upon the decisions of your agent if the doctor believes that you lack the capacity to give informed consent to health care treatment or even the refusal and termination of care.

to tell or not? Disclosure should be made By Enid Vázquez Deciding to tell someone your HIV status can be nervewracking. It’s a double-edged sword that can help you, but it might also hurt you. The benefit of disclosing to your loved ones, of course, is the chance to gain their support and a sense of relief and freedom, both good for your health. By not telling, when you would like to, you may increase your sense of burden and isolation. Among the risks is rejection. Worse, people may repeat 46

your disclosure to others, though in many places, disclosing someone else’s status is against the law. Letting people know about that may help keep them quiet about your status. As stated in the article “Rights and Wrongs,” you don’t have to tell anyone, except for sexual and needlesharing partners. That’s the law in most of the 50 states and territories, and the District of Columbia. Remember that you can take steps to protect yourself if you feel that disclosure

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might put you in harm’s way or that having a witness could be beneficial. You can ask a friend or other advocate to accompany you. In addition, your local public health department can contact your sexual and needle-sharing partners to tell them they may have been exposed to HIV, without naming you. “When you first get diagnosed, I recommend telling one or two close friends,” said Kristin Keglovitz, PA, medical director of Howard Brown Health Center in Chicago. “I’ve never had anyone regret telling

a couple of close friends, but I’ve had many patients who’ve told me, ‘I regret telling as many people as I did.’” Keglovitz has role-played disclosure with dozens of patients. “I tell people they should be prepared for the worst reaction,” said Keglovitz. “Prepare yourself for those who reject you, even when you expect support. Prepare yourself for people who need to take some time, who can become supportive after some education and awareness. Practice so that you’re not totally devastated.” P os it i v elyAware .com

A health care power of attorney grants your agent the authority to give consent to and authorize, or refuse, or withhold medical care and life-sustaining treatment, even if death would ensue. In Illinois, an HCPA grants your agent the authority to give consent to and authorize, or refuse, or withhold any and all types of medical care and life-sustaining treatment, even if death would ensue. This would include the right to admit you to or discharge you from any and all types of hospitals, institutions, homes, residential or nursing facilities, or treatment centers. n

Talk candidly and explicitly with your doctor about what you want him or her to do or not do, make sure you have a meeting of the minds.

Don’t keep your HCPA in a safe deposit box. You may need it on the weekend when the banks are closed.

If you want to be at home, remember you always have the right to check out of a hospital if that’s your desire. You are not a prisoner.

Or don’t check into a hospital—stay at home. It is easier to not start treatment

than to terminate it once it has started. The subjects of death and disability are not pleasant, but with modern medicine’s ability to keep people alive longer, each person should make these decisions themselves. e

support to Chicago’s LGBT community for more than 34 years. You may contact him at rvmlawyer@aol.com or 312-263-8800 with questions.

Resources in Illinois This material is for informational purposes only and subject to the unique needs of each individual. As laws differ from state to state, please check the laws in your state and please consult your own attorney for specific answers to your individual needs and situation. A consultation with your attorney can answer questions about your individual rights for any of the matters raised in this article.

Roger V. McCaffrey-Boss, Esq. is an attorney in private practice in Chicago. He is a graduate of Hamlin University School of Law in St. Paul, Minnesota; a member of the Chicago Bar Association and LAGBAC; and has provided legal services and

Chicago Commission on Human Relations 740 N. Sedgwick Chicago, IL 60654 312-744-4111 Cook County Commission on Human Rights 69 W. Washington Blvd., Suite 3040 Chicago, IL 60602 312-603-1100 Illinois Department of Human Rights 100 W. Randolph St., Suite 10-100 Chicago, IL 60601 312-814-6200

to measure Keglovitz refers patients with intricate legal questions to the AIDS Legal Council of Chicago (ALCC). She said her patients usually wonder if they have to tell their employer about a new HIV diagnosis. “There’s fear of not knowing their rights, of wondering if HR [human resources] can tell their co-workers.” She points out that Illinois is an at-will state, where employees can be fired for any reason, or no reason at all. “I have some patients who did disclose and sure enough, their jobs evaporated a few weeks later. P osi t i v elyAware .com

“There’s no reason to disclose if you’re not putting someone at risk,” said Keglovitz. “I’ve had a lot of people who work with children, such as teachers and care providers, ask if they need to disclose. They don’t.” On the other hand, when someone needs a medical excuse for being absent from work, it must note that the absence was HIV-related. The Center for HIV Law and Policy (CHLP) produces a manual on HIV laws, including cases in which people with HIV can be imprisoned, such as

biting or spitting, despite the nearly-zero risk of transmission. In addition, time can be added to certain convictions, such as prostitution, when the defendant is HIV-positive. And in states where there is no HIV-specific law, such as Connecticut, people with HIV can still be charged with reckless endangerment and/or aggravated assault. Last year, CHLP established the Positive Justice Project to combat HIV-related stigma and discrimination in the legal system. The project’s goal is to repeal laws that create

HIV-specific crimes or which enhance penalties for HIVpositive people convicted of criminal offenses. “You’re required by law to tell your partners before engaging in sex, and that’s regardless of using a condom or not,” Keglovitz notes. “I recommend that people tell their partner first, before sex, because it’s going to be a lot harder later.”

You can learn more about disclosure and other legal issues at the CHLP website: www.hivlawandpolicy.org.

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TO YOUR HEALTH Practically everything you ever wanted to know about the meds by Enid Vázquez

ou may have seen a handy little graphic on what to use when starting HIV therapy. It appears in every issue of Positively Aware’s Annual HIV Drug Guide, among other places. That graphic is taken from U.S. HIV treatment guidelines, but there is so much more to the guidelines than just that one table. There are dozens of tables, in fact: advantages and disadvantages of every HIV drug; drug interactions between medications for HIV and those for opioid dependence; HIV drug combinations never to take; and so on and so forth. All basically handy-dandy little lists of good things to know. 48

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Then there is the text, in mostly understandable language, though not fun to read. This 166-page manual can put you to sleep with just one paragraph. (To wit, its very title is “Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents.” Simple, yes. Exciting? No.)

Some of the many topics covered include co-infection with hepatitis B and C; lab tests and how often to take them; HIV drug resistance; and adherence (how to take the medications correctly). So you can think of the guidelines as a useful manual to race through, looking for what you need to know, when you need to know it. Just remember that the guidelines are just that—a guide, not rules set in stone. And furthermore, that they are updated on a regular basis. Recommendations are rated according to the strength of the evidence behind them. One of the best things about the guidelines is that they follow the ups and downs of treatment knowledge and controversy, although not necessarily instantaneously. The guidelines are issued by the U.S. Department of Health and Human Services (DHHS), and produced by a panel of experts, including people living with HIV. The panel looks at the latest and most important data. For example, the consensus on when to start treatment has changed over the years from beginning at a low CD4+ T-cell count to starting at higher levels, and will continue to change. That question has not yet been absolutely answered! In cases where the best scientific data has yet to be produced, the DHHS panel “attempted to reflect reasonable options in its conclusions.” The manual also notes that, “Guidelines are only a starting point for medical decision-making. They can identify some of the boundaries of highquality care but cannot substitute for sound judgment.” Another important use for the guidelines is to guide health care workers (the reason for its existence, actually), especially those providers with less experience P os it i v e lyAware .com

in treating HIV. So, pointing out some information to your providers, as you see fit, might be helpful. It’s also good to see what your providers might be thinking. In addition to this most often referenced set of guidelines (for adults and adolescents), the DHHS also produces HIV treatment guidelines for opportunistic infections, pediatrics, pregnant women, and post-exposure prevention (both health care-related and non-medical). Moreover, the International AIDS Society–USA also produces a set of HIV treatment guidelines, as well as HIV drug resistance testing guidelines; go to www.iasusa.org. Go to www.aidsinfo.gov to view all the government guidelines. Note: DHHS no longer mails out copies.

Highlights from the Guidelines The following are taken directly from the guidelines for HIV treatment from the U.S. Department of Health and Human Services, with minor editing: n

Patients living with HIV infection must often cope with multiple social, psychiatric, and medical issues that are best addressed through a patient-centered, multidisciplinary approach to the disease. The evaluation also must include assessment of high-risk behaviors, substance abuse, social support, mental illness, co-morbidities, economic factors (e.g., unstable housing), medical insurance status and adequacy of coverage, and other factors that are known to impair adherence to treatment and to increase the risk of HIV transmission. Once evaluated, these factors should be managed accordingly. n It is critical that all newly diagnosed patients be educated about HIV disease and linked to care for full evaluation, follow-up, and management. Once in care, focused effort is required to retain patients in the health care system. n Initial evaluation should include: • CD4 T-cell count; • Plasma HIV RNA (viral load); • Complete blood count, chemistry profile, transaminase levels, blood urea nitrogen (BUN) and creatinine, P osi t i v elyAware .com

urinalysis, and serologies for hepatitis A, B, and C viruses; • Fasting blood glucose and serum lipids; and • Genotypic resistance testing at entry into care, regardless of whether [HIV treatment] will be initiated immediately. In addition, screening tests for sexually transmitted infections and tests for determining risk for opportunistic infections and need for prophylaxis [prevention], should be performed as recommended by HIV primary care and opportunistic infections guidelines. When ascertained in a simple, nonjudgmental, routine, and structured format that normalizes less-than-perfect adherence and minimizes socially desirable responses [providers should be neutral—not showing disapproval when behavior is undesirable; patients may feel pressured to lie to avoid disapproval], patient self-report remains the most useful method for the assessment and longitudinal [long-term] monitoring of a patient’s adherence in the clinical setting. More recent data suggest that most virologic failure on first-line regimens occurred due to either pre-existing (transmitted) drug resistance or suboptimal adherence. For incomplete adherence, identify and address the underlying cause(s) (e.g., difficulties accessing or tolerating medications, depression, active substance abuse) and simplify the regimen if possible (e.g., decrease pill count or dosing frequency). Assess the patient’s tolerance of the current regimen and the severity and duration of side effects, keeping in mind that even minor side effects can impact adherence. Management strategies for intolerance in the absence of drug resistance may include: • using symptomatic treatment (e.g., anti-emetics and anti-diarrheals) • changing one ARV to another within the same drug class, if needed (e.g., change to [Viread] or [Ziagen] for [zidovudine]-related toxicities; change to [Viramune] or [Intelence] for [Sustiva]-related toxicities)

• changing from one drug class to another (e.g., from a non-nucleoside reverse transcriptase inhibitor [NNRTI] to a protease inhibitor [PI], from [fusion inhibitor Fuzeon] to [integrase inhibitor Isentress]) if necessary and no prior drug resistance is suspected Review food/fasting requirements for each medication. Review recent history of gastrointestinal symptoms (such as vomiting or diarrhea) to assess the likelihood of short-term malabsorption. Review concomitant [taken at the same time] medications and dietary supplements for possible adverse drug-drug interactions (consult Drug Interactions section and tables for common interactions) and make appropriate substitutions for ARV agents and/or concomitant medications, if possible. [There is also a section on how to simplify treatment.] Viremia “blips” (e.g., viral suppression followed by a detectable HIV RNA level [viral load] and then subsequent return to undetectable levels) usually are not associated with subsequent virologic failure. For some highly ART-experienced patients, maximal virologic [viral load] suppression is not possible. In this case, ART should be continued with regimens designed to minimize toxicity, preserve CD4 cell counts, and avoid clinical progression [disease]. [See much more information on this topic in the guidelines.] Education about HIV risk behaviors and effective strategies to prevent HIV transmission should be provided at each patient visit… Each patient encounter provides opportunities to reinforce HIV prevention messages— messages that patients often look to their providers to deliver but may fail to receive. [See the guidelines for more on prevention.] The guidelines cannot always keep pace with the rapid evolution of new data in this field, and they cannot provide guidance for all patients. Clinicians should exercise clinical judgment in management decisions tailored to unique patient circumstances. e S E P T E M B E R + O C TO B E R 2 01 1

Know Where to Look Consider the source when searching for information

If you’ve just discovered that you’re HIV-positive, you might turn to the Internet for help. But if you don’t know where to look or whom to trust, you could find yourself confused—and misinformed. Remember, just because you found something online doesn’t make it true or accurate. Always consider the source! Here are some online sources you can trust: General AIDS information AIDSmap Operated by NAM, a community-based organization in the United Kingdom, NAM offers informational booklets and more than 100 factsheets. NAM’s publications are evidence-based and reviewed by two international medical panels and one panel of people living with HIV. www.aidsmap.org AIDSmeds An easy to navigate and understand website that allows you to quickly find answers to questions about the basics of HIV and AIDS, available treatments, and other resources. www.aidsmeds.com AIDS InfoNet The InfoNet originated as a resource in both English and Spanish for residents of New Mexico, but has become an international resource of information on HIV/AIDS. www.aidsinfonet.org The Body This comprehensive website provides up-to-date information on current events, treatment issues, and profiles of people living with HIV/AIDS. www.thebody.com 50

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i-base Provides HIV treatment information for healthcare professionals and people living with HIV. www.i-base.info AIDS Treatment Data Network (ATDN) HIV and hepatitis treatment education and information, as well as advocacy, case management support and counseling, and other services in both English and Spanish. phone: 800-734-7104 www.atdn.org Positively Aware The website of Positively Aware magazine. Features exclusive online-only content not found in the print version of the magazine, as well links to the digital edition of the publication and a weekly email newsletter, PA E-News. www.positivelyaware.com PoWeR—Program for Wellness Restoration This comprehensive website offers links to patient-friendly information about ways to improve HIV treatment response, side effects, and quality of life. The organization also advocates for ethical and compassionate research protocols in the areas of HIV treatment, HIV cure, aging, side effect management, and complementary therapies. www.powerusa.org

Project Inform Treatment information and action alerts are available via the Internet, hotline and/or snail mail. 205 13th Street, #2001 San Francisco, CA 94103 phone: 800-822-7422 www.projectinform.org

Government sponsored AIDS.gov The federal government’s AIDS website is a gateway to federal domestic HIV/AIDS information and resources, including prevention, testing, treatment, and research programs, policies, and other resources. www.AIDS.gov AIDSInfo Current HIV treatment guidelines established by the U.S. Dept. of Health and Human Services (DHHS), as well as information on clinical trials. P.O. Box 6303, Rockville, MD 20849 phone: 800-HIV-0440 (448-0440) www.aidsinfo.nih.gov CDC (Centers for Disease Control and Prevention) Counselors are available 24 hours a day, seven days a week, to answer questions about personal health issues, including HIV/AIDS and other STDs. You can also register to receive regular e-mail updates. English: 800-342-AIDS (342-2437) Spanish: 800-344-SIDA (344-7432) www.cdc.gov

Pos i t i ve lyAware .com

African Americans

Gay Men

Black AIDS Institute Weekly news updates and treatment information specific to African Americans and other people of color. phone: 213-353-3610 1833 W. 8th St., Suite 200 Los Angeles, CA. 90057 www.blackaids.org RAP-IT-UP The HIV awareness campaign of BET. phone: 866–RAP-IT-UP (727–4887) www.rapituppresents.com

Gay Men’s Health Crisis (GMHC) A volunteer-supported and communitybased organization located in New York City providing treatment education and information, peer counseling and support. GMHC is also heavily involved in activism and advocacy regarding social and policy issues specific to the general health of gay men and lesbians. The agency also publishes Treatment Issues, a quarterly publication. 446 W. 33rd St. New York, NY 10001-2601 phone: 800-AIDS-NYC (243-7692) www.gmhc.org

Women Sisterhood Mobilized for AIDS/HIV Research and Treatment (SMART) Provides treatment and prevention education and support for all women living with HIV/AIDS. SMART 1751 Park Ave., New York, NY 10035 phone: 212-633-2500 ext. 601 www.smartuniversity.org

Other websites LifeLube.com To quote their website, “a field guide to gay men’s health with all the gay, sexy, and healthy you can take. Physical, sexual, mental, and emotional health, plus resources around communication, intimacy, and spirituality.” www.lifelube.org

Incarcerated The Well Project An initiative developed and administered by women living with and affected by HIV. www.thewellproject.org Women Alive A treatment focused, non-profit organization designed for and run by women living with HIV/AIDS. 1566 Burnside Avenue, Los Angeles, CA 90019 phone: 800-554-4876 www.women-alive.org P osi t i v elyAware .com

Project UNSHACKLE and the HIV/AIDS Prevention Justice Alliance are two groups that grew out of CHAMP, the Community HIV/AIDS Mobilization Project. Prison issues are a primary concern. The HIV Prevention Justice Alliance is now hosted by the AIDS Foundation of Chicago. 646-431-7525 www.preventionjustice.org Project UNSHACKLE is now hosted by VOCAL. 718-802-9540 www.vocal-ny.org

The Osborne Association’s AIDS in Prison Project The Osborne Association operates a broad range of treatment, educational, and vocational services for people involved with the adult criminal and juvenile justice systems, including prisoners and former prisoners, their children, and other family members. 809 Westchester Ave. Bronx, NY 10455 phone: 718-378-7022 www.osborneny.org

Adult AIDS Clinical Trials Group The largest HIV clinical trials organization, AACTG plays a major role in defining the standards of care for treatment of HIV infection and opportunistic diseases related to HIV/AIDS around the world. www.aactg.org The AIDS Treatment Activists Coalition A national coalition of AIDS activists working together to end the epidemic by advancing research on HIV/AIDS. www.atac-usa.org The Fair Pricing Coalition A national coalition of activists working on pricing issues for HIV and HCV drugs. www.fairpricingcoalition.org The Henry J. Kaiser Family Foundation Statistics; fact sheets; daily updates; webcasts. www.kaisernetwork.org S E P T E M B E R + O C TO B E R 2 01 1

Ask the HIV SPECIALIST Paul DenOuden, MD, AAHIVS

Take this to heart

What you can do to control your risk for heart complications Question: I am a 43-year-old male who has been in regular care for my HIV for almost 10 years. I’m stable on my HIV drugs and I feel good. My T-cells are pretty great at around 700 and I’ve been undetectable for some time now. Lately, my doctor seems more worried about my risk of heart attack, and wants me to start a couple of meds for blood pressure and cholesterol. I feel way too young to worry about heart problems and I really don’t want to take even more pills every day. Are my doctor’s suggestions now typical? Answer: First, congratulations on how well you seem to be doing with your HIV treatment. As an HIV Specialist, my primary goal is to optimally treat my patients’ HIV, but as an internist and primary care physician, I also have the goal of managing my patients’ overall wellness. So, we as HIV caregivers now give more attention to other issues that can affect lifespan and quality of life. I understand your concern with adding more pills. Recommendations like this are never made lightly by your doctor. But when there is clear evidence that options to prevent or treat other related medical issues are available and beneficial, it’s advisable to consider those treatments, even if you don’t feel symptomatic. Your doc’s recommendations for reducing your chance of a heart attack or stroke are important, but are also only one part of a larger strategy that anyone can employ for themselves. I would advise you to work with your doctor to understand the risks vs. benefits of adding the protective treatments you inquired about. In a vast number of cases, the risks and inconvenience are far outweighed by the benefits to your general long-term health, but each case is unique. Don’t be unduly afraid of having to add 52

SEPTEMBER+OCTOBER 2011

medicines to manage or avoid these problems. HIV regimens are often much simpler than they used to be anyway, so adding new therapies is often not too difficult. In addition, here are some ways you can help protect yourself from CV (cardiovascular) complications of normal aging and life with HIV disease: Stop smoking! This may be the most critical item for CV health (not to mention lung health and cancer prevention). There are several medical options now available to help you quit too; definitely speak to your doctor about these if you think you need help. Eat a healthy diet and maintain a healthy weight! Patients with stable HIV are just like anyone else, and in our calorie-dense, fast food society we often slowly gain weight in middle age and beyond. Also, our food choices are often not dense in nutrients. Keeping ahead of the weight curve and choosing nutritious foods are important for everyone for the prevention and treatment of CV disease, diabetes, and hypertension, and to keep feeling well and energetic. There are many resources available to help you to make better food choices. The “Nutrition Center” on the American Heart Association website

(www.heart.org) is a good start, as is the section called “HIV and Your Heart”. Get regular exercise! If you already have some issues that limit your physical abilities, get guidance from your doctor, but even moderate daily movement like long, brisk walks are very helpful. More vigorous exercise is suggested for those who are able. Since you are obviously already adherent to a daily medication regimen, I would expect that you will be as good as, or even better than, the average population at controlling any issues with your added medicines. As a last note to other readers, there are now several studies and observations showing potential adverse effects of untreated HIV on many other aspects of your health besides just your T-cell count, in part due to chronic inflammation and inflammatory responses. This may be particularly important as a CV risk factor, and any patient not on HIV therapy should discuss these issues with their doctor. It is increasingly important to keep HIV viral load suppressed to reduce these other risks, especially if you have other baseline cardiac risks. Good luck, and best wishes for continued good health! —Paul DenOuden, MD, AAHIVS Multnomah County Health Department Portland, OR

Search for an HIV Specialist™

Finding an HIV Specialist™ is easy with AAHIVM’s Referral Link at www.aahivm.org. Enter your ZIP code on the home page, and click on the “Go” button for a list of HIV Specialists™ near you.

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Salient Ramblings Sal Iacopelli

“What’s so funny ’bout peace, love, and understanding?” —E

lvis

What is the secret to survival? I progressed to AIDS years before my friend Robb, and I had assumed he would easily outlast me due to his barely controlled, constant rage. Hatred born of a childhood where he was the victim of routine bullying and intolerance for being queer. Yet, his deeply rooted anger did not keep him from succumbing to an AIDS-related illness. Was his death caused in part by the toxicity of hatred that consumed him so? It’s simple to spout off about what one must do to live a healthy and long life once one is HIV-diagnosed. Eat well, get plenty of rest, exercise, meditate, medicate, etc. But where does one find the strength, the will to live with HIV? Those of us living with a life-threatening illness are urged to view the disease within us as a hated, villainous enemy to conquer, our struggle with it as a war to win. Indeed, it is a fight, but couldn’t this attitude exponentially increase anger and frustration?. Whether one battles HIV, breast cancer, emphysema, diabetes—it is the focus on and commitment to living, as well as the acceptance and love of others that helps one survive. Without the determination to live, what good is eating well and exercising? Why bother swallowing handfuls of poisonous medications? After being HIV-positive for two years, I became increasingly weak, struggled with cryptosporidium, pneumonia, severe weight loss, and got my AIDS diagnosis. Back in the bad old days before combo therapy, such a diagnosis was a death sentence. I distinctly remember coming home, sitting on my bed alone in my room, considering the scientific data that stated I only had two years left. Fuck it. I decided I was not going to die and would do what it took to live. Miraculously, at my lowest P osi t i v elyAware .com

point, HIV combo therapy became available and I returned to health within three months. Was it also the decision to live? My AIDS survival technique seems to be a combination of self-reflection, a determined commitment to live, and a piquant dash of dark sarcasm. My friend Sher has battled breast cancer for five years. I have always known her to be extremely fastidious in how she treats her body, refusing to ever take even an aspirin, and giving birth to her beautiful baby, Max, without an epidural. Yet, when faced with life or death, Sher didn’t hesitate to opt for a double mastectomy and chemotherapy. Oh, how it devastated her, not to mention how excruciating it was for her to watch a glowing, neon orange poison invading her body. Yet, she pulled through valiantly, is once again a model of health and an inspiration to me. Goddammit, she has better biceps than I do. She didn’t focus on hating her cancer, or questioning “why me?” She decided to live, to stay with her (now teenage) daughter, and to continue evolving as a loving human being. Is the will to live correlated with the connection one has to others? Indeed. I recently went to see a new play, The Homosexuals, touted to be heartwarming and to “transcend stereotypes.“ Though

Costello

performed well by a cohesive ensemble and filled with witty dialogue, I found it to be painfully superficial, which is ironically a stereotype the gay community struggles to deflect. However, one character’s speech stood out glaringly. He raged against heterosexual hatred of gay people and ranted that every heterosexual man should be sodomized. It was disturbingly poisonous, full of the very hatred he raged against. I have lived with HIV for 18 years, AIDS for 15 years, and have tried not to do so in a sequestered, hate-filled way. Many have been at my side, heterosexual, bisexual, and homosexual alike. My life is enriched by friends and co-workers Patty, Val, Tim, Keith, and Mike who acknowledge my sexual preference, and understand and support my life with HIV. Where would I be without my dear Sue who has stood with me through illness, a move to San Francisco and back, many love interests, and sexual diatribes? Or my friend Ellen who, since my HIV diagnosis, sometimes treats me as if I am a bit delicate, but only does so out of her love and concern for me? How could I have gotten so far without the love and acceptance I receive from my (mostly) heterosexual family who first accepted my being gay and then accepted my HIV diagnosis? How life-affirming my cousins Marc, Ross, and Liz have been by honoring me with the pleasure of performing their marriage ceremonies. Where would I be without my mother, who although she did have difficulty with my coming out at age 19, accepted without question my HIV diagnosis 14 years later? Don’t put limits on others and propel hatred inward or outward. Don’t put limits on what you think you can do. S E P T E M B E R + O C TO B E R 2 01 1

get in the picture.

A DAY WITH HIV

IN AMERICA SEPT 21, 2011 a photo essay project presented by positively aware

What does it mean to live with HIV? Positively Aware magazine presents its second annual A Day with HIV in America, an online photo essay project focused on destigmatizing and demystifying HIV. Because whether youâ&#x20AC;&#x2122;re negative or positive, we all live with HIV. On Sept. 21st, grab your digital camera or smartphone. Take a snapshot and capture a moment of your day. Each photo tells a story. Get in the picture, and tell your story. Photo submissions will be posted. Select pictures will be published in Positively Awareâ&#x20AC;&#x2122;s November+December issue. Send your photo by Sept. 26 to artdirector@tpan.com.

For more details, go to www.ADayWithHIVinAmerica.com

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