Positive Aware (Sep-Oct 2011)

UPDATE: 2010 International AIDS Conference

Positively Aware september/october 2010

The cure?

New approaches as the search heats up.

ADAP CRISIS

Republicans to the rescue?

VIRTUAL YOU Tips for writing your online profile

The HIV Treatment & Health Journal of

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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.

•Have ever had seizures: Seizures have occurred in patients taking a 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 IMPORTANT SAFETY INFORMATION of suicide, and a few have actually committed suicide. These problems Contact your healthcare provider right away if you get the following may occur more often in patients who have had mental illness. side effects or conditions associated with ATRIPLA: •Kidney problems (including decline or failure of kidney function).

• Nausea, vomiting, unusual muscle pain, and/or weakness. These If you have had kidney problems, or take other medicines that may may be signs of a buildup of acid in the blood (lactic acidosis), cause kidney problems, your healthcare provider should do regular which is a serious medical condition. blood tests. Symptoms that may be related to kidney problems include • Light-colored stools, dark-colored urine, and/or if your skin or the a high volume of urine, thirst, muscle pain, and muscle weakness. whites of your eyes turn yellow. These may be signs of serious •Other serious liver problems. Some patients have experienced liver problems. serious liver problems, including liver failure resulting in transplantation or death. Most of these serious side effects occurred in patients with a • If you have HIV-1 and hepatitis B virus (HBV), your liver disease chronic liver disease such as hepatitis infection, but there have also may suddenly get worse if you stop taking ATRIPLA. been a few reports in patients without any existing liver disease.

Do not take ATRIPLA if you are taking the following medicines •Bone changes. Lab tests show changes in the bones of patients treated because serious and life-threatening side effects may occur when with tenofovir DF, a component of ATRIPLA. Some HIV patients treated taken together: Vascor® (bepridil), Propulsid® (cisapride), with tenofovir DF developed thinning of the bones (osteopenia), which Versed® (midazolam), Orap® (pimozide), Halcion® (triazolam), ® ® could lead to fractures. Also, bone pain and softening of the bone or ergot medications (for example, Wigraine and Cafergot ). (which may lead to fractures) may occur as a consequence of kidney In addition, ATRIPLA should not be taken with: problems. If you have had bone problems in the past, your healthcare Combivir® (lamivudine/zidovudine), EMTRIVA® (emtricitabine), Epivir® provider may want to check your bones. or Epivir-HBV® (lamivudine), Epzicom® (abacavir sulfate/lamivudine), SUSTIVA® (efavirenz), Trizivir® (abacavir sulfate/lamivudine/zidovudine), Common side effects: TRUVADA® (emtricitabine/tenofovir DF), or VIREAD® (tenofovir DF), because they contain the same or similar active ingredients as ATRIPLA. •Dizziness, headache, trouble sleeping, drowsiness, trouble concentrating, and/or unusual dreams. These side effects tend to ATRIPLA should not be used with HEPSERA® (adefovir dipivoxil). go away after taking ATRIPLA for a few weeks. These symptoms may Vfend® (voriconazole) or REYATAZ® (atazanavir sulfate) with or without be more severe with the use of alcohol and/or mood-altering (street) Norvir® (ritonavir) should not be taken with ATRIPLA since they may drugs. If you are dizzy, have trouble concentrating, and/or are drowsy, lose their effect and may also increase the chance of having side effects avoid activities that may be dangerous, such as driving or operating ® ® from ATRIPLA. Fortovase or Invirase (saquinavir) should not be used machinery. as the only protease inhibitor in combination with ATRIPLA. •Rash is a common side effect that usually goes away without any Taking ATRIPLA with St. John’s wort or products containing St. John’s wort change in treatment, but may be serious in a small number of patients. is not recommended as it may cause decreased levels of ATRIPLA, •Other common side effects include: tiredness, upset stomach, vomiting, increased viral load, and possible resistance to ATRIPLA or gas, and diarrhea. cross-resistance to other anti-HIV drugs.

This list of medicines is not complete. Discuss with your healthcare Other possible side effects: provider all prescription and nonprescription medicines, vitamins, •Changes in body fat have been seen in some people taking anti-HIV-1 or herbal supplements you are taking or plan to take. medicines. The cause and long-term health effects are not known.

Tell your healthcare provider if you: •Skin discoloration (small spots or freckles) may also happen.

•Are pregnant: Women should not become pregnant while taking •If you notice any symptoms of infection, contact your healthcare ATRIPLA and for 12 weeks after stopping ATRIPLA. Serious birth defects provider right away. have been seen in children of women treated during pregnancy with one of the medicines in ATRIPLA. Women must use a reliable form of •Additional side effects are inflammation of the pancreas, allergic barrier contraception, such as a condom or diaphragm, even if they also reaction (including swelling of the face, lips, tongue, or throat), use other methods of birth control, while on ATRIPLA and for 12 weeks shortness of breath, pain, stomach pain, weakness, and indigestion. after stopping ATRIPLA. You should take ATRIPLA once daily on an empty stomach. Taking ATRIPLA at bedtime may make some side effects less bothersome.

•Are breastfeeding: Women with HIV should not breastfeed because they can pass HIV through their milk to the baby. Also, ATRIPLA is one of several treatment options your doctor may consider.

ATRIPLA may pass through breast milk and cause serious harm to the baby.

You are encouraged to report negative side effects •Have liver problems, including hepatitis B or C virus infection.

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. © 2010 Bristol-Myers Squibb & Gilead Sciences, LLC. All rights reserved. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. EMTRIVA, VIREAD, and TRUVADA are trademarks of Gilead Sciences, Inc. SUSTIVA and REYATAZ are registered trademarks of Bristol-Myers Squibb. All other trademarks are owned by third parties.

697US09AB07040/TR6109 07/10

“My entire HIV regimen in one pill daily.

For me, that’s great.”

Phil li p

on ATRIPLA for 2 years

ATRIPLA is the #1 prescribed HIV regimen.* About ATRIPLA: • Only ATRIPLA combines 3 HIV medications in 1 pill daily. †

• Proven to lower viral load to undetectable in approximately 7 out of 10 patients new to therapy, and also raise T-cell‡ (CD4+) count to help control HIV through 3 years of a clinical study.§ • 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. †

Defined as a viral load of less than 400 copies/mL. Average increase of 312 cells/mm3. § In this study, 227 patients took the meds in ATRIPLA. ‡

Patient model. Individual results may vary.

Your doctor may prescribe ATRIPLA alone or with other HIV medications.

Talk to your doctor to see if ATRIPLA is right for you. * Synovate Healthcare Data; US HIV Monitor, Q1 2010.

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. 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® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) 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 (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 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.

• Do not share personal items that can have blood or body fluids on them, like toothbrushes or razor blades.

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

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 breast-feeding (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. • 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 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.

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

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

•

May 2010 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-B0001B1-05-10

21-937-GS-007

TR5827

May 2010

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september/october 2010 P os i t i v e lyAwar e .co m

SepTember/october 2010 V OL U M E 2 2 N U M B ER 5

D epa r t m ent s

6 Editor’s Note

12 Briefly Atripla co-pay program saves more money.

Rapid hepatitis C test available. CDC launches new screening campaign. R.I.P., vicriviroc. New Selzentry dose for renal patients. Safe sex intervention for African American couples.

30 One on One

Sharon Lewin discusses emerging strategies in cure research.

42 Ask the HIV specialist

Understanding the difference between a doctor and a nurse practitioner.

43 get sharp

19 Renewed hope

Faith, hope, and destiny.

7 In Box

c o v e r F eatu r e

Quest for a cure.

Efforts to discover a cure for HIV take on a new life—but it still won’t be easy.

27 Getting closer

Studies take aim at eradicating the virus.

F eatu r e s

14 Update: International AIDS Conference

The world AIDS community converges upon Vienna.

32 Republicans to ADAP’s rescue?

Senate Democrats are MIA in the effort to end ADAP waiting lists.

38 Virtual you

Tips for writing your online profile.

40 Status symbols

Wearing the fight against stigma on your sleeve.

44 What’s Goin’ ON?

Lessons from the Book of Real.

45 Wholistic Picture

Advance and retreat.

P os i t i velyAwa re.com

Paradigm shift: A demonstration of hope at the 2010 International AIDS Conference in Vienna.

Cover image by Chris Knight Photo this page: ©IAS/Steve Forrest/Workers’ Photos

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Editor’s Note Jeff Berry

Faith, hope, and destiny

Near the end of the Tuesday afternoon press conference, Hilary Beard of the Black AIDS Institute asked the study’s lead investigator what the gel looked, smelled, and tasted like, and was offered an applicator like those used in the study to see for herself.

Beard walked to the front of the room and dabbed some on the back of her hand, and after tasting it, looked around the room and nodded her approval. She then held the applicator up for others in the room. Nearly a dozen reporters, this one included, rushed to the stage to sample the gel (for the record it’s tasteless, odorless, and looks and feels just like ordinary lubricant).

Later that evening during the Human Rights Rally and March, conference attendees paraded down the streets of Vienna holding banners and shouting slogans, and ended up at a gathering of over 10,000 people at Heldenplatz, the same site where Hitler once spoke after Germany invaded Austria. The rally included inspirational speakers and videos, and ended with a moving musical performance and powerful speech by Annie Lennox.

Also during the conference, the two Bills (Gates and Clinton), NIH’s Tony Fauci, and other leading researchers and advocates spoke of advances in prevention and treatment, all the while advocating for wider access for everyone. The advancement of human rights was the overall theme of this year’s conference, with a call for an end to discriminatory policies and practices which continue to contribute to the escalating pandemic worldwide.

But underneath it all ran an undercurrent which is the theme of this issue of 6

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Positively Aware, and which has slowly and steadily been gaining momentum once again—the search for a cure.

Talk of a cure has been going on for decades, although it’s been somewhat of a roller-coaster ride, much like the pendulum swing of antiretroviral treatment.

At first there was no treatment, then not very effective ones, then, with the onset of HAART, we had “hit hard, hit early.” Due to some of the toxicities it was then recommended for some to defer treatment, and now it’s back to starting treatment earlier, with some even recommending treatment for everyone when they first test positive.

And so it goes with talk of a cure. Back in the 1980’s, when I was first diagnosed, it seemed like a pipe dream. Friends were dying left and right, and we were hungry for something, anything, that might offer us hope. Then came the protease inhibitors, which produced “the Lazarus Effect,” and were a lifeline for many. Death rates were dramatically reduced, people became healthier, and there was talk of a cure once again—it suddenly seemed within reach. Dr. David Ho, a leading AIDS researcher, was Time magazine’s Man of the Year in 1996.

Ho and his group published data that demonstrated that combination therapy could possibly eradicate the virus from the body.

Unfortunately, the hopes for eradication never quite panned out at the time, and the main reason, it is thought, is because there are reservoirs hidden within the body which house latently-infected cells. There is now, however, renewed interest and research being focused on purging these latently-infected cells from

their hiding places, and eradicating the virus once and for all. And there are some other promising strategies, compounds, and areas of research being looked at, some of which are discussed in this issue, and many of which are yet to be discovered.

Regrettably, all of this takes time and money. Inadequate funding and scant attention have been given thus far to cure research, but with today’s economic realities, it makes even more sense than ever. Vaccine study results have been disappointing so far. Prevention outcomes, at least up until the recent microbicide news, have been less than stellar. And ramping up access is starting to look like a pipe dream itself. Not that we shouldn’t continue to strive for developments and advancements in all of these areas, but just as no one drug suppresses the virus on its own, no one strategy is going to end this pandemic. It will take a combination of successful, affordable, and tolerable therapies; prevention strategies that work and are feasible; guarantees of human rights and dignity for everyone infected and at risk; and ramped up access to health care and treatment for all who need it.

There is an excellent article by Virginia Hughes in the July online supplement of Nature (see page 13) that ends with a quote by Mario Stevenson, professor of molecular medicine at the University of Massachusetts, that for me, sums it up perfectly, and gives me hope.

“Scientists are stubborn,” says Stevenson. “That persistence on the part of the scientific community hopefully exceeds the persistent qualities of the virus.”

Take care of yourself, and each other.

s eptember/october 2010 P os i t i v e lyAwa r e .co m

PHOTO: Chris Knight

At the 2010 International AIDS Conference in Vienna this July, there was genuine excitement in the air. The big news to come out of the conference was the CAPRISA 004 study, which for the first time established proof of concept for a vaginal microbicide.

In Box

Good question The July/August 2010 issue of Positively Aware was terrific. Dr. Wohl’s review of the “when-to-start?” question was nicely done and the editorials from Wohl, Dr. Gallant, Bob Huff and others provided some fresh perspectives I hadn’t yet considered. Whatever START’s answers, however, we face even bigger challenges: getting HIV-positive people tested and into care earlier (too many are being diagnosed with CD4s in the double digits) and ensuring that everyone in the U.S. who requires HIV treatment has access to it, regardless of ability to pay.

Jeff, your summary of the FDA advisory committee tesamorelin hearing was spot on. If it wasn’t for the testimony of people living with HIV, I don’t know if the drug would have been recommended for approval. As you point out, this is a very real example of community advocacy at work and evidence that just a few people can make important things happen for the rest of us. Congratulations and thank you.

—Tim Horn President and Editor-in-Chief AIDSmeds.com Re-wiring yourself I just finished reading the article “On the Front Line” by Enid Vázquez and found it to touch on subjects that sometimes get overlooked in the community.

When some (at least I and some friends of mine) were first diagnosed almost 20 years ago, there was the feeling that you were worthless and practically dead and that was the feeling that society gave off. In her article, she touched on the subjects of having to re-wire and respect yourself, with which

I could not agree more. From many years of re-wiring, I now feel that I am someone of worth, with many accomplishments that I thought I would never be able to finish, and I’ve seen many things that I would have never been able to see. Post re-wiring (in a sense), I made changes to my life which involved taking better care of myself both physically and mentally.

I think back to one of my favorite movies that dealt with HIV and its stigma, entitled “An Early Frost.” When the star (Aidan Quinn) told his grandmother about his status and she went to kiss him, he pulled back—then she uttered the most thought-provoking line which gets me through and helped me re-wire myself. The line was, “HIV is a disease, not a disgrace.”

That line has stuck with me for many years and is a reminder that I am of worth. Thanks, Enid, for the reminder after reading that article. I truly enjoyed it and keep being inspired.

—Sean via the Internet

Positivelyaware.com Last issue’s poll question:

When deciding whether or not to go on HIV meds, what concerned you more—the effects of untreated HIV, or the long-term side effects of the drugs?

drug side effects:

37%

untreated HIV:

63%

comments: “The side effects of meds for HIV may be uncomfortable, but the side effects of HIV are fatal.”

“I think as long as you’re stable with minimal viral load and CD4s above 500, why put the extra drugs into your body? I want to keep my options as long as possible so long as my body is managing the virus on its own accord.”

“Both scare me every day.”

This issue’s poll question:

Do you think a cure for HIV is possible? cast your vote at positivelyaware.com

Follow us on Twitter:

twitter.com/PosAware

Positively Aware will treat 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.

Write to: Positively Aware, 5537 N. Broadway St., Chicago, IL 60640 E-mail: readersforum@tpan.com

P os i t i velyAwa re.com

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INDICATION: REYATAZ® (atazanavir sulfate) is a prescription medicine used in combination with other medicines to treat people 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.

On REYATAZ,

IMPORTANT SAFETY INFORMATION: 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, breast-feeding, planning to become pregnant or breast-feed, or 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.

• Severe rash has occurred in a small number of patients taking REYATAZ. This type of rash is associated 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 – Conjunctivitis (red or inflamed eyes, like “pink-eye”) – General ill-feeling or “flu-like” symptoms – Blisters – Fever – Mouth sores – Muscle or joint aches – 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.

• 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.

Wedn esda y Ma ry ’s birthd ay pa rty Thursda y 5:30 C h oi r e practic

Bu y new shoes for Latish a

Fight HIV your way.

Please see Important Patient Information about REYATAZ on the adjacent pages.

how you spend your time is up to you.

Individual results may vary.

Once-daily REYATAZ can help fight your HIV. REYATAZ, a protease inhibitor (PI), in HIV combination therapy: ◆ Can

help lower your viral load and raise your T-cell (CD4+ cell) count

◆ Has

a low chance of diarrhea (shown in clinical trials)

— REYATAZ in combination therapy had a 1%-3% rate of moderate-to-severe diarrhea in adults. ◆ Is

taken once a day with a snack or meal REYATAZ is one of several treatment options your doctor may consider.

Do not take REYATAZ if you are allergic to REYATAZ or to any of its ingredients.

Ask your healthcare team about REYATAZ www.REYATAZ.com REYATAZ does not cure HIV, and has not been shown to reduce the risk of passing HIV to others.

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. © 2010 Bristol-Myers Squibb, Princeton, NJ 08543 U.S.A. 687US10AB05510 05/10

FDA-Approved Patient Labeling Patient Information

REYATAZÂŽ (RAY-ah-taz) (generic name = atazanavir sulfate) Capsules

ALERT: Find out about medicines that should NOT be taken with REYATAZ. 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 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: t 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. t 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: t If you are pregnant or planning to become pregnant. It is not known if REYATAZ can harm your unborn baby. 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. t 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. t If you have liver problems or are infected with the hepatitis B or C virus.

See “What are the possible side effects of REYATAZ?� t If you have end stage kidney disease managed with hemodialysis. t If you have diabetes. See “What are the possible side effects of REYATAZ?� t If you have hemophilia. See “What are the possible side effects of REYATAZ?� t 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.

REYATAZÂŽ (atazanavir sulfate) How should I take REYATAZ? t 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.

t 'PS BEVMUT XIP IBWF OFWFS UBLFO BOUJ )*7 NFEJDJOFT CFGPSF UIF EPTF is 300 mg once daily with 100 mg of NORVIRÂŽ (ritonavir) once daily taken with food. For adults who are unable to tolerate ritonavir, 400 mg (two 200-mg capsules) once daily (without NORVIRÂŽ) taken with food is recommended.

t 'PS BEVMUT XIP IBWF UBLFO BOUJ )*7 NFEJDJOFT JO UIF QBTU UIF VTVBM dose is 300 mg plus 100 mg of NORVIRÂŽ (ritonavir) once daily taken with food. t :PVS EPTF XJMM EFQFOE PO ZPVS MJWFS GVODUJPO BOE PO UIF PUIFS BOUJ )*7 medicines that you are taking. REYATAZ is always used with other anti-HIV medicines. If you are taking REYATAZ with SUSTIVAÂŽ (efavirenz) or with VIREADÂŽ (tenofovir disoproxil fumarate), you should also be taking NORVIRÂŽ (ritonavir). t 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. t If you are taking antacids or didanosine (VIDEXŽ or VIDEXŽ EC), take REYATAZ 2 hours before or 1 hour after these medicines. t If you are taking medicines for indigestion, heartburn, or ulcers such as AXIDŽ (nizatidine), PEPCID ACŽ (famotidine), TAGAMETŽ (cimetidine), ZANTACŽ (ranitidine), AcipHexŽ (rabeprazole), NEXIUMŽ (esomeprazole), PREVACIDŽ (lansoprazole), PRILOSECŽ (omeprazole), or PROTONIXŽ (pantoprazole), talk to your healthcare provider. t 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. t 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. t 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. t If you take more than the prescribed dose of REYATAZ, call your healthcare provider or poison control center right away.

Can children take REYATAZ? Dosing recommendations are available for children 6 years of age and older for REYATAZ Capsules. Dosing recommendations are not available for children from 3 months to less than 6 years of age. REYATAZ should not be used in babies under the age of 3 months.

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: t 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. t severe rash: In a small number of patients, a rash can develop that is associated 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:

t TIPSUOFTT PG CSFBUI

t HFOFSBM JMM GFFMJOH PS iGMV MJLFw TZNQUPNT

t GFWFS

t NVTDMF PS KPJOU BDIFT

t DPOKVODUJWJUJT SFE PS JOGMBNFE FZFT MJLF iQJOL FZFw

t CMJTUFST

t NPVUI TPSFT

t TXFMMJOH PG ZPVS GBDF t 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). Call your healthcare provider if your skin or the white part of your eyes turn yellow.

Although these effects may not be damaging to your liver, skin, or eyes, it is important to tell your healthcare provider promptly if they occur.

REYATAZŽ (atazanavir sulfate) 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. t 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. t if you have liver disease including hepatitis B or C, your liver disease may get worse when you take anti-HIV medicines like REYATAZ. t 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. t some patients with hemophilia have increased bleeding problems with protease inhibitors like REYATAZ. t 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.

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. t &SHPU NFEJDJOFT EJIZESPFSHPUBNJOF FSHPOPWJOF FSHPUBNJOF BOE methylergonovine such as CAFERGOTŽ, MIGRANALŽ, D.H.E. 45Ž, ergotrate maleate, METHERGINEŽ, and others (used for migraine headaches). t 03"1Ž (pimozide, used for Tourette’s disorder). t 13016-4*%Ž (cisapride, used for certain stomach problems). t 5SJB[PMBN BMTP LOPXO BT )"-$*0/Ž (used for insomnia). t .JEB[PMBN BMTP LOPXO BT 7&34&%Ž (used for sedation), when taken by mouth.

Do not take the following medicines with REYATAZ because of possible serious side effects: t $".1504"3ÂŽ (irinotecan, used for cancer). t $3*9*7"/ÂŽ JOEJOBWJS VTFE GPS )*7 JOGFDUJPO #PUI 3&:"5"; BOE $3*9*7"/ sometimes cause increased levels of bilirubin in the blood. t Cholesterol-lowering medicines MEVACORÂŽ (lovastatin) or ZOCORÂŽ (simvastatin). t 6309"53"-ÂŽ (alfuzosin, used to treat benign enlargement of the prostate). t 3&7"5*0ÂŽ (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 EFWFMPQ t 3JGBNQJO BMTP LOPXO BT 3*."$5"/&ÂŽ, RIFADINÂŽ, RIFATERÂŽ, or RIFAMATEÂŽ, used for tuberculosis). t 4U +PIO T XPSU (Hypericum perforatum), an herbal product sold as a dietary TVQQMFNFOU PS QSPEVDUT DPOUBJOJOH 4U +PIO T XPSU t 7*3".6/&ÂŽ (nevirapine, used for HIV infection).

The following medicines are not recommended with REYATAZ: t 4&3&7&/5 %*4,64ÂŽ (salmeterol) and ADVAIRÂŽ (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 NORVIRÂŽ together: t 7'&/%ÂŽ (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): t $*"-*4ÂŽ (tadalafil), LEVITRAÂŽ (vardenafil), or VIAGRAÂŽ (sildenafil), used to treat erectile dysfunction. REYATAZ may increase the chances of serious side effects that can happen with CIALIS, LEVITRA, or VIAGRA. Do not use CIALIS, LEVITRA, or VIAGRA while you are taking REYATAZ unless your healthcare provider tells you it is okay. t "%$*3$"ÂŽ (tadalafil) or TRACLEERÂŽ (bosentan), used to treat pulmonary arterial hypertension. t -*1*503ÂŽ (atorvastatin) or CRESTORÂŽ (rosuvastatin). There is an increased chance of serious side effects if you take REYATAZ with this cholesterollowering medicine. t

REYATAZÂŽ (atazanavir sulfate) t

FEJDJOFT GPS BCOPSNBM IFBSU SIZUIN $03%"30/&ÂŽ (amiodarone), lidocaine, . quinidine (also known as CARDIOQUINÂŽ 26*/*%&9ÂŽ, and others). t .:$0#65*/ÂŽ (rifabutin, an antibiotic used to treat tuberculosis). t #613&/&9ÂŽ 46#65&9ÂŽ 46#090/&ÂŽ, (buprenorphine or buprenorphine/ naloxone, used to treat pain and addiction to narcotic painkillers). t 7"4$03ÂŽ (bepridil, used for chest pain). t $06."%*/ÂŽ (warfarin). t 5SJDZDMJD BOUJEFQSFTTBOUT TVDI BT &-"7*-ÂŽ (amitriptyline), NORPRAMINÂŽ (desipramine), SINEQUANÂŽ (doxepin), SURMONTILÂŽ (trimipramine), TOFRANILÂŽ (imipramine), or VIVACTILÂŽ (protriptyline). t .FEJDJOFT UP QSFWFOU PSHBO USBOTQMBOU SFKFDUJPO 4"/%*..6/&ÂŽ or NEORALÂŽ (cyclosporin), RAPAMUNEÂŽ (sirolimus), or PROGRAFÂŽ (tacrolimus). t 5IF BOUJEFQSFTTBOU USB[PEPOF %&4:3&-ÂŽ and others). t 'MVUJDBTPOF QSPQJPOBUF '-0/"4&ÂŽ, FLOVENTÂŽ), 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 NORVIRÂŽ. t $PMDIJDJOF $0-$3:4ÂŽ), 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: t */7*3"4&ÂŽ (saquinavir). t /037*3ÂŽ (ritonavir). t 4645*7"ÂŽ (efavirenz). t "OUBDJET PS CVGGFSFE NFEJDJOFT t 7*%&9ÂŽ (didanosine). t 7*3&"%ÂŽ (tenofovir disoproxil fumarate). t .:$0#65*/ÂŽ (rifabutin). t $BMDJVN DIBOOFM CMPDLFST TVDI BT $"3%*;&.ÂŽ or TIAZACÂŽ (diltiazem), COVERA-HSÂŽ or ISOPTIN SRÂŽ (verapamil) and others. t #*"9*/ÂŽ (clarithromycin). t .FEJDJOFT GPS JOEJHFTUJPO IFBSUCVSO PS VMDFST TVDI BT "9*%ÂŽ (nizatidine), PEPCID ACÂŽ (famotidine), TAGAMETÂŽ (cimetidine), or ZANTACÂŽ (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? t 4UPSF 3&:"5"; $BQTVMFT BU SPPN UFNQFSBUVSF ÂĄ UP ÂĄ ' ÂĄ UP ÂĄ $

Do not store this medicine in a damp place such as a bathroom medicine cabinet or near the kitchen sink. t ,FFQ ZPVS NFEJDJOF JO B UJHIUMZ DMPTFE DPOUBJOFS t ,FFQ BMM NFEJDJOFT PVU PG UIF SFBDI PG DIJMESFO BOE QFUT BU BMM UJNFT %P OPU 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 XJUI ZPVS IFBMUIDBSF QSPWJEFS PS ZPV DBO DBMM 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.

7*%&9ÂŽ and REYATAZÂŽ are registered trademarks of Bristol-Myers Squibb Company. COUMADINÂŽ and SUSTIVAÂŽ are registered trademarks of Bristol-Myers Squibb Pharma Company. DESYRELÂŽ JT B SFHJTUFSFE USBEFNBSL PG .FBE +PIOTPO and Company. Other brands listed are the trademarks of their respective owners and are not trademarks of Bristol-Myers Squibb Company.

1SJODFUPO /+ 64" 1246226A7

F1-B0001B-04-10

Rev April 2010

Briefly reported by enid Vázquez Sign up for weekly e-updates, Visit PositivelyAware.com

The co-pay program for Atripla now eliminates the requirement that people first pay $50 out-of-pocket before financial assistance begins. The same is true for the drugs that make up Atripla (Sustiva and Truvada), as well as the medications that make up Truvada (Emtriva and Viread).

According to a spokesperson for Gilead Sciences, “Going forward, the Atripla Co-Pay Assistance Program will pay up to $200 per month (or $2,400 per year) toward out-of-pocket expenses for Atripla beginning with the first dollar of co-payment required by a patient’s insurance plan. Bristol-Myers Squibb and Gilead Sciences, LLC [the makers of Atripla], are working as quickly as possible to implement this change [at the time of this announcement in June].”

The program is not available to patients in Massachusetts or to those whose prescriptions are eligible to be reimbursed, in whole or part, by Medicare, Medicaid, any other federal- or

state-funded health care benefit program, or by private plans or other health or pharmacy benefit programs which reimburse patients for the entire cost of their prescription drugs.

To enroll, people taking Atripla must get a co-pay assistance card from their health care provider, or call the toll-free number 1-866-784-3431. The card must be activated before first use by calling this number.

People who do not have insurance, are underinsured, or who otherwise need assistance may call the Atripla Patient Assistance Program (PAP) toll-free at 1-866-290-4767.

For updates on all HIV drug co-pay assistance programs, see the 14th Annual HIV Drug Guide article “Pick a Card, Pick a Plan,” or go to www.positivelyaware. com and search the e-updates for patient assistance programs. You can also get the latest information by searching the website of the drugs you are taking, such as www.atripla.com.

Rapid hepatitis C test now available On June 25, the U.S. Food and Drug Administration (FDA) announced the approval of “the first rapid blood test in the U.S. for antibodies to the hepatitis C virus (HCV) in whole blood specimens (from venipuncture), for individuals 15 years and older. The OraQuick HCV Rapid Antibody Test, a test strip for the detection of antibodies to the hepatitis C virus, is indicated for testing individuals who are at risk for infection with HCV, and people with signs or symptoms of hepatitis. No additional instrumentation is required for diagnosis, and results are available in about 20 minutes. Results are presumptive, meaning that a positive test result should be followed up by a confirmatory test using traditional HCV testing methods to make a definitive diagnosis.”

HCV is transmitted primarily through exposure to infected blood, and intravenous drug use is the most common means of transmission in the United States. Hepatitis C can lead to liver inflammation and dysfunction and, over time, to liver disease and liver cancer —Sue Saltmarsh, from PA E-Update

12

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Testosterone: A Man’s Guide HIV health and treatment advocate Nelson Vergel’s new book, Testosterone: A Man’s Guide—Practical Tips for Boosting Physical, Mental and Sexual Vitality, is now available.

Vergel, who is living with AIDS, is a highly knowledgeable, long-time advocate of exercise and nutrition for people with HIV. He cowrote Built to Survive: A Comprehensive Guide to the Medical Use of Anabolic Steroids, Nutrition and Exercise for HIV (+) Men and Women. Both books are available online at Amazon.com, including Kindle editions. Testosterone: A Man’s Guide is also available as an app for iPhone, iPad, Blackberry, and Android.

See a cover story on Vergel in the May/ June 2009 issue of Positively Aware. Visit Nelson’s website: www.powerusa.org.

New Selzentry dose for renal disease patients On May 27, the U.S. Food and Drug Administration (FDA) reported making changes to the HIV medication Selzentry (maraviroc) drug label. In a new contraindication, Selzentry should not be used in patients with severe renal impairment or end-stage renal disease (ESRD) (CrCl <30 mL/min) who are taking potent CYP3A inhibitors or inducers (check with your doctor or pharmacist). There is also a dose change for people with kidney disease experiencing certain side effects. The drug’s medication guide has been updated to include the statement, “Talk to your health care provider before taking this medicine if you have kidney problems.”

Visit www.selzentry.com.

september/october 2010 P os i t i v e lyAwar e .co m

VÁzquez: JOSHUA THORNE

Atripla’s co-pay program now saves more money

CDC launches new screening initiative It was announced on June 16 that the U.S. Centers for Disease Control and Prevention’s (CDC) Division of HIV/AIDS Prevention will launch a new phase of its Act Against AIDS campaign, “HIV Screening. Standard Care.” (HSSC) to assist physicians in making HIV testing a standard part of medical care.

The CDC’s 2006 HIV screening recommendations advise that all patients between the ages of 13 and 64 be tested for HIV as a routine part of medical care at least once—regardless of perceived risk for the disease—and that individuals at high risk (such as those with multiple or HIV-infected partners) be tested at least once annually. HSSC is designed to help medical providers comply with the recommendations.

HSSC resources and materials will be available to providers, including a quick annotated guide to the recommendations and patient education materials that will help answer patients’ questions about HIV testing. The materials will be available free of charge to providers at www. cdc.gov/HIVStandardCare.

—Sue Saltmarsh, from PA E-Update

Successful safe sex intervention for African American couples According to a press release from the UCLA AIDS Institute, “A new study published online [July 12] in the Archives of Internal Medicine has found that heterosexual African American couples in which only one partner is HIV-positive practiced safer sexual behaviors after participating in a culturally specific intervention program designed to reduce the risk of HIV and other sexually transmitted diseases.”

The program was based on Eban, an African concept which symbolizes “safety, security, and love within one’s family and relationship space.” “The study of 535 couples, about half of whom received the Eban intervention while the others received a different intervention, was conducted in four cities with high HIV rates (Los Angeles, New York, Atlanta, and Philadelphia) through a grant from the National Institute of Mental Health. In addition to promoting safer sex, the study also worked on the couples’ ability to communicate with each other, to stay in healthy relationships, and to respect their communities.”

According to the release, “This study is the first to report a significant reduction in risky behavior among heterosexual African American couples.” Those who went through the program based on Eban reported more frequent and consistent condom use and fewer acts of unprotected sex, changes maintained through 12 months of follow-up.

2,937 The number of people on ADAP waiting lists in 13 states as of Aug. 12, according to the National Association of State & Territorial AIDS Directors (NASTAD).

R.I.P., vicriviroc Merck & Co. announced in July that it will stop its development efforts on an experimental HIV drug called vicriviroc.

The drug is an HIV CCR5 inhibitor, of which there is already one on the market (Selzentry, generic name maraviroc). In recent results (see May/June Positively Aware), it was noted that the use of newer and more powerful HIV drugs to optimize the background treatment of study participants made it difficult for vicriviroc to show additional benefit.

P os i t i velyAwa re.com

Special issue of Nature focuses on HIV A special supplement of Nature magazine focusing on HIV/AIDS is available free online.

The topics reported in the 13 articles include vaccine research, people who are “elite controllers” of HIV, and the search for a cure. There is also an opinion piece from HIV doctors. Visit www.nature.com/nature/ journal/v466/n7304_supp/index.html. s e p t e m b e r /o c to b e r 2 01 0

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13

UPDATE: 2010 INTERNATIONAL AIDS conference

Conference attendees gather at the Human Rights Rally and March held at Heldenplatz in Vienna.

The world’s AIDS community converges upon Vienna for the International AIDS Conference reported by Enid Vázquez

More than 16,000 delegates traveled to Vienna, Austria for the 18th International AIDS Conference held in July. Abstracts (summaries) and many webcasts are available at www.aids2010.org.

Leading the news from the conference: the first ever antiviral-based gel to show effectiveness in preventing HIV in women.

A new weapon women can use against the virus Doctors don’t usually get a standing ovation when presenting data from a study, but Dr. Quarraisha Abdool Karim did.

She presented study results showing a 39% decrease in HIV infections in women using a vaginal gel containing tenofovir, an anti-HIV medication. The gel was used up to 12 hours before sex and again afterwards.

Moreover, in women who used the 14

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microbicide (germ-killing) gel in 80% of the incidences of sexual intercourse, there was a 51% reduction in infection. These women made up the majority of the participants using the gel.

A smaller group of women using the gel less than half the time had a lower success rate, a 28% reduction in infection, but this is still one in four women remaining uninfected.

In addition, the gel prevented herpes infection in 54% of women.

After years of disappointing results with microbicide research, advocates around the world expressed elation. “Goooooal!” wrote Science reporter Jon Cohen.

Nearly 900 women participated in the study at the Centre for the AIDS Programme of Research in South Africa (CAPRISA), with the major funder being USAID (U.S. Agency for International Development).

The U.S. and South African governments were the primary forces behind the study. Dr. Abdool Karim is with Columbia University and associate director of CAPRISA, where her husband, Dr. Salim S. Abdool Karim is director. He is also a vice-chancellor at the University of KwaZulu-Natal (UKZN) in South Africa.

In a UKZN press release, Dr. Quarraisha Abdool Karim says that, “Tenofovir gel could fill an important HIV prevention gap by empowering women who are unable to successfully negotiate mutual faithfulness or condom use with their male partners.

This new technology has the potential to alter the course of the HIV epidemic, especially in southern Africa where young women bear the brunt of this devastating disease.”

A YouTube video of interviews with some of the women and medical providers

september/october 2010 Pos i t i v e lyAwa r e .co m

Heldenplatz: Jeff Berry

Tales from Vienna

Fauci: ©IAS-Steve Forrest-Workers’ Photos | CLINTON, Karim: ©IAS/Marcus Rose/Workers’ Photos

Anthony Fauci at the CAPRISA press conference. Former president Bill Clinton. Columbia University’s Quarraisha Abdool Karim.

in the study, entitled “Gabi’s Gift,” is available, along with other information on the results, at www.caprisa.org. In it, Gabi Nxele explains that a friend died of AIDS and participating in the study was her gift to the women of the world.

A mathematical model presented at the conference estimated that “a vaginal microbicide with an efficacy of 40% to 50% could prevent between 271,000 and 602,000 new HIV infections in 10 years [in South African women] depending on coverage.” This depends on the gel’s effectiveness being confirmed in further research. For example, a tenofovir gel combined with pills is being studied by the Microbicide Trials Network (MTN). The model also depends on the gel becoming available within five years.

In the CAPRISA study, usage fell off over time. There was a 50% prevention rate in the first year, which went down to 39% for the entire two and a half years of the study. The success rate was compared against women who were given a placebo gel (no active substance).

Tenofovir is available as an HIV drug called Viread, and is in the HIV medications Truvada and Atripla, both best-selling compounds. It is also being studied as a prevention pill for HIV-negative people at high risk of infection. There’s long P os i t i velyAwa re.com

been hope and excitement for tenofovir, and Truvada, to help in the prevention of HIV during sexual encounters. Newer HIV drugs are also being studied for this purpose.

Two U.S.-based organizations, FHI (Family Health International) and CONRAD (Contraceptive Research and Development Program), collaborated with CAPRISA. MTN reported that Gilead Sciences, which makes tenofovir, initially created the gel and granted a royalty-free license for it to CONRAD and to the International Partnership for Microbicides. Gilead provided tenofovir for free to MTN. CONRAD is a division of the Department of Obstetrics and Gynecology at Eastern Virginia Medical School, with a mission to help rapidly develop safe, affordable, and effective products for contraception and prevention of sexually transmitted HIV and other infections.

CONRAD offered to lead the movement to have the gel released as soon as possible if it continues to show effectiveness. Advocates noted that government regulations around the world prevent the availability of products for years after they are found to be effective.

The study publication is available free online at www.sciencemag.com.

The Vienna Declaration It’s time to stop the harmful laws and discrimination associated with the international war against drugs, according to doctors, researchers, and advocates who created the Vienna Declaration. The statement urges the promotion of syringe exchange and other proven methods of protecting health.

“The criminalization of illicit drug users is fuelling the HIV epidemic and has resulted in overwhelmingly negative health and social consequences,” they wrote. “A full policy reorientation is needed.”

The declaration goes on to briefly review the history of this war on drugs and discuss its failings.

Among the problems discussed is a high rate of HIV among injection drug users (IDUs) in areas of the world where the virus is “spreading rapidly.” In Eastern Europe and Central Asia, as many as 70% of IDUs become infected, and in some areas, more than 80% of this group acquires HIV. “In the context of overwhelming evidence that drug law enforcement has failed to achieve its stated objectives, it is important that its harmful consequences be acknowledged and addressed,” the declaration continues.

The following points, taken directly s e p t e m b e r /o c to b e r 2 01 0

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15

UPDATE: 2010 INTERNATIONAL AIDS conference

from the declaration, represent some of the consequences of the war on drugs: n A crisis in criminal justice systems as a result of record incarceration rates in a number of nations. This has negatively affected the social functioning of entire communities. While racial disparities in incarceration rates for drug offences are evident in countries all over the world, the impact has been particularly severe in the U.S., where approximately one in nine African American males between the ages of 20 to 34 is incarcerated on any given day, primarily as a result of drug law enforcement. n Stigma towards people who use illicit drugs, which reinforces the political popularity of criminalizing drug users and undermines HIV prevention and other health promotion efforts. n Severe human rights violations, including torture, forced labor, inhumane and degrading treatment, and execution of drug offenders in a number of countries.

“Unfortunately, evidence of the failure of drug prohibition to achieve its stated goals, as well as the severe negative consequences of these policies, is often denied by those with vested interests in maintaining the status quo,” the declaration says. “This has created confusion among the public 16

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and has cost countless lives. Governments and international organizations have ethical and legal obligations to respond to this crisis and must seek to enact alternative evidence-based strategies that can effectively reduce the harms of drugs without creating harms of their own.” The document goes on to make several recommendations.

The declaration also notes that, “Basing drug policies on scientific evidence will not eliminate drug use or the problems stemming from drug injecting. However, reorienting drug policies towards evidence-based approaches that respect, protect, and fulfill human rights has the potential to reduce harms deriving from current policies and would allow for the redirection of the vast financial resources towards where they are needed most: implementing and evaluating evidence-based prevention, regulatory, treatment and harm reduction interventions.”

Individuals and organizations are invited to sign the Vienna Declaration at www.viennadeclaration.com.

572 integrase inhibitor The HIV integrase inhibitor drug S/GSK1349572 (572 for short) continued forward in development. 572 may help people who develop drug resistance to Isentress, an integrase inhibitor already on the market.

ViiV Healthcare, which is developing 572, also has another integrase inhibitor in the works. The options are important because some people may need a new drug to turn to if an older drug stops working for them.

Two other advantages with 572: oncedaily dosing compared to twice a day for the very popular Isentress and no need for a boosting drug as with another integrase inhibitor in development, elvitegravir.

Interim 16-week results of a Phase 2b study, called SPRING-1, were presented.

The study is scheduled to go for 24 weeks.

Three doses of 572 (10, 25, and 50 mg) all resulted in strong viral load decreases.

More than 96% of participants on all doses (150 individuals) reached viral loads of less than 50 copies per ml (undetectable) at week 16. They also had a T-cell increase of more than 150.

572 was compared to Sustiva (efavirenz), a best-selling HIV medication from another drug class. Both were taken with either Combivir or Truvada.

As with the other two integrase inhibitors mentioned above, there was a shorter time to reaching undetectable viral load with 572. Rapid decrease in viral load is a class effect of the integrase inhibitors.

Study participants were also taking HIV medication for the first time, which means they are likely to show the best results.

september/october 2010 P os i t i v e lyAwar e .co m

SCHMEID, GATES: ©IAS/Steve Forrest/Workers’ Photos

Brigitte Schmied was among the presenters at the opening press conference. Bill Gates discusses HIV prevention strategies.

LENNOX: JEFF BERRY | Methadone man and buprenorphine Babe courtesy of open society Institute

Annie Lennox performs at the rally. Comic book heroes Methadone Man and Buprenorphine Babe. PA Editor Jeff Berry with a friend.

ViiV Healthcare announced that it would move into advanced Phase 3 studies with the 50 mg dose, a decision questioned by treatment advocates, who wondered why the highest dose was selected when all three doses performed about the same.

A representative for ViiV Healthcare said that generally, higher doses provide a higher barrier to drug resistance and the promise of greater durability. “We believe we can rescue some of those people [who have a greater amount of drug resistance] with a higher dose,” said Dr. Garrett Nichols of GlaxoSmithKline, which combined their HIV work with Pfizer to create ViiV Healthcare.

572 and drug resistance 572 drug resistance patterns were looked at in ViiV Healthcare’s VIKING study, reported in Vienna by Dr. Joseph Eron of the University of North Carolina (Abstract MOAB0105).

There were 27 study participants, all of whom had HIV that was growing resistant to their Isentress. In addition, they also had drug resistance to two other classes of HIV medications. Participants started out with a viral load of more than 1,000. The median viral load (half above, half below) was 30,000. Their Isentress was switched to 572 and results at 11 days were reported.

P os i t i velyAwa re.com

Once again, it’s important to know the results of drug resistance testing when a patient is looking to change to another HIV medication.

In short, there was success in overcoming Isentress resistance with 572 in all 16 of the individuals with a drug resistant pattern of N155H, Y143H, or Q148 single mutant pathways and in three of four individuals with Q148 plus one mutation.

In none of the five individuals with Q148 plus two or more drug resistant mutations was there success.

So, to date, you don’t want to see more than two mutations at the Q148 codon on a resistance test. All but one of the other individuals in the study succeeded in meeting the study endpoint—viral load of less than 400 or a greater than .7 log drop (a five-fold decrease) in viral load.

All in all, after 11 days, 21 of the 27 individuals had viral loads of less than 400.

For those whose viral load begins rising while using Isentress, they may want to stop while they’re ahead, before their virus develops more and more resistance.

More good drug news: TMC278 TMC278 (generic name rilpivirine) is a nonnucleoside analog (like Sustiva) in Phase 3 (advanced) study.

Results from two large Phase 3 studies of TMC278 were put together for a presentation on the drug. The bottom line: TMC278 was found to be non-inferior to the kingpin Sustiva.

These are advanced 48-week results from 1,368 patients. They started out with a median viral load of 100,000 and T-cells of 256.

There was virologic failure (a lack of adequate viral load suppression under study standard) in 9% of people using TMC278 vs.

4.8% of those taking Sustiva, but this was offset by a greater rate of discontinuation due to adverse events with Sustiva. The discontinuation due to adverse events was 3.4% for TMC278 vs. 7.6% for Sustiva.

The lower rate of lipid elevations with TMC278 (total cholesterol, LDLcholesterol, and triglycerides) was also statistically significant.

Tibotec Therapeutics, the developer of TMC278, is working to combine it with Truvada from Gilead Sciences. The three-inone pill would compete with the top-selling Atripla, which combines Truvada with Sustiva.

Tibotec submitted its New Drug Application (NDA) for TMC278 to the FDA on July 26. They also currently have a nonnucleoside drug on the market, Intelence (etravirine). TMC278 is taken once daily as opposed to twice a day for Intelence. s e p t e m b e r /o c to b e r 2 01 0

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17

By starting HIV

treatment,

I went from living in shame to

standing up and taking control.

If youâ&#x20AC;&#x2122;re HIV positive, the decision to begin taking medication can be difficult. But it can be the first step toward reclaiming your life and living longer. Talking to your doctor and getting the right information on HIV treatment can help take you from feeling ashamed to feeling in control.

Take the next step and go to hivtreatmentispower.com or call (877) Y-TREAT-HIV Š2009 Gilead Sciences, Inc. All rights reserved. PT0560A 03/09

renewed

hope

Efforts to discover a cure for HIV take on a new life—but it still won’t be easy

By Bob Huff | Photos by chris knight

Finding a cure for HIV is one of the “Holy Grails” of medical research. Yet even as progress in treating HIV has leapt forward, and while AIDS vaccine research remains a high research priority, the search for a cure has received little attention.

But hopes for a cure are on the rise.

The government and drug companies are starting to take cure research seriously, and more and more scientists are joining the effort. At the 2010 International AIDS Conference in Vienna, curing HIV took a prominent spotlight in the opening presentations.

P os i t i velyAwa re.com

A vaccine would protect people who do not have HIV from getting it. A cure would remove or disable the virus for people who already have it. While HIV medications are extremely effective at stopping the virus from replicating within the body, there is no effective preventive vaccine and no practical cure for HIV.

Unfortunately, unlike many diseases that can be eliminated by antibiotics or other medications, HIV becomes a permanent part of the body (see sidebar, “Reservoir Dogs: A virus goes into hiding”).

Curing it is not going to be easy, but the impact of a permanent cure would be so important—especially in light of the high cost of lifetime treatment for the millions of people in the world who are infected—that it is important for scientists to make a strong effort to search for it.

Fortunately, the outlook for eventually finding a cure for HIV infection has never s e p t e m b e r /o c to b e r 2 01 0

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been better, as some of the top scientists in HIV research begin turning their attention to the problems of persistent HIV infection and how the virus might be permanently switched off or even eradicated from the body.

New day for cure research There are a few reasons why the search for a cure has been reawakened. First, there is the need for a new paradigm for controlling HIV. While lifetime treatment is effective at preventing AIDS, it is expensive and may cause side effects for many of those on therapy—even after many years.

There has been backpedaling among big government donors about funding longterm ARV (antiretroviral) treatment for the millions of people in Africa and Asia who need it. Even in the United States, waiting lists for the states’ AIDS Drug Assistance Programs (ADAPs) are growing as budget deficits soar (see page 32).

There are also growing concerns that people with HIV—even after the virus has been suppressed with drugs—may be experiencing signs of premature aging, such as cardiovascular problems, kidney disease, diabetes, and cognitive dysfunction. It is not yet clear if these are due to the drugs or to HIV itself. One theory is that the low levels of HIV proteins produced by infected cells—even if not

capable of infecting other cells—can disrupt how the immune system is regulated and stimulate inflammation, causing the body to attack itself.

Another reason for the renewed interest in a cure is the disappointment that has dogged vaccine research. After searching for 25 years, hopes for a vaccine to prevent HIV infection were again dashed after the failure of a large clinical trial in 2007. While vaccine research has not been abandoned (much, much more research money goes to it than to cure research), some scientists felt it was time for a fresh look at finding a longterm solution to HIV. As one key scientist in the search for a cure put it, “Lots of people are working on vaccines, but the people who are working on eradicating the latent reservoir of HIV is a pretty small group.”

And finally there is the intriguing possibility that one individual may have received a virtual cure for his infection.

An oncologost in Germany treated an HIV-positive leukemia patient from the U.S., who had been on ARV drugs, with a bone marrow transplant, a procedure where the patient’s cancerous immune system is destroyed and replaced with healthy immune system cells from a donor.

In this case, the doctor used donor cells that coincidentally lacked the CCR5 receptor protein that HIV generally requires to infect new cells. So far, going on three

RESERVoiR DOGS: a virus Goes into When combination antiretroviral (ARV) therapy was first shown in the mid-1990s to reduce HIV in the blood to undetectable levels, some of the first questions to arise were: What will happen if the drugs are stopped? Will the virus remain undetectable?

Will the patient be cured?

Unfortunately, it soon became clear that the ARV drugs that suppress HIV so effectively are not a cure and that the viral load can bounce back once they begin to leave the bloodstream. As more 20

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and more people started ARV medications—and as the death rate from AIDS plummeted— most HIV research focused on improving treatment, and the quest for a cure took a back seat.

The reason why the HIV viral load comes back when ARV meds are stopped is the same reason why permanently curing HIV infection will be such a difficult problem to solve.

A virus is not a selfsufficient living creature like a bacterium or a parasite. A virus is basically a container

for a small strand of DNA—the genetic code for the virus itself.

For HIV to cause an infection, it must enter a host body (that’s you), enter a host cell (such as the immune system’s CD4 T-cell), then deliver its DNA payload to the nucleus of the cell, where the body’s own DNA is stored.

DNA is a chemical code in the form of a long chain that tells the body’s machinery how to make all of the proteins and parts it needs to live and grow.

Every cell in your body (and you have trillions) contains a

complete copy of your unique DNA, even if the cell only uses part of it for its own purposes.

While the body’s DNA chain is long (about six feet, stretched out), only a tiny strand of DNA is needed to hijack the cell’s machinery into making new copies of the virus. This process is called replication, and when an infected cell begins cranking out new HIV particles, it is like a Xerox machine, spitting out copies, each of which can travel through the bloodstream and infect new cells, creating

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years after the transplant, the patient is not taking ARV drugs and continues to have an undetectable viral load.

Has he been cured? It seems unlikely that his latent reservoir of HIV has been eradicated, but rather that he has been made resistant to HIV infection.

Bone marrow transplantation is an expensive and dangerous step to take, so it is not a viable risk for anyone without a life-threatening cancer or certain other diseases. But if his virus remains at bay, this case proves that the quest for a cure is not foolish.

If HIV can’t be eradicated, then the next best thing would be a “functional cure” that uses the immune system to control the virus, much like that which occurs naturally to a small percentage of people with HIV called elite controllers who maintain low viral loads without drugs. There are several avenues of research investigating these ideas. A spinoff of preventive vaccine research may produce a therapeutic vaccine that trains the immune system of an already infected person to keep viral load levels in check. Some vaccines have already been tested in people with HIV, though none have been able to consistently control the virus.

Another approach is experimenting with gene therapy to modify the body’s immune cells to make them HIV resistant— a less drastic step than bone marrow

transplantation. Any kind of breakthrough that allows a person to control their HIV without taking drugs would be a huge step forward in the history of this disease.

The Martin Delaney Collaboratory In June, Dr. Anthony Fauci of the National Institutes of Health announced an $8 million grant program called the Martin Delaney Collaboratory: Toward an HIV-1 Cure. The program offers two $3-5 million grants to research institutions who will partner with industry to solve some of the key problems standing in the way of a cure for HIV infection. The outline for this approach was presented in a 2009 article in Science magazine authored by Douglas Richman, of the University of California, San Diego, along with several other key scientists in cure research, and AIDS activist Martin Delaney.

Delaney, who died of liver disease in 2009, was not a scientist, but a pioneer AIDS treatment advocate and founder of the San Francisco AIDS education and advocacy group Project Inform. Even during the enthusiasm surrounding the success of the first effective drug regimens in the 1990s, Delaney continued to remind government scientists, drug companies, and other activists that curing HIV remained the ultimate prize.

The goal of the collaboratory proposal

hiding new viral copy machines.

Fortunately, ARV drugs can effectively shut down the viral replication copy machine—but they can’t remove the viral infection.

Some viral infections, like hepatitis C virus (HCV), can be cured if replication can be stopped long enough. Among viruses, HIV is unusual because it carries integrase, a special protein tool that guides the small thread of viral DNA into the infected cell’s DNA. Integrase makes a break in the human DNA, then inserts the P os i t i velyAwa re.com

HIV genetic material seamlessly. This means that HIV actually becomes part of the cell, and has access to the same cellular machinery that the human DNA has. This is also one of the key reasons why HIV infection will be so difficult to eradicate.

Sleeper cells Having the HIV DNA become a permanent part of a cell’s DNA would not be so bad if the cells died off on a regular basis and were replaced by new, uninfected cells, as happens with most cells in the body.

You could simply stop new cells from becoming infected by taking ARV drugs, then wait for the infected virus to be retired and recycled.

But HIV infects cells of the immune system, and some of the infected cells become part of the system of immune memory, which helps the body respond quickly to infections it has experienced in the past.

Some of these infected immune memory cells—perhaps one in a million—become dormant, and may remain quiet and hidden away for decades.

Scientists call these sleeper cells the “latent reservoir” of HIV. When awakened by an immune challenge or other stimulus, the memory cells begin to spit out new HIV particles, which go out into the body to infect new cells—unless they are stopped by ARV meds.

This persistence of HIV in the body is why taking ARVs consistently for a lifetime is necessary, and why curing HIV will be such a great challenge.

—Bob Huff

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If the immune system won’t clean house, then we will need to develop medicinal torpedoes to destroy the infected cells. is to quickly move forward on answering some key questions about curing HIV and to develop some drugs that may lead to tests in people. Just as important is the goal of getting a new generation of young scientists involved in this area of HIV research.

The amount of money in this initial wave is small compared to vaccine funding, but aims to plant seeds and create a foundation for building more focused research in the future. Unless we are incredibly lucky, curing AIDS will not happen in the next few years.

The way to a cure The simplest proposed scenario for eradicating HIV involves giving a person an experimental treatment that causes the cells that comprise the latent HIV reservoir to wake up and start producing virus (see sidebar below). Ideally, this person will be someone who started on ARV medications soon after infection and has remained undetectable ever since. It seems likely (though we don’t know for sure) that people who start treatment very early may have a smaller number of latently infected cells harboring hidden HIV. One type of treatment would act like an alarm clock to wake the cell up. Another type would enter the cell’s DNA and unlock the HIV genes and allow them to produce virus. It’s likely a combination of these kinds of drugs may be needed.

Because the individual will continue taking ARV drugs, any virus produced will be stopped from spreading and infecting cells in other parts of the body. After the latent reservoir has been activated by the experimental treatment, it is thought that the immune system will clean house and destroy the infected cells. This general approach has already been tested in people, but the drugs tried so far have not been effective.

So, what are some of the basic science questions that research must address in the coming years to make this scenario a reality? First, we want to find out where 22

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the latent HIV is hidden in people who are taking ARV drugs. Where are the reservoirs? How much viral DNA is stored away? Is the virus replicating? Or is it lying completely dormant in resting immune cells? What happens to these cells when they begin to produce viruses or HIV proteins? Will the immune system really recognize them as foreign and destroy them?

That is a key question, because the simplest strategy for eradication envisions “waking up” the infected resting cells and getting them to announce themselves to the immune system, which then destroys them. We think that is what happens, but we’re not sure. If the immune system won’t clean house, then we will need to develop medicinal torpedoes to destroy the infected cells.

But to find out where the latent reservoir cells are in the body, scientists will need to develop better ways of testing whether HIV is actually present in these cells and if they are producing viable, infectious virus or not. Only one in a million immune cells may harbor viral DNA in a person taking ARV drugs. How can scientists tell if the treatments they are using to flush out those cells have worked or not? There are a lot of cells infected with HIV DNA that only produce broken, noninfectious virus. How can we tell if we’re getting to the cells that matter?

But most urgently, a test must be developed that can be used to identify potential drugs to activate the latent HIV in these cells.

The drugs tested so far for unlocking HIV in a latently infected cell have been fairly crude. A class of drug used in cancer chemotherapy called HDAC inhibitors has been used at lower doses in people with HIV to activate the HIV reservoir. The problem is that these cancer drugs do not act specifically to unlock HIV. Scientists need a way to test large numbers of compounds and molecules to find those that will make a good drug. It must be safe for use in people and must have a

strong and specific effect on the target, in this case, activating latently infected cells.

It may be that more than one drug will be needed to address different types of cells if we find that the HIV reservoir is more widely distributed than we hope.

The ultimate challenge will be to test these new compounds in people and to prove that they work. At first, human testing is likely to go slowly and be aimed at answering the scientific questions facing cure researchers. Hitting a home run with the first molecules to be tested is very unlikely.

One of the key problems is learning how to tell if the treatment has had an effect or not. The test subjects for this early research will be taking antiretrovirals and will have undetectable viral loads by the most sensitive tests available—less than one copy per milliliter of blood. One way to test for a cure in someone who had taken an experimental treatment is to stop the ARV drugs and wait to see if the viral load bounces back or remains undetectable. This is a risky way to go, since the rebounding virus can cause an immune reaction, re-seed new cellular reservoirs, and possibly develop resistance to the drugs remaining in the body after the last dose. The SMART study showed that people who stopped and started ARVs had a somewhat greater risk of inflammationrelated diseases, such as heart and vascular problems. So stopping someone’s HIV meds is not a step to be taken lightly. But, as with the HIV-positive leukemia patient, showing that the virus remains undetectable after ARVs have been stopped is the best proof that a cure for HIV has been achieved.

It may never be possible to prove that every single cell containing HIV has been removed by a curative treatment, but the promise of a lifetime free of HIV and HIV drugs is compelling scientists and people with HIV to finally imagine what was only recently thought impossible: A cure for AIDS. e

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Day 1 Of my next treatment regimen: KALETRA once a day with my other HIV medicines.

Ask your doctor if KALETRA once daily is right for you.

KALETRA once daily should not be given to children. KALETRA once daily should not be taken with efavirenz (Atripla® and Sustiva®), nevirapine (Viramune®), amprenavir (Agenerase®), nelfinavir (Viracept®), carbamazepine (Tegretol® and Epitol®), phenobarbital (Luminal®), or phenytoin (Dilantin®). There may be a greater chance of getting diarrhea with the once daily regimen compared with the twice daily regimen.

Use KALETRA® is a prescription anti-HIV-1 medicine called a protease inhibitor that contains lopinavir and ritonavir. KALETRA is used with other anti-HIV-1 medicines to increase the chance of treatment response in people with human immunodeficiency virus (HIV-1) infection. It is not known if KALETRA is safe and effective in children under 14 days old.

KALETRA does not cure HIV-1 infection or AIDS and does not stop you from passing HIV-1 to others. You may still get opportunistic infections or other conditions that happen with HIV-1.

KALETRA Safety Considerations Do not take KALETRA® if you are allergic to any of its ingredients, including lopinavir or ritonavir. Do not take KALETRA with certain medicines, as they can cause serious problems, death, or make KALETRA less effective against HIV. Some patients taking KALETRA can develop inflammation of the pancreas and liver problems, which can cause death. Patients may develop changes in heart rhythm, large increases in triglycerides and cholesterol, diabetes, high blood sugar, changes in body fat, and/or increased bleeding in people with hemophilia. Some patients may develop signs and symptoms of serious infections they already have after starting anti-HIV medicines.

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 (1-800-332-1088).

If you cannot afford your medication, contact: www.pparx.org or call the toll-free number (1-888-4PPA-NOW) or (1-888-477-2669) for assistance.

For additional information about KALETRA, call 1-866-KALETRA (1-866-525-3872) or visit KALETRA.com.

Please see Brief Summary on adjacent pages.

Model is for illustrative purposes only. ©2010 Abbott Laboratories Abbott Park, IL 60064 039-403018 July 2010 Printed in U.S.A.

KALETRA® (kuh-LEE-tra) (lopinavir/ritonavir) Tablets KALETRA® (kuh-LEE-tra) (lopinavir/ritonavir) Oral Solution Patient Information What is the most important information I should know about KALETRA? KALETRA may cause serious side effects, including: • Interactions with other medicines.

It is important to know the medicines that should not be taken with KALETRA. Read the section “What should I tell my doctor before taking KALETRA?” • Changes in your heart rhythm and the electrical activity of your heart. These changes may be seen on an EKG (electrocardiogram) and can lead to serious heart problems. Your risk for these problems may be higher if you: ° already have a history of abnormal heart rhythm or other types of heart disease. ° take other medicines that can affect your heart rhythm while you take KALETRA. Tell your doctor right away if you have any of these symptoms while taking KALETRA: • dizziness • lightheadedness • fainting • sensation of abnormal heartbeats See the section below “What are the possible side effects of KALETRA?” for more information about serious side effects.

CONSUMER BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION

Read the Medication Guide that comes with KALETRA before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.

You and your doctor should talk about your treatment with KALETRA before you start taking it and at regular check-ups. You should stay under your doctor’s care when taking KALETRA.

Who should not take KALETRA? • Do not take KALETRA if you are taking certain medicines. For more information about medicines you should not take with KALETRA, please see “Can I take other medicines with KALETRA?” and consult with your doctor about all other medicines you take.

• Do not take KALETRA if you have an allergy to KALETRA or any of its ingredients, including ritonavir and lopinavir.

What should I tell my doctor before taking KALETRA?

KALETRA may not be right for you.

Tell your doctor about all your medical conditions, including if you: • have any heart problems, including if you have a condition called Congenital Long QT Syndrome.

• have liver problems, including Hepatitis B or Hepatitis C. • have diabetes.

• have hemophilia. People who take KALETRA may have increased bleeding.

• have low potassium in your blood.

• are pregnant or plan to become pregnant. It is not known if KALETRA will harm your unborn baby. Birth control pills or patches may not work as well while you take KALETRA. To prevent pregnancy while taking KALETRA, women who take birth control pills or use estrogen patch for birth control should either use a different type of birth What is KALETRA? control or an extra form of birth control.

Talk to your doctor about how to prevent KALETRA is a prescription anti-HIV pregnancy while taking KALETRA. medicine that contains two medicines: lopinavir and ritonavir. KALETRA is called • take KALETRA during pregnancy, talk with your doctor about how you can a protease inhibitor that is used with other take part in an antiretroviral pregnancy anti-HIV-1 medicines to treat people with registry. The purpose of the pregnancy human immunodeficiency virus (HIV-1) registry is to follow the health of you infection. HIV-1 is the virus that causes and your baby.

AIDS (Acquired Immune Deficiency • are breast-feeding. Do not breast-feed if Syndrome). you are taking KALETRA. You should not It is not known if KALETRA is safe and breast-feed if you have HIV-1. If you are effective in children under 14 days old.

a woman who has or will have a baby while taking KALETRA, talk with your doctor about the best way to feed your baby. If your baby does not already have HIV-1, there is a chance that HIV-1 can be passed to your baby through your breast milk.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Many medicines interact with KALETRA. Do not start taking a new medicine without telling your doctor or pharmacist. Your doctor can tell you if it is safe to take KALETRA with other medicines. Your doctor may need to change the dose of other medicines while you take KALETRA.

Medicines you should not take with KALETRA. Serious problems or death can happen if you take these medicines with KALETRA: • ergot containing medicines, including: ° ergotamine tartrate (Cafergot®, Migergot, Ergomar, Ergostat, Medihaler Ergotamine, Wigraine, Wigrettes) mesylate ° dihydroergotamine (D.H.E. 45®, Embolex, Migranal®) ° ergonovine, ergonovine and methylergonovine (Ergotrate, Methergine), ergotamine and methylergonovine ° Ergotrate Maleate, methylergonovine maleate (Methergine) • triazolam (Halcion®), midazolam hydrochloride oral syrup • pimozide (Orap®) • the cholesterol lowering medicines lovastatin (Mevacor®) or simvastatin (Zocor®) • sildenafil (Revatio®) only when used for the treatment of pulmonary arterial hypertension. (See “Medicines that may need changes” and “What are the

possible side effects of Kaletra?” for information about the use of sildenafil for erectile problems.)

• alfuzosin (Uroxatral®) Medicines that you should not take with KALETRA since they may make KALETRA not work as well: • the herbal supplement St. John’s Wort (hypericum perforatum) • rifampin (Rimactane®, Rifadin®, Rifater®, or Rifamate®) Medicines that may need changes: • birth control pills that contain estrogen (“the pill”) or the birth control (contraceptive) patches • certain anticancer medicines, such as nilotinib (Tasigna®) and dasatinib (Sprycel®) • certain cholesterol lowering medicines, such as atorvastatin (Lipitor®) or rosuvastatin (Crestor®) • certain other antiretroviral medicines, such as efavirenz (Atripla® and Sustiva®), nevirapine (Viramune®), amprenavir (Agenerase®) and nelfinavir (Viracept®) • anti-seizure medicines, such as phenytoin (Dilantin®) carbamazepine, (Tegretol®), phenobarbital • medicines for erectile problems, such as sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®) • medicines for tuberculosis (TB), such as rifabutin (Mycobutin®) • inhaled steroid medicines, such as fluticasone propionate (Flonase®) • inhaled medicines such as salmeterol (Serevent®) or salmeterol in combination with fluticasone propionate (Advair®). Your doctor may need to change to a different medicine • medicines for gout, such as colchicine (Colcrys®) • medicines to treat pulmonary arterial hypertension (PAH), such as bosentan (Tracleer®) or tadalafil (Adcirca®) • pain medicines, such as fentanyl (Duragesic®, IonsysTM, Fentora®) and methadone If you are not sure if you are taking a medicine above, ask your doctor.

• KALETRA tablets can be taken with or without food.

• If you are taking both Videx® (didanosine) and KALETRA: ° didanosine can be taken at the same time as KALETRA tablets, without food. ° take didanosine either one hour before or two hours after taking KALETRA oral solution.

• Do not miss a dose of KALETRA. This could make the virus harder to treat. If you forget to take KALETRA, take the missed dose right away. If it is almost time for your next dose, do not take the missed dose. Instead, follow your regular dosing schedule by taking your next dose at its regular time. Do not take more than one dose of KALETRA at one time.

• If you take more than the prescribed dose of KALETRA, call your local poison control center or emergency room right away.

• Take KALETRA oral solution with food to help it work better.

• If KALETRA is being used for your child, tell your doctor if your child’s weight changes.

• KALETRA should not be given one time each day in children. When giving KALETRA to your child, give KALETRA exactly as prescribed.

• KALETRA oral solution contains a large amount of alcohol. ° If a young child drinks more than the recommended dose, it could make them sick from too much alcohol.

Contact your local poison control center or emergency room right away. ° Talk with your doctor if you take or plan to take metronidazole or disulfiram. You can have severe nausea and vomiting if you take these medicines with KALETRA. • When your KALETRA supply starts to run low, get more from your doctor or pharmacy. It is important not to run out of KALETRA. The amount of HIV-1 virus in your blood may increase if the medicine is stopped for even a short time. The virus may become resistant to KALETRA and become harder to treat.

How should I take KALETRA? • KALETRA can be taken with acid • Take KALETRA every day exactly as reducing agents used for heartburn or prescribed by your doctor. reflux such as omeprazole (Prilosec®) • It is very important to set up a dosing and ranitidine (Zantac® ) with no dose schedule and follow it every day. adjustment.

• Do not change your treatment or stop • KALETRA should not be administered treatment without first talking with your once daily in combination with doctor. carbamazepine (Tegretol® and Epitol®), • Swallow KALETRA tablets whole. Do phenobarbital (Luminal®), or phenytoin not chew, break, or crush KALETRA (Dilantin®). tablets.

Avoid doing things that can spread HIV infection. KALETRA does not stop you from passing HIV infection to others. Do not share needles, other injection equipment or personal items that can have blood or body fluids on them, like toothbrushes and razor blades. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.

What are the possible side effects of KALETRA? KALETRA can cause serious side effects.

• See “What is the most important information I should know about KALETRA?” • Liver problems. Liver problems, including death, can happen in people who take KALETRA. Blood tests in people who take KALETRA may show possible liver problems. People with liver disease such as Hepatitis B and Hepatitis C who take KALETRA may have worsening liver disease. Tell your healthcare provider right away if you have any of these signs and symptoms of liver problems: ° loss of appetite ° yellow skin and whites of eyes (jaundice) ° dark-colored urine ° pale colored stools, itchy skin ° stomach area (abdominal) pain.

• Inflammation of the pancreas (pancreatitis). Some people who take KALETRA get inflammation of the pancreas which may be serious and cause death. You have a higher chance of getting pancreatitis if you have had it before. Tell your doctor if you have nausea, vomiting, or abdominal pain while taking KALETRA. These may be signs of pancreatitis.

• Increases in certain fat (triglycerides and cholesterol) levels in your blood. Large increases of triglycerides and cholesterol can be seen in blood test results of some people who take KALETRA. The longterm chance of getting complications such as heart attacks or stroke due to increases in triglycerides and cholesterol caused by protease inhibitors is not known at this time.

• Diabetes and high blood sugar (hyperglycemia). Some people who take protease inhibitors including KALETRA get new or more serious diabetes, or high blood sugar. Tell your doctor if you notice an increase in thirst or urinate often while taking KALETRA.

• Changes in body fat. Changes in body fat in some people who take antiretroviral therapy. These changes may include 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.

• Increased bleeding for hemophiliacs. Some people with hemophilia have increased bleeding with protease inhibitors including KALETRA. • Increased risk of certain problems when you take medicines used for the treatment of erectile problems such as sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®) with KALETRA: ° low blood pressure. If you get dizzy or faint, you need to lie down.

Tell your doctor if you feel dizzy, or have fainting spells. ° vision changes. Tell your doctor right away if you have vision changes. penis erection lasting more ° than 4 hours. If you are a male and have an erection that lasts longer than 4 hours, get medical help right away to avoid permanent damage to your penis. Your doctor can explain these symptoms to you.

• Allergic reactions. Skin rashes, some of them severe, can occur in people who take KALETRA. Tell your healthcare provider if you had a rash when you took another medicine for your HIV infection or if you notice any skin rash when you take KALETRA. Common side effects of KALETRA include:

How should I store KALETRA?

polyethylene glycol 400, hydroxypropyl cellulose, talc, colloidal silicon dioxide, KALETRA tablets: polyethylene glycol 3350, yellow ferric • Store KALETRA tablets at room oxide 172, and polysorbate 80. temperature, between 59°F to 86°F KALETRA 100 mg lopinavir and (15°C to 30°C).

• Do not keep KALETRA tablets out of the 25 mg ritonavir tablets: copovidone, sorbitan monolaurate, colloidal silicon container it comes in for longer than dioxide, and sodium stearyl fumarate. The 2 weeks, especially in areas where film coating contains: polyvinyl alcohol, there is a lot of humidity. Keep the titanium dioxide, talc, polytheylene glycol container closed tightly.

3350, and yellow ferric oxide E172.

KALETRA oral solution: KALETRA oral solution: acesulfame • Store KALETRA oral solution in a refrigerator, between 36°F to 46°F (2°C potassium, alcohol, artificial cotton candy flavor, citric acid, glycerin, high to 8°C). KALETRA oral solution that is kept refrigerated may be used until the fructose corn syrup, Magnasweet-110 flavor, menthol, natural and artificial expiration date printed on the label. vanilla flavor, peppermint oil, polyoxyl • KALETRA oral solution that is stored at 40 hydrogenated castor oil, povidone, room temperature (less than 77°F or 25°C) should be used within 2 months. propylene glycol, saccharin sodium, sodium chloride, sodium citrate, and • Keep KALETRA away from high heat. water.

Throw away any medicine that is out of KALETRA oral solution contains date or that you no longer need.

42.4% alcohol (v/v). “See How Keep KALETRA and all medicines out should I take KALETRA?”. of the reach of children.

KALETRA Tablets, 200 mg lopinavir/50 mg General information about ritonavir Manufactured by Abbott Pharmaceuticals KALETRA PR Ltd., Barceloneta, PR 00617 KALETRA does not cure HIV-1 or AIDS. for Abbott Laboratories, North Chicago, IL The long-term effects of KALETRA are not 60064, U.S.A. known at this time. People taking KALETRA KALETRA Tablets, 100 mg lopinavir/25 mg may still get opportunistic infections or ritonavir and KALETRA Oral Solution other conditions that happen with HIV-1 Abbott Laboratories, North Chicago, IL infection. Some of these conditions are 60064, U.S.A. pneumonia, herpes virus infections, and 2010, ALL RIGHTS RESERVED Mycobacterium avium complex (MAC) infections. * The brands listed are trademarks of their Medicines are sometimes prescribed respective owners and are not trademarks for purposes other than those listed in a of Abbott Laboratories. The makers of Medication Guide. Do not use KALETRA for these brands are not affiliated with and a condition for which it was not prescribed. do not endorse Abbott Laboratories or its Do not give KALETRA to other people, even products. if they have the same condition you have.

It may harm them.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

• diarrhea This Medication Guide summarizes • nausea the most important information about Ref: 03-A387-R8 • stomach area (abdominal) pain KALETRA. If you would like more • feeling weak Revised: June, 2010 information, talk with your doctor. You • vomiting 036-395112 MASTER can ask your pharmacist or doctor for • headache information about KALETRA that is • upset stomach written for health professionals. For more These are not all of the possible side information about KALETRA call 1-800effects of KALETRA. For more information, 633-9110 or go to www.KALETRA.com.

039-403018 ask your doctor or pharmacist. Tell your doctor about any side effect that bothers What are the ingredients in KALETRA? you or that does not go away.

Active ingredient: lopinavir and ritonavir Call your doctor for medical advice about Inactive ingredients: side effects. You may report side effects KALETRA 200 mg lopinavir and 50 mg to FDA at 1-800-FDA-1088. ritonavir tablets: copovidone, sorbitan monolaurate, colloidal silicon dioxide, and sodium stearyl fumarate. The film coating contains: hypromellose, titanium dioxide,

Dr. Robert Murphy: “We know that with the drugs that we use, we can drop the virus to undetectable levels, but …we can’t cure the virus.”

Getting closer Studies take aim at eradicating the virus

by Enid Vázquez

PHOTO: JOSHUA THORNE

Yes, the search for a cure continues. “Now more than ever,” says Robert Murphy, MD, an HIV specialist and researcher at Northwestern University Feinberg School of Medicine in Chicago, and its Director of Global Health.

Dr. Murphy oversees a small study that takes another step towards eradication. In other words, the cure. The year-long trial began enrollment in August.

Among the many research routes to the cure, the concept of chasing HIV from its hiding spots in the body in order to kill it is the hottest in the field today. This study aims at doing just that.

It focuses on people who’ve had P os i t i velyAwa re.com

undetectable virus on HIV therapy for at least three years, “the longer, the better,” says study coordinator Baiba Berzins.

The study intensifies their alreadysuccessful therapy with two of the newer HIV drugs on the market, drugs which function in a way that’s of particular interest in the search for eradication, Isentress (raltegravir) and Selzentry (maraviroc).

Then participants are given a vaccine to

flush out that hidden virus in order to see if the intensified therapy can decrease the levels of that now-activated virus.

A number of pilot studies in conjunction with a French research organization, including this study, are scheduled to run for just over a year.

“Right now,” said Dr. Murphy, “we know that with the drugs that we use, we can drop the virus to undetectable levels, but …we can’t cure the virus. As soon as you stop the drugs—even if you’ve been on them for 10 years—it’s really just a matter of time before the virus returns in the blood. That can be anywhere from a few days to a month or so. s e p t e m b e r /o c to b e r 2 01 0

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“We don’t really know how big the reservoirs are, but we think they’re much smaller than what is floating around.”

“That happens because the virus is integrated into a group of long-living, what’s called ‘latently infected’ cells,” he continued. “So they’re infected, but they’re just sitting there. They’re not replicating.

And when they periodically do start to activate and replicate, the virus comes back. Those cells are in what’s called the reservoir. Over a period of time after a lot of therapy, there’s actually not that many of those cells. What we hope to do, based on a couple of experiments that have been done in the last couple of years, is to try to activate those cells so that they basically extinguish themselves and you would decrease the amount of virus that’s in the reservoir and hopefully—theoretically— eradicate the virus.”

Moreover, some of the virus in the reservoir of a person on successful treatment is not functional, he explained, which is yet another reason for hope.

Newly infected people generally have between 10,000 and a million viral particles per milliliter of blood, “an enormous amount,” Dr. Murphy explains, which becomes undetectable with treatment.

“We don’t really know how big the reservoirs are, but we think they’re much smaller than what is floating around [in the blood and plasma]. If we could just activate those cells that are latently infected, we think it’s possible to eradicate the virus.

It may not be eradicable in every patient, but we think there are some patients who could respond to a therapeutical approach like this.

“If we can decrease the viral reservoir, then we can do an experiment where we actually stop the drugs. But we’re not anywhere near that,” he said.

The HIV research world still has much to learn about viral reservoirs. Among other things, the best way to measure virus in the reservoir is not known. “There’s been a huge amount of attention in the last couple of years in this area,” he said.

“We’re going to certainly learn more about 28

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the reservoirs and how to measure the level of virus in them. That’s going to be a secondary objective in this process. Maybe there are more sanctuary sites. Maybe it’s in the brain. Maybe it’s in a place that’s not going to be affected by the therapy that we’re doing.”

In the meantime, with longstanding lack of attention and money, the search for a cure remains behind the eight ball. As such, as small as this study is—only 28 participants—it represents a big step forward.

“I don’t know anyone who’s gotten to the point of doing a study like ours,” said Dr. Murphy. “This group we’re working with [in France] is the furthest ahead clinically.

We’re ready to actually test the concept.

We’ve got the drug. We’re working with the NIH—the National Institutes of Health—and two pharmaceutical companies, and a small biotech company has applied for the parallel IL-7 study [in Europe]. We have several other companies lined up to work with once these studies are done.

“We’re giving the NIH adenovirus vector vaccine,” he continued. “It’s very similar to the Merck vaccine that was used in a prevention trial, and what they found in that study was that the vaccine did not work. Not only did it not work, but patients on the vaccine were more likely to get infected. It’s the immune stimulation that was detrimental at preventing the infection that actually may be beneficial in a person who’s already infected.”

Dr. Murphy said that ultimately, the two therapies—the immodulatory NIH vaccine and the IL-7—may be put together, perhaps with a third drug. “If we see a decrease in the viral particles [at this point], and we’re seeing this by measuring HIV DNA in the blood and seeing what happens in the lymphoid tissue of the gut, that alone is a positive sign. And then we have to continue on in that vein,” he said.

There’s a small chance that stimulating the immune system in this way may backfire. “Could that have a detrimental

effect? We don’t know. We don’t think so, because these drugs are used for other things,” said Dr. Murphy. “There’s plenty of safety data on them. The adenovirus vector vaccine—you’re not talking about doing multiple doses of this product. It’s a relatively short period. So, although you’re stimulating the immune system, and that’s a potential downside, we’re not going to be doing it for a very long period of time.

These are pilot studies and the drugs so far have been used and are safe.”

If even one of the 28 study participants shows a drop in the reservoir virus mentioned, Dr. Murphy said he would be “ecstatic. That means it can be done.”

For more information on the EraMune 02 HIV Eradication study, visit http:// globalhealth.northwestern.edu/Projects/ Eramune.html. The two other sites are San Francisco (Dr. Steven Deeks) and New York City (Dr. Timothy Wilkin).

Stem cells, gene therapy, and more There are hundreds of studies working towards an HIV cure. Many involve the very early work of basic science, with lots of test tubes in the mix. Others that are much further along, involving actual people, are fewer. Researchers looking for a cure have even created their own conference, the International Workshop on HIV Persistence during Therapy, also known as the “HIV eradication conference.” The fifth workshop is scheduled for December 2011.

Contrary to the idea that pharmaceutical companies are not interested in finding a cure when they can make money from selling drugs, there are private firms investigating potential compounds for the cure, as well as ways to do the work that is necessary to establish it, such as looking at how the body responds to HIV. Among these companies is Gilead Sciences, the maker of the successful HIV drugs Viread and Truvada, and one of the two pharmaceutical companies, along

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One cure research approach is gene therapy —can someone’s cells be modified so they are resistant to HIV?

Photo: Joshua Thorne

with Bristol-Myers Squibb, behind the topselling antiviral drug, Atripla.

The U.S. National Institutes of Health (NIH) is the main player involved in the quest for the cure. In Minnesota, the University of Minnesota took out a fullpage ad in a local gay news publication inviting both HIV-positive and -negative people to join them in various studies to figure out why HIV persists and can’t be cured through antiviral treatment.

Understanding that problem can help lead to a solution.

One cure research approach is gene therapy—can someone’s cells be modified so they are resistant to HIV? What about a stem cell transplant, with cells from someone who is already genetically resistant to the virus?

The American Foundation for AIDS Research (amfAR), has funded cure studies for years. In May, the foundation announced the establishment of a collaborative effort among four research teams in search of a cure. Among the work which received grants: a look into the circumstances of the Berlin patient, a man from the U.S. who appears to have been cured of HIV following treatment of his cancer; an examination into the role of ongoing activation of the immune system in HIV’s ability to persist for a lifetime; and attempts to determine which cellular reservoirs are most responsible for the persistence of the virus and the extent to which they can be affected by HIV drugs.

In the conclusion of a report issued in July, the AIDS Policy Project, an advocacy group for cure research, writes, “It comes down to both money and vision—the vision to imagine a world where people in Philadelphia and Capetown are lining up at clinics not for their monthly allotment of AIDS medication, but for the last AIDS drug they will ever need.”

To look into cure studies, visit www.clinicaltrials.gov and search for “HIV eradication.” e P os i t i velyAwa re.com

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One on One

plotting a strategY Interview by Jeff Berry

PA sat down in Vienna with Australian researcher and physician Sharon Lewin to get her thoughts on some of the emerging strategies for a cure, and what work may still lie ahead.

JB: Could you summarize for us some of the highlights from the talk you gave at the opening plenary of the conference?

SL: The main areas I wanted to cover in my talk were why we need a cure, why we don’t have one, and what strategies we’re going to need to get there. Why we need one is that HAART is not perfect. HAART is great—it’s changed people’s lives, and it’s been fantastic, but life expectancy is still reduced and there are ongoing treatment related toxicities. And then the argument is the sustainability of long-term treatment for everyone. It’s not a problem if you live in the U.S. or Australia, but it’s still a threat if you’re living in a lower income country.

I think we know a lot more now about 30

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why HAART doesn’t cure HIV and what the causes of viral persistence are, and I explained the difference between persistent infected cells, which we measure by DNA, and persistent low-level viremia. There’s really no such thing as an undetectable viral load—there’s always low-level viremia and persistent infected cells. There’s a lot of debate and argument amongst scientists about what’s contributing to low-level viremia. Is it latently infected cells, residual viral replication or anatomical reservoirs? I don’t think that’s the fight we need to have.

I think they all probably play a role, but the biggest hurdle will be getting rid of latently infected cells.

Latency is when the virus enters into a resting cell, integrates, and then sits there

and doesn’t do anything unless the cell gets activated. What we now know is that latency can be established in lots of resting cells including memory cells. We now know there are a whole lot of other cells including stem cells where latency can be established. And that’s going to be pretty tricky, first of all understanding if latency is the same in all those cells and whether you can target all of those cells with the same strategy.

Latently infected cells have a very long half-life and they also can probably proliferate and divide. Then what’s called daughter cells will contain a latent virus as well, so there’s probably a source that’s replacing these latently infected cells all the time.

JB: So what happens is you suppress the virus for a long time and then suddenly these other latent cells become activated?

SL: When you’re on treatment you can suppress the virus for a long, long time, or you’ll have low-level viremia (meaning detectable virus of less than 50 copies/ml in blood). In most people low level viremia sits at around 3-5 copies/ml. But the minute you take away antiretroviral therapy the virus takes off again. That’s because latently infected cells can be activated, release virus, and then go on to infect new cells. I think anatomical reservoirs are also going to be important because you have very high levels of virus replication in some of these sites, specifically the gut—and in the CNS and genital tract there are specialized, long-lived infected cells. The evidence for brain and genital tract reservoirs in patients on HAART is not really great, they’re very hard areas to access. But in the gut there are lots of studies now showing that there’s probably about 10 times as much virus there than in blood, even in people who have been on treatment for years.

I talked about the difference between functional cure and sterilizing cure—maybe simpler words for these are “cure” or “remission” so that cure means eliminating every single infected cell. To achieve a “cure” you would give HAART plus a certain treatment for a number of years and have no virus detectable, and that’s what scientists are now calling sterilizing cure. The other strategy [functional cure] may be just

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Photo: ©IAS/Steve Forrest/tWorkers’ Photos

Dr. Sharon lewin: “..the biggest hurdle will be getting rid of latently infected cells.”

to induce remission, meaning that you lower the virus to a level less than 50 copies per ml in the absence of treatment. That’s what I’d call the cancer model—the virus is always there, but you can control it, not have any immune damage, and not be taking HAART. I also talked about what strategies we’re going to be able to use, and those include optimizing HAART, which could be with intensification or starting early. I’ve reviewed some of the intensification studies that show no difference in persistent DNA and low-level viremia if you’re adding T-20 [Fuzeon], or more protease inhibi-

about is trying to push virus out of these latently infected cells. They’re trying to “reverse” latency, or what some call “purge the reservoir” or wake up the virus so it starts to replicate.

JB: It’s almost counter-intuitive.

SL: Yes, it’s counter-intuitive because you’re causing the virus to replicate, but the basis of why people think that this might work is if you cause the virus to replicate and it can’t get into new cells, then the latently infected cells will die. Once the virus comes

“All of these strategies are designed to come in after several years of HAART... the aim is to get people off HAART, but it’ll never replace it.” tors, or adding raltegravir [Isentress]. In other words, all of these studies showed no change in the measures of persistent reservoir. But in one very good study from Spain, probably the largest intensification study so far, they gave patients raltegravir and a third of them had an increase in 2-LTR circles [another marker of virus replication] and that was really proof that there must be ongoing virus replication in at least some patients on treatment. That doesn’t mean that’s the explanation for the fact that we can’t cure HIV, it just means that there’s still some residual replication, and that has to be addressed with any kind of purging strategy.

The other interesting data concerning treatment is that if you do treat early, during acute infection, the size of the reservoir is much smaller than if you treat late. There’s some pooled data from a large French cohort that if you treat very early, the number of latently infected cells is about 1 to 2 logs less than if you treat someone who’s got a chronic, established infection. So the optimal way to really crunch the reservoir down to its smallest size would be treating early and treating with maximal therapy to turn off any replication. That still doesn’t get rid of the reservoir—it just makes it as small as possible.

And then I think that even if we do all of that, all the evidence says that we still haven’t eliminated the reservoir, and the next strategy that people are thinking P os i t i velyAwa re.com

out of a latently infected cell, it destroys the cell it was in. For this to work, HAART has to block 100% of any new rounds of replication. That’s the idea behind purging the reservoir, or pushing the virus out.

And the last thing I talked about is that there may be ways that you can make cells resistant to HIV using gene therapy. The gene that is the most attractive target is the CCR5 gene and there are now mouse models that have shown it is possible to introduce a gene that knocks out CCR5.

None of these strategies will replace HAART. All of these strategies are designed to be used after several years of HAART. We don’t really know how long, but maybe three to five years, and the aim is to get people off HAART, but it’ll never replace HAART. So, therefore universal access still has to be number one.

I also talked a little about community engagement because I think this is really complex science, and the community hasn’t come along in understanding what people are thinking. I think clinical trials with people taking antiretroviral therapy and having a really good quality of life, that then introduce something that’s potentially unknown or toxic, is one of the challenges in designing those studies. And then if we can achieve an effective cure, when will we feel comfortable interrupting treatment knowing that interrupting treatment is unsafe?

So there are lots of issues to explore in how best to design clinical trials.

JB: So, what are the implications of the Berlin patient? Obviously it’s not something you’d want to try in everyone.

SL: I think that case is really interesting. We have to absolutely know everything about that patient and what happened to him, and why they got that result of basically a sterilizing cure. No HIV in the blood, the gut, or the cerebral spinal fluid (CSF)—it shows that you can eventually get rid of these latently-infected cells. You can also get rid of anatomical reservoirs, and it’s possible to have no replication when off HAART. The next question is, what’s done it? Is it the transplant, so that you’ve made every cell resistant to HIV? The Berlin patient received a transplant of bone marrow from a donor that contained a delta 32 mutation in the CCR5 gene so that there was no CCR5 expressed on the donor bone marrow cells. The strategy to mimic this would be to knock out CCR5 by gene therapy. But I’m not sure it was just the transplant that “cured” this man—I wonder if there are other factors at play. Another theory could be that he had total body irradiation which knocked out all of his T-cells in the very earliest phase in bone marrow and it got completely replaced by new T-cells so any reservoirs in the bone marrow would have been knocked out. He had chemotherapy, and whenever you give someone a transplant, you have something called graft versus host disease, so the cells in the new bone marrow get rid of any cells from the patient that are lurking around. I agree that you’re never going to be able to use this as a strategy, but we have to try and pick out what might have worked. I think that’s the basis for thinking that maybe gene therapy and altering CCR5 expression may be one strategy.

JB: Is there anything you’d like to add?

SL: I think we shouldn’t be embarrassed to talk about a cure. With cancer, which is far more diverse and likely to be more challenging to cure, people proudly say they’re “aiming for a cure.” So I think it should just be part of the language, a goal that we need to strive for. We shouldn’t be timid about using the word. e To view a webcast of Dr. Lewin’s opening plenary talk visit www.aids2010.org. s e p t e m b e r /o c to b e r 2 01 0

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Republicans to ADAP’s rescue?

In the effort to end ADAP waiting lists, Democrats in the Senate are MIA

By Sue Saltmarsh

Two Republican U.S. Senators have introduced legislation to help struggling state AIDS Drug Assistance Programs by using money from the federal economic stimulus package that was signed into law last year. But Democratic lawmakers, who have traditionally supported HIV/AIDS legislation, have yet to sign on to the proposal.

The Access ADAP Act, also known as S.3401, was introduced in May by Republican senators Richard Burr of North Carolina and Tom Coburn of Oklahoma.

Two other Republican senators, Michael Enzi of Wyoming and George Lemieux of Florida, have co-sponsored the bill.

This legislation would allow for $126 million to be appropriated from unobligated discretionary funds in the American Recovery and Reinvestment Act. Because the money is already allocated, no additional funds would have to be found or taken away from other programs. The money would shore up the struggling AIDS Drug Assistance Program (ADAP) in states that have instituted waiting lists or other cost-cutting restrictions that prevent HIVpositive people from getting the medications they need to stay alive.

According to the National Association of State and Territorial AIDS Directors (NASTAD), which monitors the ADAP situation nationally, as of Aug. 12, there were 2,937 people on waiting lists in Florida, Hawaii, Idaho, Iowa, Kentucky, Montana, North Carolina, South Carolina, South Dakota, Utah, and Wyoming.

In addition, the following states, while not establishing waiting lists so far, have instituted cost containment strategies such as lowering eligibility levels and reducing their formularies, which also 32

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restrict access to antiretrovirals: Arizona, Arkansas, Colorado, Illinois, Louisiana, Missouri, North Dakota, and Washington.

Murray Penner, Deputy Director of NASTAD, acknowledged the many challenges facing state budgets. But he also notes some successes. “North Carolina is a great example and so is Wyoming where we’ve seen state legislators step up and say, ‘We have to be part of the solution’ and they put money forward. You’ll see the waiting list numbers go down from what they were most recently because North Carolina has been able to enroll almost 600 people back into their program.”

So what motivated Senators Burr and Coburn to introduce the bill? Though both have a history of supporting HIV/AIDS funding from Ryan White to ADAP, this is a hard time to propose any kind of funding. Senator Coburn is also a doctor and perhaps understands, from a medical standpoint, the costs, both financial and in human terms, of people not being able to get treatment. In a phone interview, Senator Burr told PA, “I think it’s common sense. The compassionate thing to do is to make sure people get the medications they need. But if you look at it from a budgetary standpoint, it’s much more cost effective to provide medication than it is to treat the devastating effects for individuals who don’t receive treatment.”

When asked if he thought most of his Congressional colleagues understand that, he said, “No, I think very few do or this would not even be an issue.”

Penner agrees that there is a definite need for education, both of state and federal political leaders. “I think it’s always a struggle to convey the understanding that it’s cost saving to provide money for a program like this.” He continued, “Plus, as a country, we’re much more focused on treatment, on trying to fix something once it goes bad than we are on trying to prevent things.”

Commenting on the lack of Democratic support for the bill, Burr said it was “shocking” and theorized that it wasn’t a result of political maneuvering, but rather the fact that “it wasn’t a Democratic idea.”

But according to Burr, “Authorship isn’t what’s important to us. If Harry Reid [the Senate majority leader] said, ‘It’ll pass tomorrow, but I’ve got to put my name on it,’ we’d give it to him.”

Reid’s office was called for comment, but did not respond.

Asked how he would go about convincing his colleagues to vote for the bill, Burr replied, “I think we’d look at this somewhat like members of Congress have looked at SCHIP [State Children’s Health Insurance Program]. There are some populations you focus on because of their vulnerability

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“I think it’s safe to say that most members of Congress don’t like to get into health care, one—and two, probably are pretty aggressive at not getting involved in HIV/AIDS.” —U.S. SENATOR Richard burr, (r., north carolina)

and, more importantly, the long-term impact you can have on overall health care costs.” He acknowledged that compassion plays a role, but added, “When you’re talking about selling it to the body that makes appropriations, sometimes you’ve got to break it down into dollars and cents.”

Senator Burr admitted that it was hard to say how long it would take for it to pass.

“I think it’s safe to say that the likelihood of a stand-alone bill passing is probably slim to none, so Tom and I are looking for a vehicle that we think the President would sign that we can amend with this language.”

Burr noted the recent infusion of $25 million, which may be due in part to his and Coburn’s efforts, but acknowledges that it’s a “drop in the bucket.” He wondered, “If you recognize that $25 million has a positive quality of life story, then why wouldn’t you do the full $126 million and take care of everybody on the waiting list?”

While the $25 million doesn’t meet all the need, it is a “bit of relief,” and Penner thinks that the Obama administration was smart in making the money a part of the existing program as an administrative supplement to current grants, which then makes it flow pretty quickly. He estimates that “$25 million will be out the door by a month from now [August 15].” He also said he hopes that if Congress passes S.3401, they would “do some similar type of vehicle that would actually get the money moving.”

According to Brendan Macsata, CEO of ADAP Advocacy Association (aaa+), the thing that would perhaps be the deciding factor would be for President Obama to join in the fray and propose something. As he said, “The community still has hope in him, despite his poll numbers,” and he noted that Obama is the first president to establish an Office of National HIV/AIDS Policy and to bring the dialog to the forefront.

In light of the unveiling of the National HIV/AIDS Strategy on July 13, would the Strategy provide support for S.3401?

P os i t i velyAwa re.com

Senator Burr replied, “I don’t think so.

There’s just such a disconnect between members. I think it’s safe to say that most members of Congress don’t like to get into health care, one—and two, probably are pretty aggressive at not getting involved in HIV/AIDS.” If it’s not a question of political will, does ignorance, stigma, or the categorization of HIV/AIDS as a “behavioral disease” play a part in politicians’ slowness to act?

Burr theorized that it was “all of the above.” Macsata agreed, “Stigma exists. HIV is not glamorous. Fighting cancer is glamorous. Investigating autism is glamorous.”

Macsata also made the point that of the three major players—the pharmaceutical industry, the state governments, and the federal government—only the federal government has failed to pitch in. Asked if he was satisfied with the efforts made by the pharmaceutical companies to stem the tide, he said, “They’re certainly trying.

The Fair Pricing Coalition and NASTAD deserve credit for going to the companies and negotiating, asking them for help and some are doing more than others, but really, it’s the federal government that needs to step up.”

Penner commented, “We’re very pleased that the pharmaceutical companies have stepped up to the plate and have made additional concessions, instituted price freezes, and done other creative things to be a part of the solution.”

When asked if NASTAD expects to see a decrease in the number of people getting tested because they’re afraid they won’t be able to access treatment, Penner said, “I think it’s a double-edged sword.

Some folks will hear that their programs are closed and therefore not test, but with the CDC emphasis on testing and now, the national strategy and the goals of actually getting more people identified and into treatment, I think it’s going to push more individuals who might not know the care

side is constricted to test and learn their status. I think you’re going to see some of both that is unfortunately going to contribute to this continued challenge of not having enough resources.”

As always, the best way for individuals to have an impact on the outcome of this legislation is to communicate—by letter, phone call, or e-mail—with their Congressional legislators. As Senator Burr contends, “When there are not a lot of options, quite frankly, the human face behind the issue is a very compelling thing.” And for Senate bill 3401, there aren’t a lot of options.

Even if S.3401 does pass and the $126 million finds its way to ADAPs across the country, it is only a temporary band-aid.

When asked if he had any plans to propose legislation that would create a more permanent funding mechanism for ADAP, Senator Burr replied that he and Coburn were “in discussions now as to how to change the system so that this isn’t an annual process that we go through. I think it’s a fairly easy calculation to make, at least from how we look at it, as to what the needs are going to be.” He added that he thought the current state budget crises were just the tip of the iceberg and stated, “Tom and I share a fear that potentially this is going to be a population that’s thrown overboard first. I hope we can find the right category to put this in where it receives the funding and the importance and the attention it deserves.” e To find contact information for your Senators and Representatives, go to www.senate.gov or www.house.gov.

To learn the names of your elected officials, go to www.congress.org.

For the latest on this and other stories, go to PositivelyAware.com

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ABOUT PREZISTA

IMPORTANT SAFETY INFORMATION

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

Belief {

in myself in my doctor in my meds

ONCE-DAILY PREZISTA FOR ADULTS TAKING HIV MEDS FOR THE FIRST TIME In a clinical study* of almost 2 years (96 weeks) in people who had never taken HIV meds before, ONCE-DAILY PREZISTA with low-dose ritonavir plus Truvada®…

• Helped 8 out of 10 people achieve undetectable viral load (less than 50 copies/mL) • May help to increase T-cell count • Was associated with low rates of diarrhea, stomach pain, nausea, and vomiting — Diarrhea (8%), stomach pain (5%), nausea (3%), and vomiting (2%) were reported as moderate to severe PREZISTA must be taken with and at the same time as 100 mg of Norvir® (ritonavir), and with other HIV meds and with food.

Once-daily dosing of PREZISTA is not recommended for adults who have taken HIV meds in the past.

Please read Important Safety Information below and ask your doctor if once-daily PREZISTA is right for you.

Individual results may vary.

What are the possible side effects of PREZISTA? • Tell your healthcare professional if you are taking estrogen-based contraceptives • High blood sugar, diabetes or worsening of (birth control). PREZISTA might reduce diabetes, and increased bleeding in people the effectiveness of estrogen-based with hemophilia have been reported in patients contraceptives. You must take additional taking protease inhibitor medicines, precautions for birth control, such as condoms including PREZISTA • Changes in body fat have been seen in some What should I tell my doctor before I take patients taking HIV medicines, including PREZISTA? PREZISTA. The cause and long-term health • Before taking PREZISTA, tell your healthcare effects of these conditions are not known at professional if you have any medical conditions, including allergy to sulfa medicines, this time diabetes, liver problems (including hepatitis B • As with other protease inhibitors, taking or C), or hemophilia PREZISTA may strengthen the body’s immune response, enabling it to begin to fight infections • Tell your healthcare professional if you are that have been hidden. Patients may experience pregnant or planning to become pregnant, or signs and symptoms of inflammation that can are breastfeeding include swelling, tenderness, or redness – The effects of PREZISTA on pregnant women • The most common side effects related to or their unborn babies are not known. You taking PREZISTA include diarrhea, nausea, and your healthcare professional will need to rash, headache, stomach pain, and vomiting. decide if taking PREZISTA is right for you Uncommon but severe side effects such as – Do not breastfeed if you are taking PREZISTA. inflammation of the pancreas and increased You should not breastfeed if you have HIV blood fat levels have also been rarely reported. because of the chance of passing HIV to This is not a complete list of all possible side your baby effects. If you experience these or other side effects, talk to your healthcare professional.

Do not stop taking PREZISTA or any other medicines without first talking to your healthcare professional Distributed by: Tibotec Therapeutics/Division of Centocor Ortho Biotech Products, L.P. Titusville, NJ 08560 ©2010 Tibotec Therapeutics 05/10 28PRZDTC0010R3 All trademarks are property of their respective owners.

• Please refer to the ritonavir (Norvir ®) Product Information (PI and PPI) for additional information on precautionary measures 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 adults taking HIV meds for the first time: PREZISTA 800 mg (two 400-mg tablets) must be taken at the same time with 100 mg Norvir ® once daily every day. PREZISTA must be taken with food Please see Important Patient Information on the next page for more information, or visit www.PREZISTA.com.

If you or someone you know needs help paying for medicine, call 1-888-4PPA-NOW (1-888-477-2669) or go to www.pparx.org. *343 adult patients (30% women) received combination therapy with PREZISTA/ritonavir. At the start of the study, the average T-cell count was 245, and 66% of patients had a viral load less than 100,000 copies/mL.

ONCE DAILY www.PREZISTA.com/patient

IMPORTANT PATIENT INFORMATION PREZISTA® (pre-ZIS-ta) [(darunavir) (da-ROO-nuh-veer)] Tablets ALERT: Find out about medicines that should NOT be taken with PREZISTA. Please also read the section “Who should not take PREZISTA?”.

Please read this information before you start taking PREZISTA. Also, read the leaflet each time you renew your prescription, just in case anything has changed. Remember, this leaflet does not take the place of careful discussions with your doctor. You and your doctor should discuss your treatment with PREZISTA prior to the first time you take your medicine and at regular checkups. You should remain under a doctor’s care when using PREZISTA and should not change or stop treatment without first talking with a doctor.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT PREZISTA? PREZISTA, together with NORVIR® (ritonavir), has rarely been observed to cause liver problems which may be life-threatening. It was not always clear if PREZISTA caused these liver problems because some patients had other illnesses or were taking other medicines. Your healthcare professional should do blood tests prior to initiating combination treatment including PREZISTA. If you have chronic hepatitis B or C infection, your healthcare professional should check your blood tests more often because you have an increased chance of developing liver problems. Please also read the section “What are the possible side effects of PREZISTA?”.

Rarely, PREZISTA has been reported to cause a severe or life-threatening rash. Contact your healthcare provider immediately if you develop a rash.

Your healthcare provider will advise you whether your symptoms can be managed on therapy or whether PREZISTA should be stopped.

WHAT IS PREZISTA? PREZISTA is an oral tablet used for the treatment of HIV (Human Immunodeficiency Virus) infection in adults. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). PREZISTA is a type of anti-HIV medicine called a protease (PRO-tee-ase) inhibitor.

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. Because of this, it is very important for you to remain under the care of a doctor. 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 doctor if you have any questions on how to prevent passing HIV to other people.

WHAT SHOULD I TELL MY DOCTOR BEFORE I TAKE PREZISTA? Tell your doctor about all of your medical conditions, including if you: • are allergic to sulfa medicines.

• have diabetes. In general, 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 doctor will need to decide if taking PREZISTA is right for you. If you take PREZISTA while you are pregnant, talk to your doctor 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 doctor about the best way to feed your baby.

WHO SHOULD NOT TAKE PREZISTA?** Together with your doctor, 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 doctor 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 doctor 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 doctor 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 doctor 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®) – dexamethasone, fluticasone (Advair Diskus®, Cutivate®, Flonase®, Flovent Diskus®) – bosentan (Tracleer®) – atorvastatin (Lipitor®), pravastatin (Pravachol®), rosuvastatin (Crestor®) – cyclosporine (Sandimmune®, Neoral®), tacrolimus (Prograf®), sirolimus (Rapamune®)

IMPORTANT PATIENT INFORMATION – salmeterol (Serevent®) – methadone, buprenorphine/naloxone – risperidone (Risperdal®, Risperdal® Consta®,Risperdal® M-TAB®), thioridazine – sildenafil (Viagra®), vardenafil (Levitra®), tadalafil (Cialis®) – tadalafil (Adcirca®) – paroxetine (Paxil®), sertraline (Zoloft®) Tell your doctor 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 doctor 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 doctors and pharmacists any time you get a new medicine. Both your doctor 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 doctor or pharmacist. You can ask your doctor 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 doctor. You must take ritonavir (NORVIR®) at the same time as PREZISTA. • For adults who have never taken anti-HIV medicines, the usual dose is 800 mg (two 400 mg tablets) of PREZISTA, together with 100 mg (one 100 mg capsule) of ritonavir (NORVIR®), once daily every day.

• For adults who have taken anti-HIV medicines in the past, the usual dose is 600 mg (one 600 mg tablet or two 300 mg tablets) of PREZISTA, together with 100 mg (one 100 mg capsule) of ritonavir (NORVIR®), twice daily every day. Do not take PREZISTA once daily if you have taken anti-HIV medicines in the past.

PREZISTA and ritonavir (NORVIR®) should be taken together at the same time every day. If you have questions about when to take PREZISTA and ritonavir (NORVIR®), your doctor can help you decide which schedule works for you.

Take PREZISTA and ritonavir (NORVIR®) with food. Swallow the whole tablets with a drink such as water or milk. Do not chew the tablets.

Continue taking PREZISTA and ritonavir (NORVIR®) unless your doctor tells you to stop. Take the exact amount of PREZISTA and ritonavir (NORVIR®) that your doctor tells you to take, right from the very start. To help make sure you will benefit from PREZISTA and ritonavir (NORVIR®), you must not skip doses or interrupt therapy. If you don’t take PREZISTA and ritonavir (NORVIR®) as prescribed, the beneficial effects of PREZISTA and ritonavir (NORVIR®) may be reduced or even lost.

Patients taking PREZISTA once daily 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 the 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®) immediately. Then take your next dose of PREZISTA and ritonavir (NORVIR®) at the regularly scheduled time.

Patients taking PREZISTA twice daily 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 the 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®) immediately. Then take your next dose of PREZISTA and ritonavir (NORVIR®) at the regularly scheduled time.

You should always take PREZISTA and ritonavir (NORVIR®) together with food.

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? Like all prescription drugs, 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 anti-HIV medicines. Do not rely on this leaflet alone for information about side effects. Your doctor can discuss with you a more complete list of side effects.

PREZISTA, together with NORVIR® (ritonavir), has rarely been observed to cause liver problems which may be life-threatening. It was not always clear if PREZISTA caused these liver problems because some patients had other illnesses or were taking other medicines. Your healthcare professional should do blood tests prior to initiating combination treatment including PREZISTA. If

you have chronic hepatitis B or C infection, your healthcare professional should check your blood tests more often because you have an increased chance of developing liver problems.

Talk to your healthcare professional 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 few patients, PREZISTA has been reported to cause a severe or life-threatening rash. Contact your healthcare provider immediately if you develop a rash.

Your healthcare provider will advise you whether your symptoms can be managed on therapy or whether PREZISTA should be stopped.

Other relevant severe side effects reported at an uncommon or rare frequency were inflammation of the liver or pancreas, increased blood fat levels, diabetes, and changes in body fat.

Some side effects are typical for anti-HIV medicines in the same family as PREZISTA. These are: • 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. 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.

The most common side effects include diarrhea, nausea, rash, headache, abdominal pain and vomiting.

Tell your doctor 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 doctor.

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, Ltd.

Manufactured for Tibotec, Inc. by: JOLLC, Gurabo, Puerto Rico Distributed by: Tibotec Therapeutics, Division of Centocor Ortho Biotech Products, L.P., Raritan NJ 08869 Patent Numbers: 5,843,946; 6,248,775; 6,335,460 and other US patents pending NORVIR® is a registered trademark of its respective owner.

PREZISTA® is a registered trademark of Tibotec Pharmaceuticals, Ltd.

© Tibotec, Inc. 2006

Revised: April 2010

10101711P

Virtual you Tips for writing your personal profile

By Brett Grodeck

choose one answer that best describes you. Sometimes your choices are clear cut, other times not so much. Defining your race—such as African American, Caucasian, or Hispanic—might not work for people from mixed-race backgrounds. You can choose “other” or “I’ll tell you later.”

Age can be a touchy subject. People in their 40s or 50s might feel “too old” to date someone in their 20s or 30s. On the flip side, those in their 20s or 30s might feel too unsure of themselves to date someone older and more secure. Whatever your age, it’s a good idea to be honest about it.

Why? When you join a site, you’ll need to provide at least one recent photo of yourself, if not more. A good photo shouldn’t lie. Eventually, you’ll meet someone face to face. Starting a relationship in the context of deceit might not work in your favor.

Writing about your personal interests is the fun part. Some sites require you to pick from a range of interests, such as different music, sports, or pastimes such as astrology or cooking. Having a common interest with a potential dating partner can be a great online ice breaker. Even if the relationship turns towards a friendship, you can always talk about horoscopes and casserole recipes.

The appearance paragraph

Finding that special someone can be tricky if you have HIV. Some HIV-positives prefer to date other HIV-positives.

But how do you meet other compatible people who are also HIV-positive?

“Online dating is a great way to meet like-minded people,” says Donald Johnson, who’s been HIV-positive for over 20 years.

Johnson is also the founder of PozMatch. com, the first-ever online dating website for people with HIV. Joining any dating website, he notes, can be intimidating, especially if you’re uncomfortable writing about yourself.

If you’re considering online dating, you’ll need to write a personal profile.

A successful profile reflects who you are and what you want. Most profiles 38

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are composed of four general areas: the personal particulars, the appearance paragraph, the personal pitch, and your ideal relationship.

Here’s a quick primer on how to think about—and write—your own personal profile.

Personal particulars Whatever dating website you join, you’ll need to disclose the realities of who you are: gender, age, race, religion, education, and so on. Most sites have a predefined menu of choices, so you can just

Most dating websites require a few lines about your own appearance: height, body type, best features, or even personal style, such as conservative or casual. When writing this, you’ll want to put your best foot forward without lying. Lying isn’t cool.

Being forthright about body type and weight may be difficult for you. However, let’s face it, most of us have felt too thin, too fat, or too something. For people with HIV, another concern might be lipodystrophy, the telltale physical side effects from some long-term HIV medicine.

Whatever you believe is your worst feature, it’s very normal to compare yourself to other people—and then feel some inadequacy. We all do that sometimes. So when writing about your body, instead of fudging the truth, try writing about your physical self with a tone of confidence and appreciation of your uniqueness. For example, a female friend of mine carries some extra weight. But instead of making apologies, she exudes confidence about herself—and it shows. She’s constantly swarmed by men.

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When you write about your ideal partner, stay general

and avoid being too specific. If you’re looking for “a 35 year-old man with blue eyes and black hair who plays the violin,” good luck.

When writing about your appearance, be honest and be confident.

The personal pitch The personal pitch paragraph is difficult to write because it should convey who you are and what you’re about. Here, you’ll describe your personality. For example, you might be a type-A person who values a career. In that case, you might describe yourself as, “a workaholic who’s the first to arrive and the last to leave.” Or, you might value family life or recreational time. You might write, “I love spending time remodeling my house, puttering around the garden, or catching a good sci-fi movie.”

Try to avoid clichés when describing yourself. Clichés are common phrases that tend to get overused and lack specific meaning. Examples of clichés are: “I live life to the fullest.” You might recast this sentence to: “I love parties and BBQs with friends and my monthly whitewater rafting

trips.” Another common cliché: “I take care of myself.” You might rewrite to: “I spend three days a week at the gym lifting weights.” Don’t hint at how you spend your time; actually describe the little stuff that makes up your life.

Your ideal relationship What do you want from a potential relationship? What characteristics are acceptable in someone else? Here you state what you want and what you don’t want. When you write about your ideal partner, stay general and avoid being too specific. If you’re looking for “a 35 year-old man with blue eyes and black hair who plays the violin,” good luck. You’ll better your odds with: “a 30-something man who appreciates music.”

For what you don’t want, here’s where you note any relationship deal-breakers.

For example, if you’re newly sober and in a 12-step program, you probably want to stick with other sober people. Maybe

you’re a former cigarette smoker and you can’t handle an ashtray kiss. Maybe you’re allergic to cats, kids, or even flashy gold jewelry. Here’s where you say so.

Now imagine you’ve written your personal profile, clicked all those buttons, uploaded a recent picture of yourself, and you’re just about ready to go live. Just click Enter and don’t over-think things.

Give it a few days and see what happens.

You can change your profile and picture any time. Once your profile is live, it’s easy to compulsively check your email for responses. Instead, play it cool. Most of all, however, just have some fun with your new online community. e Brett Grodeck served as the editor of Positively Aware from 1997 to 1998 and is the author of The First Year—HIV: An Essential Guide for the Newly Diagnosed.

He is currently working on a social media project related to HIV medicine.

Subscribe or donate. ❑ 1-year subscription: $30. (Subscriptions are mailed free of charge to those who are HIV-positive.)

❑ renewal: $30. Enclosed is my payment. ❑ Back issues: $3 per copy. Enclosed is my payment.

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enclosed is my donation of: ❑ $25 ❑ $50 ❑ $100 ❑ $250 ❑ $500 ❑ $_______ Your contribution helps provide subscriptions to people who can’t afford them. All donations are tax-deductible to the full extent allowed by law.

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Charges will appear on your credit card bill as TPA Network. Test Positive Aware Network (TPAN) is a not-for-profit organization dedicated to providing support and information to all people impacted by HIV.

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39

Members of TPAN were among those who joined in ATGC’s anti-stigma campaign.

Cleveland rocks at fighting stigma and discrimination

by Sue Saltmarsh A press release came across my desk at the beginning of March announcing the AIDS Taskforce of Greater Cleveland’s (ATGC) anti-stigma campaign, during which people in Cleveland, Ohio would wear red t-shirts that said, “HIV Positive” throughout the day. The idea was to combat stigma and negative judgment by displaying that message, whether HIVpositive or not, and educating the public about the facts of the disease. It seemed like a good, courageous idea and I called the ATGC to see if TPAN could get in on it.

Rebecca Strong, newly hired Development Associate, informed me that we could order the t-shirts at $10 per shirt 40

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and they would be shipped in time for the event. Unbeknownst to her, that press release had set off a flurry of interest, both in the Cleveland area and throughout the country.

Speaking to Rebecca four months later, she’d had a chance to recover from the chaos of getting e-mail orders, sorting, boxing, and shipping t-shirts, and facilitating the Cleveland event. Her calm, friendly voice was completely devoid of the edge of panic I’d heard back in March and it was clear that she was rightfully proud of the event as she gave me the stats.

Over 400 people participated in Antistigma Day on March 26. AIDS service organizations (ASOs) and individuals had

ordered the t-shirts from such places as Washington, D.C., Texas, Chicago, San Francisco, Seattle, and Toronto. At TPAN, a group of 10 of us wore them. 30 people wore them in Bangladesh, and the wife of ATGC’s executive director Earl Pike wore one in Israel. In Ohio, the Secretary of State, the Lieutenant Governor, several judges, and a mayor and his daughter wore them.

Asked where the shirts came from, Rebecca explained that the Treatment Action Group (TAG), who had originally created them for a march in Cape Town, South Africa during the International AIDS Society (IAS) conference of 2009, had given ATGC the design and permission to adapt it for their agency. They had an order printed up, not knowing how soon they would be sold out!

What was the result of the day? Many

september/october 2010 P os i t i v e lyAwar e .co m

PHOTO: JOSHUA THORNE

Status symbols

people told of sideways looks on trains or buses, and conspicuous silence in elevators.

In the Cleveland Starbucks where Rebecca and her ATGC colleagues took a break, there was actually applause since most of the people had read about the event as reported by a local paper’s theatre critic who’d worn a t-shirt in advance.

Could we conclude from this experience that perhaps stigma and prejudice are more internal than external? Could we hope that there is less stigma than we think? We can always hope, but one thing is clear—the level of ignorance about the disease has not decreased. Based on several naïve questions asked of the t-shirt wearers, the fact that knowledge is centered within the HIV community and is not getting out into the general public is only too easy to see.

Rebecca and I fantasized about somehow organizing a “Million Meds March” on Washington, especially at this time of crisis for ADAPs across the country. Could there be a better time to bring the challenges faced by the HIV community out of our insulated niches and up in the face of the public, most of whom don’t even know what “ADAP” stands for? What better way to join with the National HIV/AIDS Strategy to start a national dialogue that would educate, empower, and influence behavior enough to put a dent in the rising infection rates?

For me, one of the beauties of the t-shirt campaign was that HIV-negative people enthusiastically participated too. Following the examples of Annie Lenox and Bono, non-celebrities put on a shirt that declared them to be, if not HIV-positive themselves, at least positive towards the people living with HIV. It seems only wise to build upon that alliance, to continue to reach beyond just those living with, affected by, and at high risk of contracting HIV to those who really know very little about our world. I’m reminded of “We Are the World” and the Hands Across America experience I had in the ’80s—now is the time to find that kind of human commonality again. How will we fund it? Who will organize it? I don’t know, but surely there are others, besides Rebecca and I, who are willing to keep the dream alive, despite the daunting logistics.

Ideas, anyone? E-mail me at s.saltmarsh@ tpan.com. e P os i t i velyAwa re.com

s e p t e m b e r /o c to b e r 2 01 0

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41

Ask the HIV Specialist Mary Beth Alder, Phd, Aprn, AAHIVS

Dear HIV Specialist,

The clinic where I get my HIV care is a really great place and I am very happy with my doctor there. Sometimes when I go for my routine visits, and also on some occasions when I have needed something quick or when I was actually really sick with a flu, I was seen by the clinic nurse practitioner.

The NP is great; he is also an HIV Specialist, and he seems to be as knowledgeable about things as my doc, but can you tell me, what is the real difference between my doctor and the NP who sometimes sees me?

—John

Dear John, This is a great question, and we hear it often. I’ll describe what an NP is in a moment, but for starters, there are many levels of nursing care, and each is differentiated by education and responsibility.

For example, a Licensed Practical Nurse, or LPN, is trained to perform basic medical tasks and usually requires a certificate from a one- or two-year program following high school. A Registered Nurse, or RN, must obtain a Bachelor’s degree at an accredited university. An RN has an understanding of anatomy, physiology, and disease processes. RNs employ greater critical thinking skills and are able to apply nursing concepts to individual patient problems. An RN cannot make medical diagnoses though, and by law cannot prescribe medications or order medical interventions.

A nurse practitioner, or NP, is an RN with a graduate degree in advanced practice nursing. Licensed by both the Departments of Medicine and Nursing in most states, an NP requires a minimum of a master’s degree education. They are licensed to provide a broad range of health care services, including taking a patient’s history, performing a physical exam, ordering lab tests, and making clinical decisions on medications and other treatments. Nurse Practitioners are also able to diagnose, treat and manage diseases, 42

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provide prescriptions, and coordinate referrals to other health care providers.

In some states, NPs work completely independently, while in others they are required to work with an MD. In short, your nurse practitioner can often provide the same level of medical care as an MD. In a lot of ways, nurse practitioners are ideally suited to the type of care that HIV disease calls for. A much higher frequency of visits, and the fairly concise nature of HIV specialized care, make your NP the ideal provider to provide very high quality and competent care for almost anything related to your health and well-being with HIV. Moreover, the nursing scope of practice differs somewhat from the medical scope of practice in that it centers around a holistic approach to patient care. This holistic approach recognizes the impact of social and psychological factors that affect one’s health. Social and psychological factors are extremely important in HIV care, and so receiving the benefits of this aspect of care likely benefits your health in indirect ways. Nurse practitioners often take the time to ask about things like your medication “compliance,” non-medical factors in your life that may be affecting that compliance, your sexuality, social support, stress, mental health, family, finances, career, and relationships. Looking at your life and your person as a whole can greatly impact the success of your

medical care, and may ultimately help you feel better about your body and your life in general.

Best wishes for good health, and please share this response with your own NP. He may be able to offer even more insight into the way our profession offers an additional aspect of care for a healthy life with HIV. —Mary Beth Alder, PhD, APRN, AAHIVS Capital Medical Associates Washington, D.C.

Submit your questions to AAHIVM@tpan.com Due to space limitations, not all submitted questions can be answered in this column. For more information about AAHIVM, call 202-659-0699 or visit www.aahivm.org.

Search for an HIV Specialist™ Finding an HIV Specialist™ is easy with AAHIVM’s Find-A-Provider directory at www.aahivm.org.

Click on the “Find-A-Provider” window on the home page, enter your location, and click on the search button for a list of HIV Specialists™ near you.

september/october 2010 P os i t i v e lyAwar e .co m

Get Sharp Matt Sharp

Quest for a cure An activist donates his DNA to the cause

“A cure is possible.” These words are scrawled in red on a grease board in my office at Project Inform to remind me and anyone else who walks by that a cure for AIDS is not entirely out of the question. There was a time I wouldn’t have thought a cure would ever be possible or that I would survive to see it. But in the last few years researchers have been quietly studying various pathways towards a cure that are now getting more attention. We are only just touching the surface in understanding eradication or “drug-free” remission of HIV and most likely it will require a combination of biological and chemical strategies. But new federal and non-profit funding is also being offered in the area of cure research, still a long way from what is needed, but a good start.

I am one of the lucky survivors who has benefited from the great success with HIV care and treatment over the past 25 years. But current treatments will not be the answer for everyone and certainly won’t be sustainable as the world scales up access. Drug resistance, long-term side effects, and adherence will continue to be challenges to a lifetime of taking medications.

Scientifically, curing HIV has long been elusive, as scientists have tried to crack the complexity of a “shape-shifter” virus and an enigmatic immune system. In 1996, when combination antiretroviral therapy was found to be effective in bringing the virus to undetectable levels, it was proposed that HIV could be eradicated. It was later deemed by a majority of researchers that complete eradication was impossible.

Since then, any mention of a cure was defensively disputed by scientists and activists alike. Virtually the only time you would see mention of an AIDS cure was from snake oil salesmen on the Internet.

Until recently, the challenge of stopping P os i t i velyAwa re.com

HIV transmission through preventative vaccines or a microbicide has failed to live up to the expense and effort that went into it, even though there is new evidence that shows these strategies may be at least partially effective. But it wasn’t until the news of the Berlin “cure” patient surfaced that people began to open their minds to the possibility of actually curing HIV. This was the extraordinary case of an HIV-positive man living with leukemia who received a bone marrow transplant with CD4 cells that lacked CCR5 and was later found to be free of HIV. The news unleashed a wave of intense interest among researchers.

But one “cure” does not mean a worldwide cure. This case was certainly unusual and most would agree it will be nearly impossible to reproduce. There are many scientific, strategic, and funding barriers to address before we can claim victory against HIV. At least one company has developed a technology now in clinical trials to try and mimic the Berlin cure. This is where I

come in. I volunteered for a pilot study to look at this new technology that uses zinc fingers, tiny molecular scissors that snip the CCR5 gene off my DNA in CD4 cells that are removed from my body and then expanded. These manipulated cells will be infused back into my body, and this early study will look to see if they survive and for how long. Eventually, if this procedure works, many more people will be studied to see if virus levels decrease when they go off antiretroviral drugs. Then confirmation studies will proceed.

I have been down this road before with a thymus transplant study in 1987, desperately seeking a biological fix to my weakened immune system. Back then I was fighting to stay alive. This time, I’m fighting for a cure.

This may seem like a far-fetched idea, but research and technologies like this will collectively provide more answers through laboratory and clinical trials. Today, drugs are being studied that help activate sleeping cells that are holding HIV inside. Once the virus is purged from these activated cells, current regimens will kill any remaining virus in the plasma. Therapeutic vaccines are being explored to restore lost immunity in those who have been living with HIV. So, I am excited about the prospects, even if it is early and even if there are still skeptics who doubt a cure for HIV can ever happen. Consider the beginning of HIV when discoveries were made in understanding the HIV lifecycle, an incredible breakthrough in a span of two decades that led us to where we are today.

Discoveries of this kind occur rarely; more often there are steps backward, but we are clearly on the right track.

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What’s Goin’ On? Keith R. Green

Lessons from the Book of Real As cliché as it may sound, I stand firm in the conviction that the only way to reach our young people today is to keep it real with them. I’m also clear that, in order to keep it real with them, we must make a conscious decision to always keep it real with ourselves!

I was recently engaged in conversation with a young man interested in participating in one of the research studies that I oversee.

Incredibly inquisitive, with an impressive degree of insight, his questions challenged me to contemplate the difficulty associated with HIV acquisition. From his perspective, the statistics give the impression that HIV is easy to get—it’s estimated that one out of every four young Black men who has sex with other men (MSM) in his age group in Chicago is living with HIV. His personal “high-risk” sexual behavior, however, which includes frequent unprotected receptive anal intercourse, seems to contradict this idea.

So, how exactly has he been able to remain HIV-free up unto this point, he asked me? Could it be something genetic?

Or had he simply been lucky?

Without any information to support that he has some type of genetic protective factor, I deferred to my toolbox of basic HIVtransmission information. Premised by very clear-cut categories around modes of transmission and infectious fluids, the level of risk that he reportedly assumes would make luck (and perhaps a grandmother’s prayers), the only logical explanation for this young man’s ability to remain HIV-negative.

My efforts to help him to understand how such a thing might happen forced me to take a critical look at the messages that are often given to young men who have sex with men about the risks associated with their sexual practices. For the most part, we teach them a public health rendition 44

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of the old trusty ABCs (Abstinence before marriage; Be Faithful to one’s partner; and always use Condoms). All other practices are then demonized and sure to result in HIV infection. The blame (and stigma and shame) is then placed on those who are HIVpositive for contracting a virus that is 100% preventable.

What we often neglect to teach young people, however, is that even when an unwrapped, cum-filled, newly infected penis penetrates a tight, throbbing, bubbleshaped rear-end, the finished product does not necessarily result in transmission. We don’t explain to them that there would need to be a rupture or some type of irritation to the “pink parts” of that rear-end, in order for HIV acquisition to occur. Granted, the actual act of penetrating the rectal cavity can cause such a tear or irritation, as can the cleansing routine used to prepare it for penetration and a myriad of other things (including the presence of sexually transmittable infections such as rectal gonorrhea or chlamydia).

The truth of the matter, though, is that as risky as the act described above is, it is not always the catastrophe that people like me have been programmed to teach other people that it is. And, more importantly, knowledge of this can help those who opt out of using condoms, for whatever reason, make better educated choices about the way that they engage in sexual activity.

And this is where I was forced to get real with myself.

Understanding the alarming infection rates among men who look like me, and being heavily involved in a pre-exposure prophylaxis (PrEP) study for the past year, I’ve become a staunch advocate for concepts of biomedical prevention (microbicides, PrEP, etc.). I’ve been saying for years that what we are currently doing is obviously not enough to curb the epidemic, and that biomedical interventions, if proven efficacious, could become powerful tools in our proverbial toolbox of HIV prevention interventions.

What my encounter with this young man made me realize, however, is that we haven’t been making the best use of the tools that we already have. This young man has been involved in several of the HIV prevention programs offered throughout this city. But, for whatever reason, HIV transmission and acquisition had not quite been broken down to him in this way. As a result, the world is now beginning to believe that the only hope for him is medicalized HIV prevention (at least as a temporary fix until he is able to make “better choices” to decrease his risk).

If he’s not given better information, though, he can’t make better choices. And, if he can’t make better choices, then what happens? He’ll either eventually seroconvert, or be on a pre-exposure prophylaxis regimen for the rest of his life.

In my humble opinion, neither of those options is acceptable or feasible.

Therefore, the real in me has returned to the drawing board to strategize more efficient methods of information dissemination…THAT KEEPS IT REAL! If knowing is half the battle, then our problem is that we are ill-equipped for war. And that’s “realer than real deal Holyfield,” as Snoop Dogg would say.

september/october 2010 Pos i t i v e lyAwa r e .co m

PHOTO: Sal Iacopelli

Critical conversation produces critical reflection

WHolistic picture Sue Saltmarsh

Advance and retreat

Photo: CHeryl Mann

It seems to be an aspect of human nature that we hardly ever confront a problem head-on and solve it once and for all without setbacks, without trial and error, or “if at first you don’t succeed…”

Medical advancement is just one reflection of this human characteristic.

HIV and AIDS have been consciously with us for almost three decades now and we have indeed witnessed great progress.

Who in 1983, desperate for something, anything, to repeal the death sentence of HIV could have imagined AZT or d4T? Who in 1990, taking AZT and thinking the medicine was worse than the disease, could have foreseen Sustiva or Isentress?

Who in 1997, suffering kidney stones from Crixivan could have conceived of Atripla—one pill you take once a day, with or without food.

Of course, there have been flies in the ointment—metabolic complications, bone loss, cognitive dysfunction, perhaps even cardiac ramifications caused or exacerbated by these medications that provided a reprieve from death. I am still blown away every year when working on our annual drug guide, to read the litany of possible side effects that must be listed with the large majority of drugs currently on the market.

But just as with progress of any kind, the advances and retreats, the pros and cons, must be assessed when choosing your best treatment options. Are the benefits of Sustiva worth the nightmares, the “personality changes?” Is it better in the long run to have an undetectable viral load if the PI you’re on makes you diabetic or your NRTI causes lipoatrophy?

So much of life in this world, at this time, seems fraught with seemingly nowin situations. People in Louisiana say they’re angry at the Obama administration P os i t i velyAwa re.com

for “not doing more” about the BP oil spill, but when a moratorium on deep water drilling is announced and the plan to make BP establish a fund to pay damages is achieved, they wail about the loss of jobs on oil rigs and the danger of losing BP’s presence (and business) in the Gulf. For years, people have cried out for our soldiers to come home from Iraq and Afghanistan and yet, nothing but criticism is heard about the plan to start bringing them back next year. Every day it seems some new information comes out on the beneficial effects of eating organic food, yet the people who need it the most can’t begin to afford to buy it. Legislators in states like California, New York, Massachusetts, and Illinois have resisted raising taxes to solve their huge budget crises and yet people rant against cuts to education, human services, and infrastructure—do they not understand that the extra $5 or $10 taken out of their paycheck is not so high a price to pay?

And then there is the issue of profit motive in finding a cure. In this time when almost daily we hear about some Wall Street financier who got a bonus of millions while bilking his clients of their life savings; of a governor who worked eight hours a week while taking thousands in kickbacks; of a doctor who diluted cancer chemo drugs in order to sell them while patients died from not getting the correct dose, is it any wonder that there is a prevalent suspicion that even if a cure is discovered, it won’t be made available because pharmaceutical companies, hospitals, and insurance companies are

making too much profit with the current treatments that keep HIV a chronic condition, not to mention treatment for the related conditions or co-infections that often occur in the HIV-positive?

Having worked in non-profit all my life, I just can’t wrap my mind around how, exactly, any sane person could justify putting the acquisition of money before helping to improve or save lives. Thankfully, I’ve met a number of well-intentioned, altruistic doctors, drug reps, clinic directors, and even one insurance saleswoman who value human life and respect for others above their bank balances and who give me hope for the future.

At this stage in the evolution of HIV/AIDS, it’s been proven that, while trade-offs are unavoidable, the potential for continued progress is huge. Every day scientists and doctors and analysts and social workers and HIV-positive people think, invent, experiment, conduct trials, pass tests.

Every day a light bulb goes on over somebody’s head and progress is made.

Each of us makes choices that affect our quality of life, our relationships, our finances, our health, our sanity. Too often those choices come down to the lesser of two or more evils. But in making them, we continue to go on, we hold out for a brighter day, some even dare to dream of the possibility of being able to choose from a multitude of “goods.”

And someday, somehow the oil will stop leaking, wars will end, clean and wholesome food will be available to everyone, the economy will truly recover, programs that help people will be strongly funded because our society knows it’s right to do so, and there will be a cure for cancer, Alzheimer’s, diabetes, and HIV. We just have to hang on.

Breathe deep, live long. s e p t e m b e r /o c to b e r 2 01 0

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