JULY+AUGUST 2011

Treatment AS Prevention?

Positively Aware J U L Y + A U G U S T

2 0 1 1

Inflamed reSPONSE Chronic inflammation is the body’s paradoxical response to HIV

The HIV Treatment & Health Journal of

Test Positive Aware Network

Understanding Viral load Tests It gets better

PREZISTA IMPORTANT SAFETY INFORMATION AND INDICATION Talk to your healthcare ABOUT PREZISTA professional about the ® PREZISTA (darunavir) is a signs and symptoms of liver prescription medicine. It is one problems. These may include treatment option in the class of yellowing of your skin or whites HIV (human immunodeficiency of your eyes, dark (tea-colored) virus) medicines known as urine, pale-colored stools protease inhibitors. (bowel movements), nausea, PREZISTA is always taken with vomiting, loss of appetite, and at the same time as ritonavir or pain, aching or sensitivity on (Norvir®), in combination with other your right side below your ribs HIV medicines for the treatment of • In a small number of patients, HIV infection in adults. PREZISTA PREZISTA has been reported should also be taken with food. to cause a severe or life• The use of other medicines active threatening rash. Contact against HIV in combination with your healthcare professional PREZISTA/ritonavir (Norvir®) may immediately if you develop increase your ability to fight HIV. a rash.

Your healthcare professional will Can PREZISTA be taken with work with you to find the right other medications? combination of HIV medicines • Taking PREZISTA with • It is important that you remain certain medicines could under the care of your healthcare cause serious and/or lifeprofessional during treatment with threatening side effects PREZISTA or may result in loss of its effectiveness. Do not take PREZISTA does not cure HIV PREZISTA if you are taking infection or AIDS, and does not the following medicines: prevent passing HIV to others. alfuzosin (Uroxatral®), dihydroergotamine (D.H.E.45®, Please read Important Safety ® ), ergonovine, Migranal Information below, and talk to ergotamine (Wigraine®, your healthcare professional Ergostat®, Cafergot®, Ergomar®), to learn if PREZISTA is right methylergonovine, cisapride for you.

(Propulsid®), pimozide (Orap®), oral midazolam, triazolam IMPORTANT SAFETY (Halcion®), rifampin (Rifadin®, INFORMATION Rifater®, Rifamate®), sildenafil ® (Revatio ) when used to treat What is the most important pulmonary arterial hypertension, information I should know indinavir (Crixivan®), lopinavir/ about PREZISTA? ritonavir (Kaletra®), saquinavir • PREZISTA, together with (Invirase®), lovastatin (Mevacor®, Norvir®, has been observed Altoprev®, Advicor®), pravastatin in a small number of (Pravachol®), simvastatin (Zocor®, patients to cause liver Simcor®, Vytorin®), salmeterol problems which may be life(Serevent®), or products threatening. Your healthcare containing St. John’s wort professional should do • Before taking PREZISTA, tell your blood tests prior to starting healthcare professional if you combination treatment are taking sildenafil (Viagra®), including PREZISTA. If you vardenafil (Levitra®), tadalafil have chronic hepatitis B or (Cialis®, Adcirca®), atorvastatin C infection, your healthcare ® (Lipitor ), atorvastatin/amlodipine professional should check (Caduet®), rosuvastatin (Crestor®), your blood tests more or colchicine (Colcrys®). This often because you have is not a complete list of an increased chance of medicines. Be sure to tell developing liver problems

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

• As with other protease inhibitors, taking PREZISTA may strengthen the body’s immune response, enabling it to begin to fight infections that have been hidden.

Patients may experience signs and symptoms of inflammation that can include swelling, tenderness, or redness • Tell your healthcare professional if you are taking estrogen-based • The most common side effects contraceptives (birth control). related to taking PREZISTA include PREZISTA might reduce the diarrhea, nausea, rash, headache, effectiveness of estrogen-based stomach pain, and vomiting. Other contraceptives. You must take important severe side effects additional precautions for birth include inflammation of the liver control, such as condoms or pancreas and increased blood fat levels.

What should I tell my • This is not a complete list of healthcare professional all possible side effects. If you experience these or other side before I take PREZISTA? effects, talk to your healthcare • Before taking PREZISTA, tell your professional. Do not stop taking healthcare professional if you PREZISTA or any other medicines have any medical conditions, without first talking to your including allergy to sulfa medicines, healthcare professional diabetes, liver problems (including You are encouraged to report hepatitis B or C), or hemophilia negative side effects of • Tell your healthcare professional prescription drugs to the FDA. if you are pregnant or planning Visit www.fda.gov/medwatch, to become pregnant, or are or call 1-800-FDA-1088 breastfeeding Please refer to the ritonavir (Norvir®) - The effects of PREZISTA on Product Information (PI and PPI) pregnant women or their unborn for additional information on babies are not known. You and precautionary measures. your healthcare professional Dosing Information: will need to decide if taking PREZISTA is right for you For adults taking HIV meds for the first time and for many - Do not breastfeed if you are adults who have taken HIV meds taking PREZISTA. You should in the past: PREZISTA 800 mg not breastfeed if you have (two 400-mg tablets) must be taken HIV because of the chance of at the same time with 100 mg passing HIV to your baby Norvir® once daily every day.

PREZISTA must be taken with food.

What are the possible side For some adults who have taken effects of PREZISTA? HIV meds in the past: • High blood sugar, diabetes or PREZISTA 600 mg/Norvir® 100 mg worsening of diabetes, and must be taken twice daily at the increased bleeding in people with same time every day with food. hemophilia have been reported in Your healthcare professional can patients taking protease inhibitor determine which dose is right for you. medicines, including PREZISTA Please see Important Patient • Changes in body fat have been Information on the next page for seen in some patients taking HIV more information, or visit www. medicines, including PREZISTA. PREZISTA.com.

The cause and long-term health effects of these conditions are not If you or someone you know needs help paying for medicine, call known at this time 1-888-4PPA-NOW (1-888-4772669) or go to www.pparx.org.

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

©2011 Tibotec Therapeutics

05/11

28PRZDTC10035R

ONCEDAILY PREZISTA

EXPANDED ONCE-DAILY DOSING FOR PREZISTA For adults who have not taken HIV medications before and ALSO for many adults who have taken HIV medications in the past Once-Daily PREZISTA 800 mg (two 400-mg tablets) must be taken with Norvir速 100 mg and food at the same time every day, as part of combination HIV therapy.

Talk to your healthcare professional about your HIV treatment options and ask if Once-Daily PREZISTA is right for you.

Please read Important Safety Information and dosing information on adjacent page.

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

IMPORTANT PATIENT INFORMATION PREZISTA (pre-ZIS-ta) Darunavir ALERT: Find out about medicines that should Not be taken with PREZISTA. Please also read the section “Who should not take PREZISTA?”.

Read this Patient Information before you start taking PREZISTA and each time you get a refill. There may be new information.This information does not take the place of talking to your doctor or healthcare provider about your medical condition or your treatment.

What is the most important information I should know about PREZISTA? PREZISTA, together with NORVIR® (ritonavir), has been observed in a small number of patients to cause liver problems which may be life-threatening.

Your healthcare provider should do blood tests prior to initiating combination treatment including PREZISTA. If you have chronic hepatitis B or C infection, your healthcare provider should check your blood tests more often because you have an increased chance of developing liver problems. Talk to your healthcare provider about the signs and symptoms of liver problems. These may include yellowing of your skin or whites of your eyes, dark (tea colored) urine, pale colored stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching or sensitivity on your right side below your ribs.

In a small number of patients, PREZISTA has been reported to cause a severe or life-threatening rash. Contact your healthcare provider immediately if you develop a rash.

Please also read the section “What are the possible side effects of PREZISTA?” What is PREZISTA? PREZISTA is a prescription anti-HIV medicine used with other anti-HIV medicines used to treat adults. PREZISTA is a type of anti-HIV medicine called a protease (PRO-tee-ase) inhibitor. PREZISTA is used with ritonavir and other anti-HIV medicines to treat people with human immunodeficiency virus (HIV-1) infection. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

How does PREZISTA work?

PREZISTA blocks HIV protease, an enzyme which is needed for HIV to multiply. When used with other anti-HIV medicines, PREZISTA can help to reduce the amount of HIV in your blood (called “viral load”) and increase your CD4 (T) cell count. HIV infection destroys CD4 (T) cells, which are important to the immune system. The immune system helps fight infection. Reducing the amount of HIV and increasing the CD4 (T) cell count may improve your immune system and, thus, reduce the risk of death or infections that can happen when your immune system is weak (opportunistic infections).

PREZISTA is always taken with and at the same time as ritonavir (NORVIR®), in combination with other anti-HIV medicines. PREZISTA should also be taken with food.

Does PREZISTA cure HIV or AIDS? PREZISTA does not cure HIV infection or AIDS. At present, there is no cure for HIV infection. People taking PREZISTA may still develop infections or other conditions associated with HIV infection. Some of these conditions are pneumonia, herpes virus infection, and Mycobacterium avium complex (MAC) infections. Because of this, it is very important for you to remain under the care of a healthcare provider. Although PREZISTA is not a cure for HIV or AIDS, PREZISTA can help reduce your risks of getting illnesses associated with HIV infection (AIDS and opportunistic infection) and eventually dying from these conditions.

Does PREZISTA reduce the risk of passing HIV to others?

PREZISTA does not reduce the risk of passing HIV to others through sexual contact, sharing needles, or being exposed to your blood. For your health and the health of others, it is important to always practice safer sex by using a latex or polyurethane condom or other barrier method to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood. Never re-use or share needles.

Ask your healthcare provider if you have any questions on how to prevent passing HIV to other people.

What should I tell my doctor before I take PREZISTA? PREZISTA may not be right for you. Before taking PREZISTA, tell your doctor or healthcare provider if you: • are allergic to sulfa medicines.

• h ave diabetes. Anti-HIV medicines, such as PREZISTA, might increase sugar levels in the blood.

• have liver problems, including hepatitis B and/or C. • have hemophilia. Anti-HIV medicines, such as PREZISTA, might increase the risk of bleeding.

• are pregnant or planning to become pregnant. The effects of PREZISTA on pregnant women or their unborn babies are not known. You and your healthcare provider will need to decide if taking PREZISTA is right for you. If you take PREZISTA while you are pregnant, talk to your healthcare provider about how you can be included in the Antiretroviral Pregnancy Registry.

• are breastfeeding. Do not breastfeed if you are taking PREZISTA. You should not breastfeed if you have HIV because of the chance of passing HIV to your baby. Talk with your healthcare provider about the best way to feed your baby. The Centers for Disease Control and Prevention (CDC) recommends that HIV-infected mothers not breastfeed to avoid the risk of passing HIV infection to your baby.

Who should not take PREZISTA?** Together with your healthcare provider, you need to decide whether taking PREZISTA is right for you.

Do not take PREZISTA if you: • are allergic to darunavir or any of the other ingredients in PREZISTA • are allergic to ritonavir (NORVIR®) • take any of the following types of medicines because you could experience serious side effects: – alfuzosin (Uroxatral®) – dihydroergotamine (D.H.E. 45®, Migranal®), ergonovine, ergotamine (Cafergot®, Ergomar®), methylergonovine – cisapride – pimozide (Orap®) – oral midazolam, triazolam (Halcion®) – St. John’s wort (Hypericum perforatum) – lovastatin (Mevacor®, Altoprev®, Advicor®), simvastatin (Zocor®, Simcor®, Vytorin®) – rifampin (Rifadin®, Rifater®, Rifamate®, Rimactane®) – sildenafil (Revatio®) when used to treat pulmonary arterial hypertension Can PREZISTA be taken with other medications?** Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. PREZISTA and many other medicines can interact. Sometimes serious side effects will happen if PREZISTA is taken with certain other medicines (see “Who should not take PREZISTA?”).

Tell your healthcare provider if you are taking estrogen-based contraceptives (birth control). PREZISTA might reduce the effectiveness of estrogen-based contraceptives. You must take additional precautions for birth control such as a condom.

Tell your healthcare provider if you take other anti-HIV medicines.

PREZISTA can be combined with some other anti-HIV medicines while other combinations are not recommended.

Tell your healthcare provider if you are taking any of the following medicines: – bepridil, lidocaine, quinidine, amiodarone (Cordarone®), digoxin (Lanoxin®), flecainide (Tambocor®), propafenone (Rythmol®) – warfarin (Coumadin®) – carbamazepine (Tegretol®, Carbatrol®), phenobarbital, phenytoin (Dilantin®, Phenytek®) – trazodone (Desyrel®), desipramine (Norpramin®) – colchicine (Colcrys®) – clarithromycin (Biaxin®) – ketoconazole (Nizoral®), itraconazole (Sporanox®), voriconazole (Vfend®) – rifabutin (Mycobutin®), – metoprolol (Lopressor®, Toprol-XL®), timolol (Betimol®, Combigan®, Istalol®, Cosopt®, Timoptic®) – midazolam administered by injection – felodipine (Plendil®), nifedipine (Adalat®), nicardipine (Cardene®)

IMPORTANT PATIENT INFORMATION – dexamethasone, fluticasone (Advair Diskus®, Cutivate®, Flonase®, Flovent Diskus®) – bosentan (Tracleer®) – atorvastatin (Lipitor®), pravastatin (Pravachol®), rosuvastatin (Crestor®) – cyclosporine (Sandimmune®, Neoral®), tacrolimus (Prograf®), sirolimus (Rapamune®) – salmeterol (Serevent®) – Methadone, buprenorphine, buprenorphine/naloxone – risperidone (Risperdal®, Risperdal® Consta®, Risperdal® M-TAB®), thioridazine – sildenafil (Viagra®), vardenafil (Levitra®), tadalafil (Cialis®) – tadalafil (Adcirca®) – paroxetine (Paxil®), sertraline (Zoloft®) Tell your healthcare provider if you are taking any medicines that you obtained without a prescription.

This is not a complete list of medicines that you should tell your healthcare provider that you are taking. Know and keep track of all the medicines you take and have a list of them with you. Show this list to all of your healthcare providers and pharmacists any time you get a new medicine. Both your healthcare provider and your pharmacist can tell you if you can take these other medicines with PREZISTA. Do not start any new medicines while you are taking PREZISTA without first talking with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for a list of medicines that can interact with PREZISTA. How should I take PREZISTA? Take PREZISTA tablets every day exactly as prescribed by your healthcare provider. You must take ritonavir (NORVIR®) at the same time as PREZISTA. • Do not change your dose of PREZISTA or stop treatment without talking to your healthcare provider first.

• Take PREZISTA and ritonavir (NORVIR®) with food.

• Swallow PREZISTA tablets whole with a drink.

What should I do if I miss a dose?

People who take PREZISTA one time a day: • If you miss a dose of PREZISTA or ritonavir (NORVIR®) by more than 12 hours, wait and then take the next dose of PREZISTA and ritonavir (NORVIR®) at your regularly scheduled time. If you miss a dose of PREZISTA or ritonavir (NORVIR®) by less than 12 hours, take your missed dose of PREZISTA and ritonavir (NORVIR®) right away. Then take your next dose of PREZISTA and ritonavir (NORVIR®) at your regularly scheduled time.

People who take PREZISTA two times a day • If you miss a dose of PREZISTA or ritonavir (NORVIR®) by more than 6 hours, wait and then take the next dose of PREZISTA and ritonavir (NORVIR®) at your regularly scheduled time.

• If you miss a dose of PREZISTA or ritonavir (NORVIR®) by less than 6 hours, take your missed dose of PREZISTA and ritonavir (NORVIR®) right away.

Then take your next dose of PREZISTA and ritonavir (NORVIR®) at your regularly scheduled time.

If a dose of PREZISTA or ritonavir (NORVIR®) is skipped, do not double the next dose. Do not take more or less than your prescribed dose of PREZISTA or ritonavir (NORVIR®) at any one time.

What are the possible side effects of PREZISTA? PREZISTA can cause side effects. The following is not a complete list of side effects reported with PREZISTA when taken either alone or with other antiHIV medicines. Do not rely on this leaflet alone for information about side effects. Your healthcare provider can discuss with you a more complete list of side effects.

PREZISTA, together with NORVIR® (ritonavir), has been observed in a small number of patients to cause liver problems which may be life-threatening.

Your healthcare provider should do blood tests prior to initiating combination treatment including PREZISTA. If you have chronic hepatitis B or C infection, your healthcare provider should check your blood tests more often because you have an increased chance of developing liver problems.

Talk to your healthcare provider about the signs and symptoms of liver problems. These may include yellowing of your skin or whites of your eyes, dark (tea colored) urine, pale colored stools (bowel movements), nausea,

vomiting, loss of appetite, or pain, aching or sensitivity on your right side below your ribs.

Rash has been reported in 10.3% of patients receiving PREZISTA. In a small number of patients, PREZISTA has been reported to cause a severe or life-threatening rash. Contact your healthcare provider immediately if you develop a rash.

Other relevant severe side effects were inflammation of the liver or pancreas, increased blood fat levels, diabetes, and changes in body fat.

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

Other side effects of PREZISTA include the following: • high blood sugar (hyperglycemia) and diabetes. This can happen in patients taking PREZISTA or other protease inhibitor medicines. Some patients have diabetes before starting treatment with PREZISTA which gets worse. Some patients get diabetes during treatment with PREZISTA. Some patients will need changes in their diabetes medicine. Some patients may need new diabetes medicine.

• increased bleeding in patients with hemophilia.

• changes in body fat. These changes can happen in patients taking anti-HIV medicines, including PREZISTA. The changes may include an increased amount of fat in the upper back and neck, breast, and around the back, chest, and stomach area. Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions are not known.

• immune reconstitution syndrome. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment, including PREZISTA, is started.

Tell your healthcare provider promptly about these or any other unusual symptoms. If the condition persists or worsens, seek medical attention.

This medication is prescribed for your particular condition. Do not use it for any other condition or give it to anybody else. Keep PREZISTA and all of your medicines out of the reach of children. If you suspect that more than the prescribed dose of this medicine has been taken, contact your local poison control center or emergency room immediately.

This is a brief summary of information about PREZISTA for adult patients with HIV. If you have any questions or concerns about either PREZISTA or HIV, talk to your healthcare provider.

For additional information, you may also call Tibotec Therapeutics at 1-877-REACH-TT or 1-877-732-2488. ** The brands listed are the registered trademarks of their respective owners and are not trademarks of Tibotec Pharmaceuticals

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

PREZISTA® is a registered trademark of Tibotec Pharmaceuticals © Tibotec, Inc. 2006

Revised: December 2010

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E d it o r i a l

editor Jeff Berry

associate editor Enid Vázquez copy Editor Sue Saltmarsh

proofreaders Jason Lancaster, David Perez

contributing writers Keith R. Green, Liz Highleyman, Sal Iacopelli, Laura Jones, Jim Pickett, Matt Sharp

photographers Chris Knight, Joshua Thorne

art director Rick Guasco M e d i c a l a d vi s o r y b o a r d Daniel S. Berger, MD; Gary Bucher, MD; Michael Cristofano, PA; Joel Gallant, MD; Swarup Mehta, PharmD

The Digital Edition:

Positively Aware Now you can read the print version of the nation’s leading HIV treatment journal from your computer. More than that, you can print articles, e-mail them to friends, post them online, or share them on Facebook and Twitter.

A d v e r ti s i n g & Di s t r i b u ti o n advertising inquiries Jessie Mott j.mott@tpan.com

distribution coordinator Brad Mazzie

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Positively Aware is published bi-monthly by Test Positive Aware Network.

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© 2011. Positively Aware (ISSN: 1523-2883) is published bi-monthly by Test Positive Aware Network (TPAN), 5537 N. Broadway St, Chicago, IL 60640. TPAN is an Illinois not-for-profit corporation, providing information and support to anyone concerned with HIV and AIDS issues. Positively Aware is a registered trademark of TPAN. All rights reserved. Circulation: 85,000. For reprint permission, contact Sue Saltmarsh. Six issues mailed bulk rate for $30 donation; mailed free to TPAN members or those unable to contribute.

Or, go directly to

We encourage contribution of articles covering medical or personal aspects of HIV/AIDS. We reserve the right to edit or decline submitted articles. When published, the articles become the property of TPAN and its assigns. You may use your actual name or a pseudonym for publication, but please include your name and phone number.

www.PositivelyAware.com “Read the Digital Edition of our latest issue.” go to

www.Issuu.com/PositivelyAware Using a QR code reader app, you can also scan the QR code at left with your iPhone or

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Although Positively Aware takes great care to ensure the accuracy of all the information that it presents, Positively Aware staff and volunteers, TPAN, or the institutions and personnel who provide us with information cannot be held responsible for any damages, direct or consequential, that arise from use of this material or due to errors contained herein. Opinions expressed in Positively Aware are not necessarily those of staff or membership or TPAN, its supporters and sponsors, or distributing agencies. Information, resources, and advertising in Positively Aware do not constitute endorsement or recommendation of any medical treatment or product. TPAN recommends that all medical treatments or products be discussed thoroughly and frankly with a licensed and fully HIV-informed medical practitioner, preferably a personal physician.

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A model, photographer, or author’s HIV status should not be assumed based on their appearance in Positively Aware, membership in TPAN, or contributions to this journal.

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Distribution of Positively Aware is supported in part through an unrestricted grant from ViiV Healthcare.

| J U LY+AUGUST 2011

P os it i v elyAwar e .co m

I NS I DE

JULY+AUGUST 2011 VO L U ME

2 3

N U MBER

5

cover Story

HIV provokes the immune system into a hyperactive state that can lead to chronic inflammation; but new research and strategies offer hope. page 14

D e pa r t m e n t s

F e a t u r e s

6 | editor’s Note

21 | Undetectable—says who?

34 | Condom in a pill bottle?

Balancing act.

New viral load tests are more sensitive—but what does that mean?

A major study finds that treatment protects HIV-negative partners. Will gay couples stop using condoms?

7 | In Box 12 | Briefly FDA approves Edurant as latest HIV medication. New hepatitis drugs get approval. New study offers the best proof yet of treatment as prevention.

37 | Ask the HIV specialist

25 | Another blue pill for sex Preventing HIV with Truvada-based PrEP—already at a pharmacy near you.

28 | USCA coming to Chicago Chicago to host the U.S. Conference on AIDS, Nov. 10-13.

36 | Finding the POWER within Success through courage, learning, and empowerment.

38 | I’ve taken charge One man’s story of taking HIV meds for prevention.

Chronic inflammation and HIV.

30 | Unbalanced budget Fiscal health vs. human health—which will it be?

c o v e r

42 | What’s Goin’ on?

33 | It gets better

HIV provokes the immune system into a hyperactive state that can lead to chronic inflammation.

Let’s agree to meet in the middle.

44 | Wholistic Picture Good, good, good, inflammation.

P os i t i ve lyAwa re.com

Dan Savage works to break the connection between bullying and HIV.

S t o r y

14 | Inflamed response

J U LY + AU G U ST 2 01 1 |

5

Editor’s NOTE Jeff Berry

Balancing act The circus image that immediately comes to my mind is a performer wearing white tights and a tutu, riding a unicycle, while balancing spinning plates on long wooden sticks using both hands and his mouth. Entertaining to look at, but you know eventually it’s all going to come crashing down around him. The question is: will he be able to control the chaos, or will everything quickly fall apart and break into a million tiny pieces?

I don’t know how strongly I believe in astrology, but I do admit to reading my horoscope from time to time. Perhaps I find some odd comfort by subscribing to the belief that my fate is decided by forces outside of myself and beyond my control, in order to not have to take full responsibility for the occasional chaos in my own life.

In any event, my sign is Libra, and the symbol for Libra is the scales. In Roman mythology, Libra is considered to be the goddess of balance and truth. I constantly find myself trying to strike an even balance every day of my life, whether it’s at the office, in my relationship, my career, my home, or my family and friends. Much of it has to do with time and scheduling, often it’s dealing with personalities, other times it’s people or groups trying to push their own, hidden agendas.

For me, I’ve come to learn that it’s not so much that everything has to be in

6

| J U LY+AUGUST 2011

balance all the time, because that’s impossible and will eventually drive you crazy.

But for my peace of mind, I need to at least strive to achieve that balance. I may not always find it, but at least I’ve made the effort. I need to let go of the end result, because often that is out of my control.

Recently I saw the movie “The Adjustment Bureau” starring Matt Damon.

While generally panned by the critics, I found the premise of the movie quite intriguing. Basically, it addresses the conflict between free will and predestination—is there a master plan, are we just pawns being moved about on a chessboard, or can we actually decide our fates and choose our own destiny? I suspect it’s a little of both, in the end.

This issue of Positively Aware looks at the immune system’s paradoxical response to HIV, chronic inflammation. Inflammation is generally a good thing, and helps to ward off infection and help the body to heal. In the case of HIV, however, the inflammation becomes chronic, and never gets switched off, wearing us down, and leading to a whole host of other problems, including heart disease and cancer. A predetermined response, or predestination, you might call it. But it’s an area in which research is now being done to see if we can intercept or control that response early in the course of infection, so that we don’t encounter problems later on.

We’ve also heard a lot in the news lately about prevention, and you’ll read more about it in this issue as well. Treatment as prevention, in which a person with HIV and who is on anti-HIV medication can lower their viral load to undetectable, and may therefore be less likely to transmit the virus to their partner during sex—does that mean we should put everyone on treatment?

You’ll also read more about the ongoing debate regarding PrEP (pre-exposure prophylaxis), in which an HIV-negative individual takes anti-HIV medication to lower their risk of becoming infected.

When I first came across Nick Litrelis’ story on LifeLube.org, I thought to myself, great story, and one people really need to hear, but how can I possibly run it?

And then I thought—how can I not? Nick, who is HIV-negative, in a sero-discordant relationship, and is currently taking PrEP, tells his own very personal journey of how he came to his decision to use it. His story is not without a bit of controversy, and no doubt will raise a few eyebrows. But it’s a story we all need to hear, and a discussion we need to be having.

Life truly is a balancing act. It may not always be pretty, and sometimes it gets messy, but it’s all we’ve got. Make the most of it by staying true to yourself and your ideals, and always try to speak your truth. And hopefully everything else will fall into place.

Take care of yourself and each other.

publications@tpan.com

P osit i v e lyAwar e .co m

Photo: Chris Knight

Many times in life we find ourselves trying to strike a balance between various relationships, obligations, and expectations, much like a circus performer displaying his or her balancing skills.

Webster defines a balancing act as an attempt to cope with several often conflicting factors or situations at the same time.

In Box

Readers’ poll

Thanks for being there

Last issue’s poll question:

Since you have a survey out, I’m taking this opportunity to send mine in and say thanks.

I got your name from my beautiful brother Jim, who died of AIDS in 1990.

There weren’t many he could trust during his illness. People like you provided reliable information which kept him reasonably healthy until the end.

In Jim’s memory, I have volunteered in the AIDS community for a number of years and I regularly refer to my Positively Aware to inform and encourage people.

Thank you for being there.

—Sherri H. Grand R apids, MI

What’s one to do?

I am an HIV-positive male in my late 50s who faced early retirement from work.

I will be 60 by the end of this year and though I have applied for many jobs, I am still unemployed. My COBRA will run out by the end of this year, so I have started to search for health insurance with no success. It seems I have a “pre-existing condition.” Even though I am totally asymptomatic and my viral load is undetectable, apparently, the insurance industry couldn’t care less.

I find myself running out of options and terribly worried about my fate. I am not poor enough to qualify for federal and state programs, and I am not wealthy enough to afford to pay out of my own pocket. Illinois’ ICHIP program is prohibitive—I would be paying about $1,700 a month for insurance and prescription drugs. What is one to do?

The above situation has driven me to ponder about the following: n Why are there no generic HIV drugs in the U.S.? n Why do insurance companies get away

with the HIV bias when there are other health conditions that require more drugs and hospital stays? n Why haven’t I heard of any activism addressing these issues?

Does anybody have any advice?

—A.G. Dear A.G., Unfortunately, you are in good company, as it is estimated that there are some 56 million un- or under-insured people in the U.S. To answer your questions, though, there are generic HIV drugs in the U.S.— AZT (zidovudine), Videx (didanosine), and Zerit (stavudine), but they don’t make up a regimen in and of themselves, and most people wouldn’t want to deal with the side effects of AZT or Zerit especially.

Insurance companies will be able to continue to get away with classifying (and penalizing for) lots of diseases besides HIV as “pre-existing” conditions until 2014, when the “no pre-existing conditions” provision of the Patients Protection and Affordable Care Act kicks in—if it ever does.

As far as activism is concerned, there are plenty of people and organizations advocating for single-payer health care and your situation is precisely why the HIV community needs to join in.

My advice is to check into the copay and/or patient assistance programs offered by the drug companies—see the chart at www.positivelyaware. com/2011/11_02/copay_chart.shtml.

Also, if you don’t already have a case manager, get one. A case manager can advise you and refer you to other resources. You might also want to check out the online forums and any support groups in your area—sometimes the best advice comes from people who have been where you are.

—Sue Saltmarsh

Do you think HIV/AIDS will still be a pandemic 30 years from now—in 2041?

No:

44%

Yes:

56%

Your comments:

“AIDS would not be a pandemic today if attention had been given in a civilized manner in the early 90s.”

“I do believe they are going to find a cure soon!”

“The pharmaceutical companies will ensure it! Can’t interrupt their cash flow.”

“It will be shockingly worse.”

“I am hoping by gene therapy or something like that it will have been eradicated.”

this issue’s poll question:

Do you support the use of PrEP? cast your vote at

positivelyaware.com Do the write thing

Positively Aware treats all communications (letters, faxes, e-mail, etc.) as letters to the editor unless otherwise instructed.

We reserve the right to edit for length, style, or clarity. Unless you tell us not to, we will use your name and city.

Correction: AIDS 30 timeline Although the timeline got it right, the article, “AIDS 30” in the print edition of the May+June issue misstated when Marc Antoni Castillo’s daughter was born. She was born healthy in July 2010. Positively Aware regrets the error.

P os i t i ve lyAwa re.com

Positively aware

5537 N. Broadway St. Chicago, IL 60640 E-Mail: readersforum@tpan.com J U LY + AU G U ST 2 01 1 |

7

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/TR9463 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 (efavirenz/emtricitabine/tenofovir disoproxil fumarate).

Please also read the section “MEDICINES YOU SHOULD NOT TAKE WITH ATRIPLA.” Generic name: efavirenz, emtricitabine and tenofovir disoproxil fumarate (eh FAH vih renz, em tri SIT uh bean and te NOE’ fo veer dye soe PROX il FYOU mar ate) Read the Patient Information that comes with ATRIPLA before you start taking it and each time you get a refill since there may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. You should stay under a healthcare provider’s care when taking ATRIPLA. Do not change or stop your medicine without first talking with your healthcare provider. Talk to your healthcare provider or pharmacist if you have any questions about ATRIPLA. What is the most important information I should know about ATRIPLA? • Some people who have taken medicine like ATRIPLA (which contains nucleoside analogs) have developed a serious condition called lactic acidosis (build up of an acid in the blood). Lactic acidosis can be a medical emergency and may need to be treated in the hospital. Call your healthcare provider right away if you get the following signs or symptoms of lactic acidosis: • You feel very weak or tired.

• You have unusual (not normal) muscle pain.

• You have trouble breathing.

• You have stomach pain with nausea and vomiting.

• You feel cold, especially in your arms and legs.

• You feel dizzy or lightheaded.

• You have a fast or irregular heartbeat.

• Some people who have taken medicines like ATRIPLA have developed serious liver problems called hepatotoxicity, with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Call your healthcare provider right away if you get the following signs or symptoms of liver problems: • Your skin or the white part of your eyes turns yellow (jaundice).

• Your urine turns dark.

• Your bowel movements (stools) turn light in color.

• You don’t feel like eating food for several days or longer.

• You feel sick to your stomach (nausea).

• You have lower stomach area (abdominal) pain.

• You may be more likely to get lactic acidosis or liver problems if you are female, very overweight (obese), or have been taking nucleoside analog-containing medicines, like ATRIPLA, for a long time.

• If you also have hepatitis B virus (HBV) infection and you stop taking ATRIPLA, you may get a “flare-up” of your hepatitis. A “flare-up” is when the disease suddenly returns in a worse way than before. Patients with HBV who stop taking ATRIPLA need close medical follow-up for several months, including medical exams and blood tests to check for hepatitis that could be getting worse. ATRIPLA is not approved for the treatment of HBV, so you must discuss your HBV therapy with your healthcare provider.

What is ATRIPLA? ATRIPLA contains 3 medicines, SUSTIVA® (efavirenz), EMTRIVA® (emtricitabine) and VIREAD® (tenofovir disoproxil fumarate also called tenofovir DF) combined in one pill. EMTRIVA and VIREAD are HIV-1 (human immunodeficiency virus) nucleoside analog reverse transcriptase inhibitors (NRTIs) and SUSTIVA is an HIV-1 non-nucleoside analog reverse transcriptase inhibitor (NNRTI).

VIREAD and EMTRIVA are the components of TRUVADA®. ATRIPLA can be used alone as a complete regimen, or in combination with other anti-HIV-1 medicines to treat people with HIV-1 infection. ATRIPLA is for adults age 18 and over. ATRIPLA has not been studied in children under age 18 or adults over age 65.

HIV infection destroys CD4+ T cells, which are important to the immune system. The immune system helps fight infection. After a large number of T cells are destroyed, acquired immune deficiency syndrome (AIDS) develops.

ATRIPLA helps block HIV-1 reverse transcriptase, a viral chemical in your body (enzyme) that is needed for HIV-1 to multiply. ATRIPLA lowers the amount of HIV-1 in the blood (viral load).

ATRIPLA may also help to increase the number of T cells (CD4+ cells), allowing your immune system to improve. Lowering the amount of HIV-1 in the blood lowers the chance of death or infections that happen when your immune system is weak (opportunistic infections).

Does ATRIPLA cure HIV-1 or AIDS? ATRIPLA does not cure HIV-1 infection or AIDS. The long-term effects of ATRIPLA are not known at this time. People taking ATRIPLA may still get opportunistic infections or other conditions that happen with HIV-1 infection. Opportunistic infections are infections that develop because the immune system is weak. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infection. It is very important that you see your healthcare provider regularly while taking ATRIPLA. Does ATRIPLA reduce the risk of passing HIV-1 to others?

ATRIPLA has not been shown to lower your chance of passing HIV-1 to other people through sexual contact, sharing needles, or being exposed to your blood.

• Do not share needles or other injection equipment.

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

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

• Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom or other barrier to reduce the chance of sexual contact with semen, vaginal secretions, or blood.

Who should not take ATRIPLA? Together with your healthcare provider, you need to decide whether ATRIPLA is right for you.

Do not take ATRIPLA if you are allergic to ATRIPLA or any of its ingredients. The active ingredients of ATRIPLA are efavirenz, emtricitabine, and tenofovir DF. See the end of this leaflet for a complete list of ingredients.

What should I tell my healthcare provider before taking ATRIPLA? Tell your healthcare provider if you: • Are pregnant or planning to become pregnant (see “What should I avoid while taking ATRIPLA?”).

• Are breastfeeding (see “What should I avoid while taking ATRIPLA?”).

• Have kidney problems or are undergoing kidney dialysis treatment.

• Have bone problems.

• Have liver problems, including hepatitis B virus infection. Your healthcare provider may want to do tests to check your liver while you take ATRIPLA or may switch you to another medicine.

• Have ever had mental illness or are using drugs or alcohol.

• Have ever had seizures or are taking medicine for seizures.

What important information should I know about taking other medicines with ATRIPLA? ATRIPLA may change the effect of other medicines, including the ones for HIV-1, and may cause serious side effects. Your healthcare provider may change your other medicines or change their doses. Other medicines, including herbal products, may affect ATRIPLA. For this reason, it is very important to let all your healthcare providers and pharmacists know what medications, herbal supplements, or vitamins you are taking.

MEDICINES YOU SHOULD NOT TAKE WITH ATRIPLA • The following medicines may cause serious and life-threatening side effects when taken with ATRIPLA. You should not take any of these medicines while taking ATRIPLA: Vascor (bepridil), Propulsid (cisapride), Versed (midazolam), Orap (pimozide), Halcion (triazolam), ergot medications (for example, Wigraine and Cafergot).

• ATRIPLA also should not be used with Combivir (lamivudine/zidovudine), EMTRIVA, Epivir, Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine), Trizivir (abacavir sulfate/lamivudine/zidovudine), SUSTIVA, TRUVADA, or VIREAD. • Vfend (voriconazole) should not be taken with ATRIPLA since it may lose its effect or may increase the chance of having side effects from ATRIPLA. • Do not take St. John’s wort (Hypericum perforatum), or products containing St. John’s wort with ATRIPLA. St. John’s wort is an herbal product sold as a dietary supplement. Talk with your healthcare provider if you are taking or are planning to take St. John’s wort. Taking St. John’s wort may decrease ATRIPLA levels and lead to increased viral load and possible resistance to ATRIPLA or cross-resistance to other anti-HIV-1 drugs.

• ATRIPLA should not be used with HEPSERA® (adefovir dipivoxil).

It is also important to tell your healthcare provider if you are taking any of the following: • Fortovase, Invirase (saquinavir), Biaxin (clarithromycin), Noxafil (posaconazole), or Sporanox (itraconazole); these medicines may need to be replaced with another medicine when taken with ATRIPLA. • Calcium channel blockers such as Cardizem or Tiazac (diltiazem), Covera HS or Isoptin (verapamil) and others; Crixivan (indinavir), Selzentry (maraviroc); the immunosuppressant medicines cyclosporine (Gengraf, Neoral, Sandimmune, and others), Prograf (tacrolimus), or Rapamune (sirolimus); Methadone; Mycobutin (rifabutin); Rifampin; cholesterol-lowering medicines such as Lipitor (atorvastatin), Pravachol (pravastatin sodium), and Zocor (simvastatin); or Zoloft (sertraline); these medicines may need to have their dose changed when taken with ATRIPLA. • Videx, Videx EC (didanosine); tenofovir DF (a component of ATRIPLA) may increase the amount of didanosine in your blood, which could result in more side effects. You may need to be monitored more carefully if you are taking ATRIPLA and didanosine together. Also, the dose of didanosine may need to be changed.

• Reyataz (atazanavir sulfate) or Kaletra (lopinavir/ritonavir); these medicines may increase the amount of tenofovir DF (a component of ATRIPLA) in your blood, which could result in more side effects. Reyataz is not recommended with ATRIPLA. You may need to be monitored more carefully if you are taking ATRIPLA and Kaletra together. Also, the dose of Kaletra may need to be changed.

• Medicine for seizures [for example, Dilantin (phenytoin), Tegretol (carbamazepine), or phenobarbital]; your healthcare provider may want to switch you to another medicine or check drug levels in your blood from time to time.

These are not all the medicines that may cause problems if you take ATRIPLA. Be sure to tell your healthcare provider about all medicines that you take.

Keep a complete list of all the prescription and nonprescription medicines as well as any herbal remedies that you are taking, how much you take, and how often you take them. Make a new list when medicines or herbal remedies are added or stopped, or if the dose changes. Give copies of this list to all of your healthcare providers and pharmacists every time you visit your healthcare

ATRIPLA® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) provider or fill a prescription. This will give your healthcare provider a complete picture of the medicines you use. Then he or she can decide the best approach for your situation.

How should I take ATRIPLA? • Take the exact amount of ATRIPLA your healthcare provider prescribes. Never change the dose on your own. Do not stop this medicine unless your healthcare provider tells you to stop.

• You should take ATRIPLA on an empty stomach.

• Swallow ATRIPLA with water.

• Taking ATRIPLA at bedtime may make some side effects less bothersome.

• Do not miss a dose of ATRIPLA. If you forget to take ATRIPLA, take the missed dose right away, unless it is almost time for your next dose. Do not double the next dose. Carry on with your regular dosing schedule. If you need help in planning the best times to take your medicine, ask your healthcare provider or pharmacist.

• If you believe you took more than the prescribed amount of ATRIPLA, contact your local poison control center or emergency room right away.

• Tell your healthcare provider if you start any new medicine or change how you take old ones. Your doses may need adjustment.

• When your ATRIPLA supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to ATRIPLA and become harder to treat.

• Your healthcare provider may want to do blood tests to check for certain side effects while you take ATRIPLA. What should I avoid while taking ATRIPLA? • Women should not become pregnant while taking ATRIPLA and for 12 weeks after stopping it. Serious birth defects have been seen in the babies of animals and women treated with efavirenz (a component of ATRIPLA) during pregnancy. It is not known whether efavirenz caused these defects. Tell your healthcare provider right away if you are pregnant. Also talk with your healthcare provider if you want to become pregnant.

• Women should not rely only on hormone-based birth control, such as pills, injections, or implants, because ATRIPLA may make these contraceptives ineffective. Women must use a reliable form of barrier contraception, such as a condom or diaphragm, even if they also use other methods of birth control. Efavirenz, a component of ATRIPLA, may remain in your blood for a time after therapy is stopped. Therefore, you should continue to use contraceptive measures for 12 weeks after you stop taking ATRIPLA. • Do not breast-feed if you are taking ATRIPLA. The Centers for Disease Control and Prevention recommend that mothers with HIV not breast-feed because they can pass the HIV through their milk to the baby. Also, ATRIPLA may pass through breast milk and cause serious harm to the baby. Talk with your healthcare provider if you are breast-feeding. You should stop breast-feeding or may need to use a different medicine.

• Taking ATRIPLA with alcohol or other medicines causing similar side effects as ATRIPLA, such as drowsiness, may increase those side effects.

• Do not take any other medicines, including prescription and nonprescription medicines and herbal products, without checking with your healthcare provider.

• Avoid doing things that can spread HIV-1 infection since ATRIPLA does not stop you from passing the HIV-1 infection to others.

What are the possible side effects of ATRIPLA? ATRIPLA may cause the following serious side effects: • Lactic acidosis (buildup of an acid in the blood). Lactic acidosis can be a medical emergency and may need to be treated in the hospital. Call your healthcare provider right away if you get signs of lactic acidosis. (See “What is the most important information I should know about ATRIPLA?”) • Serious liver problems (hepatotoxicity), with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Call your healthcare provider right away if you get any signs of liver problems. (See “What is the most important information I should know about ATRIPLA?”) • “Flare-ups” of hepatitis B virus (HBV) infection, in which the disease suddenly returns in a worse way than before, can occur if you have HBV and you stop taking ATRIPLA. Your healthcare provider will monitor your condition for several months after stopping ATRIPLA if you have both HIV-1 and HBV infection and may recommend treatment for your HBV. ATRIPLA is not approved for the treatment of hepatitis B virus infection. If you have advanced liver disease and stop treatment with ATRIPLA, the “flare-up” of hepatitis B may cause your liver function to decline.

• Serious psychiatric problems. A small number of patients may experience severe depression, strange thoughts, or angry behavior while taking ATRIPLA. Some patients have thoughts of suicide and a few have actually committed suicide. These problems may occur more often in patients who have had mental illness. Contact your healthcare provider right away if you think you are having these psychiatric symptoms, so your healthcare provider can decide if you should continue to take ATRIPLA. • Kidney problems (including decline or failure of kidney function). If you have had kidney problems in the past or take other medicines that can cause kidney problems, your healthcare provider should do regular blood tests to check your kidneys. Symptoms that may be related to kidney problems include a high volume of urine, thirst, muscle pain, and muscle weakness.

• Other serious liver problems. Some patients have experienced serious liver problems including liver failure resulting in transplantation or death. Most of these serious side effects

ATRIPLA® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) occurred in patients with a chronic liver disease such as hepatitis infection, but there have also been a few reports in patients without any existing liver disease.

• Changes in bone mineral density (thinning bones). Laboratory tests show changes in the bones of patients treated with tenofovir DF, a component of ATRIPLA. Some HIV patients treated with tenofovir DF developed thinning of the bones (osteopenia) which could lead to fractures. If you have had bone problems in the past, your healthcare provider may need to do tests to check your bone mineral density or may prescribe medicines to help your bone mineral density. Additionally, bone pain and softening of the bone (which may contribute to fractures) may occur as a consequence of kidney problems.

Common side effects: Patients may have dizziness, headache, trouble sleeping, drowsiness, trouble concentrating, and/or unusual dreams during treatment with ATRIPLA. These side effects may be reduced if you take ATRIPLA at bedtime on an empty stomach. They also tend to go away after you have taken the medicine for a few weeks. If you have these common side effects, such as dizziness, it does not mean that you will also have serious psychiatric problems, such as severe depression, strange thoughts, or angry behavior. Tell your healthcare provider right away if any of these side effects continue or if they bother you. It is possible that these symptoms may be more severe if ATRIPLA is used with alcohol or mood altering (street) drugs.

If you are dizzy, have trouble concentrating, or are drowsy, avoid activities that may be dangerous, such as driving or operating machinery.

Rash may be common. Rashes usually go away without any change in treatment. In a small number of patients, rash may be serious. If you develop a rash, call your healthcare provider right away.

Other common side effects include tiredness, upset stomach, vomiting, gas, and diarrhea.

Other possible side effects with ATRIPLA: • Changes in body fat. Changes in body fat develop in some patients taking anti-HIV-1 medicine. These changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), in the breasts, and around the trunk. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these fat changes are not known.

• Skin discoloration (small spots or freckles) may also happen with ATRIPLA. • In some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately.

• Additional side effects are inflammation of the pancreas, allergic reaction (including swelling of the face, lips, tongue, or throat), shortness of breath, pain, stomach pain, weakness and indigestion.

Tell your healthcare provider or pharmacist if you notice any side effects while taking ATRIPLA. Contact your healthcare provider before stopping ATRIPLA because of side effects or for any other reason.

This is not a complete list of side effects possible with ATRIPLA. Ask your healthcare provider or pharmacist for a more complete list of side effects of ATRIPLA and all the medicines you will take.

How do I store ATRIPLA? • Keep ATRIPLA and all other medicines out of reach of children.

• Store ATRIPLA at room temperature 77 °F (25 °C).

• Keep ATRIPLA in its original container and keep the container tightly closed.

• Do not keep medicine that is out of date or that you no longer need. If you throw any medicines away make sure that children will not find them.

General information about ATRIPLA: Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use ATRIPLA for a condition for which it was not prescribed. Do not give ATRIPLA to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about ATRIPLA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ATRIPLA that is written for health professionals.

Do not use ATRIPLA if the seal over bottle opening is broken or missing.

What are the ingredients of ATRIPLA? Active Ingredients: efavirenz, emtricitabine, and tenofovir disoproxil fumarate Inactive Ingredients: croscarmellose sodium, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, sodium lauryl sulfate. The film coating contains black iron oxide, polyethylene glycol, polyvinyl alcohol, red iron oxide, talc, and titanium dioxide.

March 2011 ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. EMTRIVA, TRUVADA, HEPSERA and VIREAD are trademarks of Gilead Sciences, Inc. SUSTIVA is a trademark of Bristol-Myers Squibb Pharma Company. Reyataz and Videx are trademarks of Bristol-Myers Squibb Company. Pravachol is a trademark of ER Squibb & Sons, LLC. Other brands listed are the trademarks of their respective owners.

SF-B0001B-03-11

21-937-GS-008

TR9171

March 2011

BRIEFLY Reported by ENid VÁZQUEz

In May, the Food and Drug Administration (FDA) approved Victrelis (boceprevir),

and Incivek (telaprevir), two new hepatitis C virus (HCV) protease inhibitors.

Both drugs are for genotype 1 infection, the most difficult of the HCV types to treat.

They must be taken with the two older hep C treatments on the market, peginterferon alfa (PegIntron) and ribavirin (Rebetol), though they can both shorten treatment time by half. The FDA noted that the addition of Victrelis to PegIntron and Rebetol significantly increased the sustained virologic response (SVR) rates compared to PegIntron and Rebetol alone (by almost double, from 38% for people taking only the two older drugs to 63–66% for those also taking Victrelis). An SVR is considered a cure. For Incivek, the percentage of treatment-naïve people who achieved an SVR was 79%.

While the approval of these drugs marks a major step forward in the

treatment of hepatitis C, advocates expressed dismay over the price of the drugs. Victrelis costs between $26,400 and $46,400, depending on the duration of treatment, which can range from 24-48 weeks. Incivek is also expensive—around $49,200 for 12 weeks of treatment. Both drugs must also be taken in combination with other hep C drugs that can cost as much as $30,000.

The Fair Pricing Coalition (FPC) is very disappointed at the price set for Victrelis and Incivek. “The FPC is concerned that the exorbitant wholesale acquisition cost (WAC) of $1,100 per week [for Victrelis] will adversely affect the ability of people with HCV to access Victrelis and that it will also set an excessively unreasonable future price point for the many HCV drugs in the pipeline,” said FPC member Lynda Dee. Both Vertex and Merck have announced financial assistance and patient support programs to provide free drug to eligible patients who do not have insurance, and to provide coverage for co-pay or co-insurance costs associated with Incivek or Victrelis for people who meet certain program criteria.

Call 855-837-8394 or go to www.incivek.com; or www. victrelis.com for details.

FDA approves two generic HIV drugs On May 25, the FDA granted approval for a generic formulation of Combivir, a two-in-one HIV medication consisting of lamivudine and zidovudine (brand names Epivir and Retrovir). Both are from the drug class called nucleoside analog reverse transcriptase inhibitors (NRTIs). The tablets are manufactured by TEVA Pharmaceuticals USA. The generic will be available in the U.S. The FDA also granted tentative approval for a generic formulation of tenofovir disoproxil fumarate (Viread) tablets under the expedited review provisions for the President’s Emergency Plan for AIDS Relief (PEPFAR). This generic will not be available in the U.S. Tentative approval does, however, make the product eligible for purchase outside the U.S. under the PEPFAR program.

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Treatment as prevention International research led by the National Institutes of Health (NIH) has now provided strong evidence that HIV treat-

ment helps prevent transmission to HIV-negative sex partners. This is the first time that gold-standard research (a randomized, controlled clinical trial) has successfully demonstrated the concept of “treatment as prevention.”

The study found a 96% drop in the risk of HIV infection with the use of antiretroviral therapy.

“Previous data about the potential value of antiretrovirals in making HIV-infected individuals less infectious to their sexual partners Fauci came largely from observational and epidemiological studies,” said Anthony S. Fauci, MD, director of the National Institutes of Allergy and Infectious Diseases (NIAID), in a press release. “This new finding convincingly demonstrates that treating the infected individual—and doing so sooner rather than later—can have a major impact on reducing HIV transmission.”

CATIE (the Canadian AIDS Treatment Information Exchange) produced a comprehensive report on the HPTN 052 findings, along with links to past research and reports that shed light on the concept of treatment as prevention (including information from the U.S. Centers for Disease Control and Prevention, or CDC, which note that it is a promising, but not foolproof, avenue for lessening the risk of infection). Go to www.catie.ca.

Read more about the HPTN 052 study on page 34.

P osi t i v elyAwar e .co m

Photo: ©IAS-Steve Forrest-Workers’ Photos

New drugs for hepatitis approved

Sign up for the weekly PA E-News, go to Positivelyaware.com

Abacavir, tenofovir, and your heart The HIV drug Ziagen has once again been associated with increased risk of heart trouble. This time, a review of patient data from the Veterans Administration suggests people taking Ziagen have

an increased risk of heart disease and stroke. Also of interest in the analysis: tenofovir, Ziagen’s competitor, was associated with an increase in heart failure.

The research on Ziagen and heart problems has been good and bad for years. Writer Keith Alcorn examines the latest information and reviews some of the past research at www.aidsmap.com.

The VA study was published in the May issue of AIDS. The VA researchers point out that there was a high rate of smoking in the entire group of patients who participated (half of them smoked). In addition, 40% of them had high blood pressure and nearly 20% of them had diabetes, both of which are associated with a higher risk of heart disease. In fact, one out of five of them already had a diagnosis of cardiovascular disease before going on Ziagen or tenofovir.

The generic name of Ziagen is abacavir; it is also found in Epzicom and Trizivir. The brand name of tenofovir is Viread, which is also found in Truvada and Atripla.

Alcorn also reported more data showing that HIV infection may have a role in heart failure. That research, looking at a large group of U.S. military veterans, was published in the April 25 Archives of Internal Medicine. As he notes, the analysis “adds to the accumulating evidence that untreated HIV infection may increase the risk of heart disease.” Once again, this group had a high rate of smoking (55%).

The researchers theorized that several factors may explain the risk: HIV itself, heavy alcohol use, HIV treatment side effects, nutritional deficiencies, and damage to the heart muscle.

P os i t i ve lyAwa re.com

New website helps HIV patients improve their heart health The American Heart Association and the American Academy of HIV Medicine (AAHIVM) have created a new website to help people living with HIV make changes to improve their heart health and overall wellness.

HIVandYourHeart.org features informative videos from healthcare providers, a wellness checklist, an HIV quiz, and personal stories from patients and behavioral change coach Michael Patterson. HIV and Your Heart also has an application for the iPhone, iPad, and iPod Touch.

The interactive tracking tool helps patients define their goals and begin the steps necessary to make changes. It’s also confidential. The desktop icon is labeled “Your Heart” and the information you enter may be password-protected.

Cardiovascular disease (CVD) is a major cause of death in HIV patients and people living with HIV often share common factors that affect cardiovascular health, including: n n n n n n

Higher triglyceride and “bad” cholesterol levels Chronic inflammation Smoking Atherosclerosis Kidney failure Diabetes

“The good news, however, is that much of this risk for coronary heart disease is remedial,” said American Heart Association spokesperson and past president, Robert Eckel, MD, of the University of Colorado Denver School of Medicine and University Hospital, Denver, Colorado. “We have concluded that the development of optimized screening, prediction, and treatment algorithms for cardiovascular disease in HIV-infected patients is crucial and timely.”

In a recent survey of Positively Aware website visitors and e-newsletter subscribers, 68% of HIV patients said they’re very interested in learning about HIV and CVD. J U LY + AU G U ST 2 01 1

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INFLAMED HIV provokes the immune system

by David H. Shepp, MD

H

IV is a viral infection that attacks the immune system.

Without treatment, it progresses to a state of immune system failure, leaving the infected person vulnerable to severe and unusual infections and cancers. These diseases are referred to as “opportunistic� because they thrive only in the setting of severely compromised immune system function. Paradoxically, this immune system failure occurs as HIV stimulates the immune system into a hyperactive state.

This hyperactivity is only partially effective in controlling HIV, fueling the fire by providing new activated T-cells that are especially vulnerable to HIV infection, and interfering with the development of the coordinated immune response needed to prevent the opportunistic AIDS-related diseases.

Immune activation and chronic inflammation The immune system is enormously complex and not completely understood. It has evolved to keep us protected from the sea of microbes and other potentially toxic substances that we inhale, ingest, and touch every day. The immune system uses two major mechanisms to recognize and respond to infection. Some immune system cells are stimulated by the general pattern of molecules found in 14

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P os it i v elyAwa r e .co m

NFLAMED RESPONSE into a hyperactive state that can lead to chronic inflammation

different broad categories of microbes.

For example, some are triggered by molecules present in many bacteria or fungi and some by the structure of the genes of viruses. This function is called innate immunity. Other immune system cells, T- and B-lymphocytes, have the ability to “learn” how to recognize short protein segments, know as antigens, that are unique to specific microbes. This function is known as adaptive immunity. When either type of immune cell encounters its trigger molecule, cell surface proteins known as receptors are engaged. A signal is then sent to the cell interior, producing cell activation. This results in a variety of functions, including cell division and the production of signal molecules (known as cytokines), that attract and activate other types of inflammatory cells, alter blood coagulation, and generate fever. Activated cells may also secrete toxic substances that help kill microbes and may engulf and digest them. The end result is a state of inflammation, a process that limits the growth and spread of the infecting agent.

This system is very effective, but it is not perfect. Inflammation can make a person feel ill. An overreaction to certain foreign substances is the cause of allergies. Even appropriately regulated inflammation can cause “collateral damage,” injuring healthy body tissues. Inflammation also alters normal body metabolism in ways that create a hostile environment for infection. Over the short term, this causes little trouble, but if inflammation becomes chronic, these metabolic disturbances increase risk for a variety of medical conditions.

Chronic inflammation and NAMIs Chronic inflammation is now understood to be an important contributing factor to P os i t i ve lyAwa re.com

many medical illnesses common in the general population, including cardiovascular disease, kidney disease, diabetes, osteoporosis, and cancer. These same illnesses are occurring in HIV-positive people at a higher rate than in the general population and possibly at an earlier age as well. In countries with good access to antiretroviral therapy (ART), classic AIDSrelated opportunistic illnesses still account for about 30% of all deaths. However, non-AIDS medical illnesses (NAMIs) now account for the majority of deaths.1 Liver failure, cardiovascular diseases, and nonAIDS–defining malignancies are most common. There are several potential explanations for increased rates of these illnesses. HIV disproportionately affects those of black race, as do chronic kidney disease, diabetes, and cardiovascular disease. Cigarette smoking, a strong risk factor for cardiovascular disease, cancer, and osteoporosis, is more common among HIV-positive patients. Hepatitis B, hepatitis C, and human papillomavirus (HPV) are more common in HIV-positive people because they share routes of transmission with HIV. These viruses can contribute to liver cirrhosis and to liver, cervical, and anal cancers. ART itself has toxic effects that may be a contributing factor to some diseases. Certain antiretrovirals may cause elevations of LDL (“bad”) cholesterol, loss of arm and leg fat, increased abdominal fat, altered glucose (blood sugar) metabolism, or loss of bone density. These conditions are risk factors for cardiovascular disease, diabetes, and bone fractures.

Another important possibility is that HIV infection directly increases the risk of NAMIs. The interval from HIV infection to initiation of ART is quite variable but is often many years. The intense, chronic inflammation occurring during the period

of untreated infection may cause irreversible organ system damage. Once ART is initiated, immune activation and chronic inflammation improve, but do not usually fall to levels seen in healthy, HIV-negative individuals. This residual inflammation may increase the risk of NAMIs. Levels of activated T-lymphoctyes and markers of inflammation in the blood are elevated in HIV-positive patients. 2,3 Activated T-lymphocytes and certain inflammatory markers in the blood such as high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), D-dimer, soluble CD14, and fibrinogen also strongly correlate with the risk of HIV disease progression and death.4-7

Effects of ART For most patients, combination ART reduces HIV replication to undetectable levels and restores immune function to levels that provide freedom from opportunistic illnesses. It also improves, but does not completely normalize, chronic inflammation and immune activation, which persist even after many years of successful treatment. 8, 9 Mortality in HIV-positive individuals declined dramatically over the past 16 years, but life-expectancy remains substantially lower than in the general population.10 Immune activation also influences the degree of immune recovery during ART. Most patients who achieve full suppression of HIV in the blood have significant improvement in the CD4+ T-cell count, critical cells needed to resist opportunistic illness. Those patients with higher levels of activated immune cells are less likely to increase the CD4+ T-cell count above 200/mm3,11 the level that confers protection against opportunistic illnesses. Understanding the causes of chronic inflammation in those on ART and J U LY + AU G U ST 2 01 1

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Effective treatment to reduce immune activation to normal levels is not established and represents an important unmet need in HIV treatment.

developing new treatments for it is now a major area of HIV research.

Causes of immune activation Why does effective ART that durably suppresses HIV growth, improves immune system function, and extends life still permit residual immune activation? There are several potential causes (see table next page). HIV itself may still be driving inflammation. Standard ART suppresses HIV in the blood to levels below the threshold of detection for most commonly used tests, but more sensitive assays employed in research laboratories show that many patients have detectable low-level HIV that does not decline even with prolonged treatment. Although their overall effect is beneficial, certain antiretroviral drugs might directly stimulate an inflammatory response, either by a toxic effect on certain cells or by triggering an allergic response.

In addition, HIV causes damage to tissues that line the intestines and are normally rich in T-lymphocytes. These tissues, known as gut-associated lymphoid tissue (GALT), form an important defense that keeps bacteria, fungi, and the other microbes that are normally present in the intestines from entering the blood stream. A subset of T-lymphocytes called TH17 cells are especially important in carrying out this function and are abnormal in HIV-infected GALT. When GALT functions abnormally, gut microbes or their components may enter the blood stream, a process called microbial translocation, which triggers a powerful inflammatory response. ART does not adequately repair GALT, leaving microbial translocation as a cause of chronic immune activation and inflammation in HIV.12 Co-infections such as hepatitis C virus (HCV) and cytomegalovirus (CMV) may persist or recur periodically, even in patients responding well to ART. As with 16

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HIV, these viruses directly trigger immune responses that do not fully resolve infection, leading to chronic immune activation and inflammation. Finally, certain components of a properly regulated immune response may be irreversibly damaged

by HIV during the highly variable period of time that HIV remains untreated, causing failure to turn off immune responses appropriately. A subset of T-lymphocytes known as regulatory T-cells are thought to be important in this process. These cells frequently are abnormal in HIV infection and may account for the failure of some immune responses to subside.

Treatment research on chronic inflammation Effective treatment to reduce immune activation to normal levels is not established and represents an important unmet need in HIV treatment. Since early use of ART is now the standard of care, treatment research should study adjunctive therapies given with standard ART, or explore the anti-inflammatory effects of new antiretrovirals or novel antiretroviral combinations. All such studies will need first to demonstrate consistent and sustained reduction in markers of immune activation and/or inflammation. Ultimately, studies that demonstrate reduced NAMIs and longer life expectancy will be needed to prove that reducing inflammation improves health outcomes.

To address residual HIV infection as a cause of chronic immune activation and inflammation, many ART intensification studies have been conducted. In these studies, patients well controlled on standard ART have one or more potent antiretrovirals added to their regimen.

Using very sensitive assays, most studies have not shown any consistent reduction in residual HIV infection,13, 14 although some

studies have suggested possible effects on inflammation, which are currently unexplained and require further study and confirmation.14, 15 Mitochondria are structures within cells that generate energy. They are thought to be derived from primitive bacteria. Mitochondrial injury is a well known adverse effect of certain antiretroviral drugs of the class called nucleoside reverse transcriptase inhibitors (NRTIs).

Damage to mitochondria may cause the release of molecules that trigger an inflammatory response from cells of the innate immune system, similar to the response triggered by bacteria. In resource-rich areas, the most toxic of the NRTIs are no longer used. However, studies comparing the effect on inflammation of standard ART containing NRTIs and newer ART regimens that do not use NRTIs should be undertaken.

Many novel treatment strategies to reduce microbial translocation are under investigation or being considered. The cytokine interleukin-7 (IL-7) recently has shown promise as a treatment that reverses T-cell depletion in GALT 16 and could, as a result, reduce translocation. Enhancing TH17 cell function by inhibiting enzymes known as indolamine dioxygenases (IDO) or administering interleukin-17, the cytokine produced by these cells, may reduce microbial translocation. Altering the composition of microbes in the gut to render them less harmful might be achieved through ingestion of dietary supplements and harmless bacteria, substances referred to as prebiotics and probiotics. Antibiotics to reduce the overall number of bacteria might also be effective, but would likely be limited by overgrowth of undesirable antibiotic-resistant microbes. Injection of antibodies to bind and neutralize microbial products that enter the blood stream could limit the ability of microbial translocation to stimulate inflammation.

In patients on effective ART, a substantial proportion of activated CD8+ T-cells are responding to CMV infection.17 A small pilot study reported that eight weeks of treatment with the anti-CMV drug valganciclovir significantly reduced levels of these cells.18 P os it i v elyAwa r e .co m

Although it was safe in this very brief study, valganciclovir has potential for serious side effects and so may not be suitable for longterm use. There is an opportunity for newer, safer anti-CMV therapy to be investigated to reduce chronic immune activation in HIV-positive patients.

If the underlying cause of chronic inflammation cannot be specifically corrected, use of anti-inflammatory, immunosuppressive, or immunomodulatory agents as adjunctive therapy to ART could be effective. There are now a very large number of such drugs in clinical use for other debilitating or life-threatening conditions. Some have serious adverse effects or predispose patients to opportunistic infections, making them less suitable for study of the prevention of NAMIs in those who are otherwise doing well. A few with a more favorable safety profile have been studied. Statins are drugs widely used to lower cholesterol and are generally safe.

They decrease the risk of death in patients at high risk for a heart attack, but only part of the benefit is due to lower cholesterol. Statins also have anti-inflammatory effects. A short course of atorvastatin lowered levels of T-cell activation better than a placebo in HIV-positive patients.19 However, these patients were not receiving ART. It is not known if the use of statins in patients already responding to ART would provide additional benefit.

Hydroxychloroquine (HCQ) is a licensed drug with immunomodulatory properties used primarily in the treatment of lupus.

It is thought to work by interfering with certain aspects of the innate immune response. A recent pilot study suggested improvement in some markers of inflammation when adjunctive HCQ was added to standard ART. 20 These findings are very preliminary and require further study. In separate studies, the rheumatoid arthritis drug salsalate and cyclosporin, a drug used to prevent rejection of organ transplants, also have been tested in patients with HIV. Neither appeared promising. 21, 22 As an alternate to adjunctive therapy, some antiretrovirals, such as the CCR5 inhibitor maraviroc (Selzentry), have immunomodulatory properties which P os i t i ve lyAwa re.com

could give them a dual mechanism of action in HIV-positive patients.

Studies adding maraviroc to standard ART have produced conflicting results, suggesting either reduced23 or increased24 immune activation. An investigational CCR5 inhibitor with additional antiinflammatory properties, called cenicriviroc (TBR-652), is currently in development.

Earlier initiation of ART may improve the chances that HIVassociated immune activation will return to normal levels. A small study has suggested early initiation of ART leads to greater improvement in immune activation. 25 A large, randomized trial known as START should help determine if early ART initiation leads to greater improvement in inflammation. The START study is also one of the only ongoing studies that will also assess the effects on NAMIs and mortality.

Possible causes of

residual chronic immune activation/inflammation after successful standard antiretroviral therapy and potential treatment strategies

Persistent low-level HIV infection n ART intensification Toxicity of antiretroviral agents n differentiate effects of standard ART regimens n new antiretrovirals with fewer toxicities Microbial translocation n prebiotics/probiotics to alter intestinal flora n antibodies against microbial components n improve function of gut-associated lymphoid tissue (eg IL-7, IL-17, IDO inhibitors) Persistent co-infections n anti-CMV antivirals n treatment of hepatitis C Irreversible damage to immune regulating mechanisms n adjunctive anti-inflammatory therapy (e.g. statins, hydroxychloroquine) n new antiretrovirals with anti-inflammatory effects n earlier ART initiation

Conclusions Chronic immune activation and inflammation is a central feature of HIV infection and is implicated in the increased risk for NAMIs in the general population and in people living with HIV. NAMIs are now the leading cause of illness and death in patients treated with ART. Effective ART reduces chronic inflammation but does not necessarily resolve it. Research to improve our understanding of the causes of chronic immune activation and chronic inflammation is needed. Many ART-based and non-ART–based approaches to treatment

are open for study. Treatments will need to reduce markers of inflammation, NAMIs, and improve life expectancy to become a standard of care in HIV therapy. e David H. Shepp, MD, is Associate Professor of Medicine at the Hofstra North Shore-LIJ School of Medicine, Division of Infectious Diseases, North Shore University Hospital in Manhasset, New York.

Go to PositivelyAware.com for references.

J U LY + AU G U ST 2 01 1

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Model

INDICATIONS ISENTRESS is an anti-HIV medicine used for the treatment of HIV. ISENTRESS must be used with other anti-HIV medicines, which may increase the likelihood of response to treatment.

The safety and effectiveness of ISENTRESS in children has not been studied.

It is important that you remain under your doctor’s care.

ISENTRESS will NOT cure HIV infection or reduce your chance of passing HIV to others through sexual contact, sharing needles, or being exposed to your blood.

IMPORTANT RISK INFORMATION A condition called Immune Reconstitution Syndrome can happen in some patients with advanced HIV infection (AIDS) when anti-HIV treatment is started. Signs and symptoms of inflammation from opportunistic infections may occur as the medicines work to treat the HIV infection and strengthen the immune system.

Call your doctor right away if you notice any signs or symptoms of an infection after starting ISENTRESS. Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness while taking ISENTRESS. This is because on rare occasions muscle problems can be serious and can lead to kidney damage.

When ISENTRESS has been given with other anti-HIV drugs, side effects included nausea, headache, tiredness, weakness, trouble sleeping, stomach pain, dizziness, depression, and suicidal thoughts and actions.

Mild rash occurred more often in patients taking ISENTRESS plus Prezista than with either drug alone.

I am active.

I am devoted to family.

I am inspired.

I am HIV positive.

You are special, unique, and different from anyone else.

And so is your path to managing HIV. When you’re ready to start HIV therapy, talk to your doctor about a medication that may fit your needs and lifestyle.

In clinical studies lasting 96 weeks, patients being treated with HIV medication for the first time who took ISENTRESS plus Truvada: Had a low rate of side effects — The most common side effect of moderate to severe intensity (that interfered with or kept patients from performing daily activities) was trouble sleeping — This side effect occurred more often in patients taking ISENTRESS plus Truvada (4%) versus Sustiva plus Truvada (3%) Experienced less effect on LDL cholesterol (“bad” cholesterol) — Cholesterol increased an average of 7 mg/dL with ISENTRESS plus Truvada versus 21 mg/dL with Sustiva plus Truvada — When they began the study, the average LDL cholesterol of patients on ISENTRESS plus Truvada was 96 mg/dL versus 93 mg/dL for those on Sustiva plus Truvada

Ask your doctor about ISeNTReSS. Not sure where to start? Visit isentress.com/questions People taking ISENTRESS may still develop infections, including opportunistic infections or other conditions that occur with HIV infection.

Tell your doctor about all of your medical conditions, including if you have any allergies, are pregnant or plan to become pregnant, or are breast-feeding or plan to breast-feed. ISENTRESS is not recommended for use during pregnancy. Women with HIV should not breast-feed because their babies could be infected with HIV through their breast milk.

Tell your doctor about all the medicines you take, including prescription medicines like rifampin (a medicine used to treat infections such as tuberculosis), non-prescription medicines, vitamins, and herbal supplements.

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

For more information about ISENTRESS, please read the Patient Information on the following page.

Need help paying for ISENTRESS? Call 1-866-350-9232 Copyright © 2011 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved.

IMMU-1001800-0000-06/11(112) Sustiva is a registered trademark of Bristol-Myers Squibb Truvada is a registered trademark of Gilead Sciences, Inc. Prezista is a registered trademark of Tibotec, Inc.

Patient Information ISENTRESS ® (eye sen tris) (raltegravir) Tablets Read the patient information that comes with ISENTRESS1 before you start taking it and each time you get a refill. There may be new information. This leaflet is a summary of the information for patients. Your doctor or pharmacist can give you additional information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.

What is ISENTRESS? • ISENTRESS is an anti-HIV (antiretroviral) medicine used for the treatment of HIV. The term HIV stands for Human Immunodeficiency Virus. It is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). ISENTRESS is used along with other anti-HIV medicines. ISENTRESS will NOT cure HIV infection.

• People taking ISENTRESS may still develop infections, including

opportunistic infections or other conditions that happen with HIV infection.

• Stay under the care of your doctor during treatment with ISENTRESS. • The safety and effectiveness of ISENTRESS in children has not been studied.

ISENTRESS must be used with other anti-HIV medicines.

How does ISENTRESS work?

• ISENTRESS blocks an enzyme which the virus (HIV) needs in order to make more virus. The enzyme that ISENTRESS blocks is called HIV integrase.

• When used with other anti-HIV medicines, ISENTRESS may do two things:

1. Reduce the amount of HIV in your blood. This is called your “viral load”.

2. Increase the number of white blood cells called CD4 (T) cells.

• ISENTRESS may not have these effects in all patients.

Does ISENTRESS lower the chance of passing HIV to other people?

No. ISENTRESS does not reduce the chance of passing HIV to others through sexual contact, sharing needles, or being exposed to your blood.

• Continue to practice safer sex.

• Use latex or polyurethane condoms or other barrier methods to lower the chance of sexual contact with any body fluids. This includes semen from a man, vaginal secretions from a woman, or blood.

• Never re-use or share needles.

Ask your doctor if you have any questions about safer sex or how to prevent passing HIV to other people.

What should I tell my doctor before and during treatment with ISENTRESS? Tell your doctor about all of your medical conditions. Include any of the following that applies to you: • You have any allergies.

• You are pregnant or plan to become pregnant.

- ISENTRESS is not recommended for use during pregnancy.

ISENTRESS has not been studied in pregnant women. If you take

ISENTRESS while you are pregnant, talk to your doctor about how

you can be included in the Antiretroviral Pregnancy Registry.

• You are breast-feeding or plan to breast-feed.

- It is recommended that HIV-infected women should not breast-feed

their infants. This is because their babies could be infected with HIV through their breast milk.

- Talk with your doctor about the best way to feed your baby.

Tell your doctor about all the medicines you take. Include the following: • prescription medicines, including rifampin (a medicine used to treat some infections such as tuberculosis) • non-prescription medicines • vitamins • herbal supplements Know the medicines you take.

• Keep a list of your medicines. Show the list to your doctor and pharmacist when you get a new medicine.

How should I take ISENTRESS? Take ISENTRESS exactly as your doctor has prescribed. The recommended dose is as follows: • Take only one 400-mg tablet at a time.

• Take it twice a day.

• Take it by mouth.

• Take it with or without food.

Do not change your dose or stop taking ISENTRESS or your other anti-HIV medicines without first talking with your doctor.

IMPORTANT: Take ISENTRESS exactly as your doctor prescribed and at the right times of day because if you don’t: • The amount of virus (HIV) in your blood may increase if the medicine is stopped for even a short period of time.

• The virus may develop resistance to ISENTRESS and become harder to treat.

• Your medicines may stop working to fight HIV. • The activity of ISENTRESS may be reduced (due to resistance).

Registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Copyright © 2007, 2009 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved.

1

If you fail to take ISENTRESS the way you should, here’s what to do: • If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do NOT take two tablets of ISENTRESS at the same time. In other words, do NOT take a double dose.

• If you take too much ISENTRESS, call your doctor or local Poison Control Center.

Be sure to keep a supply of your anti-HIV medicines.

• When your ISENTRESS supply starts to run low, get more from your doctor or pharmacy.

• Do not wait until your medicine runs out to get more.

What are the possible side effects of ISENTRESS? When ISENTRESS has been given with other anti-HIV drugs, side effects included: • nausea • headache • tiredness • weakness • trouble sleeping • stomach pain • dizziness • depression • suicidal thoughts and actions Other side effects include: rash, severe skin reactions, feeling anxious, paranoia, low blood platelet count, diarrhea, liver failure.

A condition called Immune Reconstitution Syndrome can happen in some patients with advanced HIV infection (AIDS) when combination antiretroviral treatment is started. Signs and symptoms of inflammation from opportunistic infections that a person has or had may occur as the medicines work to treat the HIV infection and help to strengthen the immune system. Call your doctor right away if you notice any signs or symptoms of an infection after starting ISENTRESS with other anti-HIV medicines.

Contact your doctor promptly if you experience unexplained muscle pain, tenderness, or weakness while taking ISENTRESS. This is because on rare occasions, muscle problems can be serious and can lead to kidney damage.

Rash occurred more often in patients taking ISENTRESS and darunavir together than with either drug separately, but was generally mild.

Tell your doctor if you have any side effects that bother you.

These are not all the side effects of ISENTRESS. For more information, ask your doctor or pharmacist.

How should I store ISENTRESS? • Store ISENTRESS at room temperature (68 to 77°F).

• Keep ISENTRESS and all medicines out of the reach of children.

General information about the use of ISENTRESS Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.

• Do not use ISENTRESS for a condition for which it was not prescribed.

• Do not give ISENTRESS to other people, even if they have the same symptoms you have. It may harm them.

This leaflet gives you the most important information about ISENTRESS. • If you would like to know more, talk with your doctor.

• You can ask your doctor or pharmacist for additional information about ISENTRESS that is written for health professionals.

• For more information go to www.ISENTRESS.com or call 1-800-622-4477.

What are the ingredients in ISENTRESS? Active ingredient: Each film-coated tablet contains 400 mg of raltegravir.

Inactive ingredients: Microcrystalline cellulose, lactose monohydrate, calcium phosphate dibasic anhydrous, hypromellose 2208, poloxamer 407 (contains 0.01% butylated hydroxytoluene as antioxidant), sodium stearyl fumarate, magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, red iron oxide and black iron oxide.

Distributed by: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, USA

Revised February 2011 9795112 U.S. Patent Nos. US 7,169,780 IMMU-1001800-0000-06/11(112)

Undetectable— By whose standard?

New viral load tests are more sensitive—but what does that really mean?

By Tony Mills, MD

When I first got involved in HIV in the mid 1980s, we hadn’t yet isolated the virus that causes AIDS. Although we didn’t know the etiology of the infection, we knew it destroyed the body’s immune system and the measurement of the CD4 T-cells was the most important number in the life of a patient with “GRID” (Gay-Related Immune Deficiency), the disease that would become known as AIDS. Soon we isolated the virus, found a cause for HIV, and an antibody that told us who was infected.

In the HIV world, a popular analogy in the early years was that having HIV was P os i t i ve lyAwa re.com

like being on a train speeding towards a cliff: the distance to the cliff was the T-cell count and the speed of the train was the HIV viral load. It was a fatalistic analogy but, unfortunately, a somewhat apt one.

The train speed (HIV VL) was impossible to control, but we fought tooth and nail to maintain the distance from that cliff (CD4 count). The T-cell count was the most important number in an HIV-positive person’s life.

From T-cells to viral load Three decades have passed since the first reports of the epidemic, and how we measure success against the virus has changed in many ways. The T-cell count is certainly still important. It predicts who might be at risk of opportunistic infections and it monitors our progress in immune restoration J U LY + AU G U ST 2 01 1

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A Low viral load is a surrogate marker of health and it tells us that the medications are working and that we are winning the battle against our foe.

as we move back towards the world of the living and contemplate the long and bright future ahead. But it is the HIV viral load that is truly the bellwether. A low viral load is a surrogate marker of health and it tells us that the medications are working well, that we are doing everything we can to fight the disease, and that we are winning the battle against our foe.

Assessment of HIV viral load is one of the best predictors of clinical disease progression and it is the main parameter used to evaluate treatment response in HIVpositive patients. Reproducible and ever more sensitive assays based on real-time PCR (polymerase chain reaction) technology have been developed to quantify HIV in the bloodstream of positive patients.

Recent improvements have allowed reliable measurements of various strains of HIV, including the difficult-to-quantitate non-B subtypes. As we look towards the future, and certainly in cutting-edge research today, testing specimens other than serum or plasma for HIV has become important. This has been a challenging task, to measure HIV viral load without plasma, but it is an important goal, particularly for developing parts of the world.

In almost all cases, HIV infection results in a lifelong persistent presence of the virus, despite evidence for almost complete suppression of viral replication using highly active anti-retroviral therapy (HAART). Sensitive and reproducible means for quantifying plasma viremia (viral load) have been developed since the mid-1990s when a landmark study conducted on specimens collected from individuals enrolled in the Multicenter AIDS Cohort Study (MACS) demonstrated that plasma HIV-RNA was a better predictor of progression to AIDS and death than CD4+ T-cell counts.1, 2 Besides having prognostic value, soon thereafter measurement of 22

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plasma HIVRNA was found to provide the most accurate information as to the efficacy of antiretroviral drugs and herein lies the key to its

importance today.

When first attempts were made to measure HIV viral load, reverse transcriptase (RT)-PCR methodologies were modified to assess as accurately as possible the circulating HIV-RNA molecules in the plasma. In more recent years, the development of RT-PCR technologies has resulted in improvements in sensitivity and in the time required for the assay. All RT-PCR assays were originally designed to measure and quantify the replication of clade B virus. As the global initiative has grown and antiretroviral therapy is now more accessible in developing regions of the world, the challenge of testing HIV-1 non-B subtypes has become more and more of an issue and the need exists for novel technologies adept at measuring this strain of the virus.

New technologies The newer real-time viral load testing technologies produce results faster, display larger dynamic ranges, use fully automated extraction procedures, and allow for measurement of greater numbers of samples. All these characteristics are important in both resource-rich countries and in resource-limited environments.

Unfortunately, in these resource-poor settings, the required laboratory infrastructure is often found only in major urban areas and isn’t available in the rural environments where much of the HIV epidemic is located. In resource-limited settings, a large emphasis has been placed on developing techniques to assess HIV viral load in some way other than using plasma. The use of dried blood spots has proven to be invaluable in these undeveloped areas for both the process of viral load monitoring and for drug resistance (genotype) testing and HIV sub-typing.

Over the years, many diagnostic

companies have been involved in the creation of assays to accurately assess HIV viral load. As a result of all of this research, several methods of quantifying HIV viral load have been developed. Four different commercial viral load assays based on distinct principles are currently approved by the regulatory agencies in the U.S. and/or Europe, and are widely used for antiretroviral treatment monitoring. The most recent tests are based on nucleic acid amplification by PCR and real-time detection. The four assays are: COBAS TaqMan (Roche; Pleasanton, CA);3 NucliSENS EasyQ HIV-1 v2.0 (bioMĂŠrieux; Boxtel, Netherlands);4,5 RealTime HIV-1 m2000rt (Abbott; North Chicago, IL);6,7 and VERSANT HIV-1 RNA 1.0 kinetic PCR (kPCR; Siemens; Berkeley, CA).8 Besides real-time detection, all these assays have an initial step of automated nucleic acid isolation, in most cases based on the use of magnetic particles, which generally improves their performance. Although commercial HIV viral load assays differ in terms of principle and performance, they have all been optimized and their current sensitivity, specificity, and reproducibility are generally excellent.

All viral load methods described have provided an overall reproducibility above 95%, with co-efficient variations below 10%. They are comparable in the range of lower HIV-RNA detection limit (less than 50 copies/mL on average, though the newest Roche assay goes down to less than 20 copies/mL), as well as upper limit (greater than 107 copies/mL). In comparison studies, there is excellent correlation between the various assays. Also of great interest is the similarity in cost between the different assays. In general, there is a less than a 10% difference in direct reagent and consumable costs between assays.9, 10 Providers are faced with a variety of choices of HIV viral load assays to order for any given patient.

Often providers opt to utilize whichever technology has been used in the past to monitor a specific patient. This reduces confusion and minimizes inter-assay variability in results. Conversely, providers might opt to utilize the newest technology or the most sensitive technology in an effort to be on the cutting edge of HIV diagnostic development.

P osi t i v elyAwar e .co m

Blips It is worth noting here that with the newer and more sensitive assays, patients who were once always “undetectable” may now show variable low-level viremia. While this can be disconcerting to the patient and to the physician, it truly is a result of the increased sensitivities of the assays at low viral loads and it is most often not an indication that the medications are not working and that resistance is developing. There was so much concern in the HIV provider community about this low level viremia that the DHHS recently addressed it directly.

In the latest version of the Guidelines for the Use of Antiretroviral Agents in HIV-1Infected Adults and Adolescents, released in January of 2011, the DHHS has this to say about the new phenomenon of low-level detectable viremia: “Optimal viral suppression is generally defined as a viral load persistently below the level of detection (<20–75 copies/mL, depending on the assay used). However,

isolated “blips” (viral loads tranWith Newer, more sensitive assays, siently detectable patients who were always “undetectable” at low levels, may now show variable low-level viremia. typically <400 While this can be disconcerting, it is truly copies/mL) are because of the assays’ increased sensitivities. not uncommon in successfully treated patients and are not thought to represent viral definition may also be useful in clinical replication or to predict virologic failure. practice.” 11 In addition, low-level positive viral load Advantages results (typically <200 copies/mL) appear The newest HIV viral load assays have to be more common with some viral load improved their sensitivity and reproducassays than others, and there is no definiibility, and require less time to process and tive evidence that patients with viral loads to provide results. It was not uncommon in quantified as <200 copies/mL using these the early 1990s for an HIV viral load assay assays are at increased risk for virologic to take two weeks to produce results. Now, failure. For the purposes of clinical trials turnover can be as quick as overnight. the AIDS Clinical Trials Group (ACTG) Another important advancement in the currently defines virologic failure as a conlatest technologies is the minimization of firmed viral load >200 copies/mL, which the risk of contamination, mainly as a result eliminates most cases of apparent viremia of the advancements of automated RNA caused by blips or assay variability. This

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The viral load assay is the most important indicator of the success of a patient’s HIV regimen.

Maintenance of an undetectable viral load is fundamental: it’s how we know we are keeping the virus in check.

isolation and real-time amplification and detection. In the past, large volumes of plasma were often needed to quantify HIV viral loads. Today, the required volume of the specimen for testing is generally much lower than that required by earlier assays. In addition to being more economical, the sensitivity of the assays continues to improve.

HIV viral load tests are often batched and run together for economic reasons. The number of tests performed in each run on most systems is 96, allowing large workflow for laboratories with a high number of patients. A further benefit of the new assays is that many of them have incorporated the option of testing specimens other than plasma/serum. Work is currently being done looking at seminal plasma viral loads to learn more about transmission risks in patients on and off of medications. In truly resource-limited areas where refrigeration, transportation, and easy access to local RT-PCR technology are the exception rather than the rule, dried blood spots (blots of blood on paper) are often used to assess the viral load. These DBS’s, as they are called, are more stable in unfavorable environments and, compared to tubes of blood, they are more easily batched and shipped to the nearest HIV clinical lab.

Limitations Though it is true that the newest HIV viral load assays offer many advantages, several limitations must also be addressed.

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The first and most important limitation is their cost. The cost of antiretroviral drugs in the developed world continues to escalate with the drive for newer, simpler, and more effective medications fueling the rising cost of the newer drugs.

In the developing world, much effort has been made to decrease the costs of drugs and thereby make them affordable and within reach for the general population.

While the ethical commitment to provide treatment to those who need it in these resource-limited areas has forced reduced medication costs, there has not been a parallel reduction in the costs of laboratory monitoring tests, especially in HIV viral load assays. The cost of viral load testing using the newest commercial realtime assays is more expensive than it ever was before. In many countries and in many settings, the increased cost per test is difficult, if not impossible, to afford.

Moreover, logistical and technical aspects represent a further limitation for the use of the tests. Correct use of the technologies is complex and requires a high level of education and skill. The diagnostics manufacturers often provide skilled specialist support, but this level of support is often very expensive. The supply of reagents, additional expenses due to consumables, constant air-conditioning requirements, regular electricity supply and power back-up, and availability of protocols and package product inserts in a variety of languages further limit the optimal implementation of the newest HIV viral load assays and further elevate the costs.

Summary In today’s HIV world, the viral load assay is the most important indicator of the success of a patient’s HIV regimen.

Maintenance of an undetectable viral load is fundamental: it’s how we know

we are keeping the virus in check and it’s how we know we are moving in the right direction towards long-term HIV suppression and long-term survival in the battle with HIV. The currently available real-time PCR assays for HIV viral load measurements are extremely accurate and reproducible in their quantification of the level of HIV activity. They provide advantages in terms of time consumption, cross-contamination, and sample volume needed to obtain results. In addition, these tests allow an improved workflow, reliable detection of non-B variants, and permit samples other than serum/plasma to be tested. These newest HIV viral load tests are not without limitations, however. They are expensive and they require a complex laboratory infrastructure that is not usually available in many resource-poor countries. In resource-limited settings, efforts to provide access to adequate laboratory facilities where HIV viral load can be tested with the newest assays has to be considered as a priority, since the success and the benefit of the rapid scaling-up of first-line HAART seems to be largely dependent on adequate laboratory monitoring, particularly when access to second-line therapies is still limited. If viral load cannot be accurately monitored and durable high level virologic suppression maintained, then infection by and accumulation of drug-resistant viruses and their subsequent transmission within the population could be an inevitable consequence that could significantly impact the life expectancy of all of us living with HIV. e This is the last of a three-part series of articles sponsored by Abbott Molecular.

Tony Mills, MD is a leading clinician in HIV disease and men’s health in Los Angeles.

He has been principal investigator on more than 50 clinical trials, is a nationally known speaker, and has most recently formulated a line of natural supplements for men. Visit www.tonymillsmd.com.

Go to PosItivelyAware.com for references.

P osi t i v elyAwar e .co m

Another Blue Pill for Sex Preventing HIV with Truvada PrEP—already at a pharmacy near you

By Enid Vázquez

Photo: Joshua Thorne

Viva Viagra. And now Truvada.

Just as the blue Viagra pill revolutionized sex, the blue HIV drug Truvada is set to revolutionize the epidemic. It is poised to become FDA-approved, as early as this year, for HIV prevention.

But in fact, the blue Truvada tablet, with “Gilead” stamped on one side and the numbers “701” on the other, is already being prescribed to HIV-negative people for prevention, under what’s called “offlabel” usage. The strategy, based on success shown in animal studies, is one that’s not widely known, even in groups at the highest risk of infection, such as gay men.

“It’s already available,” said Jim Pickett, director of Prevention Advocacy and Gay Men’s Health for the AIDS Foundation of Chicago. “That makes it a different animal from a microbicide or vaccine, which still has to be developed.”

After the international iPrEx study late last year showed that Truvada can indeed stop HIV infection in humans, it would P os i t i ve lyAwa re.com

seem to be a great time to educate the public about using it for prevention. But the strategy of using Truvada to prevent HIV, called PrEP (for pre-exposure prophylaxis), is not without its critics. Whether for it or against it, however, everyone agrees: proceed with caution.

Dr. Daniel S. Berger, an HIV specialist who writes “The Buzz” column for Positively Aware, has prescribed PrEP for fewer than a dozen patients, beginning almost a decade ago with Viread (one of the two medications in Truvada), at the time when it was shown to block infection in primates. Since then, Truvada has been shown to have even more efficacy for prevention.

“I’m very worried that if Truvada becomes approved for PrEP and is widely used, that people may not contract HIV, but they may contract hepatitis C or other sexually transmitted infections,” he said.

“The message should be ‘Beware’ with a

capital B. Beware of the risks, and beware of getting something else.”

The Centers for Disease Control and Prevention (CDC) in January issued interim guidelines for using the drug to prevent HIV infection in high-risk men who have sex with men (MSM, although transgender women also participated in the iPrEx study). And, says Pickett, Gilead Sciences is preparing documents to submit to the Food and Drug Administration (FDA) to have Truvada approved for prevention.

“The take-home messages are that if you’re interested in taking PrEP, you do it in close collaboration with your doctor—you don’t get these pills from a friend or some other source,” Pickett explained. “You need to know that you are HIV-negative and you need to get tested regularly while you’re on PrEP in case you should test positive while you’re on it. So it’s all about working with your doctor and not borrowing your friend’s Truvada for the weekend.

“The other thing is that based on the research, what we know is that you need J U LY + AU G U ST 2 01 1

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“There was a lot of doubt cast on the pills, rightfully so. But now that people know that if you take it, it works, will it improve adherence?”

to take PrEP every day,” he said. “We don’t know about intermittent use, taking it every couple of days or only when you need it.

We don’t know if those options work.” iPrEx looked at daily use of Truvada (one pill a day) vs. placebo (fake pill).

Other studies are looking at intermittent use of the drug.

The study enrolled 2,499 men and transgender women, all of whom have sex with men, from 11 sites throughout Asia, Africa, and North and South America, two of them in the U.S. (Boston and San Francisco). Half of the participants were under 25 years of age.

There was a range in decreased risk of HIV from 44% (the average efficacy rate) to 95% protection.

Why such a large range? The study is clear: Truvada PrEP worked, but only if taken as prescribed. Those in the Truvada group who became HIV-infected had very low levels of the drug in their blood, or no detectable levels at all, an indication that they were not taking it consistently on a daily basis.

In presenting the results of iPrEx earlier this year at the Retrovirus Conference (CROI), protocol chair Dr. Robert Grant said, “No one in iPrEx acquired HIV infection with a drug level that would have been expected with daily dosing.”

Moreover, when adjusting for highrisk sexual practices such as unprotected receptive anal intercourse, there was a 95% reduction in risk with having detectable levels of Truvada. This high-risk group saw the most protection, Grant reported.

However, Dr. Grant noted that the constant reminders to participants that they 26

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may have been given a placebo, and to be sure to use condoms, which were provided free at every study visit, may have led many of them to be non-adherent. If they thought they were being given placebos or even actual drugs that weren’t effective, why bother to take them as instructed?

Pickett commented, “There was a lot of doubt cast on the pills, rightfully so. But now that people know that if you take it, it works, will it improve adherence?”

The hope is that as iPrEx moves into an extension study, iPrEx OLE, where everyone is given Truvada, participants will be motivated to take it correctly now that prevention efficacy has been shown.

In addition, Grant said many of the individuals given Truvada experienced nausea, typically for four weeks, and that helping them get through this stage should help improve long-term adherence to medication.

Addressing a question from the CROI audience about the varying efficacy rates, Grant said that while the principal efficacy was 44% using a strict research standard called intent-to-treat, “I think we also need to consider that among those able to use the pill consistently, the protective effect was above 90%.

“But I think that it would be wrong to allow people to assume that they would be among the adherent group,” he continued.

“I think that adhering to any regimen has its challenges and people should know that the level of protection is extremely high if they can use the pill, but using the pill is a significant challenge that we need to help people work through. As near as we can tell, people were taking it nearly

daily or they were not taking it at all.”

The CDC stresses that high-risk MSM is the population for whom PrEP has shown efficacy (although transgender women participated in iPrEx). In April, there was disappointing news from the FEM-PrEP study using Truvada in women. The study was stopped early when the number of women infected while on Truvada was the same as those taking the placebo pill (five in each group). It was determined that if carried out to full term, the study would not be able to answer the question of whether or not Truvada PrEP was effective. FEM-PrEP researchers will look at adherence and drug levels for clues. Other studies continue to look at the drug for prevention in women.

In the meantime, FEM-PrEP shows how much is still unknown.

Out in the real world, another part of the resistance to PrEP arises from concerns that it will cause people to stop using condoms.

“I’ll say this—people have already stopped using condoms,” said Jim Pickett.

“And they stopped using condoms before PrEP. They should have an option for protection other than a condom or the highway.

“Now, is there a concern that people using condoms may stop? That’s a valid concern. But it hasn’t shown up in any of the clinical trials,” he pointed out.

In fact, iPrEx found more condom use rather than less, perhaps because they were provided for free, Dr. Grant said at CROI. The study will continue to stress condom use, as all prevention trials do. A decrease in the number of sex partners was also reported in iPrEx, again, possibly due to the safer sex counseling provided in the study.

P os it i v elyAwa r e .co m

Dr. Berger said he strongly advises safer sex, not PrEP, but that men complain condoms feel less intimate to them or that they are unable to maintain an erection with one.

“People who are negative should practice safe sex,” he said. “On the other hand, I’m not judging those who want to use PrEP. Patients should make their own decision. As long as they understand the risks and what’s required for monitoring, I’m here to support them with what they need to feel safe.”

Men also ask him about their lower risk of transmitting the virus if they have an undetectable viral load. He tells them about the data showing that some men with undetectable virus in their blood still have virus detectable in their semen, and reminds them that there’s still a risk.

He’s especially concerned about men using PrEP for anonymous sexual encounters, or when the HIV status of a sex partner is unknown. He sees a clearer role for PrEP in a committed relationship where one partner has HIV and the other doesn’t.

Pickett said studies show that such couples, called “serodiscordant,” show a high adherence to taking PrEP. “They’re going to have a high motivation to protect the negative partner,” he believes. Other people who don’t have a theoretical risk, but a very real one, include sex workers, he said, “although, we all tend to think we are much more safe than sometimes we really are, and we take risks when we don’t think we are taking them. So we’re going to be learning all this stuff—who is best suited and how to target and how to find them.

“The real critical thing for the United P os i t i ve lyAwa re.com

States will be making sure that the populations who have the highest rates of HIV—I’m thinking of gay black men in urban areas, where the HIV rates rival subSaharan Africa—can have access to PrEP if they want it.”

The question of access raises the issue of cost. Truvada runs around $1,000 a month—or more. Dr. Berger said he has not had problems with insurance companies paying for PrEP, and was able to talk with insurers and get coverage in the couple of instances where it was at first denied.

There’s also a fear of prevention dollars competing with funds for treatment.

Dr. Grant points out that preventing infections would allow treatment to catch up with the need in people who are already positive.

As for the risk of developing drug resistance (anyone infected while taking PrEP runs the risk of their HIV overcoming the suboptimal therapy of Truvada taken by itself), Grant noted that resistance cannot develop if infection does not take place.

“There’s always a fear of the new,” said Pickett, “and that’s fine. There are things we don’t know about PrEP that we will only learn through demonstration projects—more research. Things like behavioral disinhibitions and whether there will be any resistance or toxicity issues over the long term. We didn’t really see these things, again, in the studies to date, but if you’re using this over periods of years, what is the impact? We don’t know.”

The new prevention strategies of today will improve, he says. He points to HIV treatment and the first drug available to

fight the virus, AZT. It was great for some people and horrible for others, he said, taken every four hours around the clock.

Compare that to today, when one of the most-used HIV regimens is one pill taken once a day, with almost no side effects.

“So I think we’ll see PrEP improve over time, just like when we get microbicides we’ll see them improve over time,” Pickett continued. “They’re not going to be perfect.

We can’t wait for the perfect thing.” e Editor’s note:

The best doctor to consult about PrEP would be an HIV specialist. HIV specialists nationwide are listed at www.aahivm.org (the American Academy of HIV Medicine; call 202-659-0699) and at www.hivma.org (the HIV Medicine Association). In addition, clinics devoted to treating the LGBT community (lesbian, gay, bisexual, and transgender), such as Howard Brown Health Center in Chicago or Fenway Community Health Center in Boston, specialize in HIV medicine and clinical trials.

ONLINE RESOURCES A webcast of CROI presentation given by Dr. Robert Grant on Tuesday, March 1, 2011: www.retroconference.org The CDC’s interim PrEP guidelines and factsheet: www.cdc.gov PrEP education and advocacy: www.avac.org

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U.S. Conference on AIDS Coming to Chicago

by Christopher Brown, MBA, MPH with Cynthia Tucker

Chicago will welcome thousands of people living with HIV/AIDS, medical and social service providers, government officials, policy makers, community leaders, funders, clergy, advocates and activists when the 15th annual U.S. Conference on AIDS comes to the Windy City, November 10-13.

The mission of USCA is “to increase the strength and diversity of the communitybased response to the AIDS epidemic through education, training, new partnerships, collaboration, and networking.” The conference program is comprehensive and geared to address the prevention, care, and treatment needs of all people living with and affected by HIV/AIDS. Each annual USCA has a specific target population and theme. The target population for the 2011 conference in Chicago is Gay Men and Men Who Have Sex with 28

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Men. This year’s theme is Make Change Real—Unite-Speak-Act. Attendees will gather over four days to participate in institutes, workshops, seminars, lectures, and roundtable discussions to learn new skills, exchange ideas and the latest information, learn about cutting-edge tools to address the challenges of HIV/AIDS, find out about political and policy issues, and build partnerships and collaborations.

The National Minority AIDS Council (NMAC) has organized each conference, starting in 1997, in conjunction with a

multitude of co-sponsors, program partners, and host committees. The USCA Chicago Host Committee is made up of over 100 service providers from Chicago and throughout Illinois.

The Host Committee is working hard to not only provide engaging, informative, and innovative presentations at the conference, but also in conjunction with the Chicago Convention and Tourism Bureau, as well as Mayor Rahm Emanuel’s administration in order to provide attendees the chance to appreciate all Chicago has to offer, from the beautiful lakefront, to world class food, to the vital LGBT community. A balance of work and play is definitely encouraged.

For more information on USCA 2011 in Chicago, visit the NMAC website at www.nmac.org/index/2011-usca. Be sure to watch the video trailer promoting this year’s conference in Chicago. e P os it i v elyAwa r e .co m

d e c n a l a b Un

Budget

Fiscal health vs. human health—which will it be?

By Sue Saltmarsh

Our nation is only as strong as the citizens within it, and if we can’t even provide for the health and well-being of our children, who will ultimately take our place? Where is the nation going to be in 20 years?—Samantha Van Vleet, Yahoo! News First the good news—after hearing from hoards of angry, scared, and suspicious constituents at town hall meetings during the Congressional spring break, Republicans came back to Congress with a little less fire in their bellies about dismantling Medicare and Medicaid in the name of “balancing the budget.” And on May 25, the Senate sent the same clear message that the voters in New York’s 26th Congressional district sent when they elected the first Democrat to hold that House seat since the 1800s—NO DESTROYING MEDICARE! However, debate about deficit reduction and budget balancing is ongoing as of this writing and though President Obama has said that he won’t allow Social Security, Medicare and Medicaid to be dismantled, there may still be cuts and reductions in benefits that are devastating for anyone relying on public health programs for their only access to health care. There has also been no repeal of the Patient Protection and Affordable Care Act (known as the Affordable Care Act or ACA) as of yet, but bills are introduced almost daily by Republicans in both chambers seeking to de-fund or dismantle some of the most beneficial aspects of the reform law, such 30

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as the expansion of Medicaid in 2014 that would cover 23 million more people.

Unfortunately, the fact remains that no one in Congress, not even the Democrats, seems to understand what all average Americans know already: When you have cut out everything but the rent, food, and electricity, there has to be an increase in income (whether that means a second or third job or selling Grandma’s silver) before debt can be paid off and the budget can be balanced.

But until they realize that we, the voters, understand the necessity to pay for the things we want, need, and depend on for ourselves and our families, we’ll be stuck with the absurd equation of astronomical human cost being the solution to the financial crisis this country is facing.

How will the proposed budget affect you? There have been discouraging predictions from HIV/AIDS leaders and organizations about the impact these proposals may have on those who are HIV-positive.

For the purposes of this article, I’m creating and following a fictional man living with HIV as he navigates the whitewater of the things he will no longer have if the most stringent aspects of the budget proposals become law and PPACA is repealed.

Greg Meet Greg. He’s 42 years old, gay, HIV-positive for 21 years, half his life. He works as a peer educator at a non-profit AIDS service organization. He makes $32,000 a year with no prospect for a significant raise any time soon, “too much” to qualify for most assistance programs. His agency provides the supposed “gold standard” of health insurance, but in 2010, co-pays and deductibles rose so much that he can no longer afford to see his HIV doctor, his dermatologist (history of KS lesions), his podiatrist (neuropathy), or his hepatologist (hepatitis C and alcohol-induced cirrhosis) as often as he should, as each visit to a specialist requires a $40 co-pay, which equals over half his weekly food budget. The blood work he’s supposed to get regularly is sometimes postponed. The drug co-pays for his HIV meds also rose to the point where he now relies on ADAP for his meds, but the ADAP in his state is beginning to enact “cost containment” measures that might disqualify him from eligibility. In the last year, he has acquired $14,000 of medical P os it i v elyAwa r e .co m

debt due to the 10% of costs his insurance doesn’t pay, as well as treatments it doesn’t cover, such as dental work and “cosmetic” treatment for lipodystrophy.

He’s getting by, but barely.

Then, in 2014, the agency he works for shuts down having lost the federal funding it relied on to stay open. Unemployed, with no income, he starts looking for help to stay connected to his HIV treatment and medical care, as well as to find a place to live, since he had to give up the apartment he had when he was working. He is currently staying with his brother’s family, sleeping on the living room couch, dealing with his sister-in-law’s bigotry and the incessant noise of nieces and nephews. Still, he’s grateful for the roof over his head and the meals he shares there.

Closed for business Greg thinks that he may be able to qualify for Medicaid now that he’s unemployed and has no income. Because Republicans were able to repeal the ACA in 2012, the provision that would expand Medicaid to cover people like him no longer exists.

Instead, thanks to a Republican budget balancing measure, Medicaid in his state now only receives a block grant from the federal government. The amount of that grant is not sufficient to cover the portion of the state’s costs that used to be covered by federal money and the state is still struggling with a weak economy. So, not being able to pay its share of the Medicaid costs, it has chosen to cut Medicaid eligibility and services. When Greg applies for Medicaid, he’s told that, as a first-time applicant, he will be “phased in” as doctors and services become available. How long will it be before he can see a doctor? No one can (or will) tell him. 2011 predictions from the Congressional Budget Office in its assessment of Paul Ryan’s budget proposal have proven to be true—“the large reduction in payments would probably require states to decrease payments to Medicaid providers, reduce eligibility for Medicaid, provide less extensive coverage to beneficiaries, P os i t i ve lyAwa re.com

or pay more themselves than 68 American adultS under age 65 would be the case die every day because they don’t have under current access to medical care. That figure will [2010] law.” 1 climb to 84 per day by 2019.

Greg, ever the optimist, thinks he can bridge the gap while he waits But the Republicans were successful in for Medicaid by going to a community clinic de-funding and repealing any part of the near his brother’s house. Well established Affordable Care Act that would have benfor over 20 years, he’s heard of the good efitted anyone like Greg who was counting work the clinic does serving homeless on help from programs and resources that and poor patients. He takes a bus to their now no longer existed. location only to find wood covering the windows and a sign on the door informing Cautionary tale him that “due to insufficient funding, the Fast forward to 2019. Greg is now 50. clinic was forced to close. If you are havAfter his brother lost his job in 2015, Greg ing a medical emergency, please go to the lost the roof over his head and the food nearest Emergency Room.” his family shared with him. After spendWas he having a medical emergency? ing a month in a shelter where he was He wasn’t bleeding, having a heart attack, beaten, raped, and had the few meager suffering from a gunshot wound, had no possessions he still owned stolen, Greg broken bones (that he knew of). How found himself on the street. He had not much of an emergency was it that every taken any antiretrovirals in over two years day he went without his medications he could almost feel the HIV replicating inside at that point and he instinctively knew that HIV and opportunistic invaders had him and his T-cell count plummeting? claimed him once and for all. His last Back in 2011, Senator Daniel Inouye of thought before the light went out of his Hawaii stated that the Republican plan eyes was to wonder if the politicians would for the budget would “close 127 clinics in be happy—he was, after all achieving the 39 States (and two territories) and reduce ultimate cost cutting measure. services at another 1,096 Community Dead at 50. In America. Needlessly.

Health Centers nation-wide. More than 2.8 His exposure to the elements, his lack million people would likely lose access to of even substandard nutrition, repeated their current primary care provider and respiratory infections, infestations of bugs over 5,000 health center staff could lose and bacteria from not being able to clean their jobs.”2 In contrast, President Obama’s 2012 himself, a broken arm that was never set budget proposal would have included and so healed incorrectly, all conspired $3.3 billion for the Health Centers to lead the medical examiner who did his Program, including $1.2 billion in manautopsy to conclude that severe sepsis datory funding provided through the was his cause of death. HIV was, ironically, Affordable Care Act Community Health the least of it.

Center Fund.

According to a 2010 study done by the “The infusion of funding provided advocacy group Families USA, 68 adults through the Affordable Care Act, comunder age 65 living in America die every bined with the discretionary request for day because they don’t have access to FY [fiscal year] 2012, will enable health medical care. The study projects that the centers to serve 900,000 new patients figure will climb to 84 per day by 2019, the and increase access to medical, oral, and year of Greg’s death. 3 However, according to The Wall behavioral health services to a total of 24 million patients,” the Health and Human Street Journal CEO Compensation Study, “The median CEO pay [per year] in the Services budget proposal stated. 2 J U LY + AU G U ST 2 01 1

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[health insurance] industry was $10 million.”4 Evidently, they don’t have to worry about not being able to pay for their own health care.

Trying to imagine all the “Gregs” out there, male and female, HIV-positive and not, who have been, or will be, shut off from the care, treatment, and services they need if the proposed cuts are passed is an impossible task.

Are you one? Is someone you love or work with or worship with one?

Whether you will be directly affected or not, this is something we all have a stake in. And it’s not just the Medicare/Medicaid cuts that we should be knowledgeable and concerned about. There are environmental, educational, and infrastructure cuts that, if put in place, will leave us with polluted air and water, substandard and restrictive education, and roads, bridges, runways, and tunnels that are also life-threatening. All in the name of money...well, middle class and poor money, anyway. The budget protects the money of the wealthy, maintaining tax cuts for millionaires and billionaires and tax “breaks” for corporations which frequently pay no taxes at all.

Is that who we are? Is that what our country is? What can we do? Each of us must decide for him or herself just how much energy and time we spend learning, communicating, and acting. What we cannot, must not, do is sit on the sidelines telling ourselves, “Oh, it’ll be OK. Someone else will take care of it. There’s really nothing I can do.”

Many of you have had the courage to “come out”—about your sexuality, your HIV, your politics, your religion. Now it’s time to come out of your complacency. Don’t be Greg. e

Footnoted Links 1. http://cboblog.cbo.gov/?p=2128 2. http://thehill.com/blogs/ healthwatch/health-reformimplementation/144189-senateappropriator-blasts-gop-cut-tocommunity-health-centers3. http://blogs.wsj.com/ health/2010/11/16/health-care-ceosbring-home-the-bacon/ 4. http://prescriptions.blogs.nytimes. com/2010/02/26/deaths-risingdue-to-lack-of-insurance-studyfinds/

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Does America need a new healthcare system? Duh. July, 2012—start planning now!

On May 5, AIDS activist David Barr wrote a blog (http://blogs.poz.com/davidbarr/) for Poz proposing a bold idea—“In July 2012 the AIDS movement has the opportunity to once again make history and step into the forefront as a leader of a broad coalition to demand the recognition of health care as a human right and to ensure that universal access to health care around the world is the highest priority of our governments and societies. Now is the time.”

David is a global thinker and his vision is global in its scope. I have great respect for such vision, but mine is more limited. I’m a “clean up your own mess first” kind of gal and we have such a mess here in this country. Unfortunately, it appears that we will have to wait and witness the inevitable failure of the Affordable Care Act (ACA) to provide most of the benefits it promised. In preparation for that inevitability, there are now single-payer healthcare bills in Congress and in several states. Now is indeed the time.

As David said, “It is time for people with AIDS to stand up and say that it is not enough to demand HIV treatment for a woman with AIDS in Alabama while her mother is dying of hypertension and her children suffer from asthma.”

There are glimmers of hope provided by the recent uprisings across the country in protest of laws enacted unjustly or illegally. Thousands streamed into state capitols to stand together in all their different “demographics” to peacefully protest. Recall elections are being held. “Average” Americans, usually complacent, politically uninvolved, woke up, and showed up, to peacefully but firmly acknowledge that wrong had been done and they were not going to accept it.

We need to remember that we have a democracy, that we have the right to assemble and protest, and that healthcare is also our right, not a “product” to be bought and sold on Wall Street. It’s time for the Demonstration for Universal Healthcare—DUH. That’s what I’m calling it anyway.

The unanswered questions are abundant—how are we going to organize this? What about a website? Social media? What about permits? Porta-potties?

Transportation, food, water, lodging? What about all the different needs of all those people with multitudinous medical conditions? What about media coverage? Signs, banners, megaphones? Security? Surely, planning committees should be formed? But I have to let it go. I have to trust that people will get themselves to Washington, or to other gathering spots, with the supplies, devices, medications, etc. they need to get through the day. Car pools and buses will be arranged; signs will be painted in garages and apartments. It will happen because it must happen.

David called for the HIV/AIDS community to lead. The ability of HIV-positive people to push aside distractions and bureaucracy to get things done is clear.

Your courage, experience, and success in overcoming mountainous obstacles are undeniable. The rest of us need that kind of leadership.

David called for one million people to meet him at the Lincoln Memorial in Washington on July 22, 2012. We’ve got more than a year, people. The Middle East has their “Arab Spring.” Let’s generate the “Sicko Summer.”

—Sue Saltmarsh

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Making it better Activist Dan Savage works to shed light on the connection between bullying and HIV bySavage Jeff Berry Dan talks about the intersection of HIV and the bullying of LGBT youth

Photo: Kat Fitzgerald courtesy of windy city Times

by Jeff Berry

On May 2, The AIDS Foundation of Chicago held its annual Spring Luncheon, which featured humorist, columnist, and activist Dan Savage as its keynote speaker. Savage addressed a room full of local and state politicians, community representatives, and LGBT youth, speaking about the impact of bullying on LGBT youth and how it intersects with HIV. Seated at my table were two very charming students, Aaron and Hannah, who head up their high school’s Gay Student Alliance (GSA), as well as Chris, their school sponsor. Alex Sewell, the first African American openly gay student body president of Chicago’s Roosevelt University and a recent graduate, introduced Savage as “the person who started a national conversation about the impact of bullying of LGBT youth with the It Gets Better Project.”

Savage began his talk by relaying the tragic story of Indiana teenager Billy Lucas, who hanged himself after having been brutally bullied, leaving his mother to discover his body in the family barn. In a P os i t i ve lyAwa re.com

posting following Billy’s death on Savage’s Facebook page someone commented, “I wish I had known Billy Lucas, I would have told him, things get better.”

The rest is YouTube viral video history.

The project created an international antibullying movement, spawned thousands of inspirational testimonials and videos, and eventually a book, website, and a non-profit organization. The It Gets Better Project helps to raise awareness and spread encouragement by providing messages from average citizens and celebrities alike, reaching out to LGBT youth who are being bullied—it lets them know thet are not alone.

So what does all this have to do with HIV? A lot, explains Savage. LGBT youth are four times more likely to commit suicide, and eight times more likely to experience violence in the home. They are at increased risk for acquiring sexually transmitted infections (STIs) including HIV, and 40% of young homeless people are LGBT youth who have been kicked out of their homes.

A recent study in the Journal of School Health goes on to point out that there are increased public health costs over the longterm as a result of LGBT-based bullying, including not only higher risk of suicide attempts and contracting STIs, but greater levels of anxiety and depression, all of which are mostly due to decreased levels of self-worth directly related to victimization.

What the It Gets Better Project did was collapse the idea that LGBT adults could not speak to LGBT youth. “We are going to talk to your kids whether you want us to or not,” Savage says. “Whether or not you value your child’s life—we do.”

Savage recounted a conversation that he once had with his brother, who he described as having been a “geek” in high school, and who was bullied as well. The difference, though, says Savage, between a kid who’s bullied due to race, religion, or for being a geek, is that when they go home, they usually have families and parents who support them. “LGBT youth almost invariably go home to more bullying by their parents and families,” he believes, “and then get dragged to church on Sunday to be bullied by the pulpit.”

At the end of the talk, I asked Aaron and Hannah if they would like to meet Savage, and they both excitedly said yes.

We walked to the front of the room and waited as Savage patiently posed for photos, and graciously spoke with everyone who wanted to meet him. As I made the introductions, I couldn’t help but be impressed by the courage of these bright, capable young adults who were living their lives out in the open, seeking to make a difference in this crazy world we live in.

And having been bullied myself as a kid, I can honestly tell you that it does get better. But, that’s another story. e More more information, go to itgetsbetter.org J U LY + AU G U ST 2 01 1

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Condom in a Pill Bottle?

A significant study finds that treatment protects HIV-negative partners—among straight couples. Will gay couples stop using condoms?

by Stephen Fallon, PhD

Big news lit up the Internet in late May: HIV treatments seem to block the virus from spreading during sex.

In the HPTN 052 study, researchers from the National Institutes of Health (NIH) tracked more than 1,700 couples and found that “earlier initiation of (the medicines that fight HIV) led to a 96% reduction in HIV transmission to the HIV-uninfected partner.”

How does this work? Anti-HIV medicines interrupt the virus’ ability to multiply inside a person. Scientists suspected that if there’s less HIV circulating in a person’s blood, it’s less likely that any will leak out in their sexual fluids.

Up until now, most prior studies have traced backwards from outcomes.

Researchers couldn’t be sure if some other cause might have lowered contagion.

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This time, they enrolled people first then watched what happened when they took medicines. That makes this study more convincing.

But don’t flush the condoms yet. It turns out, 97% of the couples studied were heterosexual, and half of the participants were women. While the protection afforded during straight vaginal sex might apply to anal sex, too, this wasn’t

specifically proven and therefore shouldn’t be assumed until further studies are done.

It should also be noted that nearly all of the patients studied were living outside the United States. Researchers had “difficulties enrolling (U.S.) participants into the study.” It’s possible that patients in the other countries (Botswana, Brazil, India, Kenya, Malawi, South Africa, Thailand, and Zimbabwe) were more diligent about taking their medicines than typical Western patients are, because the consequences of HIV are starkly more visible in their homelands.

Unfortunately, HIV is not a forgiving disease; if patients skip more than a few doses the virus roars back. In the U.S. and Europe, many patients who start out faithfully taking HIV medications backslide after two P os it i v elyAwa r e .co m

Photo: Joshua Thorne

years on treatment, dropping to take less than three out of four doses on time.

If people skip doses, their virus levels won’t drop enough, and any prevention benefits will disappear. Worse, if they spread HIV now, it will probably be a more deadly, drug-resistant virus. A 2002 study found that among people unable to fully control their virus, every tenfold increase in HIV levels made them 81% more likely to pass HIV on to a partner.

Whether or not HIV medications stop new infections, shouldn’t everyone who’s HIV-positive take medicines right away, to protect their own health?

Here, things get much murkier. The question about when to start treatment has been debated for years. Delivered at the right time, anti-HIV medications add P os i t i ve lyAwa re.com

years, or even decades to life expectancy.

But they also often trigger troublesome side effects such as diarrhea, nausea, fatigue, sleep problems, sexual dysfunction, and even hair loss. Over time, their effects on the body’s balances can lead to heart attacks and strokes, liver failure, anemia, diabetes, chronic depression, kidney failure, embarrassing changes in body shape, and more. So the rationale has been to spare people these effects, and only start prescribing medicines when they’re truly needed to support life.

The new NIH study may lead physicians to prescribe HIV treatment even earlier than the nation’s guidelines currently recommend. But it’s not yet entirely clear that the earliest possible treatment lengthens life. It might just add more years of side effects without any net benefit.

Even the HPTN 052 study did not find a definite life benefit for those under early treatment. The authors noted, “There were also 23 deaths during the study.

Ten occurred in the immediate treatment group and 13 in the deferred treatment group, a difference that did not reach statistical significance.”

The new study raises an ethical question: who is treatment for? If HIV treatment can truly stop the virus from spreading, then shouldn’t it be “forced” on people living with HIV, whether it adds years to their lives or not? Is treatment supposed to benefit the person living with HIV, or protect the person who might have sex with you?

Unfortunately, very early treatment for the sake of prevention might cause people to “burn through” the best medicines early in their infection, leaving nothing to fall back on when their immune prognosis becomes dire. This would consign those living with HIV to additional years living with complications, and possibly a shorter life expectancy, all in the name of protecting others.

Public health officials do impose treatment for medical conditions such as multi-drug resistant tuberculosis, which can be passed to others through casual contact. But HIV is not that sort of

disease. It transmits only through specific, intimate contacts (unprotected sex, sharing needles, nursing babies, rare hospital mistakes). So uninfected people can consciously protect themselves from HIV. In fact, the most important step to prevent the spread of HIV is simply getting people tested. The vast majority of diagnosed people take steps to protect their partners. Diagnosed people living with HIV have just a one-to-two percent chance of passing their virus each year, and that number is driven up by a few bad players; many never infect anyone else. Even in the NIH study, only 27 partners of the nearly 500 persons not taking treatment became infected over six years.

What if the gay community and others at risk come to believe that treatment provides the best firewall against infection?

Will guys be less likely to use condoms?

Is the pill bottle more effective than a condom?

Pills can’t help when nearly 10% of all people newly infected acquire HIV from someone else who was also just infected.

During this early phase, the tests often can’t detect HIV. Here’s a scarier reason not to count on someone else’s medicines to protect you: it’s easier to verify that a guy is wearing a condom right now than to prove he has taken his medicines all week. What if a horny guy just tells you that he’s on treatment?

Medications should be dispensed primarily to benefit people living with a disease, not packaged in a rationale to defend the rest of us from their illness.

Of course, there will always be slipups: popped condoms and missed doses.

That’s why neither condoms nor medicines alone will prevent every infection. We need treatment and prevention, not treatment as prevention. e Stephen Fallon is the president of Skills4, a healthcare consulting firm that provides services to CDC and HRSA funded providers, primarily gay- or minority-based agencies and clinics. www.skills4.org

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Success through courage, learning, and empowerment

By Tom Holler, MA, LPC, NCC

Leslie Henderson learned he was HIV-positive in 2007. His first reaction was that he’d need to find a way to deal with it. Unlike too many others in his situation, he chose not to give in to denial, fear, and despair.

“This was something I caused myself.

Nobody held a gun to my head,” he said.

For him, HIV infection was “just another hurdle.” He was scared, but knew he could handle it. One of the things that helped him was the POWER program.

The POWER Program—Positive Outcomes for Wellness, Education, and Recovery—offered by Test Positive Aware Network (TPAN) in partnership with Heartland Alliance, offers a variety of services to men who are HIV-positive and have substance abuse issues, or who are at risk for HIV and substance abuse problems.

The keystone of the POWER program is an intervention called the Holistic Health Recovery Program (HHRP), which takes place in 12 sessions and covers a variety of issues for participants, helping them learn to live healthier, happier lives. Various topics include educating partners in safer sex 36

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practices, harm reduction for injection drug users, recovering from substance abuse, nutrition, and obtaining medical care.

More than 400 participants have been served since POWER’s inception in 2008, and many of them credit their ability to achieve stable housing, employment, and a healthier lifestyle to their participation.

Leslie is just one of many POWER success stories. He’s a fifty-something African American living on the north side of Chicago. Prior to his diagnosis, Leslie was steadily employed a with law firm, several banks, and a large shipping company.

Upon receiving his diagnosis, Leslie quit his job and temporarily moved in with his brother’s family. While they welcomed him with open arms, Leslie missed the independence of living on his own. After applying for Social Security benefits, he moved in with some friends, and soon

Tom Holler is a Behavioral Counselor and Group Facilitator with the POWER Program. He has been serving the HIVaffected population in Chicago for nearly three years, first as an intern, and now as a Licensed Professional Counselor.

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Photo: Joshua Thorne

Finding the POWER within

gained the confidence to return to an independent lifestyle. Leslie attended the Next Step program at Heartland Alliance, where he received the necessary assistance to find a place of his own. It was also through the Next Step program that he found his way to POWER. “I wanted to educate myself about HIV and find a way to live independently,” says Leslie. “While I was never a heavy substance user, there was alcoholism in my family and I wanted to keep protecting myself from those kinds of problems.

POWER helped me to do that. The POWER staff is very knowledgeable. I know they have a ‘script’ to follow, yet each counselor finds ways to personalize the information, to make sure everyone in the group knows what they need to know. It is a very welcoming and non-judgmental atmosphere and the staff works very hard to make everyone comfortable.

“POWER taught me how to defeat HIV and live everyday life. It also helped me to learn how to express my opinions, and I now have more power to reach out, to protect myself and others. As a gay black male, I believe that POWER has given me the tools to educate my partners about HIV and still have great sex. I would encourage any man who is at risk for HIV and substance abuse problems to come to the POWER groups,” he says.

Since graduating from POWER in 2009, he spends much of his time volunteering and advocating in the HIV community to get the word out about living with HIV, especially among African American gay men who are under-educated about HIV and substance abuse. As Leslie says, “If you need help, get help! It only takes one unprotected sex act or one shared needle to become infected.” He is also getting ready to reclaim his spot in the work force.

The POWER program is open to Chicago area men who are at risk for or already diagnosed with HIV and substance abuse disorders. For details, call 773-878-POWR (773-878-7697). e

Ask the HIV SPECIALIST Donna Sweet, MD, MACP. AAHIVS

Chronic inflammation Understanding the body’s response to HIV

I have heard that inflammation plays a large role in the overall damage that HIV causes and I’ve read that doctors can order some sort of test for “markers” of inflammation. Should I be asking my doctor to order those tests? And which ones should be done?

—Lindsey Jacksonville, FL Dear Lindsey, You are correct in that inflammation is the new buzzword when discussing the effects of HIV infection. Inflammation is part of the body’s response to infection, and it is now known that fighting a long-term chronic infection like HIV throws the immune system into a chronic inflammatory state. HIV activates the immune system when it reproduces. The resulting chronic inflammation is only partially corrected by your HIV medicines. This chronic inflammation contributes to many illnesses that complicate HIV disease, including cardiovascular disease, diabetes, chronic kidney disease, osteoporosis, and cancer. These same illnesses now account for a great deal of illness and death in people living with HIV. Evidence suggests these illnesses occur more often and/or at a younger age in people living with HIV due, at least in part, to chronic inflammation.

Inflammation is part of the processes that repair and defend against damage to bodily tissue. For instance, it has been known for quite a long time that atherosclerosis (hardening of the arteries) is the result of an inflammatory response to injury.

Blood vessels are damaged by high blood pressure, high blood sugar, cholesterol, smoking, etc.—and the body produces inflammation in an attempt to repair the vessel wall. However, since the damage P os i t i ve lyAwa re.com

continues—unless we are able to reduce our blood pressure, blood sugar levels, cholesterol, etc.—the inflammation persists and becomes chronic. The problem is that inflammation, which begins as a healing mechanism, eventually has the opposite effect. It causes more damage to the vessel. The accumulating damage leads to atherosclerosis: The blood vessels stiffen and thicken due to the build-up in the walls of fatty clots called plaques. These plaques contain cholesterol as well as large numbers of immune cells, including T-cells, macrophages, and something called “foam cells.”

You may have also heard of the SMART study that looked at structured treatment interruptions of antiretroviral therapy. It was found that those people who were on interrupted therapy had increased complications and death due to non-HIV related conditions such as cardiovascular and kidney disease. It is felt that the increased inflammation due to HIV replication was the cause, and consequently the study was stopped. Further tests of the blood of those patients who had their therapy interrupted have shown increased levels of certain inflammatory markers, including C-reactive protein (CRP), D-dimer, and interleukin (IL) 6.

Even though some of these markers can be checked in routine practice, we

don’t yet fully understand what they mean—and whether or not they indicate if we should do anything differently for a patient’s treatment. The important thing for any HIV patient right now is to keep the viral load as low as possible, and also to quit smoking, control blood pressure, get exercise, and keep cholesterol and diabetes (if applicable) in check to minimize inflammation. Stay tuned—you will be reading more about inflammation in HIV disease, and there may eventually be tests that we can run and possibly even certain things we can do to better control inflammation in the context of HIV. Donna E. Sweet, MD, chairs the Board of Directors of the American Academy of HIV Medicine. She is professor of Internal Medicine at the University of Kansas School of Medicine, and has a clinical practice in Wichita.

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 the American Academy of HIV Medicine (AAHIVM), call 202-659-0699 or visit www.aahivm.org.

Search for an HIV Specialist™

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

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I Haven’t Given Up, I’ve Taken Charge One man’s story of taking HIV meds for prevention

By Nick Literski

Recently, I was surprised to learn that I had allegedly “given up on gay men.” According to Michael Weinstein, president and founder of the so-called “AIDS Healthcare Foundation,” I now consider the lives of gay men, including my own, “disposable.”

What great crime have I committed to deserve Mr. Weinstein’s condemnation? I take Truvada once a day, as pre-exposure prophylaxis (PrEP), in order to protect myself from HIV infection.

My partner and I have a mutually open relationship. In reaching that point, we did the responsible things that a new couple should do to protect themselves. We used condoms until we’d been together long enough to rely on HIV testing. We then chose to be fluid bonded, while always playing “safe” with other sexual partners.

Every six months, we were both dutifully tested for the HIV virus, usually going to the local testing facility together. We were screened on a regular basis for other sexually transmitted infections. If we made 38

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a mistake with regard to our agreed precautions (and yes, I did so on at least one occasion) we were honest with each other.

About two years into our relationship, we were surprised to hear that my partner’s HIV test was “inconclusive,” and that the testing facility would be submitting it for further testing. A week later, we called back for the final report, and were relieved when an obviously hurried staffer told my partner he was “just fine.” We continued our very active sex life, which almost always involved me being the receptive

partner in anal intercourse. During the next few months, however, my normally robust partner had an unusual number of illnesses, particularly skin infections. He became suspicious, and since we were nearly due for our six month testing anyway, he scheduled another test. As I sat in the waiting area, I received a two word text from my partner: “I’m positive.” To make matters worse, the staffer had pulled my partner’s chart, and found that his last “inconclusive” test had actually been positive. Due to the mistake of a careless (former) staffer, we had received an incorrect report.

As traumatizing as it was for my partner to find out that he was HIV-positive, and as angry as he was about the earlier false report, he was truly terrified that he had exposed me to the virus innumerable times over the past several months. I was promptly tested, and we were relieved to learn that both my rapid testing and RNA results were negative. Even so, my partner continued P os it i v elyAwa r e .co m

to experience tremendous anxiety over the possibility of infecting someone he loved. His worry extended to all sorts of seemingly-mundane possibilities, even to the point of not wanting me to share the same handle on our interchangeable-head electric toothbrush. While it’s normal for newly seroconverted men to experience high levels of anxiety regarding sex, the impact on our intimate life was profound.

My partner had experienced enough broken condom incidents over the years that his concerns weren’t alleviated by using them.

At the same time, it was difficult for me to adapt to continuous condom use, due to both physical discomfort and my own emotional response to a physical barrier.

Sex became much less frequent, and was burdened by worry and frustration.

In time, and with the help of an outstanding physician, my partner’s viral load became undetectable. In the meantime, both of us had educated ourselves on HIV. We knew that a Swiss study indicated that the risk of my being infected by my partner was now extremely low, even to the point that some physicians in Switzerland believed protection was unnecessary. My partner was able to relax more, and we began to settle into the “new normal” of being a serodiscordant couple. Even at this stage, however, there were emotional challenges. I still hated using condoms, and I still wanted to feel my partner inside me. I felt the risk was low enough to be acceptable, and a selfish part of me wanted to be the one making the decision on whether or not to use protection. Another part of me knew, deep down, that by encouraging unprotected sex with my partner, I wasn’t giving my partner’s emotional well-being the importance he deserved. All too often, I placed my partner in the difficult position of wanting to protect me from infection, while at the same time wanting to satisfy my desire for sex without physical barriers. When my partner gave in to my preference, he generally pulled out before ejaculating, but afterward he dealt with understandable worry. The combination of anxiety and infrequency continued to wear on our relationship.

Somewhere in the midst of all this, I reached a state of mind that seems almost universal among HIV-negative partners P os i t i velyAwa re.com

I hated seeing my partner constantly worry about infecting me.

of HIV-positive men. As low as the risk of infection seemed to be, I still had a nagging worry that I might become positive.

I hated using condoms. I hated seeing my partner constantly worry about infecting me. I worried that my partner would grow so tired of that worry that he might choose to leave the relationship in pursuit of an HIV-positive partner. I resented that, at times, my partner seemed more comfortable having sex with another HIV-positive man than with me. None of these feelings were particularly rational, but they existed.

In keeping with that irrationality, in a very real sense, part of me wished that I would become infected, just so the whole issue would “go away.” What seemed like a “manageable condition” with new medications seemed preferable to the ongoing stress and frustration. In time, and with seeing the physical problems my partner suffered as a result of his HIV infection, I got past that stage. Unfortunately, many HIV-negative men seem to go through that stage, and some don’t come to their senses before permanently affecting their health.

We gradually settled into a “serodiscordant detente,” in which my partner reluctantly agreed that it was up to me whether I wanted to take the risks inherent in unprotected sex, but he almost always pulled out before ejaculation. At times, I selfishly prevented the latter from happening, not considering the stress I was causing him. There was no simple solution, so while we could still have great sex, it was always accompanied by some level of anxiety and guilt. We were handling it imperfectly, but perhaps as best we could at the time.

Then came November of 2010, and the New England Journal of Medicine’s publication of a study showing the effectiveness of PrEP for men who have sex with men. Our physician, a true expert in the field of HIV prevention and treatment, was familiar with the study prior to its publication. Once results were published, he had

a frank discussion with my partner about our sexual activities (something like “Don’t lie to me, I have a really big needle that I can jab you with if you’re lying”). Because we have a great deal of trust in our doctor, my partner was honest with him about our behaviors. Based on that discussion, our doctor asked me to visit him and discuss the possibility of taking PrEP. I made an appointment for a week later.

In the meantime, I agonized over the issue. I searched the Internet and read everything I could find on the subject, both for and against PrEP. In particular, I carefully read the actual study report in the New England Journal of Medicine. I made notes of the questions raised in my mind, and brought them with me when I visited my doctor. We discussed my questions thoroughly, along with the fact that I already had a recent HIV test establishing that I was still negative. My doctor outlined the requirement that I would take the medication every day as directed, and that he would test me for kidney function and other potential side effects on a regular basis. In the end, I decided that the benefits outweighed the risks, and I chose to begin taking Truvada.

The cost of PrEP is naturally a major factor. My physician informed me that several insurance companies were actively considering coverage of PrEP, knowing that it was much less expensive than treatment of an HIV-positive patient.

Fortunately, my health insurance company had already chosen to cover PrEP, and I’ve never had a problem obtaining Truvada with a reasonable co-pay.

Perhaps the second most common question I’m asked is whether I’ve had side effects from using PrEP. It’s true that for some men, Truvada can cause nausea or diarrhea (usually only for the first month of use), or even kidney damage. I’m pleased to say that I haven’t experienced such problems. The first morning after I began taking Truvada, I had some very minor J U LY + AU G UST 2 01 1 | 39

PrEp has made a Real Difference in my relationship with my partner. We’re able to be intimate in a way both of us prefer, without the fears and conflicting feelings that were present even with condoms.

diarrhea, but this has never recurred, so it may have been entirely coincidental. True to his word, my physician has insisted on regular tests to monitor my kidney function, HIV status, and other health measures. My test results have been entirely normal.

In fact, the only “side effect” I’ve experienced while using PrEP is frustration over the anti-PrEP propaganda efforts of Michael Weinstein and his AIDS Healthcare Foundation. I’ve read a great deal of the material issued by Mr. Weinstein, and I recently participated with him in a public forum on the use of PrEP, along with several committed advocates of HIV prevention. Where experts presented factual data regarding PrEP, Mr. Weinstein attempted to inspire fear of PrEP, and advocate against the makers of Truvada. Mr. Weinstein’s fear-mongering should come as no surprise, given that he previously attempted to sue the makers of Viagra, claiming that the erectile dysfunction drug contributed to the spread of HIV. Mr. Weinstein consistently misrepresents the study data. First, he claims that PrEP only proved to be 44% effective in preventing HIV infection. He avoids stating that closer examination of the study results shows that those in the study group who became infected with HIV were found to have no Truvada in their bloodstream, or only trace levels. In other words, the infected individuals failed to actually take Truvada daily as directed. None of the men who were found to actually be taking Truvada on a daily basis throughout the study became infected with HIV. Second, Mr. Weinstein complains that the study wasn’t “real world,” because those enrolled received monthly prevention counseling and health monitoring. To Mr. Weinstein, it was really the counseling that prevented infection, rather than PrEP. 40

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What Mr. Weinstein fails to recognize is that all study participants, including those taking a placebo, were given the same counseling and monitoring. In other words, the controlled study took this factor into account, so that the use of PrEP would truly be the only difference between the groups. When the study reports that PrEP was effective in reducing HIV infections, it reflects a situation in which all other factors were equal. For the men taking a placebo, counseling alone didn’t protect them from HIV infection.

Perhaps knowing that consistent, daily use of PrEP really did prevent HIV infection, Mr. Weinstein insists that gay men cannot be relied upon to take Truvada daily. Mr. Weinstein doesn’t explain why he believes that the same men who can’t be trusted to take a pill every day can be expected to use a condom every time they have sex (the only prevention method he seems to approve). My own anecdotal experience contradicts Mr. Weinstein’s theory. I take my Truvada every night before bed. In the five months I’ve been taking the drug, I’ve forgotten only once, and I took it the following morning, making it a “late” dose, rather than a “missed” dose. I’m not always the most responsible person on the planet, but I take my medication as directed because I realize that as part of a serodiscordant relationship, I have a comparatively high risk of infection.

I take my medication as directed because I have an excellent physician who reminds me about how important that is. I take my medication as directed because I love my

partner, and knowing that I take PrEP daily helps reduce his worry and stress.

Mr. Weinstein complains that the availability of PrEP will make men less likely to use condoms, thus making them less protected against HIV infection. While I can’t deny that this may occur for some men, my own experience reflects quite differently. While my partner has an undetectable viral load, resulting in a less than 1% chance of him infecting me, that chance continues to exist. Before PrEP became available, I was taking a calculated risk with my partner, because even with counseling from my trusted physician, physical comfort and intimacy without barriers were ultimately more important to me than further reducing that tiny 1%. My physician, having directly asked about this, determined that I was a good candidate for a method that would overcome those objections. PrEP didn’t make me stop using condoms. Instead PrEP provided me with protection that I would use consistently, rather than protection that I was already rejecting. With PrEP, that 1% risk of infection from my partner’s undetectable viral load has been further reduced by my own level of personal protection (92% for those who use PrEP daily).

In the end, my belief that the benefits of PrEP would outweigh the risks has proven true for me. I’m carefully monitored to ensure that I don’t develop harmful side effects. I comply with the treatment regimen faithfully. My insurance covers the medication. My overall level of protection against HIV infection has increased dramatically. Just as important, however, PrEP has made a real difference in my relationship with my partner. We’re able to be intimate in a way both of us prefer, without the fears and conflicting feelings that were present even with condoms. I haven’t “given up on gay men,” or deemed my life “disposable.” Rather, I’ve made a responsible health choice that works for me, and I’m happy with it. e

Nick Literski is a 44-year-old Seattle native, a former test subject with the HIV Vaccine Trials Unit, and a regular participant in the annual Seattle AIDS Walk. Nick has spoken at public forums in Seattle and Chicago, sharing his perspective as a PrEP user.

P osi t i v elyAwar e .co m

get in the picture.

A DAY WITH HIV

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

What does it mean to live with HIV? Positively Aware is presenting its second annual Day with HIV in America, an online photo essay that asks what does it mean to live with HIV? Because whether youâ&#x20AC;&#x2122;re negative or positive, we are all living with HIV. On Sept. 21st, grab your digital camera or camera-equipped cell phone, and take a snapshot of your everyday life. Capture a momentâ&#x20AC;&#x201D;getting ready for work, hanging out with friends, spending a quiet moment alone, of caring for someone with HIV. Each photo tells a story. Get in the picture, and tell your story.

Picture Day is Sept. 21. Submit your photos by Sept. 23.

Select photos will appear in the November+December issue of Positively Aware.

Photo submissions will appear on ADaywithHIVinAmerica.com.

Send photos or questions to artdirector@tpan.com

For more details, go to www.DayWithHIVinAmerica.com

What’s Goin’ On? Keith R. Green

We’ve got something in common Let’s meet in the middle of the aisle When Republicans gained control of the U.S. House of Representatives last November, many of us involved in the HIV/AIDS social service sector couldn’t help but feel a sense of looming defeat. Although the fight against HIV in this country is a non-partisan one, and our organizations must advocate on both sides of the aisle in order to make progress, history has proven that Republicans are generally less sensitive to the needs of the communities most impacted by the epidemic.

The reality we felt was that the progress made during the first two years of the Obama administration could come to a screeching halt. Progress that includes, but is not limited to, health care reform, the lifting of federal bans that restricted syringe exchange programs and that kept people with HIV from crossing U.S. borders, and the implementation of our nation’s first HIV/AIDS Strategy (NHAS) which prioritizes gay men of all races, including African Americans and Latinos.

Republican legislators haven’t done much in the way of calming our fears.

President Obama’s Affordable Care Act is under constant attack, proposed riders to the FY11 (the current fiscal year) federal budget threatened to reinstate the abovementioned federal bans, and the present budget battle challenges movement on NHAS with potentially historic cuts to programs critical to fighting the epidemic.

Shortly after the elections, I had an opportunity to engage Dr. Kevin 42

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Fenton, Director of the National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention at the U.S. Centers for Disease Control and Prevention (CDC), in a very open conversation with HIV/AIDS advocates and service providers here in Chicago. Dr. Fenton spoke of how he was preparing his department for the impact of the change in power. He was crystal clear that some compromise would be required, but that an equal commitment to maintaining progress was necessary.

It was during that conversation when it occurred to me that, on the ground, we’re going to have to make a sincere effort to do what our President has been calling for our political leaders to do since his time on the campaign trail—meet in the middle of the aisle. It is, after all, the only true way to compromise while remaining equally committed to maintaining progress.

Meeting in the middle of the aisle doesn’t mean that we’ll agree on everything. At the end of the day we have to

understand that we are all humans first, and thus neighbors in the world that we share. We have far more in common than we have differences, and if we could devote just a little energy to a couple of those things then we might find ourselves better equipped for civil discourse on the things with which we disagree.

Since that meeting I’ve looked for a way to consciously promote such reaching.

It has come in a rather interesting form.

During my last visit with my doctor I learned that my cholesterol is “borderline high.” My current regimen is known to increase bad cholesterol levels, so he suggested a change in meds. I’ve been on the same combination of meds for the past five years and I’ve never had an issue with cholesterol. What I have had issues with, however, are stress and junk food. My busy work life has resulted in unhealthy relationships with the local Leona’s Pizza and several 24-hour greasy spoons. The gym is but a distant memory.

I told my doc that I’d like to wait a couple of months before making any changes because there were a couple of things that I needed to do on my own.

The first thing I did was to completely clear out my refrigerator and replace anything more than a week old with a bunch of fresh stuff that I’m actually likely to eat.

Sounds like a simple trick, but it works.

Next, I started planning and preparing my own meals. No more fast food.

P os it i v elyAwar e .co m

I am personally taking on Congressman Schock’s fitness challenge.

This doesn’t mean I have to agree on everything. However, I understand that being healthy with HIV can keep the cost of my health care down significantly.

Then I started to research workout plans that could be a good fit for me.

That’s when I stumbled upon the edition of Men’s Health magazine with Illinois Congressman Aaron Schock on the cover bearing his incredible 6-pack abs.

Congressman Schock’s mention of First Lady Michelle Obama’s “Get Fit” campaign really caught my attention, and the way that he related it all back to health care and ultimately to health care reform was actually quite moving. I interpreted this as a subtle hint of reaching across the aisle, and was immediately moved to action.

Since the First Lady’s campaign is geared more towards young people, and I am committed to finally letting go of my “youth status” this year (LOL), I am personally taking on Congressman Schock’s fitness challenge. Now, as I said earlier,

this doesn’t mean that we have to agree on everything.

Respectfully, I am not interested in having abs like the Congressman (though I won’t fight them off if they happen to develop), and therefore will not be adapting his workout plan exactly. I am, however, interested in being healthy, and I also understand that being healthy with HIV can keep the cost of my health care down significantly.

So what I am committing to do, besides freshening up my diet, is to train for and run the Team 2 End AIDS Honolulu Marathon scheduled for December 2011.

I am also reaching out to the 500-plus people living with HIV in the Congressman’s

district, to take him up on his fitness challenge in their own way.

HIV-related stigma is so strong within many of the areas that the Congressman represents that he may never hear from any of the people who did. He should know, though, that a man living with HIV in Chicago whose job is to advocate on behalf of all the people in Illinois living with HIV is taking him up on his challenge on their behalf.

That’s my way of encouraging us all to reach across the aisle. I’m interested to see where it goes.

Keith R. Green is the Director of Federal Affairs for the AIDS Foundation of Chicago.

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Wholistic Picture Sue Saltmarsh

Good, good, good, inflammation Become a “Citizen T-cell” While most (if not all) in the world of HIV would say we need to find a way to reduce, if not eliminate, inflammation from our daily lives, I will play the devil’s advocate and argue that there are some instances when we need to be more inflamed.

No, of course I’m not talking about bodily inflammation, though it’s true that in its originally designed, most functional form, inflammation, like fever, works on our behalf to fight infection.

I believe there is a lesson to be learned from that. Right now in this country, there is widespread “infection.” States like Wisconsin, Indiana, Ohio, Michigan, Maine, Florida, and Arizona have seen new discriminatory laws enacted in unconstitutional, and sometimes illegal (some might say fascist), ways. Reproductive rights, as well as preventive health care, are being attacked by “conservatives” who yammer about small government out of one side of their mouths and then insist that government dictate what a woman can and cannot do with her own body and who may and may not enter into a legal marriage out of the other side—except for those Wyoming Republicans. (If you don’t know about them, Google “Wyoming Republicans defeat anti-abortion and antigay marriage bills” and learn!) The hard work that Franklin Roosevelt did to establish Social Security and Lyndon Johnson did to create Medicare and Medicaid is in danger of being trampled to dust by those who care more about financial cost than about human cost. Millions of people 44

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remain unemployed and millions have lost their homes. Thousands linger on ADAP waiting lists. Millions more, HIV-positive and not, have little or no access to the medical care they need even though they have insurance, while Congress and the top two percent of Americans enjoy “coverage” that actually provides care. It has seemed like in almost every sector of our society, except perhaps Wall Street, corporate management, and the über-rich, the “body politic” is being bombarded with this infection while having no fever, inflammation, or other weapons with which to fend it off.

But perhaps that’s changing. Perhaps our societal “immune system” has finally become activated. Maybe our usual complacency has been replaced by an awakening of sorts. Look at the hundreds of thousands of people who‘ve showed up in Wisconsin and elsewhere to protest those laws that are so symptomatic of infection.

Those crowds are not partisan or exclusive—they are a microcosm of that beleaguered body politic. They are inflamed and, if I might exhaust the metaphor, they are the T-cells of our social consciousness.

So that’s the inflammation we need more of. That’s the kind of empowerment that fights successfully against

any disease, physical or otherwise. HIVpositive people know that fight. They know the forces of fatigue, stress, worry, fear, lack of access to care, lack of money, stigma, and ignorance that they must fight every day. They also know the weapons of knowledge, discipline, tenacity, self-determination, medical science, and courage that enable them to keep their infection controlled and, hopefully someday, defeated.

Will the American people, HIV-positive and not, use the empowerment of this inflammatory time of awakening in order to cure our political infection? It will take a lot of us, maybe most of us. It will take moving beyond where we are comfortable and secure and entering unknown territory. For some it will mean speaking, writing, posting, tweeting. For others it will mean voting for the first time or, even better, returning to the voting booth after years of “what’s the use?” cynicism. For more it will mean being one of those faces in an enormous crowd of every kind of American there is; adding their one voice to millions of others. For some of us, it will be all that and more.

Whatever it takes to inflame you, act on it. Start now and join us in Washington, DC, in 2012 (see page 32). Be one of those human T-cells. Fight the infection. Do your own body some good and cure the American body.

Breathe deep, live long.

P os it i v elyAwa r e .co m

500 T-CELLS

OR LESS. IT’S TIME

TO TAKE ACTION. 250 380

500

750

Talk with your doctor and consider all the factors about starting treatment.

HIV treatment is now recommended for everyone with a T-cell count of 500 or less and should be considered when T-cells are higher than 500, according to the DHHS* and the IAS-USA†. Starting treatment early may help protect your immune system and vital organs. Today’s medicines may have fewer, more manageable side effects. They may help you live a longer, healthier life. Receive helpful information about living with HIV that you should know. Call toll free 1-888-447-1728, or visit TREATHIVNOW.COM. *DHHS = Department of Health and Human Services †IAS-USA = International AIDS Society USA. ©2011 Gilead Sciences, Inc. All rights reserved. UN8759 03/11