MAY+JUNE 2011 by POSITIVELY AWARE

Positively Aware MaY+JUNE 2011

AIDS 30

Born HIV-positive on St. Patrick’s Day 1981, Marc Antoni Castillo’s life has spanned the history of the AIDS epidemic.

DIABETES AND HIV CROI UPDATE ONE ON ONE: ANTHONY FAUCI The HIV Treatment & Health Journal of

Test Positive Aware Network

INDICATION: REYATAZ® (atazanavir sulfate) is a prescription medicine used in combination with other medicines to treat people 6 years of age and older who are infected with the human immunodeficiency virus (HIV). REYATAZ has been studied in a 48-week trial in patients who have taken anti-HIV medicines and a 96-week trial in patients who have never taken anti-HIV medicines. REYATAZ does not cure HIV or lower your chance of passing HIV to others. People taking REYATAZ may still get opportunistic infections or other conditions that happen with HIV infection.

On REYATAZ,

IMPORTANT SAFETY INFORMATION: Do not take REYATAZ if you are allergic to REYATAZ or to any of its ingredients. Do not take REYATAZ if you are taking the following medicines due to potential for serious, life-threatening side effects or death: Versed® (midazolam) when taken by mouth,Halcion® (triazolam),ergot medicines (dihydroergotamine, ergonovine, ergotamine, and methylergonovine such as Cafergot®, Migranal®, D.H.E. 45®, ergotrate maleate, Methergine®, and others), Propulsid® (cisapride), or Orap® (pimozide). Do not take REYATAZ with the following medicines due to potential for serious side effects: Camptosar® (irinotecan), Crixivan® (indinavir), Mevacor® (lovastatin), Zocor® (simvastatin), Uroxatral® (alfuzosin), or Revatio® (sildenafil). Do not take REYATAZ with the following medicines as they may lower the amount of REYATAZ in your blood, which may lead to increased HIV viral load and resistance to REYATAZ or other anti-HIV medicines: rifampin (also known as Rimactane®, Rifadin®, Rifater®, or Rifamate®), St. John’s wort (Hypericum perforatum)-containing products, or Viramune® (nevirapine). Serevent Diskus® (salmeterol) and Advair® (salmeterol with fluticasone) are not recommended with REYATAZ. Do not take Vfend® (voriconazole) if you are taking REYATAZ and Norvir® (ritonavir). The above lists of medicines are not complete. Taking REYATAZ with some other medicines may require your therapy to be monitored more closely or may require a change in dose or dose schedule of REYATAZ or the other medicine. Discuss with your healthcare provider all prescription and non-prescription medicines, vitamin and herbal supplements, or other health preparations you are taking or plan to take. Tell your healthcare provider if you are pregnant or plan to become pregnant. REYATAZ use during pregnancy has not been associated with an increase in birth defects. Pregnant women have experienced serious side effects when taking REYATAZ with other HIV medicines called nucleoside analogues. After your baby is born, tell your healthcare provider if your baby’s skin or the white part of his/her eyes turns yellow. You should not breast-feed if you are HIV-positive. Also tell your healthcare provider if you have end-stage kidney disease managed with hemodialysis or severe liver dysfunction. Tell your healthcare provider right away if you have any side effects, symptoms, or conditions, including the following: • Mild rash (redness and itching) without other symptoms sometimes occurs in patients taking REYATAZ, most often in the first few weeks after the medicine is started, and usually goes away within 2 weeks with no change in treatment. • Severe rash may develop with other symptoms that could be serious and potentially cause death. If you develop a rash with any of the following symptoms, stop using REYATAZ and call your healthcare provider right away: – Shortness of breath – Conjunctivitis (red or inflamed eyes, like “pink-eye”) – General ill-feeling or “flu-like” symptoms – Blisters – Fever – Mouth sores – Muscle or joint aches – Swelling of your face • Yellowing of the skin and/or eyes may occur due to increases in bilirubin levels in the blood (bilirubin is made by the liver). • A change in the way your heart beats may occur. You may feel dizzy or lightheaded. These could be symptoms of a heart problem. • Diabetes and high blood sugar may occur in patients taking protease inhibitor medicines like REYATAZ. Some patients may need changes in their diabetes medicine. • If you have liver disease, including hepatitis B or C, it may get worse when you take anti- HIV medicines like REYATAZ. • Kidney stones have been reported in patients taking REYATAZ. Signs or symptoms of kidney stones include pain in your side, blood in your urine, and pain when you urinate. • Some patients with hemophilia have increased bleeding problems with protease inhibitor medicines like REYATAZ. • Changes in body fat have been seen in some patients taking anti-HIV medicines. The cause and long-term effects are not known at this time. • Immune reconstitution syndrome has been seen in some patients with advanced HIV infection (AIDS) and a history of opportunistic infection. Signs and symptoms of inflammation from previous infections may occur soon after starting anti-HIV treatment, including REYATAZ. • Gallbladder disorders (including gallstones and gallbladder inflammation) have been reported in patients taking REYATAZ. Other common side effects of REYATAZ taken with other anti-HIV medicines include: nausea; headache; stomach pain; vomiting; diarrhea; depression; fever; dizziness; trouble sleeping; numbness, tingling, or burning of hands or feet; and muscle pain. You should take REYATAZ once daily with food (a meal or snack). Swallow the capsules whole; do not open the capsules. You should take REYATAZ and your other anti-HIV medicines exactly as instructed by your healthcare provider.

Wedn esda y Ma ry ’s birthd ay pa rty

Thursda y 5:30 C h oi r e practic Bu y new shoes for Latish a

Fight HIV your way.

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

how you spend your time is up to you.

Individual results may vary.

Once-daily REYATAZ can help fight your HIV. REYATAZ, a protease inhibitor (PI), in HIV combination therapy: Can help lower your viral load and raise your T-cell (CD4+ cell) count Has a low chance of diarrhea (shown in clinical trials) - REYATAZ in combination therapy had a 1%-3% rate of moderate-to-severe diarrhea in adults ◆ Is taken once a day with a snack or meal

Find out if you can save on REYATAZ. Call 1-888-281-8981 or visit ReyatazSavings.com for details.

REYATAZ is one of several treatment options your doctor may consider.

Subject to terms and conditions. Restrictions apply.

◆ ◆

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

Ask your healthcare team about REYATAZ

www.REYATAZ.com

REYATAZ does not cure HIV and has not been shown to reduce the risk of passing HIV to others. People taking REYATAZ may still get opportunistic infections or other conditions that happen with HIV infection.

REYATAZ is a registered trademark of Bristol-Myers Squibb. All other trademarks are the property of their respective owners and not of Bristol-Myers Squibb. © 2011 Bristol-Myers Squibb, Princeton, NJ 08543 U.S.A. 687US10AB06420 02/11

FDA-Approved Patient Labeling Patient Information

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

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

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

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

REYATAZ® (atazanavir sulfate) •

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

F1-B0001B-02-11

Rev February 2011

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PreP PROGReSS

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NutRitiON & HiV

The importance of vitamin D

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1:22 P.m., ChICago: kenny gets blood drawn

Positively Aware is published bi-monthly by Test Positive Aware Network. © 2011. Positively Aware (ISSN: 1523-2883) is published bi-monthly by Test Positive Aware Network (TPAN), 5537 N. Broadway St, Chicago, IL 60640. TPAN is an Illinois not-for-profit corporation, providing information and support to anyone concerned with HIV and AIDS issues. Positively Aware is a registered trademark of TPAN. All rights reserved. Circulation: 85,000. For reprint permission, contact Sue Saltmarsh. Six issues mailed bulk rate for $30 donation; mailed free to TPAN members or those unable to contribute. We encourage contribution of articles covering medical or personal aspects of HIV/AIDS. We reserve the right to edit or decline submitted articles. When published, the articles become the property of TPAN and its assigns. You may use your actual name or a pseudonym for publication, but please include your name and phone number.

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| M ay+June 2011

P os i t i v e lyAwar e .com

INSIDE

MAy+JUNE 2011 VO L U M E

2 3

N U M B ER

Positive outlook: Born HIV-positive in 1981, Marc Antoni Castillo’s life has spanned the AIDS epidemic.

D e pa r t m e n t s

6 | Editor’s Note The year of living dangerously.

7 | In Box 7 | PA Reader poll 12 | Briefly Expanded co-pay assistance for Norvir and Egrifta. Rilpivirine NDA gets re-filed. CDC issues interim PrEP guidelines. Kaletra caution for preemies. Once-daily Viramune.

15 | HIV WELLNESS Series Diabetes and HIV.

P os i t i velyAware.co m

F e a t u r e s

26 | One on One NIAID’s Anthony Fauci has been at the forefront since the early days of the AIDS pandemic.

31 | Tale of two healers

co nfe r ence r epo r t

David Moore and David Blatt remember 30 years of treating HIV-positive patients.

18 | CROI 2011

c o v e r f e at u r e

41 | Ask the HIV specialist

34 | What’s your type?

22 | AIDS at 30

HIV types, subtypes, groups, and clades. Part two of a three-part series.

On the 30th anniversary of the first CDC report about AIDS, a personal timeline set against the backdrop of an epidemic.

Liver and kidney issues can complicate life with HIV.

42 | The Buzz A new era in treating HCV.

45 | salient ramblingS

37 | Positively Aware 2011 Reader Survey 38 | Princess Warrior Survival after surviving.

The tears of a clown.

on the cover and on this page: Marc Antoni Castillo photographed by Ayrick Broin.

M ay + J u n e 2 01 1

EDitor’s Note Jeff Berry

Thirty years ago, in 1981, I moved to Chicago FRom Grand Rapids, Michigan to deejay at Dugan’s Bistro, the largest gay nightclub of its day, the “Studio 54 of the Midwest.” I was on my own for the first time in my life, in a bustling major city with a thriving gay nightlife, around the same time that the first few cases of what would later become known as AIDS were being reported in San Francisco and Los Angeles. It was a different time, but I have to admit that I took to my newfound freedom with a reckless abandon, and threw caution to the wind. It wasn’t long afterwards that I remember coming down with a flulike illness that lasted for several weeks, one that I just couldn’t seem to shake. It was also during this time that I now believe I seroconverted; however, I would remain symptom free, and it wasn’t until I took my first HIV test eight years later that I learned I was positive. That same year, in 1981, a few months before I relocated to Chicago, Marc Antoni Castillo, who is pictured on the cover of this issue, was born with HIV. Like me, he also resided in Chicago. Like me, he and his mother Marta Santiago didn’t learn until years later that they were both HIVpositive. And, like me, they are both still here. Our stories are so very different, and yet, they are the same. I have never met Marc or Marta, but I am so very honored that they have chosen to be part of this issue of Positively Aware and share their stories with us (see page 22). There are so many stories out there that, tragically, ended much too soon, or even worse, will never be heard. And there are many more still waiting to be told. 6

May+June 2011

For this issue I had the distinct privilege of speaking with Dr. Anthony Fauci, someone who has been around since the very beginning of HIV and AIDS (see the interview on page 26). Dr. Fauci has made such a tremendous impact on the course of the epidemic both in the U.S. and globally, and is someone who, as you’ll read, is committed, passionate, and articulate, while at the same time being very approachable and down to earth. Also in this issue you will read the stories of Drs. David Blatt and David Moore, HIV-treating physicians who left their own unique and indelible mark on the lives of many individuals, as well as the entire Chicago community, and who both recently retired from medical practice, but continue to touch people’s lives. And then there are the countless researchers, doctors, nurses, case managers, care providers, community workers, activists, family members, friends, acquaintances, volunteers, and yes, even members of industry—many of whom have left their own legacies and have contributed in one way or another. A few of these individuals and their stories you will read in this issue, but again, most of them you will never hear about, and they will go unrecognized and unheralded. But you will benefit from them. You will benefit when you take your meds in the morning, the ones that keep you alive and healthy, or when you need help getting housing or financial

assistance, or when you need a shoulder to cry on. You will be aware of them when you pick up a magazine that offers support and information for people with HIV, a magazine that was started by Chris Clason, a man who lived honorably, fought valiantly, and ultimately succumbed long ago to the very disease that we have subsequently learned to survive and even thrive with. This issue of Positively Aware pays tribute to those individuals whose stories have become woven into the fabric of our lives, our very beings. We will never be separate from them, and they will not have lived or died in vain. It is our charge to pick up and go on with our lives, because in doing so, we honor them and their existence, their contributions, their achievements. While there may have been times in our lives when we lived dangerously, we now choose to live responsibly, with a purpose, and a determination to carry on the work of those who came before us. Remember and honor someone you have loved and lost by making this the year of living safely, responsibly, carefully, compliantly—whichever word fits you best. Make it yours. Make it meaningful. Make it real. This is your story, your life, and your year. You are creating it, and you are writing it, so make it a story that you will be proud to share with those who, 30 years from now, just may happen to pick up a magazine, and might even become inspired by your own, unique story.

P os i t i v e lyAwar e .co m

Photo: Chris Knight

The year of living dangerously

In Box

Readers’ poll

Practicing what you preach

Last issue’s poll question:

I recently had an experience that brought home to me just how much ignorance and prejudice is still out there regarding HIV, especially in the African American community. A friend of mine invited me to attend his church with him and since I am in the process of searching for a church I feel comfortable and accepted in, I agreed. I chose to wear my anti-stigma t-shirt that day—red with “HIV Positive” in big black and white letters. After being seated and taking my coat off, an usher came up to me and told me that members of the congregation were “disturbed” by what I was wearing and suggested that “in order to avoid further disruption,” it might be best that I leave. Well, obviously that wasn’t the church for me! The fact is that no matter how much time, energy, money, or effort we spend on trying to educate a public whose ignorance and fear lead to stigma and discrimination, there will always be some who either can’t or won’t hear the message. I guess Jesus would know how that feels. As for me, I’ll keep wearing that t-shirt, keep spreading the truth about HIV, and keep searching for a church that will accept me as I am. —Arick Buckles Chicago

Heartfelt Thanks Let me begin by giving your staff my most sincere, heartfelt thanks. Please know that if it weren’t for your efforts in publishing

an up-to-date informative “sanctuary” for those of us battling HIV/ AIDS alone, I probably would have committed suicide by now, or be on the verge. I am HIV-positive and currently incarcerated. I received my diagnosis and a 25-year sentence all in a two-week span in 2009. Your publication has been my saving grace, giving hope where there was none left. Although I must admit that the long-term effects of living with this disease discussed in PA do scare me shitless, as many in the magazine convey, at least we’re alive! I’m currently taking Atripla and doing well despite fighting not to miss doses due to slow, misplaced, or never received refills—Correctional Medical Services cares more about cost containment than their patients’ well being. I would very much appreciate a subscription to PA—they have it in the library here, but I would like my own copy. While now, my need outweighs my apprehension, it took me awhile to make that request because I was afraid of the possible consequences of someone being placed in the cell with me and recognizing the magazine or looking through it and seeing an Atripla ad. Ironically, as society becomes more accepting towards the GLBT community, the incarcerated population becomes more homophobic. Anyway, I just wanted to say thank you and let you know what a difference you’ve made in my life. Keep up the good fight. —Aaron

Drug Guide correction: Kaletra dose Positively Aware’s 15th Annual HIV Drug Guide (March/April) stated that a once-daily dose of Kaletra (lopinavir/ritonavir) is available to treatment-naïve people (taking antiviral treatment for the first time). In fact, the once-daily dose was approved last year for anyone who has less than three lopinavir-related resistance mutations, including people who are treatment-experienced. Positively Aware regrets the error. —Enid Vazquez

P os i t i velyAware.co m

When you think about or refer to the HIV drugs you take, prescribe, or discuss with someone, do you call them by their brand name or their generic/common name? generic/ common name: 15%

Brand name:

85%

Your comments:

“Generic name and common name often are too much to remember, but I know what they are and if they are in my brand name drug.” “Having to call a drug by 2 or 3 different names is confusing. Why couldn’t there just be one called, ‘AIDS-be-GONE’?”

this issue’s poll question:

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

positivelyaware.com Do the write thing

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5537 N. Broadway St. Chicago, IL 60640 E-Mail: readersforum@tpan.com Follow us on Facebook and Twitter M ay + J u n e 2 01 1

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 provider all prescription and nonprescription medicines, vitamins, or herbal supplements you are taking or plan to take. Tell your healthcare provider if you: •Are pregnant: Women should not become pregnant while taking ATRIPLA and for 12 weeks after stopping ATRIPLA. Serious birth defects have been seen in children of women treated during pregnancy with one of the medicines in ATRIPLA. Women must use a reliable form of barrier contraception, such as a condom or diaphragm, even if they also use other methods of birth control, while on ATRIPLA and for 12 weeks after stopping ATRIPLA. •Are breastfeeding: Women with HIV should not breastfeed because they can pass HIV through their milk to the baby. Also, ATRIPLA may pass through breast milk and cause serious harm to the baby. •Have liver problems, including hepatitis B or C virus infection.

Other possible side effects: •Changes in body fat have been seen in some people taking anti-HIV-1 medicines. The cause and long-term health effects are not known. •Skin discoloration (small spots or freckles) may also happen. •If you notice any symptoms of infection, contact your healthcare provider right away. •Additional side effects are inflammation of the pancreas, allergic reaction (including swelling of the face, lips, tongue, or throat), shortness of breath, pain, stomach pain, weakness, and indigestion. You should take ATRIPLA once daily on an empty stomach. Taking ATRIPLA at bedtime may make some side effects less bothersome.

ATRIPLA is one of several treatment options your doctor may consider.

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

Please see Patient Information on the following pages. © 2010 Bristol-Myers Squibb & Gilead Sciences, LLC. All rights reserved. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. EMTRIVA, VIREAD, and TRUVADA are trademarks of Gilead Sciences, Inc. SUSTIVA and REYATAZ are registered trademarks of Bristol-Myers Squibb. All other trademarks are owned by third parties. 697US09AB07040/TR6109 07/10

“My entire HIV regimen in one pill daily. For me, that’s great.” Phil li p

on ATRIPLA for 2 years

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

• Proven to lower viral load to undetectable in approximately 7 out of 10 patients new to therapy, and also raise T-cell‡ (CD4+) count to help control HIV through 3 years of a clinical study.§ • ATRIPLA does not cure HIV-1 and has not been shown to prevent passing HIV-1 to others.

Selected Important Safety Information: Some people who have taken medicine like ATRIPLA have developed the following: a serious condition of acid buildup in the blood (lactic acidosis), and serious liver problems (hepatotoxicity). For patients with both HIV-1 and hepatitis B virus (HBV), hepatitis may suddenly worsen if ATRIPLA is discontinued. Please see detailed and additional Important Safety Information, including the bolded information to the left. †

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

Patient model. Individual results may vary.

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

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

To learn more, visit www.ATRIPLA.com

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

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

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

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

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

May 2010 ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. EMTRIVA, TRUVADA, HEPSERA and VIREAD are trademarks of Gilead Sciences, Inc. SUSTIVA is a trademark of Bristol-Myers Squibb Pharma Company. Reyataz and Videx are trademarks of Bristol-Myers Squibb Company. Pravachol is a trademark of ER Squibb & Sons, LLC. Other brands listed are the trademarks of their respective owners.

SF-B0001B1-05-10

21-937-GS-007

TR5827

May 2010

BRIEFLY reported by Enid VÁzquez

Abbott expands co-pay assistance Abbott is expanding access to its HIV medications Kaletra (lopinavir/ritonavir) and Norvir (ritonavir): n

The Norvir co-pay card will begin paying private insurance co-pays up to the first $50. The previous co-pay card paid from $25 through $75. Abbott will continue providing the Kaletra Co-Pay Plus card, which covers up to $50 of co-pay costs for Kaletra and up to $50 each for two additional HIV medications in the Kaletra regimen. Both co-pay cards are available through physicians. n Abbott has increased donations to the Abbott Patient Assistance Foundation, expanding eligibility for uninsured patients prescribed Kaletra, from 400% of the Federal Poverty Level (FPL) to 500% of FPL. This will match or exceed all state AIDS Drug Assistance Program (ADAP) qualifications. n Abbott is also extending its support of Welvista and the Heinz Family Philanthropies, enabling more patients on state ADAP waiting lists to get their medications quickly and easily with one application. For more information about the Abbott Patient Assistance Foundation, go to www.abbottpatientassistancefoundation. org or call 800-222-6885. For details about Welvista, visit www. welvista.org or call 877-258-1556.

May+June 2011

CDC issues interim guidelines for using HIV drugs as prevention Interim guidelines for PrEP (pre-exposure prophylaxis)—the use of HIV medications to prevent infection with the virus in the first place—were issued by the U.S. Centers for Disease Control and Prevention (CDC) in its January 28 issue of Morbidity and Mortality Weekly Report (MMWR). The guidelines followed the publication of the iPrEx study in the November 23, 2010 New England Journal of Medicine, showing a 44% drop in the risk of acquiring HIV with daily use of the HIV medication Truvada. That report also showed an even greater protective effect—a 73% drop in risk of infection—for those who took Truvada more than 90% of the time. Truvada as PrEP is one pill taken once a day. (See page 20.) According to the MMWR, “As a component of a comprehensive HIV prevention intervention, PrEP showed a significant added benefit, although effectiveness was highly dependent on medication adherence.” Although the guidelines are for MSM (men who have sex with men) at high risk of infection, transgender women (born men) who have sex with men also participated in the iPrEx study. If patients are determined to be eligible for PrEP, the guidelines suggest that medical providers: n

prescribe one tablet of Truvada daily in general, prescribe no more than a 90-day supply, renewable only after HIV testing confirms that the patient remains HIV-negative n if active hepatitis B infection is diagnosed, consider using Truvada for both treatment of active hepatitis B infection and HIV prevention n provide risk-reduction and PrEP medication adherence counseling and condoms The complete guidelines are at www.cdc.gov/mmwr/preview/mmwrhtml/mm6003a1.htm. n

TPAN receives grant from Elton John AIDS Foundation Test Positive Aware Network (TPAN), publisher of Positively Aware, has been awarded $75,000 from the Elton John AIDS Foundation to fund the L.I.F.E. Program (Learning Immune Function Enhancement), the nation’s leading health-enhancement and wellness-counseling program for people living with HIV. The L.I.F.E. Program provides participants with the knowledge, motivation, skills, and support necessary to establish and maintain routines that lead to and protect better health. “We are overjoyed by the generosity of the Elton John AIDS Foundation,” said TPAN’s CEO Bill Farrand. “TPAN is proud to continue offering such a pragmatic and dynamic program with this resounding support. The L.I.F.E. Program has proven results in Chicago and throughout the country, which is consistent with our existing programs and services.” TPAN is the eighteenth site in the U.S. to offer the L.I.F.E. Program, helping people living with HIV improve biological, psychological, and social co-factors that can impact health and reduce the number of new infections. It was developed in 1991 by Shanti, a non-profit health organization in San Francisco, and has enrolled more than 3,000 HIV-positive participants since then. P os i t i v e lyAwar e .co m

Report details transgender discrimination The National Gay and Lesbian Task Force and the National Center for Transgender Equality issued a comprehensive report, “Injustice at Every Turn,” based on the National Transgender Discrimination Survey pertaining to the lives and health of transgender people. The survey revealed the depth of discrimination against transgender and gender nonconforming people in a wide range of areas, including education, health care, employment, and housing. Among the findings: “Respondents reported over four times the national average of HIV infection, with rates higher among transgender people of color.” Read the entire report at www.TheTaskForce.org or www.TransEquality.org.

The Berlin “cure” It’s been more than three years since an HIV-positive patient from the United States had a stem cell transplant in Berlin for treatment of leukemia, and his doctors reported in March that they believe both diseases have been cured. The so-called “Berlin patient” has long held fascination for the HIV community, after reports that the virus could no longer be found in his blood following the transplant. The infusion used cells with a genetic marker known to make HIV infection difficult to take place, or to progress if infection does occur. Nevertheless, doctors say that a stem cell transplant, with its arduous risks and side effects, is not the way to go in HIV therapy. The report was published in the March 10 issue of the journal Blood, produced by the American Society of Hematology, and is available free online: http://bloodjournal.hema tologylibrary.org/content/117/10/2791.full. P os i t i velyAware.co m

Reyataz dose in pregnancy A study of 41 pregnant women taking Reyataz found that no dose adjustment is required, and they can take the standard 300 mg with a booster dose of 100 mg Norvir. However, an increase to 400 mg (along with 100 mg Norvir) is recommended for HIV treatment-experienced women in their second or third trimester if they are also taking Viread, Truvada, or Atripla, or H2-receptor antagonist medications (Tagamet, Zantac, Pepcid, or Axid). As a result of the research, Reyataz’s drug label was updated in February.

NDA for rilpivirine combo pill re-filed Gilead Sciences, Inc. has re-filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for the single-tablet regimen of Truvada (Viread/Emtriva) with an experimental drug from Tibotec Pharmaceuticals called rilpivirine. Gilead had initially submitted an NDA for the single-tablet regimen in November 2010, but reported two months later that it had received a “refuse to file” notification from the FDA. Specifically, the FDA wanted details about the analytical methodology and qualification data used to establish acceptable levels of recently identified degradants related to emtricitabine (Emtriva); this information has been included in the re-filing.

Kaletra caution urged for preemies The FDA has changed the drug label of Kaletra oral solution, citing potentially dangerous side effects in babies less than two weeks old, particularly premature infants. “Call your healthcare professional right away if your baby appears too sleepy or their breathing has changed while taking Kaletra oral solution,” warns the FDA. “Kaletra oral solution contains alcohol and propylene glycol, and babies less than 14 days old (whether premature or full-term) may develop high blood levels of these ingredients resulting in these symptoms… If your baby takes more than the usual dose of Kaletra all at once, it can make them sick. Contact your local poison control center or emergency room right away if an overdose occurs.” The label change was made in March after a review of 10 cases of life-threatening events that were reported in babies less than four weeks old who received Kaletra oral solution. The cases included cardiac toxicity, lactic acidosis, acute renal failure, central nervous system depression, and respiratory complications, and one death resulted from cardiogenic shock. See “Serious health problems seen in premature babies given Kaletra oral solution” at www.fda.gov.

Viracept drug interaction with warfarin Updating the Viracept (nelfinavir) drug label, the FDA has included an interaction with the blood thinner Coumadin (warfarin). Concentrations of Coumadin may be affected when taken with Viracept, and the FDA recommends that “the INR (international normalized ratio) be monitored carefully during treatment with Viracept, especially when starting therapy.” Talk to your medical provider for more information. M ay + J u n e 2 01 1

BRIEFLY reported by Enid VÁzquez

Viramune XR OK’d; assistance expanded On March 25, the FDA approved the extended release formulation of Viramune, Viramune XR. The new 400 mg XR tablet is taken once daily. The older Viramune is taken as one 200 mg tablet twice a day, although it is frequently prescribed as two 200 mg tablets once daily. Both versions must be taken with a lead-in dose of 200 mg once a day for 14 days, to minimize potential side effects. In related news, Boehringer Ingelheim recently announced changes to their patient assistance program for the HIV drugs Viramune and Aptivus. Patients now may qualify for the program if they are at or below 500% of the U.S. government’s established poverty level and have no prescription drug coverage other than Medicare. For those with Medicare Part D who are in the “donut hole” they must spend at least three percent of their annual income on prescription drug costs in the current calendar year to qualify for the PAP. For more information on eligibility and to apply, patients should call 800556-8317 or visit www.RxHope.com for information about the BI PAP. Information is also available at http://us.boehringer-ingelheim.com. Boehringer Ingelheim is also working with Heinz-Welvista to create a partnership that will provide access to its HIV medicines for patients on ADAP waiting lists.

Once-daily dose for Selzentry considered

ViiV Healthcare has applied for FDA approval of a once-daily dose of Selzentry (maraviroc) in combination with “certain boosted protease inhibitors without a CYP3A inducer.” Check with your medical provider and pharmacist. According to the company’s announcement, “CYP3A is an enzyme that aids in the metabolism of certain medications.” Boosted PIs are those taken with Norvir (including Kaletra, which has Norvir in it). At this point in time, all of the various doses of Selzentry are twice a day.

Co-pay and patient assistance for Egrifta EMD Serono has announced a Patient Assistance Program (PAP) and co-pay assistance for its HIV lipodystrophy medication Egrifta (tesamorelin). The drug has been shown to decrease belly fat that can occur with HIV therapy. The PAP provides free Egrifta to “eligible patients who are uninsured or underinsured.” to those with an income up to 600% of the Federal Poverty Level (approximately $60,000). Co-pay assistance covers up to $2,400 of patients’ out-of-pocket cost over a 12-month period. Call the AXIS Center for details: 877-714-AXIS (2947).

My Life with HIV “Join me on the 30th birthday of our ‘fabulous disease,’and shout from the rooftops, “I am HIV-positive and I am proud!” says Richard Cordova. Read Richard’s commentary at www. positivelyaware.com/ole.

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HIV Wellness series Patrick G. Clay, PharmD

With diabetes, actions speak louder than words “Charge!” As a former infantryman, when this word was evoked, my entire body instantly reacted. My senses became heightened; I could feel my muscles tense and my mind begin to race to absorb every aspect of my surroundings. Even today—nearly 20 years removed from that period of my life—when I hear that word, I still find myself preparing for action. I don’t know if the United States Centers for Disease Control and Prevention (CDC—you should know who these folks are, they spearheaded the fight to get HIV on the map in the early 1980s) gave much thought to former military personnel when they selected it as part of their educational campaign on diabetes or not. Regardless, I will still give them credit for considering the full implications of a word’s meaning to all parts of the population. “Take Charge of Your Diabetes” (available at www.cdc.gov/diabetes/pubs/ tcyd/index.htm) is a pamphlet the CDC launched in 1991 that informs and educates people diagnosed with diabetes. The pamphlet (updated regularly online and free to download in PDF format) covers just about every aspect of diabetes. It includes great information when someone has just been told they have diabetes. Go a little further into the pamphlet and you can learn how diabetics have to do many things differently than a non-diabetic. From dieting, to exercising, to even scheduling meetings at work—diabetics have to pause and think just a second or two about how to make these things work in their world.

P os i t i velyAware.co m

The pamphlet begins with some general information, but you have to love it when the speed of a turtle is championed as the pace a person has to use when “racing” diabetes. This may seem strange to those living with HIV, but take a minute and think about it. How many other diseases and conditions that an HIV-positive person has to deal with are approached with the philosophy of “let’s take it nice and easy and see how things go?” This is certainly not the approach normally taken with viral load reduction, T-cell increases, or even blood pressure normalization. Now, don’t begin to think this in any way means diabetes treatment isn’t important. I certainly don’t mean you should put off talking to your doctor about some things going on in your world that could represent the beginning stages of diabetes (see Table 1). What I am trying to emphasize here is that diabetes is, in many ways, like HIV, a disease that doesn’t have a quick fix; it needs to be managed. Why is Positively Aware putting out so much information on diabetes lately? In case you haven’t noticed, diabetes has been a major topic or focus in many articles in Positively Aware over the past couple years—from the HIV Wellness Series, to Briefly, to columns and blogs, to Ask the HIV Specialist. The reason PA is

bringing you more information on this is because diabetes is a growing problem in our country. Recently, the CDC released some statistics on diabetes in America that will help to illustrate this problem. From 2005 to 2008, 35% of all Americans had either “full-blown” or pre-diabetes. This jumps to 50% in people over the age of 65.1 Even though it’s “just” ranked as the seventh leading cause of death in the U.S., 2 this minimizes how many people die every year who also have diabetes listed on their death certificates. In 2007, nearly 10% (231,404 out of about 2.4 million) of death certificates listed diabetes as a contributing cause of death. So basically what this means is that not everyone dies because of diabetes, but many people die of other diseases that are more difficult to control and manage in people with diabetes. Sound familiar to people living with HIV? So why the explosion in rates of diabetes? Maybe not enough physical activity is a factor. Earlier this year, the CDC published some information that caused a bit of a stir. They looked at how people spent their “leisure time” in counties around the United States. Once they gathered that information, they classified counties into those that were more physically active during leisure time and those that were less active. When they compared the maps where most of the area was considered less active (Figure 1) to the maps of areas with the most diabetes (Figure 2), a clear pattern emerged. The greater

M ay + J u n e 2 01 1

70% of the counties reported nearly one Signs and Symptoms of Diabetes third of adults (29%) did not have any physiYou may recall having some of these signs before you cal activity during their found out you had diabetes: leisure time. Reinforcing this theory, the CDC ■ Being very thirsty. developed maps show■ Urinating a lot—often at night. ing rates (Figure 3). ■ Having blurry vision from time to time. When the three maps ■ Feeling very tired much of the time. are taken together, it is ■ Losing weight without trying. even clearer how rates ■ Having very dry skin. of diabetes are higher ■ Having sores that are slow to heal. where people are less ■ Getting more infections than usual. active and more likely ■ Losing feeling or getting a tingling feeling in the feet. to be obese. When you ■ Vomiting. take the analysis a few steps further and start Source: Centers for Disease Control and Prevention. looking at these rates Take Charge of Your Diabetes. 4th edition. Atlanta: U.S. in African Americans, Department of Health and Human Services, 2007. pages 8-9. Hispanics, and the poor, the numbers are even worse. Now, add in the the inactivity level for the county, the medicines for HIV to this picture—how higher the rate of diabetes. In the areas important does moving around become? where diabetes was the most prevalent, There have been some very insightful

articles published in Positively Aware recently about how to go about eating correctly, learning about the role HIV medicines play in diabetes, and how to take care of yourself once you have it. I would encourage you to utilize the Positively Aware archives on the website (positivelyaware.com) and use the search term “diabetes” to review this information. Whether or not you have diabetes, just like with HIV, your workplace has a huge impact on how you are able to manage your disease. Check out these websites: diabetes in the workplace (www.cdc.gov/ diabetes/pubs/factsheets/atwork.htm) and diabetes at work (http://diabetesatwork.org/). For those working and trying to do everything possible to prevent either getting diabetes or their disease getting worse, there are great tips on how to make your workplace as ”diabetic-friendly” as possible. Perhaps the human resources (HR) department would want to be made aware of how much diabetes costs. For instance, did you know that in the United States, it is estimated that annually diabetes costs

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$174 billion and 15 million lost work days? Here’s one that might get their attention: the health care costs for diabetics is 2.3 times higher than non-diabetics. The site goes on to provide useful tools to help businesses make choices to help those with diabetes, but perhaps even more importantly to help those who are trying to prevent having diabetes by supporting and reinforcing lifestyle choices. I am not trying to tell you all is lost. Quite the contrary, the development of diabetes is not inevitable even if you are HIV-positive, obese, and currently physically inactive. Over 20 years ago the CDC published the pamphlet I referenced earlier including the words “Take Charge.” Today—not tomorrow, not this summer, not after this weekend’s special activity—that is exactly what you need to do: take charge. Talk to your HIV provider, your support group, case manager, and yes, even your boss or HR department about what can be done to reduce your company’s risk for diabetes or its complications. You might end up at work in charge of programs to decrease everyone’s risk. You might end up “running” a support group based out of your HIV provider’s office for diabetics or pre-diabetics. And who knows, maybe you read this article before going walking today—after all, the turtle walked all the way to victory lane overthat rabbit. Patrick G. Clay, Pharm.D., FCCP, CCTI, is currently Associate Professor of Pharmacology/Microbiology in the College of Medicine at Kansas City University of Medicine and Biosciences. He is Director of Clinical Research for the medical school and the Dybedal Center for Clinical Research (www.kcumb.edu).

Diabetes in America County-level estimates of leisure-time phyiscal inactivity among adults over age 20 in 2008:

0–19.9% 20.0–24.1% 24.2–27.9% 28.0–32.5 32.6% or more

County-level estimates of diagnosed diabetes among adults over age 20 in 2008:

0–6.3% 6.4-7.5% 7.5-8.8% 8.9-10.5% 10.5% or more

County-level estimates of obesity among adults over age 20 in 2008:

References

1. CDC Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2011 2. Miniño AM, Xu JQ, Kochanek KD. Deaths: Preliminary Data for 2008. National Vital Statistics Reports; vol 59 no 2. Hyattsville, MD: National Center for Health Statistics, 2010 P os i t i velyAware.co m

0-19.4% 19.5-23.8% 23.9-27.0% 27.1-30.7% 30.8% or more M ay + J u n e 2 01 1

Conference report Jeff Berry & Enid VÁzquez

CROI 2011 One of the biggest stories at this year’s CROI was treatment as prevention, including more encouraging results from microbicide and PrEP studies. But there was other interesting news on drugs in development, as well as new insights on those currently in use, plus hepatitis C co-infection, complications, and cure research, just to name a few. Some of the highlights follow and are covered elsewhere in this issue (see The Buzz, page 42). To view webcasts of conference sessions or search abstracts, go to www.retroconference.org. You can also scan the QR code at left using a QR reader app on your iPhone or other smart phone.

Doctors optimistic over PrEP and Microbicide Progress The race is on. As Sharon Hillier, PhD, principal investigator of the Microbicide Trials Network said, “To put it on the table, we are looking at oral prophylaxis this year. The community needs to prepare themselves for the kind of questions that will exist.” She’s referring to PrEP, or 18

May+June 2011

“pre-exposure prophylaxis,” the use of HIV medication to prevent infection with the virus in the first place. The HIV drug Truvada is lined up this year to become approved for PrEP by the U.S. Food and Drug Administration (FDA). Last year Truvada was found to greatly cut the risk of getting HIV (see Briefly, page 12). Moreover, a gel formulation (microbicide) of one of the two drugs in Truvada (tenofovir; brand name Viread), was also found to cut

the risk of HIV infection. That gel may come on the market as early as next year. These are long-awaited results from gold-standard research for HIV prevention, as published last year in the CAPRISA 004 and iPrEx studies. The two prevention studies became the center of attention at this year’s Conference on Retroviruses and Opportunistic Infections (CROI), normally the premiere spot for HIV treatment news. The excitement, however, was tempered by the same problems found in the history of HIV treatment—the need to nail down effectiveness, to encourage adherence, and to ensure access. Note: Truvada has already been prescribed for years for the prevention of HIV through off-label usage.

CAPRISA 004 and iPrEx An overview of the use of HIV treatment for prevention was presented by Connie Celum, MD, MPH, Professor of Medicine and Global Health at the University of Washington (see the Wednesday morning plenary at www.retroconference.org). The university is a site for the Microbicide Trials Network. The CAPRISA 004 study of tenofovir gel, used 12 hours before sex and again after sex, with no more than two vaginal applications in a 24-hour period, involved nearly 900 young women in the Durbin, South Africa area. The international iPrEx study involved nearly 2,500 gay men, other men who have sex with men (MSM), and

transgender women (born men) who have sex with men. The study compared a daily Truvada tablet against placebo (dummy pill). There were 11 sites throughout Brazil, Ecuador, Peru, South Africa, Thailand, and the U.S. Again, participants were young, half of them under 25. They were at high risk for infection, reporting a median (half had more than 18 partners and half had less) of 18 sex partners in the 12 weeks before enrollment, with 40% reporting that they had accepted money for sex at some point in their lives. Despite the welcome success brought by both studies, Celum noted that they show prevention methods only work when they’re taken as directed. CAPRISA 004 reported a 39% drop in the risk of HIV overall, but a 54% drop in the women who used the gel more than 80% of the times they had sex. iPrEx researchers reported a 42% decrease in HIV infections, but again, a much higher success rate with the study participants who took their one tablet of Truvada every day. For that group there was a 68% decrease in infection when participants took more than 90% of their Truvada doses. iPrEx researchers also reported a 92% protective effect in people who took Truvada consistently enough to have it measured in their blood samples. These iPrEx results were updated at CROI, representing nearly three years of data. iPrEx Protocol Chair Robert Grant, MD, MPH, of the Gladstone Institutes and P os i t i v e lyAwar e .com

Photo: Jeff Berry

the University of California at San Francisco, pointed out that study participants were warned repeatedly that they shouldn’t depend on the pill they were taking to protect them against HIV, since some of them were given placebo. People got tired of taking a pill that might not be helping them, he said. In addition, greater adherence was seen in the U.S. participants, a population with better awareness of the importance of following the requirements of a clinical trial, he said. In her plenary talk, Celum called CAPRISA 004 and iPrEx landmark studies, with CAPRISA “turning the corner on the microbicide field” and iPrEx being the first to show that PrEP works in humans. “I think [CAPRISA 004] taught us that [tenofovir] is the right drug—if used—and delivers high concentration to the right place. Again [with iPrEx], I think we’ve learned that [Truvada] is the right drug at the right time, if taken,” said Celum. “[But] with moderate adherence we see moderate effectiveness.” She said drug levels measured in the iPrEx study were very important in “teaching us that we need high adherence to get high effectiveness.” She reviewed other drugs and formulations in development for prevention, including monthly injections of rilpivirine and vaginal rings using dapivirine, an experimental HIV drug, or maraviroc (brand name Selzentry). “At the end of the day,” she concluded, “what really matters is how do we get these products into the hands of the people who need them.” P os i t i velyAware.co m

NEW gene therapy proves safe, effective

Quest Clinical Research in San Francisco and lead author of the study, said the hope is to provide positive people An experimental gene with a reservoir of cells that therapy was found to be safe are resistant to the virus. He and to increase T-cells. It also pointed out that the Berlin successfully changed some of patient underwent a very the T-cells themselves. different process, but that To understand the study, his case validates CCR5 as a it is helpful to know that the target for therapy. therapy was developed after In this early safety study, the discovery that some six individuals who were people are naturally resistant undetectable on HIV therapy to getting infected with HIV, or had T-cells removed, modified that their disease progresses by SB-728-T, and then infused very slowly if they do become back into their bodies. All six infected. have been HIV-positive for They are protected against more than 20 years. There the virus because they have was “improved and sustained certain non-functional forms increase in total CD4+ T-cell of the CCR5 protein in their counts” in five of the indibody. The “Berlin patient” is viduals, and normalization of thought to be cured of his the CD4:CD8 ratio (further HIV infection after receiving immune system improvement) CCR5 from one of these rare in three of these five. Further, individuals (see page 13). The the modification benefit of the CCR5 protein is one of two therapy persisted naturally in receptors that HIV uses to the body after infusion, with enter the body’s T-cells. a median 2.9-fold increase of The therapy SB-728-T CCR5-modified cells. was designed to provide Short-term flu-like sympprotection against the virus toms following infusion and by genetically modifying a a garlicky body odor were person’s CCR5. Presenter the most common adverse Jay Lalezari, MD, Director of events reported. There were no serious adverse events, with a followup time for the six participants ranging from 85 to 366 days past infusion. There was no increase in liver enzymes or any other lab abnormality. SB-728-T modifies CCR5 with a technology called “zinc finger nuclease,” or ZFN. Basically, zinc Jay Lalezari, MD, director of Quest fingers are proteins Clinical Research, San Francisco. that can change

genetic material, such as DNA. In the case of SB-728-T, zinc fingers are being used to alter the CCR5 receptor on a person’s T-cells. The study found ZFN-modified T-cells grafted, expanded, and persisted in peripheral blood at higher rates than expected. They also grafted and persisted in rectal tissue, an important site for protection against HIV. At a press conference following the presentation, Lalezari cautioned reporters against using the word “cure,” as has been done with the Berlin patient, but stated that “this is the best you could hope for in this type of study.” Further studies are currently underway or being planned.

attachment inhibitorS— A new drug class emerges Data from a Phase 1-2a study showed favorable results for a new class of drug, attachment inhibitors, which are still in the experimental stage. Attachment is the step in viral replication that occurs right before entry and fusion, and an attachment inhibitor would block the virus from entering the CD4 cell. BMS-448043 demonstrated proof of concept in an earlier study. BMS-663068 (068) is actually an oral prodrug of a next generation attachment inhibitor, BMS-626529— meaning that the inactive form (068) metabolizes into the active form (529) once inside the body. 48 treatment-naïve and experienced individuals with a viral load of 5,000 or more, M ay + J u n e 2 01 1

Conference report Jeff Berry & Enid VÁzquez

who had been off treatment for eight weeks were given 8-day monotherapy using once- or twice-daily doses of 068 at 600 or 1,200 mg, with or without ritonavir boosting. Study participants saw up to a 1.78 log drop in viral load, along with increases of between 28 and 106 CD4 T-cells. There were no discontinuations due to adverse events (AEs), and no serious AEs reported. The most common side effects were headache and rash. A Phase 2b study in treatment-experienced individuals using smaller doses taken once or twice daily and potentially without boosting is scheduled to start later this year.

FDA eases Abacavir Concerns For years there’s been concern about a mystifying potential risk of heart problems with abacavir (brand name Ziagen, also found in Epzicom and Trizivir). Now a meta-analysis from the U.S. Food and Drug Administration (FDA) shows no extra risk. The FDA collected information from a number of randomized clinical trials—RCTs are one of the best ways to run a study. The FDA found “No significant difference in frequency of MI [heart attacks] between patients receiving abacavir-containing regimens vs. non-abacavircontaining regimens.” The analysis examined 26 RCTs, of which 16 were run by the maker of abacavir. There were nearly 10,000 study participants involved in these 20

May+June 2011

studies, with a little over half given abacavir. There was no difference in the results when comparing the pharmaceutical-run studies and the other trials (conducted by academic centers or the U.S. government). Nor was there a difference within the different studies themselves or with the length of time in which participants were followed. In discussing the background for conducting this analysis, the FDA cited “conflicting evidence from different datasets regarding possible association of abacavir use with increase in MI risk,” and listed the following as included in that discrepancy: n The D:A:D cohort study reported an association between recent abacavir use and increased MI risk. n The SMART study observed an association between recent use of abacavir and increased risk of cardiovascular disease when data from the continuous antiretroviral therapy arm was retrospectively analyzed. n A pooled analysis of the manufacturer’s database and meta-analysis of data from randomized ACTG [AIDS Clinical Trials Group] studies found no such association.

New integrase inhibitor and Isentress resistance The ViiV/Shionogi integrase inhibitor S/GSK1349572, now with the name dolutegravir (DTG), continued to show

activity against Isentressresistant virus and was generally well tolerated at a higher dose in an advanced population. Particpants with screening plasma HIV-1 RNA (viral load) of more than 1,000 copies/mL showing genotypic resistance to Isentress and to two or more other ARV classes received 50 mg twice daily of DTG while continuing their failing regimen (without Isentress) to day 11, after which the background regimen was optimized (changed to drugs expected to be most effective for each individual). This data was from the VIKING study, and there were two cohorts—this presentation (151LB) focused on the second cohort. Unlike cohort I, eligibility required at least one fully active ARV for day 11 optimization. Dolutegravir 50 mg twice daily will be studied in Phase 3 with those who have integrase inhibitor resistance, and 50 mg once daily for those whose virus is susceptible to integrase.

once-daily Isentress halted As reported in the January/ February issue of Positively Aware, a Phase 3 study looking at once-daily vs. twice-daily Isentress was stopped in November of last year because the 800 mg once-daily dose did not demonstrate non-inferiority to 400 mg twice-daily. According to an oral presentation (150LB) by Joseph Eron, MD, the study of 770 treatment-naïve individuals

combined Isentress with Truvada (which is one of the initial preferred regimens recommended by the DHHS), and looked at the two different doses, and 88.9% in the twice-daily group achieved an undetectable viral load at week 48, while only 83.2% reached undetectable in the once-daily group, which did not meet the 10% margin of non-inferiority.

If 3 DRUGS are good, are 5 better? Intensification of drug therapy (adding on one or more active agents to existing background therapy) in an effort to improve outcome or even eradicate the virus is something that has garnered additional interest over the last few years, especially with the advent of several new drug classes. A small study presented at this year’s CROI (148LB) looked at whether 5-drug ART initiated in the setting of acute and/or early infection, using a CCR5 antagonist and an integrase inhibitor, would improve outcomes when compared to standard 3-drug PI-based ART. Forty individuals received either a 3-drug combination of Prezista or Reyataz boosted with Norvir, in combination with Truvada, or 5-drug ART with the above drugs and the addition of both Selzentry and Isentress. The study found that adding Selzentry and Isentress to the standard PI-based ART did not provide any additional significant virological or immunological benefit. Although patients in the 5-drug arm achieved P os i t i v e lyAwar e .com

undetectable viral load more rapidly, the two groups were comparable by week 16. Three of 26 reportedly adherent patients (by history) unexpectedly experienced virologic failure on the 5-drug arm, but it remains unclear exactly why. Lead author and presenter Marty Markowitz, MD, of the Aaron Diamond AIDS Research Center in New York City, stated that he was disappointed in the study results since he was hoping that we could go further with antiretroviral therapy than we have so far, because the next strategy in HIV therapy is to think about how we can do better than lifelong therapy. He concluded with the statement that although there is more work to be done in this study and others, that perhaps “upping the ante from the get go” is not the answer.

Photo courtesy of shipra shikula, kathaka films

prodrug of Viread More potent

Life Before the Lifeboat

At CROI, a documentary chronicles the early days of AIDS in San Francisco Who better to speak about the history of the HIV epidemic in the U.S. than someone who witnessed it from the early days at San Francisco General Hospital? So it was that Paul Volberding, MD, director of the hospital’s AIDS program, was chosen to talk about that legacy as the 30th anniversary of the epidemic was examined at this year’s Conference on Retroviruses and Opportunistic Infections (CROI). Rather than lecture, however, Volberding chose to play a documentary that he helped develop a few years ago called Life Before the Lifeboat, about the city’s response when the epidemic started. “I’ve been at this for very long, since day one,” said Volberding in an interview, “and I’ve realized that none of us remember things the same way.” Moreover, he found it “striking” that many new medical providers, owing mostly to their youth, knew so little about those terrible days. In Life Before the Lifeboat, medical providers and patients recount some of the most emotional moments reflecting highlights of the epidemic: Fear of contagion and taking a fatal disease home to your family at a time when no one knew what caused it. Crying in front of a patient. Leaving the repressive atmosphere of a small home town and finding freedom in San Francisco, then one day, waiting to die. “It’s very different today, fortunately,” Volberding noted. “There was a lot of fear. Today there’s still stigma, but not much fear.” Overcoming those fears, responding quickly in the absence of adequate knowledge, and working with community organizations were among the early lessons of the epidemic. San Francisco General Hospital opened the first AIDS unit in the country, as well as the first AIDS outpatient clinic. “It’s hard to believe it’s been 30 years. Sometimes it seems like 90 years!” he said with a laugh. “It depends on how tired I am.” Tired perhaps, but also deeply satisfied. “We had an amazingly tight connection to our patients,” he recounts, “closer than seen with any other disease. It was intense. We were learning about the virus, and always willing to go as fast as we could. I consider it an amazing privilege to have been a part of that early response.” —Enid Vázquez

GS-7340 is the prodrug of Viread (tenofovir) and was shown to be much more potent than Viread in an earlier study. This Phase 1-2 dose-finding study looked at treatment-naïve individuals with 200 or more CD4s and a viral load of at least 15,000. GS-7340 is metabolized in the lymphoid tissue, so it is less likely to have the same kidney or long-term toxicities as Viread, but like Viread, should also be active against hep B. During the presentation (152LB) Andrew Zolopa, MD, stated that the lower dose (50 or 150 mg once daily) will permit coformulations with other drugs that are not possible with the current formulation of Viread. P os i t i velyAware.co m

M ay + J u n e 2 01 1

AIDS30

On the 30th anniversary of the CDC’s first AIDS report, a personal timeline set against the backdrop of an epidemic  1,500,000

By Rick Guasco

arc Antoni Castillo was born with HIV on St. Patrick’s Day, 1981. Less than three months later, on June 5, the U.S. Centers for Disease Control and Prevention (CDC) would issue its first report about the mysterious deaths being caused by GRID (Gay-Related Immune Deficiency)—what would come to

June 5, 1981 The CDC Morbidity and Mortality Weekly Report (MMWR) mentions the first cases of Pneumocystis pneumonia in young gay men and marks the official beginning of the HIV/AIDS epidemic in the U.S. The unusual occurrence of Kaposi’s sarcoma among young gay men was reported in July.

 1,300,000

 1,100,000

 900,000

 700,000

 500,000

1982

1983

1984

1985

1986

1987

Acquired Immune Deficiency Syndrome (AIDS) is established as the term used to refer to the illness. Four “identified risk factors” are defined: “male homosexuality, intravenous drug use, Haitian origin, and hemophilia.” Mainstream media coverage of the epidemic begins to be more prevalent with reports in major newspapers and on television.

In France, Dr. Luc Montagnier identifies the virus later to be known as HIV. The U.S. Public Health Service issues recommendations aimed at preventing transmission through sexual contact and blood transfusions.

American Dr. Robert Gallo identifies HIV as the cause of AIDS. The CDC states that eliminating needle-sharing and abstaining from intravenous drug use can prevent transmission of HIV. San Francisco, Los Angeles, and New York order bathhouses to be closed.

Actor Rock Hudson announces he has AIDS and later dies. Ryan White, a young teenage boy with AIDS, is barred from attending middle school in Indiana and speaks out publicly against stigma and discrimination. Project Inform is founded. An Early Frost, the first TV movie about AIDS, airs on ABC.

AZT begins clinical trials. U.S. Surgeon General C. Everett Koop calls for HIV education and condom use. The first panel of the AIDS Memorial Quilt is created.

President Ronald Reagan makes his first mention of AIDS and establishes a Presidential Commission on HIV. The U.S. puts HIV on its immigration exclusion list. ACT UP (AIDS Coalition to Unleash Power) is formed. Liberace dies of AIDS.

August 1985

➚

Marc starts preschool.

Total number of People in the U.S. living with HIV number of new hiv infections in the U.S.

 300,000

➘

 100,000

March 17, 1981 Marc Antoni Castillo is born at Illinois Masonic Hospital in Chicago. Unknown to his mother or the hospital, Marc is born with HIV. 1982

1981

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1983

1984

1985

1986

1987

P os i t i v e ly

and dying,” Marc’s mother, Marta Santiago, said. “I remember thinking this had nothing to do with me.” It wasn’t until Marc’s father died in 1994 that Marta learned her ex-husband (they divorced nearly 10 years earlier) had been HIV-positive. When Marc tested positive in 1989, doctors were so surprised that they told his mother they had “lost” the inital results

Photo: Ayrick Broin

be known as Acquired Immune Deficiency Syndrome, or AIDS. So little was known about the illness—how it was spread and who was at risk—that it wasn’t until just before Marc’s eighth birthday that he and his mom learned that she was HIV-positive and had passed the virus on to her son at birth. “Back then, it was just [gay] males who were in the news who were getting sick

1988

1989

1990

1991

1992

1993

1994

Ryan White testifies before Congress. The International AIDS Society is formed. The first World AIDS Day is held.

The U.S. bans HIVpositive foreign travelers from entering the country. Dr. Anthony Fauci of the National Institute of Allergy and Infectious Diseases endorses a policy giving those who don’t qualify for clinical trials access to experimental treatments. Dancer and choreographer Alvin Ailey and photographer Robert Mapplethorpe die of AIDS.

Ryan White dies at the age of 18 and the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act is enacted by Congress. Artist Keith Haring dies of AIDS.

The red ribbon is introduced as the symbol of AIDS awareness by Broadway Cares/ Equity Fights AIDS and Visual AIDS at the Tony Awards. Basketball star Magic Johnson announces he is HIV-positive.

AIDS becomes the number one cause of death in the U.S. for men ages 25 to 44. HIV-positive advocates Mary Fisher and Bobby Hattoy address the Republican and Democratic national conventions, respectively. Tennis star Arthur Ashe announces he has AIDS; he dies the following year.

President Bill Clinton establishes the White House Office of National AIDS Policy. Angels in America opens on Broadway. The film Philadelphia, starring Tom Hanks as a man with AIDS, opens. Ballet dancer Rudolf Nureyev dies of complications from AIDS.

AIDS is the leading cause of death for Americans ages 25-44.

1995 The FDA approves Invirase (saquinavir), the first protease inhibitor, ushering in the era of Highly Active Antiretroviral Therapy (HAART). Olympic gold medal diver Greg Louganis announces he is HIV-positive.

October 1989

June 1991

April 1993

Marc takes up martial arts training and kickboxing at the local YMCA.

Marc attends his first year at Paul Newman’s Hole in the Wall Gang Camp.

Marc begins treatment with AZT and Bactrim.

October 1994 Marc’s father dies. It is only then that the HIV status of his father is discovered.

July 1989 Marc meets Ryan White at a summer camp for kids with serious illnesses including HIV.

October 1990 March 1989 Just before his eighth birthday, doctors discover Marc has HIV.

1988

Awa r e .com

1989

1990

During a discussion in class about health, Marc blurts out loud that he has HIV. Despite some negative reaction, the overall community expresses their support for the unnamed student.

1991

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1993

1995

1994

M ay + J u n e 2 01 1

AIDS30 |

The life of One person born HIV-Positive set against the backdrop of an epidemic

1996

1997

1998

2000

The first viral load test measuring the level of HIV in the blood is approved. Rent opens on Broadway.

The first two-drug combination pill, Combivir, is approved. AIDSrelated deaths drop by over 40%. HIV researcher David Ho is Time magazine’s Man of the Year.

The DHHS issues the first set of HIV treatment guidelines for antiretroviral therapy in adults. Several reports surface of treatment failure and side effects from HAART. The U.S. Supreme Court rules that the Americans with Disabilities Act covers people in the early stages of HIV, not just AIDS.

The U.S. intelligence community and the United Nations Security Council each declare HIV/AIDS poses a global security threat.

➚

Marc gets his driver’s license and shortly thereafter, his first car.

number of new hiv infections in the U.S.

➘

1997

1998

and needed to administer a second test. “Most children who were HIV-positive were either very sick or near death,” Marta explained. “The doctors thought Marc was too healthy to be positive.” During a discussion in fifth grade health class, Marc blurted out that he had HIV. The school held an informational meeting at which doctors and HIV educators addressed concerns raised by parents. One worried father demanded to know the identity of the HIV-positive student, but 24

2002 HIV is the leading cause of death worldwide among ages 15 to 59.

June 2002

Total number of People in the U.S. living with HIV April 1997

1996

2003 George W. Bush announces the President’s Emergency Plan for AIDS Relief (PEPFAR).

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JUNE 1998

September 1999

Marc and his mother attend the XII International AIDS Conference in Geneva.

Marc begins attending community college, initially to study business.

Marc begins dating Alicja.

July 2002 Marc and his mother attend the XIV International AIDS Conference in Barcelona.

September 2002 May 1998

May 1999

Marc reveals his HIV status to the girl he has been dating.

Marc graduates from high school.

1999

As their relationship becomes more intimate, Marc discloses his status to Alicja.

March 2003 Marc and Alicja move to Central California.

2000

the school administration protected Marc’s privacy. Still, “it felt like we were criminals,” Marta said. Despite some negative reaction, however, the community on Chicago’s North Side expressed their support for the unnamed student, and Marc continued attending school without incident. There was one close call. By April 1993, Marc had begun treatment, taking AZT and Bactrim three times a day. A friend walked home from school with Marc and saw him taking his afternoon dose. The boy

2001

2002

2003

asked what the pills were for. Marc quickly answered that it was heart medication; his mother said it was for Marc’s “head.” The friend didn’t question the mixed responses. The mid-1990s saw Marc attending Gordon Tech, a Catholic high school in Chicago. Marc was like many other kids in high school—he got his first job, his driver’s license, and began deejaying at house parties. Following his junior year, he revealed his HIV status to his girlfriend P os i t i v e ly

2004

2005

2006

2007

2008

2009

2010

The first round of funding begins for PEPFAR, a five-year, $1.5 billion initiative to address the epidemic in developing countries.

The FDA grants tentative approval of a generic AIDS drug regimen for purchase through PEPFAR under the FDA’s new expedited review process.

The first once daily single-pill regimen, Atripla, is approved.

The FDA approves Selzentry (maraviroc), an entry inhibitor, and Isentress (raltegravir), the first integrase inhibitor.

The CDC releases new HIV case estimates showing that the U.S. epidemic is worse than previously thought.

A study of 532 serodiscordant couples in Kenya shows that many couples risk HIV transmission in order to become pregnant.

The White House unveils the first ever National AIDS Strategy. The “Berlin patient” is reported cured of the virus.

1,500,000 

2011

1,300,000 

Actress Elizabeth Taylor, AIDS advocate and amfAR founder, dies of heart failure. 1,100,000 

December 2007

September 2009

On Christmas Eve, Marc proposes to Alicja.

Marc and Alicja make the decision to conceive a child. Marc meets up with his mother at the U.S. Conference on AIDS in San Francisco.

January 2008 Marc and his fiancée Alicja begin discussing having children, and what that will mean for them as a sero-discordant couple.

900,000 

July 2010 October 2008 Marc and Alicja return home to Chicago to be married with family and friends present.

700,000 

Marc’s wife Alicja gives birth to a daughter, who is HIV-negative.

September 2010 Unrelated to his HIV, Marc is hospitalized over Labor Day Weekend.

500,000 

February 2011 More than 576,000 people with AIDS have died in the U.S.

Following another hospitalization, Marc has surgery.

since the epidemic began, according to the most recent CDC statistics. Still, more than 18,000 people die each year. In the U.S. men who have sex with men account for more than half of all new HIV infections, while Blacks/African Americans make up an estimated 50% of new infections. There are currently over 33 million people worldwide living with HIV/AIDS.

300,000 

March 2011 While recuperating from surgery, Marc spends time with his baby daughter. 100,000 

2004

2005

2006

as the relationship began to get more intimate. Marc’s girlfriend didn’t believe him at first—she thought he looked perfectly healthy. While attending the Hole in the Wall Gang Camp in the summer of 1989, Marc met Ryan White, the Indiana teenager who made headlines as the face of AIDS for the U.S. public. Mother and son had by then had become somewhat low-key activists. Marc and Marta attended the International AIDS Conference in Geneva in 1998. In the Awa r e .co m

2007

2008

summer of 2002, they attended the AIDS conference in Barcelona. That same summer, Marc met Alicja. The two began to date, and as their relationship became more involved, Marc disclosed his status. In 2003, the couple moved to central California. On Christmas Eve of 2007, Marc proposed to Alicja. Soon afterward, they began discussing having children and what that meant to them as a sero-discordant couple. Alicja consulted with her doctor

2009

2010

2011

and obstetrician as she considered the risk of exposure. The couple married in October 2008, but it would take nearly a year before Marc and Alicja decided to attempt conceiving a child. Their daughter was born, HIVnegative, last July. Alicja remains negative. Fatherhood suits him well. “It’s been awesome,” Marc said of his baby girl. “She’s become my everything.” e Timeline graphic by Joshua Thorne

May + J u n e 2 01 1 | 25

ONE ON ONE

Point

man

Since the beginning, Dr. Anthony Fauci has been at the forefront of the AIDS epidemic. He looks back now on how things have changed Interview by Jeff Berry

With an annual budget of nearly $5 billion, Dr. Fauci oversees research on the prevention, diagnosis, and treatment of HIV/AIDS and other sexually transmitted infections (STIs), influenza, tuberculosis, malaria, bioterrorism, transplantation, and immune-related illnesses. He is also a key advisor on global AIDS issues to the White House and the Department of Health and Human Services, and was awarded the Presidential Medal of Freedom in 2008. In his first ever interview with Positively Aware, Dr. Fauci talks about some of the many accomplishments we’ve made as well as the challenges we continue to face, while he also gives us a personal glimpse into his own life, and the things that are most important to him. JB: As someone who’s been a leader in the fight against HIV and AIDS since the beginning, what do you see as some of the most significant achievements we’ve made in the past 30 years? 26

May+June 2011

AF: Well, there’s a whole line of them—obviously the first major achievement was, a couple years into the epidemic, to identify the virus relatively rapidly. It was quite a mystery for a couple of years there, and that [identification] led to the development of a diagnostic test, which had a major impact on understanding the scope of the epidemic and practical considerations such as protecting the blood supply. I think that was the first gigantic leap forward which then led to virtually every other major advance over the last 30 years. Certainly, understanding the pathogenesis of the disease and understanding the molecular virology as a basic science tool was critical in everything else that followed, but if you were to ask me, say, ‘you have 30 seconds to tell me the most profound advance that’s occurred over the last 30 years,’ I think, unquestionably, we have to say that was in the area of treatment. As you said, very correctly and appropriately, I’ve been involved as a clinician of basic science, a clinical researcher,

Photo:

Any 30-year retrospective on the history OF HIV and AIDS would be incomplete without the voice of Dr. Anthony Fauci, the Director of the National Institute of Allergy and Infectious Diseases (NIAID) since 1984.

P os i t i v e ly

Photo: awa r e .co m

M ay + J u n e 2 01 1

look at what’s gone on over the last couple of years, particularly the last year Unlike with some other and a half, there has been infections, there will have to the realization that prevenbe a combination of prevention tion will not be unidimenmodalities that used together, sional with HIV, unlike with two, three, or four at a time, some other infections, will ultimately get us out of this that there will have to be difficult situation we’re in. a combination of prevention modalities that used together, two, three, or four at a time, will ultimately get and a science administrator in HIV literally us out of this difficult situfrom the first day that we recognized that ation we’re in with the explosive nature of this was a syndrome back in the summer of the AIDS pandemic. Just in the last year, 1981 and when I first started seeing patients the success that has been demonstrated with HIV who would come into my ward. with circumcision; the modest but, noneI refer to it when I write and speak as the theless, very encouraging success with dark years of my medical career where vira vaccine for the first time in over two tually everyone who came into the hospital and a half decades; the very encouraging would either die very soon or would go on work on topical microbicides that came for a relatively brief period of time in great from Southern Africa; and most recently, pain, discomfort, and illness, and die. In fact, the work on pre-exposure prophylaxis—I the median survival of people during the think all those things in the realm of comearly ’80s, before we had any drug to treat binations of preventions are also major the virus itself, was 27 weeks or so, so it advances and accomplishments. Not to was just a matter of a few months because mention all the other fundamental, basic they didn’t present to you until they were science things that we’ve learned, but far advanced in their disease. Whereas, when you’re dealing with a disease with a currently, given the spectacular, breathtakglobal impact such as HIV, the three major ing, stunning—whatever superlative you things you look at are diagnosis, prevenwant to use—advances in the development tion, and treatment. of an armamentarium of drugs, they have As I told you, the first advance in diagtotally transformed the lives of HIV-infected nosis was way, way back in the first years, individuals. back in 1985 when the blood test was Now, if a young person comes into my developed, the treatments began to trickle clinic—the same clinic or the same hospital in, starting in the mid-’80s with AZT in ward I saw patients in 30 years ago—who’s 1986 and ’87, up to and including the midrecently infected and I put them on an to late ‘90s and into the 21st century with appropriate regimen of a combination of new drugs that began to transform the drugs that we have available to us today, lives of people with HIV. And now we’re in you can do a mathematical modeling the era of rapid advances in prevention. and project that, if that person takes the So those are the three major things you medications, they would live an addithink about when you’re dealing with a tional 55 years. So when you stack that up pandemic. Two of them we’ve done very against the major accomplishments in the well with and right now, if you were to ask translation of basic clinical and biomedical me for the last 30 years what’s the major research to something that is extraordinarily challenge, it is certainly in the arena of critical for patient health, I think the develprevention, but also, the possibility, which opment of the armamentarium of HIV drugs is not going to be easy, of actually curing must rank up there among the very, very people with HIV, of really getting to the top, so that’s the one thing that stands out. point where you can discontinue therapy That’s not to diminish many of the in people without the virus bouncing back. other important findings—I think if you That’s going to be a particularly daunting 28

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challenge; not impossible, but daunting, but I think preventing infection will be much more practical than anything else. JB: What do you see as some of the major pitfalls or stumbling blocks we’ve encountered along the way? AF: I think one is a scientific one and many are implementation ones. I think the scientific thing is being unable, in a timely fashion the way we would have hoped, to be able to develop a safe and effective vaccine. I think that’s because HIV is such a unique virus in that the body’s immune response to HIV is not adequate or capable of ultimately suppressing or controlling the virus. If you look at all the historical maimers and killers among viral diseases—smallpox, measles, polio, hepatitis, and others—even though they cause a degree of morbidity and mortality, at the end of the day, the body is quite successful in ultimately suppressing and eradicating the virus and then giving the person who’d been infected lifelong immunity against re-infection. It’s because of that that we’ve been able to develop successful vaccines against these viruses, because the body has already proven to us the concept that it’s capable of developing an adequate immune response. We don’t have such luck with HIV because, thus far, it’s clear that the body has a real tough time in making an adequate immune response. So we have to do better than natural infection. We have to figure out a way to induce in the body a protective response with a vaccine that the actual infection itself is not capable of doing and that’s a very, very daunting and challenging task. That’s probably the prevalent, predominant, overriding scientific challenge that we face today. With regard to implementation challenges, I think they’re very, very clear. You still have 2.7 million people infected each year; we have 1.8 to 2 million deaths per year; and we still have not been able to get adequate treatments to any more than 30 or 40% of the people who need them worldwide, which means that 70% of the people who could benefit from therapy don’t have it for a variety of reasons— access, resources, health care systems, P os i t i v e lyAwar e .co m

etc. The other thing is that even though there are very effective prevention modalities, only a relatively small percentage of people who could benefit from availability of these prevention modalities actually have access to them. So I look upon it as two different types of challenges; one is the scientific challenge, as I mentioned, which is fundamentally around the vaccine; and the other is implementation challenges. JB: You’ve been a major supporter of the involvement of the community in research, drug development, and helping to identify and establish priorities. Can you tell us why you feel community involvement is so important? Is there an issue that you feel needs more community involvement? AF: I think we need to continue. You’re absolutely correct—back in the mid- to late ’80s, I got very involved in changing the paradigm of how we look at HIV research and implementation of programs because I was very impressed with the fact that this was such a unique, unusual situation early on when we had no treatments, that the people who were actually impacted by this virus really had good insight into what we in the scientific community and in the regulatory community could do to hasten the process of getting effective intervention to them. Clinical trials aren’t very good or beneficial if the people you’re doing the clinical trials on are not enthusiastic about getting involved and feel that they’re too stringent or not properly designed. The same thing holds true with policies that you need to implement. I’m a strong believer in that and I still think that we need to continue to involve the community and right now, we’re seeing a lot of that with the international community. The fact that we have therapies available in South Africa now is due, in large part, to the activist communities in South Africa demanding that the government abandon their totally unjustifiable and antiquated approach to HIV, which was really responsible for the deaths of a lot of people. The community was the one that triggered the outrage about that, so there’s still a big role for the community in pushing programs forward that are not getting the proper attention. P os i t i velyAware.co m

JB: Much of the HIV/AIDS advocacy movement was born in a time when activists were protesting by chaining themselves to the chairs of policy makers and staging die-ins. What issues do you think will motivate the advocates of the next generation and how will their actions be different?

I do think that a moderately effective vaccine in combination with other prevention modalities is going to go a really long way towards turning around this epidemic. that’s what I’m really excited about.

AF: I think that what’s going to motivate them is to call attention to the fact that, even in times of stringent resources and constraints on resources, the global society has an obligation to treat people who are infected with HIV globally—most of the difficulty goes on in the developing world, but even in the United States, when you have programs, for example, that cut the availability of drugs through our ADAPs [AIDS Drug Assistance Programs], I think the activists are going to be the ones who have to call attention to the fact that for, relatively speaking, what’s not a lot of money, you’re talking about the real capability of saving lives. Activists are very good at bringing that to the attention of the authorities.

other one is the combination of prevention, including the development of a safe and effective vaccine. I don’t think we’re going to get a vaccine that’s 95% protective the way some of our really effective vaccines are, like polio and measles and others, but I do think that a moderately effective vaccine in combination with other prevention modalities is going to go a really long way towards turning around this epidemic. So that’s what I’m really very excited about— new prevention modalities as well as trying, hopefully, to get a cure.

JB: What would you say to a health care provider or researcher just entering or thinking of entering the field of HIV/AIDS or infectious disease?

AF: I think we pretty much hit on the priorities. Obviously you always need new drugs in the pipeline, particularly if you’re thinking in terms of a cure. You need to get drugs that have mechanisms of action that actually get virus that’s not expressed but that’s hiding in the reservoirs, so that’s a big challenge—and we’re continuing to emphasize this whole issue of a cure.

AF: Well, infectious disease is certainly a general area you could say this about, but more specifically, about HIV—if you want to have an impact, a real important impact, a field like HIV where so much can be done and so much still needs to be done, I couldn’t think of a better area to get involved in than infectious diseases in general, and specifically with HIV, because for the amount of effort you put in, the amount of benefit that you can accrue to people is extraordinary. JB: What are some of the areas of research and study that you are the most excited about? AF: I think I said that one is the cure; the

JB: Are there other areas that you feel we need to focus on in the years ahead that have been unfunded, underfunded, or not viewed as a priority in the past?

JB: I’m sure you’re aware that recently there’ve been proposed budget cuts targeting research and science, so how would we prioritize what gets funded? AF: Well, prioritization is always difficult, particularly when you have many worthy projects to be done. You just have to sit down and figure out, given the resources we have, what’s the best bang for the buck? That’s a difficult process—you have to go project by project and agenda by agenda. M ay + J u n e 2 01 1

JB: What would you most like to be remembered for? AF: Ahhh, I think probably something that has indirectly to do with the science of HIV. It was my involvement in designing and being a principle architect of what ultimately turned out to be the President’s Emergency Plan For AIDS Relief [PEPFAR]. President [George W.] Bush sent me to Africa in 2002 to figure out if there was any way that we could have an impact on the epidemic in sub-Saharan Africa and the Caribbean. I spent about eight months of my life designing, fine-tuning, modeling, and finally coming up with a proposal for the PEPFAR program. It was to my great gratification that all that time I put in going back and forth to Africa, trying to model something that would be accepted and the fact that he did pledge and ultimately put more than $15 billion in that, if I were to pick out the one thing in my career, even though it wasn’t something that I did at the bench or with a patient, it was developing a program that the President was very enthusiastic about. I would consider that right up there in the top things I’ve done.

AF: Yes, in fact I was really quite successful as a basic immunology/infectious disease researcher from 1972 to 1981, and when the first cases of HIV/AIDS started to trickle in, I made a conscious decision that I felt this was going to be a huge, huge global pandemic and I actually wrote about that in 1981 and ’82—that we were being somewhat naïve to think that this was going to stay constrained to a relatively restricted population of people. I turned around the direction of my career at that point and left an area that I was very successful in to start working on HIV, and I’ve been doing that literally for the last 30 years. And I think I’m going to keep doing that until we get to the point where I can feel comfortable that we really have turned around the pandemic. The answer to your question, the short answer, is yes, this is my life’s work. JB: It’s easy to imagine that your work 30

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consumes much of your time. So may I ask what you do for fun? AF: [Laughs.] Good question! My family asks me that too! I’m really a classic case of a workaholic. My fun is modest things— I run everyday, I get a lot of pleasure out of running; whatever time I have, which isn’t a lot, I spend with my family. I have three grown children now in college, and I like [doing] outdoor things, but I don’t get a chance to do them very much. JB: Are any of your children going into research or medicine? AF: No. I think because of me and my position and my notoriety, they tend to shy away from that the way some children do. They don’t like to essentially follow the footsteps of the parent, but they’re interested in public service, for sure, deeply interested in public service. Whether that is going to be in medicine or not, I think time will tell, because they’re still relatively young. I hope they do—I think it would be a good field for them.

JB: Are you still seeing patients? AF: Yes, I am! In fact, I made rounds on AIDS patients this morning at 9:30, actually. I see patients twice a week, every week, year round. JB: How is it different now? Is it fulfilling whereas before, it was a dark time? AF: Well, it was fulfilling before even though it was dark. It’s a little different now, because you see patients come in and you put them on therapy and they turn around within a few weeks from being close to death to being able to walk out of the hospital. I never forget the days and the years when I was in there day and night and they were dying no matter what I did for them. It’s interesting—some of the residents making rounds with us are 28, 29 years old. They weren’t even born when the first cases of HIV were around, so they don’t have a clue how bad it was back then, so it’s kind of an interesting experience to make rounds with them having seen both sides of that coin. e P os i t i v e lyAwa r e .co m

Photos courtesy of Anthony Fauci

JB: Do you view this as your life’s work, and if so, did you make a conscious choice that it would be?

A Tale of Two Healers David Moore and David Blatt remember 30 years of treating HIV-positive patients By Sue Saltmarsh

Photo: Joshua Thorne

First, I must disclose my bias. David Moore was the first primary care doctor I ever had. At the age of 52, traumatized by my body’s sudden crash, I found him to be the kind of true healer I needed. So I can’t be “objective”—I like the guy, and I also like his life partner, David Blatt, who was also his partner in their medical practice. It all started in 1982 for Moore, who was involved with the group who started the original Howard Brown Memorial Clinic in Chicago. He explains, “We were seeing discrimination towards gay men in health care, so it was a great idea. It was a wonderful sort of renegade, bythe-seat-of-the-pants kind of experience, which HIV also became, so it was truly a training ground for doing what needed to be done. When we finished our residency, started our practice, we began to read in the newspapers about GRID [Gay-Related Immune Deficiency] that was happening in Los Angeles and New York with skin cancer [KS] and rare pneumonia [PCP] occurring in gay men.” P os i t i velyAware.co m

Moore went to the first AIDS gathering in New York in the fall of 1982, put together by an infectious disease doctor and a dermatologist, at Sloan-Kettering. He saw his first KS lesion in the practice two weeks later. Blatt points out, “In the whole country, the number of physicians who were dealing with this was small enough that by going to these meetings, we were able to really network with people, so it was easy to call people and say, ‘We’ve seen such and such. Have you seen this too? What are you doing?’ Often it would be informing, but other times it would be affirming and reassuring to find out that other people were doing the same thing.”

In talking about the response of the greater medical community to this emerging disease, Blatt says, “I feel like it was really mixed. From the get-go there were people who were frightened and just phobic about the groups involved, who didn’t want anything to do with it. But we also ran into this whole wellspring of people who were very eager to help, so I think we had a specialist in almost every area we needed. I felt well supported that way. But there were some…” “There were people who wouldn’t see patients,“ Moore finishes, with a hint of ire. “And there was a lot of education that had to be done among the nursing and adjunct health care staff,” Moore continues, “because they were all frightened and we didn’t know how the disease was transmitted, so everyone was gowning and gloving and masking. Early on, the CDC determined that this was being transmitted like hepatitis B, so it could be protected against with body fluid precautions. As it turns out, it was much less infectious even M ay + J u n e 2 01 1

than hepatitis B, so David and I were doing a lot of in-service to get people comfortable not donning that kind of protection so that the patients were being touched and held and cared for in an appropriate, empathic, and compassionate way.” They led by example, Blatt remembers. “When the nurses on the unit would see us just sitting on the bed, holding people— well, actions speak louder than words.” The lesson he took from their experience educating their colleagues and support staff was that there was a group of people really hungry for knowledge and to be reassured, and once you gave them the facts, they were fine. “Then with another crowd, it didn’t matter how much data or facts there were, they were just hungry to perpetuate their misconceptions. So it was really easy to teach and reassure the people who were open, but it was impossible otherwise.”

Unit 371 As scared as the hospital staff may have been, the worst fear was among the patients, and the doctors came up against a quandary. Would it be good to create a safe haven, a unit separate from other patients, where they could get the specialized, expert, and compassionate care they needed? Or would being separated from the general population just add to feelings of stigma, isolation, and discrimination that their patients already may have felt? In the end, inspired by the AIDS unit he saw at San Francisco General, Moore joined with Blatt to create Unit 371 at Illinois Masonic Hospital. “I was really impressed with what they’d done in San Francisco,” he says, “and thought this was the model, combined with an open staffing strategy where you create a nonhierarchical interdisciplinary team. That model worked really well so that every patient got an amazing amount of attention and care in a multi-disciplinary way.” In fact, Unit 371 “became a model for AIDS units in medical centers across the United States,” as stated by the Chicago Gay and Lesbian Hall of Fame, into which they were both inducted in 2007. The unit ran until 1998 when, thanks to advances in treatment, the need for AIDS inpatient care was no longer as great. 32

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There were many challenges in those early years—lack of knowledge, lack of treatments, lack of funding—but when it came to the day-to-day function of their practice, both agreed that one of the most challenging things was that they had to perform case management as well as providing medical treatment. “We had a lot of indigent or uninsured patients in those days,“ Moore explains. This was before the AIDS Foundation of Chicago offered case management services. “Between the nurse in the office and the social worker in the hospital and us, we tried to patch together care for people.” Access to housing, nutrition, in-home care, and other services was all left to them and their team. “It was the logistics of responding to what the disease was doing to the person,” he adds. Although treatment options were increasing, the slowness of the drug development process resulted in many of their patients developing drug resistance, and some would “ping-pong” between getting better and getting worse with each new experimental drug. Even with the availability of protease inhibitor drugs in the early to mid-‘90s there were difficulties. When some patients started to look and feel healthier, they also had to go through “the psychological re-adjustment from ‘I am dying’ to ‘I might live,’ which was harder for some than you can imagine,” according to Moore. Blatt remembers that another aspect of the advances in treatment was “the bittersweet phenomenon of survivor guilt, people who survived their lovers who would feel downright guilty because their lover died the day before an improvement came along.” Moore, whose first partner he met in college and lost in 1994, remarks, “Everyone has those kinds of stories. If only, if only…”

Compassionate care One of the reasons I’d chosen David Moore as my own doctor was that he was open to alternative therapies and, indeed, they included alternative therapies in their program. There was a pharmacy on the first floor that sold herbs and supplements that could ameliorate symptoms like neuropathy and diarrhea.

Moore also studied acupuncture and Reiki, and taught yoga—“I tried to learn as much as I could to help whoever I could help,” he adds. Practicing yoga and attending spiritual retreats taught him how not to identify with outcome, which helped tremendously in the years when the outcome was almost always bad. Moore believes that his more metaphysical pursuits showed him that the main thing was, as he put it, “to just be present as a human being who’s going to ultimately follow the same path sooner or later. There’s no reason to think that there’s anything but a fine line between us, so I’m here with whatever resources I have to do the best I can, given what you’re dealing with. And out of that came possibility. When you don’t have a pre-ordained idea of what healing means, you make room for different types of healing to happen.” “From the beginning, our practice was set up to bring out the best in ourselves and our patients,“ says Blatt. “It easily could’ve been either of us who was a patient…” “For a long time, we thought we probably were infected,” interjects Moore, referring to the time before there was a test. “From ’82 to ’85 there were a lot of days caring for friends and patients who were dying, assuming the same experience was in your path. It was a long, scary, frightening time and there’s a humility that certainly comes from that, and a need to do as much as you can, as quickly as you can, because you don’t know how long you’ll be able to.” There were hospital staff, family, and friends who were caregivers one day and patients the next. Blatt refers to it as “role-blur,” a term which may have been coined by the staff of their practice. They soon saw that they would take turns being sick or healthy, that everyone had stronger days and weaker ones. “We all lived with AIDS,” Moore adds, “It didn’t matter whether you were positive or negative, everyone was…in the soup.” When the need for inpatient care declined, the focus shifted more to an outpatient practice. Blatt remembers that the adjustment from the intensity and urgency of the early days to the more hopeful, less P os i t i v e lyAwar e .co m

fearful times when drugs became available was difficult for some who had participated in the inpatient unit. “We continued to care for people because we were their doctors, but a lot of the patients’ nurses were floundering. It had been so intense and so meaningful caring for patients—they were all good people, it wasn’t that they were sorry that things had improved. They just missed ‘fighting the good war,’ so to speak.”

Photo: Joshua Thorne

Health care Though neither is practicing now, I wanted to ask them about their feelings on the current health care system in the U.S. It was no surprise to hear that they are both big supporters of single-payer health care, since they had experienced it both from the physician’s point of view and also through their patients. “It just makes so much sense,” Blatt says. “I think that, prior to retirement, every single patient I saw would bring up some concern and it would be the natural response to say, ’Well, if we had a singlepayer system, we could be addressing this concern you have whether it’s paperwork, billing, pre-existing conditions, or not having coverage.’” “What’s happening in health care is P os i t i velyAware.co m

very painful to watch,” says Moore. “It’s gotten worse and will continue to deteriorate until people are ready to take a stand. Single-payer would put prevention first because there’s only one pocket and that pocket has limited resources, so you want to keep people healthy. Coming from the provider perspective, that’s where we should’ve been all along – we’re too focused on disease and procedures and not prevention or selfempowerment of patients, but it’ll bring that front and center and everyone will benefit from that.” “Towards the end of our practice,“ Blatt says, “any time I was doing preventive care, I felt like it was almost in spite of the system. You get paid for doing chemotherapy, not for doing prevention, sitting down one-on-one with a patient and talking about smoking or safer sex.” “We can’t even decide that we should pay people for counseling about end-oflife care,” says Moore, “It gets labeled a ‘death panel.’ I mean, what is wrong with this country?” he demands. “What I saw over and over was young people with this disease trapped in their jobs, concerned that they couldn’t get coverage again. And that’s just the world of HIV. Imagine it multiplied across the whole spectrum of chronic diseases and how many people are stuck where they are for fear of losing their health care benefits. We as a culture, as a society, lose their ingenuity, their passion, their ability to go out in an entrepreneurial way and create something we could all benefit from. That’s insane! The opportunity cost is huge! It hurts us all, and if there’s a single person who thinks they’re not hurt by this system, they’re not awake.”

Retirement So what brought on the decision to retire? “Life!” answers Blatt. “I loved and miss my patients, really, but my view is that if you take doctoring seriously, try to keep up, try

to really pay attention to every word, every clue, and pay attention to what you’re saying as well, it’s tiring. And David and I did this for 30 years—actually, we were 15 or 16 when we started working as orderlies in hospitals—so it’s been 45 years. I think if you do it right, the idea is to stop before you’re too fatigued to do it right.” “Sixty felt like a portal, a doorway through which one travels and there’s only one direction,” Moore adds, laughing. “You don’t know how much time is left, but what are you going to do with it? I’ve given most of my life to this, very proudly and happily, but the piano was really calling me. It wasn’t so much leaving medicine as it was being pulled to do something I’ve always wanted to do. It takes a big investment in time and energy to become as good as I would like to be, so I either have to take the time, put the energy into it, or I don’t, and I decided to do it.” I can attest to the fact that it’s time and energy well spent—I only wish all of his patients had had the chance to hear him play, for the depth of his connection to his music is, in itself, a healing force. “It seemed cataclysmically like we were supposed to be doing this,” explains Blatt. “We spent all this time training in medicine, people that were totally loveable were having the problems they were having, and our paths converged and it seemed like, boy, was I supposed to be there. I’m not sure what’s next. I’m not musical, but I did receive my paramedic license about four years ago and I’m passionate about emergency medical services, so I’m figuring out what that path will be. I love making house calls and this is the ultimate house call. I’m not sure how that will unfold, but I think that will be pretty big in my future.” Whatever the future holds, these two gentle men have left their stamp on many pages of history—in the world of HIV, in leading by example; in creating progressive models of medical care; and in being an endearingly unassuming example of the best of what marriage, gay or straight, can be. “Subjectively,” they have also made their mark on my life, which is blessed by their presence as people, as friends, who just happen to be healers. e M ay + J u n e 2 01 1

What’s your

(HIV) TYPE? What viral diversity means, and why it‘s important By Ross Slotten, MD, MPH

In the first article of this three-part series, Alicia Prater discussed the origins of HIV infection, touching on the virus’ genetic diversity. In this article, I will focus on how that diversity impacts antiretroviral therapy, vaccine development, and the ultimate control of this deadly infection. When the syndrome now called AIDS was first described in 1981, it appeared to be a disease limited to a single country and a single community. But the disease was far more widespread than anyone ever imagined; other groups besides gay men in the United States were affected. Although few grasped it at the time, AIDS had already gained a foothold on every inhabited continent. By the time its scope and magnitude were finally comprehended in the mid-1980s, AIDS had spread beyond control to become one of the greatest epidemics in human history. Currently, more than 40 million people in 150 countries are infected with HIV, men and women in equal proportion, with no signs of the epidemic leveling off. Considering that the syndrome was only identified in 1981, it did not take long to discover a causative agent (HIV-1) and develop a test to screen for it. As early as 1985, Margaret Heckler, then Secretary of the Department of Health and Human Services, optimistically predicted that a vaccine to prevent HIV would soon be 34

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produced.1 She was wrong. Twenty-five years later, there is still no vaccine and none on the immediate horizon.

HIV escapes immunity The failure to find an effective vaccine is not a conspiracy by the pharmaceutical industry to ensure big profits at the expense of human health. HIV is a clever virus, with an amazing ability to evade immune control by constantly changing form. Moreover, our immune systems are unable to manufacture antibodies that neutralize HIV. Current vaccines against other diseases, like influenza, polio, measles, hepatitis, and chickenpox, depend on this mechanism to prevent infections by their respective viruses. Although our immune systems manage to kill some HIVinfected cells, they cannot kill them all. Once HIV integrates itself into the host’s genome, the cells that are not killed are permanently infected. Without treatment, the virus wears out the immune system as more CD4+ cells are destroyed until the person dies from an overwhelming

infection or malignancy. Even with effective antiretroviral treatment, the virus hides in so-called reservoirs, not a place, but circulating CD4+ cells, waiting for an opportunity (stopping or missing medication, for example) to reproduce and infect more host cells. The force of Darwinian evolution ensures that HIV survives the weapons our immune systems try to hurl at it. Each virion (as an individual virus particle is called) contains reverse transcriptase, an enzyme that turns our cells into virus factories. Reverse transcriptase lacks proofreading ability, and develops errors, or mutations, as it is replicated. Since the viral genome is an estimated 1,000 base pairs long and reproduces at a rate of 10 trillion virions per day, millions of viral variants are produced daily in every infected individual.2 If a person is infected with two or more separate strains of HIV, recombination of those strains through “viral sex” can produce even greater diversity. Multiply that by 40 million infected people and you have untold numbers of viral variants, which have diverged from the original HIV strains that first appeared in the early 20th century.

Classifying HIV In the early days of the epidemic, scientists recognized two forms of HIV—HIV-1 and HIV-2. (Today, the latter represents only 3% P os i t i v e lyAwar e .co m

of those infected with the human immune deficiency virus.) Attempts were made to classify HIV-1 sequences by subdividing them into European/North American and African strains, at the time the main loci of the epidemic. However, as the epidemic spread, genetic sequencing of HIV worldwide revealed that this classification was far too simplistic. In September 1999, a group of experts gathered in Santa Fe, New Mexico to resolve the ambiguities around that classification system.3 Despite such advances in our understanding of this extraordinary virus, the dynamic nature of HIV evolution continues to challenge our notions of classification as new strains of HIV constantly emerge. As pointed out in the first article [see “Point of Origin” in the January/February issue], three major groups of HIV have been described, reflecting three independent transmissions from nonhuman primates to humans. Group M (or major) dominates the current pandemic; group O (outlier) and group N (non-major and non-outlier) are rare, confined mainly to Cameroon. Recently, a group P was identified, suggesting a fourth independent introduction. If another is discovered, it will be called group Q, and so forth. Group M can be further subdivided into nine subtypes or clades, denoted by letters (A-D, F, G, H, J, and K); and those subtypes can be subdivided into at least six sub-subtypes, denoted by numerals (A1-4, F1-2). To complicate things more, subtypes can combine with other subtypes in a dually infected person. If more than three people have been identified with a recombinant virus, the viral form is known as a circulating recombinant form (CRF); if only one person is found to have a recombinant virus, the viral form is known as a unique recombinant form (URF). CRF03_AB, for example, is a form that has emerged in the former Soviet Union, a combination of subtypes A and B. Even more odd, CRF01_AE, the dominant form found in Southeast Asia, is a combination of subtypes A and E, the latter never really isolated but the letter retained anyway to reduce confusion among epidemiologists! Recent research suggests that some subtypes or recombinants are more infectious than others. In Kenya, pregnant women infected with subtype C were P os i t i velyAware.co m

more likely to transmit their HIV infection than those infected Recent research suggests that with subtypes A or some subtypes or recombinants D.4 In another study are more infectious than others. from Uganda, people In Kenya, pregnant women infected infected with subtype with subtype C were more likely to D progressed more transmit their HIV infection than rapidly to AIDS than those infected with subtypes A or D. those infected with subtype A. 5 Although such studies are small and need to be viral diversity poses additional challenges confirmed, it is reasonable to hypothesize for vaccine development. Any vaccine, it that there may be subtle differences in the seems, would have to take into account behavior of HIV not explained by access to this variability, just as the influenza vaccine care or availability of adequate therapy. does. Based on present models of vaccine Subtype C accounts for 50% of all development, an HIV vaccine would have infections, while subtypes A, B, D, and G to elicit neutralizing antibodies to most or make up 12%, 10%, 3%, and 6% respecall strains, and generate strong CD4+ and tively. CRF01_AE and CRF02_AG (found CD8+ T-cell responses. Yet the question in West Africa) cause 5% of all infections.6 Yet antiretroviral drugs were developed in is, does viral diversity confound efforts to high-income countries where subtype B, find an effective vaccine or is it merely a otherwise less common worldwide, is the red herring? Up to this point, no one has dominant type. So far, those medications developed an effective vaccine against any seem to be effective in many non-subtype HIV group or subtype, making the issue B-infected individuals, but the majority of of viral diversity moot. The obstacle to people in the world with HIV have never finding an effective vaccine thus far does been treated. No one knows if current not appear to be viral diversity. The fact is, HIV treatments will be effective in all HIV HIV plays by rules of its own design, which groups, subtypes, and recombinant forms. is frustrating. Conquering it may require Resistance to current antiretroviral drugs a paradigm shift in thinking about how to comes in two forms: primary resistance find the virus’ Achilles’ heel, but a shift to and secondary, or acquired, resistance. what is unclear. In primary resistance, a newly infected That paradigm shift may lie in mode individual contracts a drug-resistant strain of transmission. It is now recognized that of HIV. In secondary resistance, resistance 90% of all infections do not occur through develops after a period of HIV treatment, the blood stream but through the virus usually because of adherence issues. crossing mucosal membranes that line the Alarmingly, HIV-2 and group O strains of genital tract and rectum during sex, when HIV-1 appear to be inherently resistant to after crossing these mucosal membranes, one class of drugs, non-nucleoside reverse the virus reaches the gastrointestinal transciptase inhibitors, which includes tract, where a huge number of our CD4+ Viramune (nevirapine) and Sustiva (efacells reside. Only two weeks after infecvirenz).7 Atripla (efavirenz/tenofovir/ tion, many of these CD4+ cells are already emtriva), the most popular combination destroyed, with immense potential consetherapy today, would not work in these quences for the host immune system. This populations. Fortunately, HIV-2 and group occurs well before the infection can be O infections are rare. Only time will tell if detected by current tests and before the all group M strains will respond to regiinfected person becomes symptomatic. 8 mens that are so effective in the industrial- Although the role of the gut in the development of infection is still not completely ized, subtype B world. understood, it may hold a key to vaccine Vaccine challenge development. Instead of targeting the Perhaps more than antiretroviral therapy, virus in the blood stream, the target would M ay + J u n e 2 01 1

in non-subtype B infections. In the United States, nonAs the demographics of HIV subtype B infections infection shift in the West, it will be are becoming increasimportant to implement testing that ingly more common recognizes HIV genetic variation. in immigrants from other parts of the world, especially from war-torn regions of sub-Saharan Africa. be the cells of the gut, where the virus first As the demographics attaches. of HIV infection shift in the West, it will be important to implement testing that recTesting ognizes HIV genetic variation. Two years In terms of testing, the standard HIV-1 ago, Abbott Laboratories presented data antibody tests (ELISA, followed by the at the 16th Conference on Retroviruses and Western Blot to confirm a positive ELISA Opportunistic Infections (CROI) from a test) detect nearly all subtypes of HIV-1 study of its RealTime assay that accurately in the M group, but not in rare groups O quantified levels of six different HIV subor N. A separate test has been developed types and eight CRFs9. The role of testing for HIV will be the subject of the third to detect HIV-2 antibodies. The most article in this series. commonly performed tests of viral levels, based on PCR or polymerase chain reacConclusion tion technology, detect subtype B virus, In conclusion, although the various HIV-1 but they are less accurate in measuring non-subtype B viral levels. That inaccuracy subtypes may differ from each other in not only affects decisions about prognosis, terms of rates of transmission, resistance, and disease progression, none has mutatbut also makes it difficult to monitor the ed into a less virulent form. Untreated success or failure of antiretroviral therapy

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HIV-1 infection of all subtypes and circulating recombinant forms still kills 98% of those infected, making HIV-1 second only to rabies in lethality. Five subtypes and two recombinant forms have a global prevalence rate of 2.5% or more, ensuring that HIV-1 will remain entrenched in human populations for decades to come. Primary and secondary resistance will continue to pose problems for clinicians and patients alike until a cure is found; but no cure is likely in the foreseeable future. Our best and only hope for curtailing the spread of HIV is through education about preventive practices, for which funding, even before the global recession, has been reduced. Yet education, even in the best of economic times, has offered sporadic success in limiting the spread of infection. e Ross Slotten, M.D., M.P.H.D, MPH, is a family practitioner in private practice in Chicago. He has treated people with HIV for 29 years. Footnoted references available online. This is the second in a three-part series of articles sponsored by Abbott Molecular.

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May+June 2011

P os i t i v e lyAwa r e .com

The Princess Warrior One woman’s battle for survival, and how it has made her stronger By Barbara Marcotte

All these years, HIV was just part of me and IT became a smaller part with each passing year. Most days I did not even think about it. I loved, I lost, and I grew into a successful, responsible adult and a leader in the HIV community. I have been really lucky to have so many great friends and a supportive family to go along with my normal life living with HIV. My parents were proud, my brother was proud, my family was proud of who I had become. It’s been a pretty simple life that, over the past few years, has been peaceful, calm, and surrounded by true love. Life goes along with its continued momentum. I always thought I lost a bit more in life than others, a husband—my soul mate—when he was just 37 and I was just 27, so many friends, then my Dad and my Mom. But then, because loss is really just a part of life, I really thought that I was left with plenty of time to do all the things I wanted to do. After all, I am the Princess Warrior. Then one day it happened…the doctor called—the doctor who I only saw every 3-4 months, because my numbers had been great for many years. I went in to see her that week. She opened the door and looked at me with sad eyes I had not seen before in what I thought was an emotionless career doctor. Younger than me, I was sure she had not seen the devastation that I had seen with this disease. But her words were filled with sorrow. Her statement was, “This is not good…this is not good…” Like an echo in my mind, my world filled up again with all that sorrow. Sorrow of loss, pain, fear, 38

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and dreams not yet achieved. This echo had not been heard for many years. I remember as a young widow who had just watched her husband die, sitting on a sunny porch with my father’s strong hand on my back, comforting me through my cries of loss for a too-young husband and all the dreams I had of a life with him. All that came slamming back into my reality. What about all those things I still want to do? I have so many things… So many warriors passed this year. They were with us, fighting, living, and loving. Then they were gone. Ann, my South Side warrior. She was the Queen Bee of warriors. She mentored me in ways I am sure she did not know. And then, Earl. If Ann was Queen Bee then Earl was Dolomite for sure! We never expected Earl, a community fixture, to leave us so suddenly. He was there to piss us off and wake us up whenever we just weren’t listening. Those kind eyes and his smile always made me realize that I couldn’t be aggravated with him for too long because he really was fighting for what we all wanted and needed. Jerome, I think of you as that quiet warrior, that silent listener, there for anyone who needed you. And Laird, the warrior who was never afraid to step up. Even before others were out in public and fighting, you were there. Where would we be without you? You fought on the front lines for us. You made things happen when no one else could. Then most recently we lost Don, aka Angel Eyes. He was the first person I met when I moved from Chicago. He really was our guardian angel. He became a voice P os i t i v e lyAwar e .co m

for those living in poverty, rural areas, and those who couldn’t be a voice for themselves because of stigma, shame, or guilt. It didn’t matter who you were, he spoke up for all of us. So the news that was “not good” made me wonder if I am the next warrior to lose this battle. Could it happen to me? Can I control this monster? My young doctor and I sat down and figured out a strategic war plan. We worked together and when we finished she hugged me and, I think, maybe cried with me. Wow…I can only imagine how rare it is for her to see someone like me. Someone who had been living a long time and in such control of her health, life, blah, blah, blah. The truth is that we all have to take this seriously. I didn’t fail because I wasn’t “adherent.” I failed because I simply have had HIV for a long time. Options are limited. And we have to remember that everyone’s body is different with this virus. We cannot become complacent for ourselves or our communities. We can’t think that HIV is over or that if I get it, then I just have to take some pills and no big deal. The truth is that there is not a cure yet. We hope, but it isn’t here yet and we don’t know exactly what it will look like when it gets here. Until then, we have to remember that this war is not over. So we must continue and perhaps now fight harder than we ever have. Yes, I have to fight harder than I ever have. To live and to finish the things that I need to do. Complacency is not a blame issue. For many of us living with HIV, it has become a small part of who we are and what we do in our daily lives. The truth is that most of America could take better care of themselves—what we eat, the amount of exercise we get, resting, reducing stress, alcohol and or drug intake, etc. But then, those of us living with HIV need to be really aware of these issues. Most of my life with HIV has been focused on really, really good self-care. But there have been times when life situations and stress led me to unhealthy thoughts or behaviors. HIV can be the blame and shame game. As a woman living with HIV for most of my adult life, I already had those pictures of what my body, my hair, my face was “supposed” to look like. HIV brought me P os i t i velyAware.co m

to thinking even less of myself at times. then do it. If it means stopping or reducWhen we don’t care about ourselves, ing drug or alcohol use, then do it or get we don’t take the best care of ourselves. help to do it. If it means learning how to Situations in life led me to be really down eat right or exercise, then ask your doctor on who I am; HIV made me feel that I did to help. We must survive. Survive to tell not always deserve the best, that I had to your story, survive to watch your children settle. All of this helped contribute to me grow up, survive to achieve your dreams, staying in an abusive relationship too long, survive to grow old. not caring about my body, and not focusing on my health. I believe we have to work harder I am 43 years at this self-care thing than your old now. It is time to average person. We must do whatever change these thoughts is necessary to survive. and behaviors. Truth is, I know I am a sexy, strong woman—a true DIVA living with HIV. I know deep down, So my fight began with five new that fight is still there. It has been buried medications…a combo not sure to work, under a lot of shit for years, but I am there. but it was the best we could come up with. The real me. I took a short-term leave from work for the We have to get through these things first time ever, even after an AIDS diagnothat society, stigma, and discrimination sis more than 15 years ago. The first week have put on us. Living with HIV is living was okay; I went into this with lots of CD4 with a disease, not a judgment of who we cells and feeling pretty good. The second are or what we have done. It’s a disease week I started to see some shortness of that we acquired because we are humans breath, then the bumps (injection site with normal human behaviors. We have reactions) started, then the rash, swollen, sex; we have other diseases like alcoholism hot, and sooo itchy. Can I really do this? or drug addictions that may have brought Could I even possibly go back to work like HIV into our lives. this? Low energy, tired, tired. Old—that is Be proud of who you are, be it gay, what I felt when I looked down at the large straight, bi, or whatever. Media and society pill box, my lack of energy, and my shortpaint a picture of what is “normal” looking ness of breath. I must do this. I won’t give or being. But the truth is that we are all up. Too much to lose, too much to do still. who we are. I have listened to what I was So I am fighting with all the passion supposed to look like, be like, for too long. inside of my soul. The passion for helping In order to really live well with HIV, we others, for loving, for laughter. I go into must each address the underlying “root” this fight with the people who love me, the causes of our HIV. HIV is not the problem, community I am committed to, and the life but rather the symptom. The symptom of not yet lived that I dream for. My fight is bigger issues that each of us, our comnot over. Imagine what our world could be munities, and our world has. We must all if we all found our fights? decide to dig deep and start this fight. Are Now is the time to realize that we all you a warrior? have this fight inside us; do we decide to Warrior: One who is engaged in or fight or just let that dark monster come experienced in battle; one who is engaged and steal us away from all of this? Do we aggressively or energetically in an activity, have that choice? Can we stop it? I am not cause, or conflict. giving up. In my mind, I believe we have to work Are you a warrior? I am. I am the harder at this self-care thing than your Princess Warrior. Forever. e average person. We must do whatever is Barbara Marcotte is an HIV educator and a necessary to survive. If it means going to member of the steering committee for the see a mental health specialist for stress, U.S. Positive Women’s Network. depression, anger, or other life situations, M ay + J u n e 2 01 1

Ask the HIV specialist Agnes Cha, PharmD, AAHIVE

ELEVATED (Liver) concerns Q: My son has been on a combination of d4T [Zerit], 3TC [Epivir], and nevirapine [Viramune] since 1997 and has done extremely well. In addition to being HIV-positive, he also has chronic HBV. A number of years ago, he had a blip in his liver enzymes which disappeared quite quickly.

Photo courtesy of Agnes Cha

Now his liver enzymes have risen again, and he feels the need to change his treatment regimen. It has been suggested that he switch to Truvada and perhaps delavirdine [Rescriptor] or efavirenz [Sustiva]. Does such a combination make sense in his case? Would it make a difference with his liver enzymes? —Concerned Mother A: Family support can be very important for one’s treatment success and it is wonderful that you are involved with your son’s care. There are a few points to be considered in your question, which like many HIV treatment questions, does not have a simple answer. As a pharmacist in an HIV clinic, I get asked very frequently, “What does it mean to have elevated liver enzymes?” Liver enzymes, commonly referred to as AST, ALT, alkaline phosphatase, and GGT, are elevated when there are some abnormalities in the liver or bile ducts, including liver damage and/or inflammation of the liver. These liver enzymes can be increased by alcohol use (even just a few drinks), hepatitis, fatty liver, or some medications. We monitor blood levels regularly (about every three months) when patients are on medications that are known to cause hepatotoxicity (when liver enzymes are increased 3-5 times above normal). Hepatotoxicity may be seen with antiretrovirals; all protease inhibitors (PIs) and nucleoside reverse transcriptase inhibitors (NRTIs) like d4T (stavudine, Zerit), ddI (didanosine, Videx) and AZT (zidovudine, P os i t i velyAware.co m

Retrovir) can also cause injury to the liver by causing fatty liver. It’s no surprise patients are concerned about their HIV medications being “toxic” to the liver. But most patients tolerate their medications very well and I always remind them that we monitor the liver enzymes and will know well in advance when it is necessary to stop antiretroviral treatment. In your son’s situation, his liver enzymes may have risen because of his medications, hepatitis B infection, or a combination of both. Treatment for HIV as well as hepatitis B (HBV) is important because untreated HIV can cause a more rapid progression of liver disease, cirrhosis, liver cancer, or liver failure. Patients who are co-infected with HIV and HBV may experience a “flare” in their hepatitis if treatment of hepatitis B is stopped or resistance develops. There are three HIV medications that also have activity against HBV: tenofovir (TDF, Viread), emtricitabine (FTC, Emtriva), and lamivudine (3TC, Epivir). Guidelines recommend co-infected patients be treated with two agents that are effective against both HIV and HBV, because use of only one can lead to hepatitis B resistance. Although it is difficult to know exactly what is going on with your son, there is a possibility his hepatitis is not being controlled on just lamivudine. If that is the case, Truvada (which is a combination of tenofovir and emtricitabine) would be an appropriate choice, as long as his kidneys are okay. I recommend you and your son speak with his physician about the situation. There are several newer antiretrovirals that

may better control his HBV and are much less toxic. Use of d4T (Zerit) has largely fallen out of favor. As of 2009, the World Health Organization (WHO) has recommended that all countries phase out the use of d4T. Integrase and entry inhibitors are considered to have very low hepatotoxicity, and keep in mind that hepatitis or slightly increased liver enzymes are not a contraindication for the use of protease inhibitors (PIs). In our clinic, I see numerous co-infected patients who do well without toxicities on a PI-based regimen. After consideration of any prior resistance tests, hepatitis B viral load, and potential side effects, the primary physician and a clinical pharmacist together can formulate a new regimen that will be most optimal for your son. There may not be a clear cut answer to your question, but one recommendation is definite: he does not stop or change medications on his own before consulting his physician. I hope this information has been helpful!

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.

M ay + J u n e 2 01 1

The buzz Daniel S. Berger, MD

A new era in HCV treatment New therapies signal a renaissance in treatment of hepatitis C

Additionally, there are more than 20 candidate agents in development for the treatment of hepatitis C. As such, the potential to achieve successful treatment in patients with both HCV mono-infection and HIV/HCV co-infection will improve dramatically. However, many questions are still unanswered for co-infected individuals, as they generally have higher HCV loads, higher rates of HCV treatment failure, and more treatment-related side effects. Individuals within high-risk populations and those that are HIV-positive should have some basic understanding of hepatitis C risks and transmission, as should their health care practitioners. The increasing prevalence of hepatitis C infection has long been apparent, especially among individuals who are already HIV-positive due to the commonality in transmission: HCV has also been shown to be transmitted sexually and through needle sharing. But avoidance of intravenous drug use and unsafe sexual practices can prevent HCV infection and spread. Also, despite clearance of HCV among patients co-infected in the MSM (men who have sex with men) population, alarmingly high rates of HCV re-infection are also occurring (CROI ABST #958). Worldwide estimates of chronic HCV are at 180 million people. Current treatment for hepatitis C infection is peginterferon plus ribavirin (P/R) for 24 or 48 weeks, depending on HCV genotype (strain) and initial response to 42

May+June 2011

therapy. Statistically, patients who are coinfected with HIV have a lower potential to achieve a sustained virologic response (current rates are at less than 50%) than those who are mono-infected. Also, current treatment is fraught with many side effects and it is anything but easy. Various sessions during CROI (the 18th Conference on Retroviruses and Opportunistic Infections) in Boston in March delved into the differences in liver pathology for individuals co-infected by both viruses, new genetic testing that may help predict response to P/R therapy, and new agents that will improve HCV treatment success.

News in pathogenesis Aside from the knowledge that persons co-infected with HIV and HCV pose unique treatment challenges, it is understood that HIV appears to enhance progression of hepatitis C infection. The difference in pathogenesis for co-infection and possible mechanisms for which individuals tend to progress more rapidly are still being investigated (CROI ABST #940, 941). Envelope proteins on the surface of HIV appear to bolster the damage and death of hepatocytes (liver cells). HCV-RNA synthesis and protein production is increased by the presence of HIV in vitro (in a test tube), but when adding specific HIV antiretroviral agents, this effect was blunted. Thus HIV antiretroviral treatment may be important in helping to reduce HCV progression.

Back in medical school, we were taught that once individuals developed end-stage liver disease and cirrhosis, there was never a way back—it was not reversible. However, we now know this is not true. Two studies at CROI this year (ABST #966, 967) showed that sustained virologic response to treatment of P/R demonstrated improvement in liver fibrosis, lower liver stiffness, and reversion of clinically significant severe portal hypertention (high pressure within the circulatory system in proximity to the liver that causes reversal of blood flow and complications).

Genetics are not always in our favor Clinicians have attempted to predict a patient’s potential for successful treatment with P/R by assessing their response during the first 12 weeks and sparing some individuals from further treatment and toxicities. More than 50% of individuals who harbor HCV genotype 1 more often than other genotypes fail to achieve an SVR to treatment. Most of our efforts to predict SVR are related to viral dynamics. Recent studies have focused more on host factors and genetic variability. At CROI (ABST #943–948), discussions centered around prediction through testing based on the genetic variations of a particular region on the interleukin-28B (IL-28B) gene. These variations are associated with achievement of SVR in HCV treatmentnaïve patients. These tests will soon be available in the clinic.

Advances in treatment Two agents, both orally administered, telaprevir (TVR) and boceprevir (BOC), are inhibitors of NS3/4A (nonstructural 3/4A) P os i t i v e lyAwa r e .com

Photos courtesy of Daniel S. Berger

Two direct acting antivirals for the treatment of hepatitis C virus (HCV) infection are about to be added to our current standard. The two HCV protease inhibitors, boceprevir (BOC) and telaprevir (TVR) are the first new therapies to become available for HCV in many years.

HCV protease. These are only two of several agents developed to improve our ability to achieve an SVR beyond what is currently observed with P/R treatment alone. In a previous study (PROVE3), TVR was combined with the standard treatment of P/R in patients who had been previously treated without achieving an SVR (nonresponse and relapse). The study subjects were infected with genotype 1; 58% had genotype 1a. Patients were randomly assigned to one of four arms; 1. TVR administered for 12 weeks plus P/R for 24 weeks. 2. TVR for 24 weeks plus P/R for 48 weeks. 3. TVR plus peginterferon for 24 weeks. 4. Standard P/R for 48 weeks. The study results showed patients in the first two arms demonstrated greater improvement in SVR (51–3%) than the ones on P/R alone. Moreover, patients who previously relapsed had 69-76% SVR rates compared with the other two arms. These findings were especially provocative, since patients infected with genotype 1a and who have previously failed are the most difficult to treat successfully with current standards. Incidentally, boceprevir has also been shown to result in high rates of SVR in hepatitis C genotype 1 patients who are naïve (SPRINT-2), as well as nonresponders (RESPOND-2), when added to standard therapy. At CROI, the interim analysis of a trial of HCV/HIV co-infected patients treated with telaprevir was highlighted (ABST #146LB). This was the first study ever presented of co-infected patients administered an HCV protease inhibitor as part of triple therapy for HCV. TVR was given at 750 mg every 8 hours (TVR dose was 1,125 mg every 8 hours when ART contained Sustiva) plus P/R for the first 12 weeks followed by P/R for an additional 36 weeks vs. the control group—patients being administered standard treatment plus placebo for 48 weeks. Of the first 59 of 60 patients, at baseline, 13 were not on ART and 46 were on either Sustiva plus Truvada, or Norvirboosted Reyataz plus Truvada; 68% had genotype 1a; 83% had HCV viral loads of greater than 800,000; 10% had biopsyproven advanced liver fibrosis. At four and 12 weeks, significantly more patients P os i t i velyAware.co m

on the treatment containing TVR showed are varying rates of reversion to wild type undetectable HCV viral loads. At week 4, that occur, the longest taking about 1.5 71% (no ART arm), 75% (Sustiva arm) and years for reversion. The investigation of 64% (boosted Reyataz arm), compared to the effect of re-treatment with HCV PIs in only 5% in all the patients receiving only patients who revert back to wild type virus P/R achieved undetectable HCV levels. remains an intriguing area of research. Results were similar for week 12 with rates of undetectable HCV Boceprevir and Telaprevir RNA again being subare the first of many agents to stantially higher in all be added to our HCV treatment TVR arms compared armamentarium, and many to patients on P/R pharmaceutical companies have alone. Although side drugs coming down the pipeline effects were more over the next few years. frequent in patients in the TVR arms, they were no greater for co-infected patients. Conclusion Pruritus (skin itching), nausea, vomitWhile rates of required hospitalizations ing, fever, anorexia, and dizziness were for HIV have decreased in recent years, more frequent in patients who received co-infected individuals with untreated TVR/P/R than in controls. HCV have added risks of developing When TVR and BOC become available, liver fibrosis, cirrhosis, liver cancer, and physicians treating HIV/HCV co-infection other complications. Looking into the will need to have a thorough understanding future, HCV progression will undoubtedly of the drug-drug interactions, since both lead to increasing health care costs and agents pose challenges. BOC levels are hospitalizations. compromised when used with Sustiva or However, the science and treatment Atripla; TVR showed alterations in levels of HCV is undergoing a renaissance. BOC of various protease inhibitors, including and TVR are the first of many agents to be Prezista; TVR is associated with 52% reducadded to our HCV treatment armamention in levels of Kaletra. Overall, some comtarium, and many pharmaceutical compabinations may require dosage adjustments nies have drugs coming down the pipeline while some may be outright ill-advised. over the next few years. Eventually, P/R This article would not be complete may not be required for treatment, thus without at least one paragraph about its harsh side effects will no longer be resistance to HCV treatment. Similar to encountered. With the upcoming availHIV therapies, patients who fail on direct ability of many new agents, we will witness acting antivirals for HCV can develop a marked change in our ability to treat resistance and cross resistance to other HCV-infected patients. However, education treatments within the same class. Thus, as on the risks of transmission and screening described with boceprevir (ABST #954), of all individuals in high risk populations various resistance-associated amino acid remains a challenge. variants (RAV) were seen in patients who did not achieve an SVR. However, unlike Dr. Daniel S. Berger is a leading HIV physiHIV, resistance mutations are not incorcian in the U.S. and is Clinical Associate porated into the host genome and thus, Professor of Medicine at the University of after withdrawal from treatment, amino Illinois at Chicago. He is founder and mediacid substitutions on the genetic codon cal director of Northstar Healthcare, the can revert to wild type (naïve virus that largest private HIV treatment and research does not harbor resistant mutations) and center in the greater Chicago area. Dr. thus, theoretically regain susceptibility Berger can be reached at DSBergerMD@ to all treatment. Also, depending on the aol.com and www.Nstarmedical.com. particular mutation(s) that develop, there M ay + J u n e 2 01 1

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May+June 2011

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It’s been a while since we did this. So,

Salient ramblings Sal Iacopelli

The tears of a clown This June, we mark the 30th anniversary OF HIV. “Anniversary.” A word synonymous with celebration, yet a celebration couldn’t be further from my consciousness. On this anniversary and for every “HIV-iversary,” I mourn the warriors we have lost to this unending battle. One of whom was Pat Brown. I hired him as an acupuncturist at the now defunct AIDS Alternative Health Project (AAHP) in 1992 and I consider him to be one of the greatest hires of my career. Pat’s curriculum vitae was so impressive, I was nervous to meet him but was immediately put at ease by his warm, brilliant, “old soul” presence. He was bearded and stocky, gruff yet compassionate, with a deliciously dry sense of humor. Mark Reese, one of the finest acupuncturists in this city (and another of my great hires), had his first Eastern medicine encounter and inspiration from Pat. Solidly scientific, with a Western medicine background, Mark became enthralled and fascinated with Eastern medicine and Pat quickly became his mentor. Shortly after Pat joined AAHP, I tested positive and sought Pat’s acupuncture treatments and guidance. It was a trying time in my life as in addition to a stressful full-time job with a bullying megalomaniac boss, I was doing five to six shows a week (anyone remember Party?) and was newly diagnosed. I will never forget gazing up into Pat’s warm brown eyes as I lay on his treatment table, with him holding my arm while he took my pulse. Besides benefiting from his exceptional skills, it was comforting to talk to him about my life’s trials and tribulations. The consummate listener, he always made me feel as if I were the most important person in the world. P os i t i velyAware.co m

I didn’t realize he was gay until I ran into him at a leather bar. The picture of propriety (as I was his supervisor), I refrained from dragging him home... though I very much wanted to. Pat was an intriguing mass of contradictions. I pictured him on his days off stalking the streets, smoking cigars, and kicking stray cats out of his way—then showing up at the clinic for his six-hour shift with a stunning ikebana flower arrangement. Fast forward to mid-late ’90s. While living in San Francisco, I received an invitation to celebrate Pat’s 50th year. I couldn’t go, but sent a heartfelt note to be read. A few months later, while Mark was visiting San Francisco, he commented on the beautiful note I sent to have read at Pat’s memorial service. Apparently the 50th year celebration was in fact a memorial for Pat, who had died of complications from AIDS. I hadn’t had a clue to his status. I’d just assumed he must be negative. To learn of his death was shocking and crushing. Another lost hero was Gerardo Montemayor. We met in the Manhandler’s “back 40” in the late ’80s when he was not yet the activist many would come to know him to be. Compassion and warmth radiated from his sultry, dark brown eyes. He was a soft-spoken, smart, “Mexi-Bear”—a smoldering, enigmatic bull of a man who, even in his early 20s, was a sure dad type. He began his career

at Horizons Community Services in the Anti-Violence Project. In 1999, he became Director of Education and Training for Rape Victim Advocates and provided prevention education and training to more than 4,500 people each year, as well as presenting sexual assault prevention curricula at national conferences, including the Centers for Disease Control and Prevention’s Sexual Violence Prevention Conference and the National Gay and Lesbian Task Force’s Creating Change Conference. He was a tireless fighter for justice in this world, a fierce ally who could always be counted on, and truly a man of great integrity. When I decided to return to Chicago from San Francisco in ’98, I drove crosscountry in a moving van packed with my irreplaceable mid-century modern furniture. There, at the end of my travels, was Gerardo (with other friends and family), waiting to greet me and help schlep my heavy-ass belongings up three flights of stairs. I saw Gerardo a few months before we lost him. He was always a husky bear, but had lost so much weight, I barely recognized him. The former 230-pound man must have lost 80 pounds. He looked fine, not sick at all. I didn’t think anything of it, as I thought he was HIV-negative. Two months later, his partner called and told me Gerardo had died. AIDS-related pneumonia. At the age of 36. Again, I’d simply assumed Gerardo was negative. As grateful as I am to haunt this planet, I look forward to the time I can once again be honored by the company of these great men. If I am lucky, Gerardo and Pat will be there to greet me at the end of life’s journey.

M ay + J u n e 2 01 1

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