SEP+OCT 2013

Clinical Trials Aging Positively

POSITIVELY AWARE S E P T E M B E R + O C TO B E R 2 0 1 3

PLUS

CURE NEWS FROM THE International AIDS conference

GETTING STARTED

WITH YOUR HIV CARE

Legal and Health care issues

What is STRIBILD? STRIBILD is a prescription medicine used to treat HIV-1 in adults who have never taken HIV-1 medicines before. It combines 4 medicines into 1 pill to be taken once a day with food. STRIBILD is a complete single-tablet regimen and should not be used with other HIV-1 medicines.

STRIBILD does not cure HIV-1 infection or AIDS. To control HIV-1 infection and decrease HIV-related illnesses you must keep taking STRIBILD. Ask your healthcare provider if you have questions about how to reduce the risk of passing HIV-1 to others. Always practice safer sex and use condoms to lower the chance of sexual contact with body fluids. Never reuse or share needles or other items that have body fluids on them.

IMPORTANT SAFETY INFORMATION What is the most important information I should know about STRIBILD? STRIBILD can cause serious side effects: • Build-up of an acid in your blood (lactic acidosis), which is a serious medical emergency.

Symptoms of lactic acidosis include feeling very weak or tired, unusual (not normal) muscle pain, trouble breathing, stomach pain with nausea or vomiting, feeling cold especially in your arms and legs, feeling dizzy or lightheaded, and/or a fast or irregular heartbeat.

• Serious liver problems. The liver may become large (hepatomegaly) and fatty (steatosis). Symptoms of liver problems include your skin or the white part of your eyes turns yellow (jaundice), dark “tea-colored” urine, light-colored bowel movements (stools), loss of appetite for several days or longer, nausea, and/or stomach pain.

• You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight (obese), or have been taking STRIBILD for a long time. In some cases, these serious conditions have led to death. Call your healthcare provider right away if you have any symptoms of these conditions.

• Worsening of hepatitis B (HBV) infection. If you also have HBV and stop taking STRIBILD, your hepatitis may suddenly get worse.

Do not stop taking STRIBILD without first talking to your healthcare provider, as they will need to monitor your health.

STRIBILD is not approved for the treatment of HBV. Who should not take STRIBILD? Do not take STRIBILD if you: • Take a medicine that contains: alfuzosin, dihydroergotamine, ergotamine, methylergonovine, cisapride, lovastatin, simvastatin, pimozide, sildenafil when used for lung problems (Revatio®), triazolam, oral midazolam, rifampin or the herb St. John’s wort.

• For a list of brand names for these medicines, please see the Brief Summary on the following pages.

• Take any other medicines to treat HIV-1 infection, or the medicine adefovir (Hepsera®).

What are the other possible side effects of STRIBILD? Serious side effects of STRIBILD may also include: • New or worse kidney problems, including kidney failure. Your healthcare provider should do regular blood and urine tests to check your kidneys before and during treatment with STRIBILD. If you develop kidney problems, your healthcare provider may tell you to stop taking STRIBILD. • Bone problems, including bone pain or bones getting soft or thin, which may lead to fractures. Your healthcare provider may do tests to check your bones.

• Changes in body fat can happen in people taking HIV-1 medicines.

• Changes in your immune system.

Your immune system may get stronger and begin to fight infections. Tell your healthcare provider if you have any new symptoms after you start taking STRIBILD. The most common side effects of STRIBILD include nausea and diarrhea. Tell your healthcare provider if you have any side effects that bother you or don’t go away.

What should I tell my healthcare provider before taking STRIBILD? • All your health problems. Be sure to tell your healthcare provider if you have or had any kidney, bone, or liver problems, including hepatitis virus infection.

• All the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. STRIBILD may affect the way other medicines work, and other medicines may affect how STRIBILD works. Keep a list of all your medicines and show it to your healthcare provider and pharmacist. Do not start any new medicines while taking STRIBILD without first talking with your healthcare provider.

• If you take hormone-based birth control (pills, patches, rings, shots, etc).

• If you take antacids. Take antacids at least 2 hours before or after you take STRIBILD. • If you are pregnant or plan to become pregnant. It is not known if STRIBILD can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking STRIBILD. • If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV-1 can be passed to the baby in breast milk. Also, some medicines in STRIBILD can pass into breast milk, and it is not known if this can harm the baby.

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 Brief Summary of full Prescribing Information with important warnings on the following pages.

STRIBILD is a prescription medicine used as a complete single-tablet regimen to treat HIV-1 in adults who have never taken HIV-1 medicines before. STRIBILD does not cure HIV-1 or AIDS.

I started my personal revolution Talk to your healthcare provider about starting treatment.

STRIBILD is a complete HIV-1 treatment in 1 pill, once a day.

Ask if it’s right for you.

Patient Information STRIBILDTM (STRY-bild) (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) tablets Brief summary of full Prescribing Information. For more information, please see the full Prescribing Information, including Patient Information.

What is STRIBILD? • STRIBILD is a prescription medicine used to treat HIV-1 in adults who have never taken HIV-1 medicines before. STRIBILD is a complete regimen and should not be used with other HIV-1 medicines.

• STRIBILD does not cure HIV-1 or AIDS. You must stay on continuous HIV-1 therapy to control HIV-1 infection and decrease HIV-related illnesses.

• Ask your healthcare provider about how to prevent passing HIV-1 to others. Do not share or reuse needles, injection equipment, or personal items that can have blood or body fluids on them. Do not have sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.

What is the most important information I should know about STRIBILD? STRIBILD can cause serious side effects, including: 1. Build-up of lactic acid in your blood (lactic acidosis). Lactic acidosis can happen in some people who take STRIBILD or similar (nucleoside analogs) medicines. Lactic acidosis is a serious medical emergency that can lead to death. Lactic acidosis can be hard to identify early, because the symptoms could seem like symptoms of other health problems. Call your healthcare provider right away if you get any of the following symptoms which could be signs of lactic acidosis: • feel very weak or tired • have unusual (not normal) muscle pain • have trouble breathing • have stomach pain with nausea or vomiting • feel cold, especially in your arms and legs • feel dizzy or lightheaded • have a fast or irregular heartbeat 2. Severe liver problems. Severe liver problems can happen in people who take STRIBILD. In some cases, these liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Call your healthcare provider right away if you get any of the following symptoms of liver problems: • your skin or the white part of your eyes turns yellow (jaundice) • dark “tea-colored” urine • light-colored bowel movements (stools) • loss of appetite for several days or longer • nausea • stomach pain You may be more likely to get lactic acidosis or severe liver problems if you are female, very overweight (obese), or have been taking STRIBILD for a long time.

3. Worsening of Hepatitis B infection. If you have hepatitis B virus (HBV) infection and take STRIBILD, your HBV may get worse (flare-up) if you stop taking STRIBILD. A “flare-up” is when your HBV infection suddenly returns in a worse way than before.

• Do not run out of STRIBILD. Refill your prescription or talk to your healthcare provider before your STRIBILD is all gone

• Do not stop taking STRIBILD without first talking to your healthcare provider • If you stop taking STRIBILD, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking STRIBILD Who should not take STRIBILD? Do not take STRIBILD if you also take a medicine that contains: • adefovir (Hepsera®) • alfuzosin hydrochloride (Uroxatral®) • cisapride (Propulsid®, Propulsid Quicksolv®) • ergot-containing medicines, including: dihydroergotamine mesylate (D.H.E. 45®, Migranal®), ergotamine tartrate (Cafergot®, Migergot®, Ergostat®, Medihaler Ergotamine®, Wigraine®, Wigrettes®), and methylergonovine maleate (Ergotrate®, Methergine®) • lovastatin (Advicor®, Altoprev®, Mevacor®) • oral midazolam • pimozide (Orap®) • rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®) • sildenafil (Revatio®), when used for treating lung problems • simvastatin (Simcor®, Vytorin®, Zocor®) • triazolam (Halcion®) • the herb St. John’s wort Do not take STRIBILD if you also take any other HIV-1 medicines, including: • Other medicines that contain tenofovir (Atripla®, Complera®, Viread®, Truvada®) • Other medicines that contain emtricitabine, lamivudine, or ritonavir (Combivir®, Emtriva®, Epivir® or Epivir-HBV®, Epzicom®, Kaletra®, Norvir®, Trizivir®) STRIBILD is not for use in people who are less than 18 years old.

What are the possible side effects of STRIBILD? STRIBILD may cause the following serious side effects: • See “What is the most important information I should know about STRIBILD?” • New or worse kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys before you start and while you are taking STRIBILD. Your healthcare provider may tell you to stop taking STRIBILD if you develop new or worse kidney problems.

• Bone problems can happen in some people who take STRIBILD. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do tests to check your bones.

• Changes in body fat can happen in people who take HIV-1 medicine. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the middle of your body (trunk). Loss of fat from the legs, arms and face may also happen. The exact cause and long-term health effects of these conditions are not known.

• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting your HIV-1 medicine.

The most common side effects of STRIBILD include: • Nausea • Diarrhea Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

• These are not all the possible side effects of STRIBILD. For more information, ask your healthcare provider.

• Call your healthcare provider for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my healthcare provider before taking STRIBILD? Tell your healthcare provider about all your medical conditions, including: • If you have or had any kidney, bone, or liver problems, including hepatitis B infection • If you are pregnant or plan to become pregnant. It is not known if STRIBILD can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking STRIBILD. – There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.

• If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed if you take STRIBILD. - You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.

- Two of the medicines in STRIBILD can pass to your baby in your breast milk. It is not known if the other medicines in STRIBILD can pass into your breast milk.

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

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements: • STRIBILD may affect the way other medicines work, and other medicines may affect how STRIBILD works.

• Be sure to tell your healthcare provider if you take any of the following medicines: - Hormone-based birth control (pills, patches, rings, shots, etc) - Antacid medicines that contains aluminum, magnesium hydroxide, or calcium carbonate. Take antacids at least 2 hours before or after you take STRIBILD - Medicines to treat depression, organ transplant rejection, or high blood pressure - amiodarone (Cordarone®, Pacerone®) - atorvastatin (Lipitor®, Caduet®) - bepridil hydrochloric (Vascor®, Bepadin®) - bosentan (Tracleer®) - buspirone - carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegreto®) - clarithromycin (Biaxin®, Prevpac®) - clonazepam (Klonopin®) - clorazepate (Gen-xene®, Tranxene®) - colchicine (Colcrys®) - medicines that contain dexamethasone - diazepam (Valium®)

- digoxin (Lanoxin®) - disopyramide (Norpace®) - estazolam - ethosuximide (Zarontin®) - flecainide (Tambocor®) - flurazepam - fluticasone (Flovent®, Flonase®, Flovent® Diskus, Flovent® HFA, Veramyst®) - itraconazole (Sporanox®) - ketoconazole (Nizoral®) - lidocaine (Xylocaine®) - mexiletine - oxcarbazepine (Trileptal®) - perphenazine - phenobarbital (Luminal®) - phenytoin (Dilantin®, Phenytek®) - propafenone (Rythmol®) - quinidine (Neudexta®) - rifabutin (Mycobutin®) - rifapentine (Priftin®) - risperidone (Risperdal®, Risperdal Consta®) - salmeterol (Serevent®) or salmeterol when taken in combination with fluticasone (Advair Diskus®, Advair HFA®) - sildenafil (Viagra®), tadalafil (Cialis®) or vardenafil (Levitra®, Staxyn®), for the treatment of erectile dysfunction (ED). If you get dizzy or faint (low blood pressure), have vision changes or have an erection that last longer than 4 hours, call your healthcare provider or get medical help right away.

- tadalafil (Adcirca®), for the treatment of pulmonary arterial hypertension - telithromycin (Ketek®) - thioridazine - voriconazole (Vfend®) - warfarin (Coumadin®, Jantoven®) - zolpidem (Ambien®, Edlular®, Intermezzo®, Zolpimist®) Know the medicines you take. Keep a list of all your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. Do not start any new medicines while you are taking STRIBILD without first talking with your healthcare provider.

Keep STRIBILD and all medicines out of reach of children.

This Brief Summary summarizes the most important information about STRIBILD. If you would like more information, talk with your healthcare provider. You can also ask your healthcare provider or pharmacist for information about STRIBILD that is written for health professionals, or call 1-800-445-3235 or go to www.STRIBILD.com.

Issued: August 2012

COMPLERA, EMTRIVA, GILEAD, the GILEAD Logo, GSI, HEPSERA, STRIBILD, the STRIBILD Logo, TRUVADA, and VIREAD are trademarks of Gilead Sciences, Inc., or its related companies. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other marks referenced herein are the property of their respective owners. © 2013 Gilead Sciences, Inc. All rights reserved. QC15554 01/13

POSITIVELY AWARE JOURNALISM. INTEGRITY. HOPE.

Jeff Berry editor-in - Chief

Enid Vázquez a s s o c i at e e d i t o r

Sue Saltmarsh copy Editor

Jason Lancaster p r oo f r e a d e r

Joshua Thorne Web Master

Rick Guasco C r e at i v e d i r e c t o r contributing writers

Liz Highleyman, Sal Iacopelli, Laura Jones, Jim Pickett, Matt Sharp On the cover Brian Heckler, at Northstar Medical in Chicago.

Photograph By Chris Knight.

Watch the video brian made After he learned he was HIV-positive: youtu.be/ Uc8K6iHOUok

photogr aphers

Chris Knight Joshua Thorne M e dical advisors

Daniel S. Berger, MD Gary Bucher, MD Michael Cristofano, PA Joel Gallant, MD Swarup Mehta, PharmD

See you in new orleans If you’re Attending the U.S. Conference on AIDS, Look for positively Aware AT Booth 612 and Find out about our anti-stigma campaign, A Day With HIV.

adve rtising inq u irie s

Subscription services

distribution@positivelyaware.com

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/PositivelyAware

@PosAware

inbox@positivelyaware.com

All communications (letters, email, etc.) are treated as letters to the editor unless otherwise instructed. We reserve the right to edit for length, style, or clarity. Let us if know you prefer we not use your name and city. You can also write: Positively Aware, 5537 N. Broadway St., Chicago, IL 60640.

We accept 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.

POSITIVELY AWARE IS PUBLISHED BY

5537 N. Broadway St. Chicago, IL 60640 phone: (773) 989–9400 fax: (773) 989–9494 email: inbox@positivelyaware.com www.positivelyaware.com 4

S eptem b er+ o c to b er 2 013

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

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

P OSITIVELY AWARE

Photo ©IAS/Steve Forrest-Workers’ Photos

Lorraine Hayes l.hayes@positivelyaware.com

SEP+OCT 2013 V O LU M E 2 5

NU M BER 6

Traditional dance performers from the University of Malaya Cultural Centre during the opening session of the 2013 International AIDS Conference in Kuala Lumpur.

Departments

F e at u r e s

Online

6 In Box and

10 Getting started with your health care

Advocacy and activism

Readers Poll

Things to know for the first doctor visits.

ACTing UP is still important.

by Jennifer A. Johnson, MD and Paul E. Sax, MD

by Sue Saltmarsh

7 Editor’s Note

HIV never takes a holiday.

8 BRIEFLY

15 (Clinical) Trials without tribulations Design, participation, and goals of clinical trials.

by Bran LeFae

positivelyaware.com/ 2013/13_06/Actup.shtml

IAS PrEP update

Gardasil. Poz Cruise to set sail. Bangkok tenofovir study.

19 Questions of law

New drugs, pregnancy, intermittent use, and more.

Legal and health care issues for people living with HIV.

by Enid Vázquez

22 CONFERENCE

27 Some thoughts on living with HIV

positivelyaware.2013/13_06/ iasprep.shtml

UPDATE Cure at IAS. Updated WHO guidelines.

Once-a-month dose.

36 THE BUZZ Aging positively.

by Daniel S. Berger, MD

40 2013 Reader survey

by Ann Hilton Fisher

Lessons learned by someone living with the virus.

It’s in your blood

Some of the most important lab tests and what they mean.

by Dan Gebhardt

30 The rides of a lifetime Friends take part in two AIDS rides to help fight stigma

and raise awareness.

http://positivelyaware. com/2011/11_06/Blood.shtml

Unfolding picture

by David Duran

32 Nothing small about microaggression

How we can hurt and be hurt and never know it.

by Jeff Levy, LCSW and Amber Jones, AM P OSITIVELY AWARE

Understanding the puzzle that is our immune system. positivelyaware.com/ 2011/11_06/Unfolding.shtml S eptem b er+ O c to b er 2 013

5

IN B OX

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Readers poll

inbox@postivelyaware.com

Authentic Response Thanks for sharing such personal and deeply emotional things, Jeff [Editor’s Note, “The Struggle to be authentic,” July+August issue]. I have always found you to be “authentic!” You have always been the same kind-hearted and genuinely caring guy that I met almost 30 years ago. You are one of the guys that I have always admired and wished I could be like. Thinking back on my life experiences, I realize that we have much more in common than I had ever imagined. Thanks for sharing, Jeff. You made my day. You’re a good guy and I wish you all the best.

—Bill McMillan There’s plenty of authenticity in this piece, Jeff, that’s for sure. While many of us are wounded or flawed, the trick is to have the ability to speak your truth about it, without (too much) fear. Yours comes from a sincere wish to help other people. That’s inspiring and the best anyone could possibly aspire to. Good for you.

—Mark S. King I was thumbing through Positively Aware (July+August 2013) and read your

Editor’s Note. I really appreciate your honesty in discussing “authenticity” to oneself.

It is a struggle for all humans regardless of HIV status. Your column points out a variety of truths about the need for each individual to care for and love him– or herself.

As an HIV provider since 1998 at UCSD Owen Clinic, I have seen firsthand the stress, anxiety, and depression that affect our patients (as well as our staff). As you

astutely point out, we “selfmedicate and numb” ourselves through drugs, alcohol, sex, food, etc. in an attempt not to feel pain caused by stress, anxiety, and depression.

I have had my own share of life difficulties, but it wasn’t until I started doing Kelee meditation after a breakup with my partner that I began to develop more selfawareness and clarity of mind to see and understand my own difficulties. Kelee meditation has helped me to be more authentic as an individual and as a medical provider through my own self-understanding. I even did a study with my HIV-positive patients showing the benefits of the meditation and developed a medical model as to how this leads to improvement in stress, anxiety, and depression. Check out the Kelee Foundation website (thekelee.org).

Thank you for your time and the work you do.

—Daniel Lee, MD San Diego, CA

Insider’s view Thank you so much for your efforts to share participant voices on an issue which is usually mired in silence and shame! [“Views from the inside,” Sue Saltmarsh’s online interview with two injection drug users.] What you uncovered glimpses of is the all too human nature of a group often hated and blamed for everything from terrorism to handgun violence. It has been a pleasure working with TPAN for going on two decades now!

—Dan Bigg Director, Chicago Recovery Alliance

CLARIFICATION: In the section on hepatitis C drugs in the July+August issue (p. 37 in print), the following statement appeared: “Anemia is when hemoglobin, a critical type of red blood cell, declines to unhealthy levels.” Hemoglobin is not a red blood cell itself, but rather a protein in red blood cells.

The text in the online version has been changed as follows: “Anemia is when red blood cells (RBCs) and hemoglobin, a protein in RBCs that carries oxygen, decline to an unhealthy level.”

Thanks to Dr. Ryan D. Racino, PharmD, AAHIVP, for bringing this to our attention.

In the July+August issue, we asked

Do you think decriminalizing prostitution would reduce new HIV infections?

NO 30%

NOT SURE

10%

Your comments

“Yes, I believe in the decriminalization of prostitution and drug use.”

“All you have to do is look at the general HIV infection rate in the Netherlands (legal prostitution is .2%) vs. ours (illegal prostitution is .6%). Do the math.”

“Americans’ repressive attitude about sex in general is one of the things driving the epidemic.”

this issue’s poll question

You’ve just tested positive–what do you do now? Rank the following things in order of importance: (1 being most important): o o o o o o o o

Tell family/partner(s) Find a doctor Quit smoking Start on treatment Get counseling Change diet/exercise habits Get a case manager Connect with a support organization

cast your vote at positivelyaware.com

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P OSITIVELY AWARE

Yes 60%

E d ito r ’ s n ot e

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Jeff Berry

HIV never takes A holiday

I

Photo: Chris Knight

live and breathe HIV. That was an observation someone made of me recently when explaining to someone else why I was successful in my work. It made me stop and think. Do I really live and breathe HIV? Is that even healthy—can one hyperventilate on HIV? And if that is indeed true, am I overdoing it? Or is that what it takes? And at what cost?

I’m guessing I’m not alone in this, in fact I’m sure of it. There are countless people around this country, and around the world for that matter, who are living and breathing HIV every day. There are those, both HIVpositive and negative, who get up every morning to work in the field of HIV. Whether they are a researcher, social worker, clinician, case manager, specialty pharmacist, receptionist, volunteer, or work on an HIV-related publication, from sunrise to sunset and every waking moment in between, it’s all HIV, all the time.

I suppose it’s not that much different from any other profession. In order to succeed and be the best at what you do, sometimes you have to take your work home with you and work weekends. Even as you sleep you’re sometimes at work in your dreams. (I usually don’t feel too rested when this happens and I have to get up and work the next day!).

I think for those who are both working in the field and HIV-positive, it can add another dimension or layer on top of it, because you can never, ever, really turn it off. For some of us, we are reminded every time we take our pills, or look in the mirror, or have sex (or not), or when we eat (take with food!), or when we go to the clinic or pharmacy.

Wouldn’t it be nice if maybe, just once in a while, we could take an HIV holiday? I don’t mean a drug holiday— we know that’s not necessarily a good thing and can lead to drug resistance. I’m thinking more like Audrey Hepburn in “Roman Holiday.” You know, the story of the princess who wants to escape the duties of being a royal and experience freedom, and meets the dashing American newspaper reporter played by Gregory Peck, who eventually sweeps her off her feet. Sounds lovely, doesn’t it? Sweep me off my feet and away from HIV, please. Sorry, HIV, but I’m on holiday. Time to turn on my “Out of HIV” auto-notification.

One of the problems with living and breathing HIV

is that you never feel like you’ve done quite enough, and there is this nagging little voice telling you that you could somehow be doing more.

Maybe it’s the email you flagged but haven’t gotten around to responding to yet, or the meeting you blew off last week, or the article you haven’t finished reading.

It’s important that we find those little things that can help rest our body and mind and rejuvenate our soul, so that we can do the work, and remain effective.

Like splurging on a full spa treatment, or perhaps just a manicure or massage. Take an entire day (my partner calls mine a “Jeffy” day) and do whatever it is you want to do, like some shopping, catching a movie, or going to the beach (or all three!). Something as simple as not eating at your desk but going out to lunch with a friend or co-worker can sometimes make all the difference. And I realize it’s not a little thing, but I’ve never taken a sabbatical or leave of absence—after 20-plus years and seeing some of my peers doing it now (and feeling incredibly jealous!), I’m thinking maybe it’s time.

Whatever it is, discover your holiday from HIV and be sure to take it. As a wise man once said, the work will always be there. Create the order and structure you need to make it all work, and then every once in a while, break up the routine. It is the nature of the work we do that we are always “doing” for others, but it’s important to “do” for ourselves once in a while, and to also let others “do” for us from time to time.

In a few weeks, I will be joining many of my friends and peers at the United States Conference on AIDS in New Orleans, where I will be encouraging everyone to take part in our annual A Day with HIV anti-stigma photo campaign which takes place on Saturday, September 21 (see inside back cover or go to adaywithhiv.com for details). But I will also be asking what it is that they’re doing to take care of themselves. Because we may be living and breathing HIV, but in the end, we should be, ultimately, surviving and thriving.

Take care of yourself, and each other.

P OSITIVELY AWARE

It’s important that we find those little things that can help rest our body and mind and rejuvenate our soul, so that we can do the work, and remain effective.

Follow Jeff: @PAEDITOR

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7

Briefly Enid Vázquez @ENIDVAZQUEZPA

New HIV drug approved—Tivicay

Isentress results better than Sustiva’s

Generic Atripla-like STR available abroad

The FDA approved a new HIV drug, dolutegravir (brand name Tivicay), on August 12 as this issue went to press. Tivicay is a secondgeneration integrase inhibitor, and is expected to work if other integrase inhibitors no longer control viral load. Tivicay can be used to treat HIV-positive adults who have been treated with other drugs or are new to treatment, and in children aged 12 years and over, who weigh at least 88 lbs. and who have not received treatment with a drug that has the same mechanism of action. It is the first drug from the ViiV Healthcare pipeline.

The Fair Pricing Coalition (FPC), which works with pharmaceutical companies on drug pricing and access issues for HIV and hepatitis drugs, commended ViiV for its pricing of Tivicay in a statement. While the FPC said it believes that all HIV drugs are priced too high, they were satisfied that ViiV’s Wholesale Acquisition Cost (WAC) for Tivicay is $14,105 per year, $1,037 more than its nearest competitor. FPC member Lynda Dee states, “We believe we can declare a victory here since ViiV followed our request, pricing Tivicay very close to its nearest competitor. ViiV could have priced Tivicay much higher based on its efficacy and improved dosing indication.” Tivicay will be covered under ViiV’s patient assistance and co-pay programs, with co-pays covered up to $400 per month for Tivicay ($200 per month for all other ViiV drugs). See the conference —Jeff Berry report on page 24.

In July, the FDA approved an update to the Isentress (raltegravir) drug label with data showing that it was non-inferior to Sustiva (efavirenz) at 240 weeks (nearly five years).

The STARTMRK study enrolled 563 people with HIV who had never been on antiviral treatment before. Half were given Isentress and half were given Sustiva, all taken with Truvada. More people reached undetectable viral load (less than 50 copies per mL) with Isentress than Sustiva (71% vs. 61%). This was a statistically significant difference.

CD4 cell count increase was similar for both groups (about 220), but twice as many people discontinued Sustiva due to adverse events (10% vs. 5% of those on Isentress). On the other hand, Sustiva/ Truvada may have been at a disadvantage because it was given as two pills a day. In the real world, the combination is almost always given as the single pill regimen of once-daily Atripla. The results were published in the May 2013 issue of JAIDS.

In June, the Food and Drug Administration (FDA) granted tentative approval for a single tablet regimen (STR) like Atripla, containing efavirenz, lamivudine, and tenofivir DF, available only abroad due to U.S. patents. Atripla contains efavirenz, tenofovir DF, and emtricitabine (a drug which is almost the same as lamivudine).

The generic single tablet regimen would be available for sale through PEPFAR, the President’s Emergency Plan for AIDS Relief. The generic will be manufactured by Aurobindo Pharma Limited, based in India.

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n Selzentry

(maraviroc) by itself plus Emtriva n Selzentry plus Viread n Truvada n Selzentry

Truvada, a combination pill containing Emtriva and Viread, is already on the market as an HIV prevention pill, or PrEP (pre-exposure prophylaxis). All these medications are also used to treat HIV. Go to the HIV Prevention Trials Network website, hptn.org, for more information.

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Gardasil vaccine might benefit positive men A Gardasil vaccine study looking at 235 HIV-positive men who have sex with men (MSM) without a history of anal cancer, or precursors to it, found that although 45 percent had normal anal cells, a significant

TIVICAY: COURESY OF VIIV HEALTHCARE

HPTN 069, called NEXT-PrEP, is open for enrollment. The nationwide Phase 2 study is looking at four different medications to prevent HIV in men and women at risk of infection:

ACT UP New York staged a protest at Mt. Sinai Hospital in Manhattan after three nurses denied a gay man treatment with PEP (post-exposure prophylaxis) after a potential exposure to HIV. If started within 72 hours after exposure, PEP—HIV medications taken for 28 days—can prevent infection with the virus. “Mt. Sinai is not alone,” ACT UP reported in a press release. “There are several reports of delays or refusals by other New York City health care providers in getting PEP to those who need it. And the NYC Department of Health’s Bureau of HIV/AIDS is doing a lousy job of getting the word out about this important tool of HIV prevention.” ACT UP also helped the man gain access to PEP within the 72 hours. Go to actupny.com for more information, including safer sex strategies.

VÁZQUEZ: JOSHUA THORNE

HIV prevention study open

ACT UP protests hospital’s denial of PEP

number of them—30 percent—had high-grade anal intraepithelial neoplasia (HGAIN), a preliminary sign of cancer. ”This study documents a substantial prevalence of [HGAIN] on high-resolution anoscopy among HIV-infected men with no prior history of the disease. Only 33 percent of participants had HPV-16 and HPV-18 [the viruses most associated with abnormal anal cells], suggesting that most HIV-infected MSM without a prior history of HGAIN could benefit from HPV vaccination,” wrote HIV specialist Carlos del Rio, MD, in the July AIDS Clinical Care newsletter. The study was published in the March/ April HIV Clinical Trials.

Last year’s Poz cruise

POZ CRUISE: Courtesy PAUL STALBAUM

LGBT POZ Cruise The ninth annual cruise for gay men and women living with HIV takes place November 2–9, sailing from Miami on the Carnival Liberty to Cozumel, Belize City, Roatan, and Grand Cayman. For more information, call 888-640-SHIP (7447), email Paul@cruisedesignstravel.com, or go to hivcruise.com.

South Carolina last state to stop segregating HIV-positive prisoners The ACLU (American Civil Liberties Union) reported that in July, South Carolina announced it would stop segregating its HIV-positive prisoners from the general inmate population. Its 600 male prisoners with HIV, even those incarcerated for

“trivial offenses,” were placed in solitary confinement and then housed in maximum security, and forced to wear badges showing that they were in HIV-only quarters, the ACLU noted. According to the report, “This HIV segregation policy has long subjected all South Carolina prisoners to far harsher and more degrading conditions, with far fewer opportunities for rehabilitation, than their HIV-negative peers—and in many cases it has resulted in people with HIV serving longer time in prison solely because of their HIV status.”

HIV prevention for IDUs in Bangkok study A daily dose of tenofovir, a medication used to treat HIV, reduced the risk of contracting HIV by 49% among people who inject drugs, according to a report from the Centers for Disease Control and Prevention (CDC) last June.

The drug users who took the medication more consistently, however, had an even greater level of protection against the virus. “This is the first evidence that preexposure prophylaxis (PrEP) offers significant protection to individuals exposed to HIV through injection drug use,” the CDC noted. The findings of the Bangkok Tenofovir Study were published June 12 online in the Lancet. The study enrolled more than 2,400 men and women in the Bangkok, Thailand city-run drug treatment clinics. Tenofovir, available under the brand name Viread, is one of the two medications in Truvada, an HIV medication that is also FDA-approved for PrEP in the U.S.

Getting all studies reported The London-based charitable organization Sense about Science created the AllTrials campaign to force pharmaceutical companies to register all their clinical trials and release all of the data, not just positive results. According to an item in The Guardian newspaper on July 21,

however, the organization announced that the two most powerful pharmaceutical industry representatives in the world, the Pharmaceutical Research and Manufacturers of America (PhMRA) of the U.S. and the European Federation of Pharmaceutical Industry Associations (EFPIA), are organizing patient groups to oppose the effort. In response, HIV treatment advocates in the U.S. are urging patient groups worldwide to sign on to the AllTrials call for openness; go to alltrials.net.

New PEP guidelines The Public Health Service now recommends Isentress plus Truvada as post-exposure prophylaxis (PEP) for occupational exposure to HIV for health care workers. Immediate treatment should be administered with a follow-up appointment no later than 72 hours after exposure. Four months of follow-up testing can be used instead of six months if a newer fourth-generation antigen/antibody test is used. Clinicians and institutions should make providers and staff aware of the importance of reporting exposures and seeking immediate care. See details, including different situations, at jstor.org.

Examining art’s impact on an epidemic NOT OVER: 25 Years of Visual AIDS is a new book that captures the first quarter century of work from the organization responsible for Day With(out) Art and the Red Ribbon. The book spans the devastating days of the early epidemic to present day, and is an intimate chronicle of art, action, and culture trying to grapple with order, time, and loss. NOT OVER includes essays, color reproductions of over 50 artworks and projects, memorable quotes by artists, activists, and writers, and a timeline of exhibitions, programs, and other Visual AIDS milestones.

To order the book go to visualaids.org.

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Getting started with your HIV care Important things to know for the first few doctor visits

by Jennifer A. Johnson, MD and Paul E. Sax, MD

S

o, you got the result of your HIV test: it’s positive.

What do you do now? It’s common to feel overwhelmed, angry, even scared. But, it’s important to move forward and get into medical care—don’t delay, even if you feel fine physically. Find some resources to learn more about HIV. Take stock of your friends and family, evaluate where you can best draw support and consider disclosing your HIV status to those that can support you through the process. And get in to a treatment center to see an HIV clinician. With early initiation of treatment, HIV-positive people can stay healthy and live just as long as people without HIV. So, it is more important than ever to get into medical care to take advantage of early therapy.

Unfortunately, in the U.S., approximately 25 percent of people who receive a positive HIV test result don’t connect with an HIV treatment center after receiving their result. Of those that do make it in for an initial visit, approximately one third do not stay in care. Finding an HIV treatment provider with whom you feel comfortable is an important step toward staying healthy. Your HIV clinician may be a doctor; alternatively, it can be a nurse practitioner or a physician’s assistant working with a doctor.

Getting to know you

T

he first visit with your new HIV clinician starts

with introductions: you getting to know the clinic or office and them getting to know you as a person. Of course, much of the visit will focus on your medical information, but the introductions are important to build a lasting relationship so that you can get the best possible medical care.

Meet the front desk staff and the nurses. Find out

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the easiest ways to contact them to schedule appointments, request medication refills, or talk with your nurse or doctor about a health concern. Many clinics have confidential web-based systems that allow patients to interact virtually, without picking up the phone. Meet with a social worker, if one is available.

Social workers can help with a wide range of issues, including insurance concerns, accessing programs and resources, and providing emotional support as you navigate the world with your new HIV diagnosis. In some clinics, this role might be shared with an HIV-specific case manager.

Your clinician should want to get to know you as well. Your living situation, employment status, personal relationships and other social supports, and your decisions about disclosure of your HIV status will all affect your ability to manage your health, so all of this should be part of the discussion. Your clinicians will want to review your personal health habits, including tobacco, alcohol, and use of illicit drugs such as cocaine, crystal meth, and heroin; honesty with your clinicians is very important in order to allow them to provide the best medical care.

Your clinician will review the circumstances of your HIV diagnosis, any recent symptoms, your last HIV test before you tested positive, and any other data that helps indicate the timing of infection and how far along the infection may have progressed. Prior sexually transmitted infections (STIs) will be reviewed, and a full medical history of any other non-infectious conditions in the past or ongoing will be taken. All current treatments you take, including over-the-counter or alternative medications and supplements, will be reviewed. HIV medications may have

25% of people who receive a positive HIV test result don’t connect with an HIV treatment center after receiving their result.

many drug-drug interactions, so an accurate list of everything you take is important to prevent toxicities. You will be asked about possible allergic reactions to medications. Any history of illness in your family, especially your immediate family, will be reviewed to determine if you are at increased risk for any particular diseases, and whether more aggressive screening is indicated.

A full physical exam is an important part of the visit, focusing on any areas of active symptoms. Expect a careful examination of the skin, eyes, mouth, lungs, heart, and stomach area. HIV can cause swelling of the lymph nodes; these are located in the neck, under the arm, and in the groin, so these areas will also be examined. Some sexually transmitted infections may not be obvious to you, but can be assessed on examination; although it might be embarrassing, your clinician should examine the penis and anal areas; women will be asked to have a pelvic examination if they have not had one recently, though sometimes this is scheduled for a different visit.

Unfortunately, there will be blood tests at the first visit—this is unavoidable. These “basic labs” will include blood counts, electrolytes, and kidney and liver tests. The HIV viral load test will show how much virus is circulating in your bloodstream. The initial viral load measurement may be high, anywhere from thousands to millions. The goal of antiretroviral therapy (ART) is to reduce the HIV viral load in the bloodstream to an undetectable level,

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Testing cheat sheet

The CD4 cell count provides an indication of how strong your immune system is—how well you can fight off infections and other complications of HIV. It also tells you how soon you should consider HIV treatment.

An HIV genotype test will provide a list of resistance mutations found in your virus that could lead to resistance to treatment; this could affect treatment decisions.

Women who are pregnant need to start medications as early as possible in order to prevent transmission of HIV to the fetus.

Pap smears (anal for everyone and cervical for women) are part of the initial evaluation but might not always be done during the first visit.

which may be less than 20–75, depending on the test used. The CD4 cell count gives us a sense of the strength of your immune system—in other words, how well you can fight off infections and other complications of HIV. It also tells us how urgently we should be moving towards starting HIV treatment. The lower the CD4 cell count, the sooner you should be started on HIV treatment. For example, if the CD4 count is less than 200, then the risk of other infections is much higher. The CD4 count responds more slowly to ART than the viral load, but will eventually increase after starting ART. An HIV genotype test will provide a list of resistance mutations found in your virus that could lead to resistance to ART, which may affect treatment decisions. Additional labs will include screening tests for hepatitis B and C infections, and for syphilis, gonorrhea, and chlamydia if there are symptoms or a history of possible exposure. Cholesterol screening (lipid panel) can be done even when you have eaten recently, and will provide information about this possible risk factor for cardiovascular disease, which is more common among HIV-positive people. Pap smears, both anal for everyone and cervical for women, will be a part of the initial evaluation but may not always be done during the first visit.

The results of the CD4 count and viral load tests, taken together with some of the other information, will help determine how urgent the need is to start therapy.

The genotype will help your clinician figure out which medication regimens should work well for your virus.

Even though these tests may take around a week to be completed, you can start a discussion about HIV 12

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If you also have hepatitis B, HIV treatment might overlap with hepatitis treatment. These treatments must be started together, which could mean an earlier start.

If HIV infection is causing kidney damage, HIV meds might help protect your kidneys.

treatments at the first visit and continue the discussion when these results are available.

How soon do you need to start medications?

A

t this point, the guidelines from the U.S. Department of Health and Human Services (DHHS) recommend starting HIV medications for most HIV-positive people, even if they are feeling fine and have high CD4 cell counts. But, most of the time, medications don’t have to be started right away, especially if your CD4 cell count is above 350. On the other hand, if your immune system has already been significantly weakened by HIV, then it is important to start medications relatively soon to prevent complications, such as serious infections. For example, if your CD4 count is less than 200, then your immune system has become quite weak and you should start on ART sooner rather than later. This is particularly important if you have an “opportunistic infection,” or an infection that is typically only seen when the immune system is compromised. If you have been losing weight or otherwise feeling ill due to the HIV infection, then medications may also be more urgent.

Certain other conditions may increase the urgency of starting HIV medications. Women who are pregnant need to start medications as early as possible in order to prevent transmission of HIV to the fetus. If HIV infection is causing kidney damage, HIV medications may help protect the kidneys. If you also have hepatitis B,

treatment for HIV may overlap with treatment for hepatitis B, so these treatments must be started together, which may mean an earlier start.

But, if none of these conditions apply to you, starting HIV medications is not an emergency. If you are generally healthy and have a high CD4 count (at least more than 350, preferably above 500) then HIV medications are still beneficial for you—they may decrease the chance of developing some complications of HIV such as cancer and cardiovascular disease, and definitely decrease the risk of transmitting HIV to others.

However, if you fit in this group, you have a little time to determine the best HIV medications for you and to make a sustainable plan to take your medications regularly.

improve your chances of success with treatment. If you are using recreational drugs or have problems with alcohol, you may have a difficult time taking your medications regularly. Depression and other psychiatric conditions can also be barriers to medication adherence.

Seeking treatment for drug and alcohol use and finding mental health resources are great first steps toward resolving these issues. Insurance or financial barriers to starting HIV treatment can often be resolved by working with a social worker. >>

How soon do you feel that you can start medications?

S

tarting HIV medications is a big commitment. It can be daunting to think about starting medications that you are going to take every day, especially if you are young and healthy and not used to taking medications regularly. But we know from clinical studies that stopping and starting medications is not good for your health. When people go on and off their HIV medications, they are at higher risk of developing resistance (meaning certain antiviral drugs won’t work as well) and have more HIV complications. So, when you start ART medications, the hope is that you will continue on a successful medication regimen. This does not mean that you are stuck with the same regimen that you start on initially for the rest of your life—many people make changes to their treatment if there are side effects. Such changes are safe provided that some sort of medication is given continuously. You may change medications multiple times if you have trouble with side effects, or if the medication interacts with other drugs that you need.

In order to prepare to take your medications regularly, it is important to identify your strengths, as well as any potential barriers to making this commitment. One key strength for many people is support from family or friends. If you are able to tell even one family member or friend about your HIV diagnosis so that you have some support throughout the process, this can significantly

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A collaborative plan

F The results of the CD4 count and viral load tests, along with other information, will help determine how urgent the need is for starting therapy.

eel free to discuss medication options with your HIV clinician. Your clinician can explain to you which medication regimens would be safe and appropriate for you based on the results of your blood tests and your medical history. Then you can work together to choose the best option for you based on the potential side effects, any requirements for dosing, and the number and size of pills with each regimen. For instance, one medication often causes sleep disturbances, especially during the first weeks of treatment, so this may not be a good fit for people who work night shifts or have to get up very early for work. Another medication must be taken with a meal every day in order for it to work well, so this may not be a good fit for people who have irregular meal schedules or eat small meals and snacks rather than any full meals.

Once you have chosen the best initial HIV treatment for you, you will review exactly how to take it and any anticipated side effects. You will come back soon after starting new HIV medications to check in about side effects and have blood tests to make sure that the medications are succeeding in decreasing your HIV viral load and that they are not causing any harm. Today’s HIV treatments are so effective that big changes in the viral load can be measured just a few weeks after starting treatment.

If you have trouble remembering to take your medication properly or if you are having side effects that are difficult to manage, it is important to contact your medical provider to see if a change is warranted. Fortunately, there are many antiretroviral medications available in the U.S., including three different one-pill-once-daily regimens, so there are plenty of options to make a switch if your first regimen is not working out.

Sustaining adherence

A

fter you get over any initial hesitancy and get

started on HIV medications, it can be difficult to keep up with the new habit of taking medications

Jennifer A. Johnson, MD is an HIV and Infectious Diseases physician at Brigham and Women’s Hospital (BWH) in Boston, MA. After medical school at the University of California at San Francisco, she did her Internal Medicine residency at BWH and also completed HIV and Infectious Diseases fellowships there and at Massachusetts General Hospital. Dr. Johnson works in HIV vaccine research and medical education, but her primary focus and true passion is patient care. She treats patients at the Infectious Diseases clinic at BWH, for infectious diseases and HIV, including HIV primary care.

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every day. Even without any specific barriers to taking medications, many people have trouble with the emotional issues connected to their HIV treatment, the number and size of pills, or just remembering to take them every day. Drawing on family and friends, social workers, or mental health providers can help alleviate some of the emotional stress associated with the HIV medications.

Pillboxes, with an individual compartment for each day of the week, are a big help for many people, even wellorganized people—they’re not just for the elderly!

Looking forward

O

nce you are taking your medications regularly and your viral load is “undetectable,” you won’t have to see your HIV clinician quite as often.

Many people who are doing well with their HIV treatment see their providers only twice, and sometimes only once, every year, though it’s still important to get monitoring blood tests (especially the viral load) twice a year.

However, keeping your HIV viral load controlled is not the only focus of your medical care. Your HIV clinician will make sure that you have had all of the recommended vaccines, and that you have regular screening for other infections that you may be at risk for, such as syphilis and hepatitis C. People with even well-controlled HIV may also have a higher risk of developing heart disease and some cancers. So, decreasing those risks as much as possible will be an important part of your care. You can decrease your risk of heart disease by avoiding tobacco use, maintaining a healthy weight, watching your blood pressure and cholesterol, and exercising. Avoiding tobacco will also decrease your risk for many cancers.

Your medical team will also ensure that you get regular screening tests for breast, cervical, anal, and colon cancers.

Developing a good relationship with your HIV treatment team is important in order to facilitate the best possible medical care. This can keep you healthy for many years to come!

Paul E. Sax, MD is Clinical Director

of the Division of Infectious Diseases and the HIV Program at Brigham and Women’s Hospital (BWH), and Professor of Medicine at Harvard Medical School. Dr. Sax received his MD from Harvard Medical School and is board certified in Internal Medicine and Infectious Diseases. He is Editor-in-Chief of Journal Watch: AIDS Clinical Care. Dr. Sax’s ongoing areas of research include clinical trials of antiretroviral therapies, cost-effectiveness of management strategies for HIV, and toxicity of antiretroviral therapy. He is presently the principal investigator at the BWH AIDS Clinical Trials Unit.

Trials

Without Tribulations What you should know about the design, participation, and goals of clinical trials

by Bran LeFae

H

IV is a tricky virus. Even after decades of research, it continues to challenge scientists and doctors as each piece of the puzzle is revealed. Finding new ways to treat the virus or prevent transmission is a process that involves researchers and the volunteers that make the research possible.

Since the 1980s, scientists and doctors have been working hard to discover everything possible about the virus. How it works, what might stop it, how to treat

it—all these questions have been explored through clinical research trials. Many successful prevention and treatment strategies started in these trials.

Clinical trials exist to add to general medical knowledge. Dr. Cal Cohen, Director of Research at the Community Research Initiative of New England, is clear on this distinction. “Research is being done because there’s something we think we can make better than what we have now.

It is part of the process of acknowledging what is available now and the desire to make things better. There’s always uncertainty. Nothing is guaranteed. Accepting

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Explaining clinical studies

Easy as 1, 2, 3... 4 When a treatment is ready for study in people it is called a Phase 1 trial. Phase 1 and 2 studies evaluate the safety of the previous work done in the lab.

These phases look at how people react to the treatment, with extra attention given to any unfavorable reactions.

that uncertainty and being a part of a process to answer it is research. For some people that’s exciting and they want to be involved,” says Cohen.

It’s an important point. Most clinical trials don’t offer a direct benefit to the volunteers. Often they only provide benefit to the greater community. Asking people to take risks for research is serious business.

Before a trial can even start to recruit volunteers it has to go through many steps to ensure safety. Depending on the degree of risk in the study, many levels of behind-thescenes supervision can be required.

How do clinical trials work?

A

clinical research study has distinct phases—Phases 1–4. Once a treatment is ready for study in people it is called a Phase 1 trial. Phase 1 and 2 studies evaluate the safety of the previous work done in the lab. These phases look at how people react to the treatment, with extra attention given to any unfavorable reactions. Phase 3 studies look at the treatment in different populations. These trials also look for any interactions with common treatments that patients might typically use.

Phase 3 is generally the final stage of research before the treatment is reviewed for use in the general public. Sometimes clinical studies will continue with Phase 4, where more safety, efficacy, or optimal use data will be analyzed. These studies often take place after the treatment has been approved for use.

Each phase requires in-depth analysis 16

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Phase 3 studies look at the treatment in different types of people. These trials also look for any interactions with common treatments that patients might typically use. Phase 3 is generally the final stage of research before the treatment is reviewed for use in the general public.

by a wide range of experts. Before a single volunteer can be recruited, the study design has been analyzed by funding agencies, regulatory boards, oversight committees, and experts from many fields. The research plan must cover many elements of safety for participants. From ethics to practical concerns, clinical studies must prove their worth many times over before they can get started answering the question that is at the heart of it all.

How do clinical studies stay safe for volunteers?

T

wo key players who help keep studies safe are committees of experts called the Data Safety Monitoring Board (DSMB) and the Institutional Review Board (IRB). Both boards have important roles to play in clinical trial safety and can wield serious power. They can ask research staff to make changes in research activities based on their review. They can even suspend or stop a study if there are serious safety concerns or if the study data is showing that the treatment isn’t effective.

Clinical research studies can go on for quite some time, from months to years.

Instead of evaluating the study data at the end, it’s helpful to look at it as the study proceeds. That analysis can inform important safety decisions. A DSMB is an independent group that reviews the data regularly as it is generated by the study.

This group of experts works together to make sure that study safety is maintained

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Sometimes clinical studies will continue on to Phase 4, where more safety, efficacy, or optimal use data are analyzed. These studies often take place after the treatment has been approved.

based on the data coming out of it.

Because of the possible risk involved, there are strict regulations about how clinical studies are run. The IRB is a group of experts that makes sure clinical studies stay within the regulations. Composed of medical doctors, nurses, scientists, and community members, these boards review the ethical and safety considerations unique to each study.

Both boards use ethical standards as part of their review process. Looking at study ethics has always been a challenging issue in HIV research. David Evans, Director of Research Advocacy at Project Inform, spoke about the issue of asking people to go off of their antiretroviral treatment when testing potential new strategies in HIV cure research, as an example of that challenge.

“When and where is it okay to ask someone to go off of antiretroviral treatment for a research study—typically for about four months? During that period of time we usually see virus levels peak within about four weeks. That’s when we start to see the effect of the [experimental] therapy, if there’s any effect at all. One of the things we worry about is that we don’t want their reservoir of HIV to grow larger. One of the risks of treatment interruptions is that this reservoir could increase, especially if they started treatment early and have a low reservoir.”

Both the IRB and the DSMB are guided by ethical principles that have their roots in some of humanity’s most disturbing history. These principles began during the Nuremburg War Crime Trials after World War II. Known initially as the Nuremburg

Code, they were used to judge the doctors and scientists who had exploited concentration camp prisoners for their research.

In the early 1970s, a group of experts met to continue refining those principles. Called the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, they met for four years.

In 1974, the Commission condensed their findings, during an intensive meeting, into a set of basic ethical principles. These ideas inform research staff as well as IRB and DSMB board members. They help create studies that are safe for volunteers and offer benefit to the community.

Three basic principles came out of these meetings: Beneficence: examines when risk is justified and if there is any possible benefit. n Justice: one group should not be asked to experience risk for the benefit of another group. One way or another, the people who take on the risk of volunteering should be able to benefit from their contribution. n Respect for persons: people should be respected as capable of making their own informed decisions. n

These principles guide the creation and performance of clinical research to this day.

How is research different from clinical care?

E

ven the idea that something is

research instead of regular medical care requires careful thinking. After all, medicine isn’t a one-size-fits-all situation. Doctors are constantly adjusting treatment plans for their patients and sometimes a new procedure is exactly what’s needed.

When does it become research instead of just regular medical care?

Most people go into medicine in order to help other people. And if they can help many people instead of just one, all the better. Knowing when it’s clinical care and when it’s research is guided by the idea of generalizable knowledge. When medical care is given to test an idea and hopefully lead to conclusions that can help the general public, that is research. When medical care is an intervention that helps a single

patient, even if it’s unusual or groundbreaking, it’s regular medical care.

This distinction can seem complicated because many clinical studies rely on standard care practices. Volunteers often receive the accepted medical treatment along with the treatment that’s being studied. This approach allows the researchers to know that any effects they see will likely be the result of the new treatment. It also ensures that volunteers receive the same medical care that they would if they went to their own doctor.

Informed consent Informed consent is more than just telling people about a study. The study staff makes sure that the person interested in participating understands both the risks and the benefits. Study volunteers are also told about treatment alternatives that may be available.

Clinical trial safety and oversight on the job

T

here’s no doubt that the experts who analyze and watch clinical trials behind the scenes are playing an important role in safety. But day to day, it’s the research study staff and clinicians with the study who play the most critical role in maintaining safety standards. Not only are they experts in their field, they are also the people who recruit participants and explain the study to eligible volunteers. They are in charge of making sure that each participant should be in the study and that they are treated safely while participating.

One major piece of that process is called “informed consent”. This process is more than just telling people about a study. The study staff makes sure that the person understands the information they’ve been given—including both the risks and the benefits involved. During the consent process, study staff members explain the study’s purpose. They also tell volunteers about any alternatives that may be available. The person who’s thinking about volunteering can ask questions and clarify anything that may have been confusing.

This process honors the principle that people are capable of making their own informed decisions. It’s a critical piece of running an ethical research study.

“We never enroll someone on the same day they review the consent for the first time,” says Cohen. “We ask them to go home and talk to anyone they want to talk to and then come back on the second day and proceed if they want to. People often come back in with questions. We see this as essential to make sure someone believes this trial is a good fit for them.”

If a participant decides to take part in the study, they sign a consent form. This can consist of complicated documents, depending on the research. A slowly growing movement in clinical research is centered around an idea called plain language.

Plain language creates effective communication about complicated topics and is meant to be easily understood the first time it’s read or heard. Even though consent forms have to meet certain regulatory standards, it’s still important to make sure they’re understood by the study volunteer.

It’s often the only document that person will take home with them from the study.

Cohen sees informed consent as being more than just an information session. With all of the medical jargon in many studies, it’s easy to miss something that is potentially confusing. “If someone tells you that there’s a 20% chance of nausea, some people think they’re going to feel nausea 20% of the time. It doesn’t say to people that one in five people will feel nausea.” This is why the use of plain language in consent forms is so important. Comprehension is essential to the act of informed decision making.

HIV research hot topics

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linical research is exciting because it is responsive to change.

A new discovery can push research in a different direction than expected. HIV research is no exception. Both Cohen and Evans agree that one of the new frontiers in HIV research is the possibility of finding a cure. Once thought to be the stuff of

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It can be exciting to be a part of finding new treatments or even a cure—but it’s important to remember the old adage, safety first.

dreams, cure research is starting to take center stage.

This new direction has been inspired by several events. Most people have heard about Timothy Ray Brown, the man who was the first person to be effectively cured of HIV. Brown’s case is unique. Because he also had leukemia, he received a bone marrow transplant and stopped taking antiretroviral therapy. His doctor intentionally used bone marrow from a donor who had cells that weren’t receptive to the virus. When new blood cells were made from the transplanted marrow, the virus couldn’t get into these cells. HIV was, essentially, locked out.

Brown’s case isn’t something that can be used to develop therapy for many HIVpositive people because it was so extraordinary, but it showed that a cure was possible. There is another cause for hope— from what seems like an accidental finding.

It was reported at CROI 2013 that an HIVpositive woman in Mississippi gave birth to a baby who tested positive when born and was given three antiretroviral drugs within 30 hours of birth. The treatment continued until the child was just over a year old and doctors lost contact with the mother, who discontinued the medications.

Here’s where the story gets interesting. At just under two years old, the child returned to care. Initial tests showed that there was no detectable viral load even though the child had been off the antiretroviral treatment for over a year.

Doctors were shocked. Tests were checked and re-checked. But the initial results held up—this child, given an unusually aggressive treatment so quickly after birth and after testing positive for HIV, was truly HIV-negative. Researchers are cautious about calling this a cure just yet—but there’s no doubt that it’s a promising development.

Being able to turn around HIV infection at birth could mean a lifetime free of treatment for the hundreds of HIV-positive 18

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children born in the U.S. every year.

Cure research is not only bringing new hope to people living with HIV, it’s also a new area for ethical considerations in research studies. As Evans explains, “In the past in HIV research, we had riskier trials where we may expose someone to a risk that’s not clear. Those people were more desperate. In the past, we only exposed people who were very sick to new therapies. This is the same model we use in cancer, MS, and many other diseases. That is being turned on its head with new cure therapies. We’re not going to the sickest people but to the healthiest people who have the most to lose and the least to gain.”

Even with the excitement of a possible cure out there, it’s important to remember that the results of other studies hold value too. Another area of focus in HIV research is prevention. PrEP, short for pre-exposure prophylaxis, holds serious potential to prevent transmission. People at high risk of infection can take a daily pill to cut their risk. When used consistently, PrEP can lower the risk of infection by a significant degree. Though PrEP is now approved and available, research continues to investigate how PrEP works in the real world.

What to think about before participating

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eople participate in research projects as volunteers for many reasons. Some are looking for a more effective treatment for themselves. Others are inspired to give freely to the pursuit

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of knowledge, even when it won’t benefit them directly. Evans recently worked with another activist, Nelson Vergel, to create a survey that looked at whether people would be willing to participate in cure research that wouldn’t benefit them. “The vast majority were at least somewhat willing to participate in cure research for altruistic reasons,” said Evans.

Many people want to make this world a better place, especially when it comes to health. It can be exciting to be a part of finding new treatments or even a cure—but it’s important to remember the old adage, safety first.

How can a potential volunteer evaluate a clinical trial? Don’t be afraid to ask questions! Make sure they are answered thoroughly and that the information makes sense. Talk to health care providers, friends, and family members. Do research online.

Read and understand the consent form.

Don’t take volunteering lightly. Be objective and take a step back to look at the big picture before deciding either way.

Clinical trials depend on volunteers to help medicine move forward. Volunteers depend on research staff and oversight committees to make sure these trials stay as safe as possible. By working in this atmosphere of mutual trust and respect, hopefully someday HIV research will become a thing of the past.

For links to selected HIV/AIDS research

and trials websites, go to hivinsite.ucsf.edu and enter seatch terms, “clinical trials.”

Bran LeFae is a communications specialist with a background in research science and business operations. Living in the Pacific Northwest just north of Seattle, she often writes about HIV as a memorial to her uncle, Dwight (Tad) Gast. Bran is also a professional photographer with an interest in abstract works and photodocumentation. As a queer, genderfluid individual, she is pleased to contribute to her community through her work with POSITIVELY AWARE.

Questions of Law Legal and Health Care issues for people with HIV

by Ann Hilton Fisher

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f you’ve been newly diagnosed with HIV, you probably have lots of questions—some legal, some non-legal. Although this article talks specifically about people who are newly diagnosed, the information should be useful to you no matter how long you’ve been living with HIV.

Who should I tell?

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n most circumstances, your HIV status

is your business. There may be people you want to tell so that you can get their support. But no law says you have to tell your family, your school, your landlord, or your employer. However, there may be laws in your state requiring you, or your doctor, to disclose your status in certain situations.

In every state, HIV is a reportable diagnosis. That means that your doctor, and probably the laboratory that ran the test, is required to report your HIV status to your local health departments. Health departments have been collecting information on scores of communicable and

sexually transmissible diseases, ranging from chicken pox to gonorrhea, for more than a century. Although there have been some security breaches, overall, public health departments have an excellent track record protecting the confidentiality of their information. Most say the information in the database cannot be revealed even in response to a court subpoena.

The reporting does mean, however, that your public health department knows about your HIV status, and, in an increasing number of states, learns your viral load and CD4 count every time you get lab work done. Some states are now using this data to identify people who have tested positive for HIV but then never started HIV care or

dropped out of care. This means that you may get a follow-up visit or call from either your health care provider or your public health department if you do not get regular care for your HIV. Many states also have HIV criminal transmission laws that require you to disclose your status to your sexual partners.

In some states, these laws are so broad that they even cover kissing. In others, they apply only if you are deliberately trying to spread HIV. In some, like Illinois, you don’t have to disclose if you’re using a condom.

If you’re lucky enough to have HIV legal services in your state, they can tell you exactly what law applies to you. If not, your health department should be able to tell you. On the Kaiser Family Foundation’s website, http://kff.org/other/state-indicator/criminal-statutes-on-hiv-transmission, you can find the citations (the unique number given to each law) for each state’s law— then just Google the citation. Advocates are working to eliminate all HIV criminal

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transmission laws nationwide—the REPEAL (Repeal Existing Policies that Encourage & Allow Legal) HIV Discrimination Act, for instance, would decriminalize HIV—but until that happens, it makes sense to know what law applies to you.

How am I going to get my health care?

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his question has two parts: where are you going to get your health care, and how are you going to pay for it?

You will get the best care if you can go to an HIV specialist. But you may live far away from the nearest specialists and you will surely need to interact with other providers even if you see an HIV specialist for your primary care. You should know that it is illegal for medical providers to discriminate against you based on your HIV status.

Fortunately, such discrimination is rare.

If you feel you have been discriminated against by a health care provider because of your HIV status, you can file a complaint online at ada.gov/AIDS. You may be concerned about your health care providers disclosing your HIV status to other people, especially if you live in a small community where everyone knows everyone else’s business. The Health Insurance Portability and Accountability Act (HIPAA), a federal law, makes that strictly illegal. Because the penalties for violating HIPAA are so severe, most health care providers have had lots of training on confidentiality and take it seriously. But you should feel free to emphasize this point with your health care providers.

Now, how are you going to pay for your health care? Fortunately, health care reform should make the answer much simpler than it used to be for most people.

First, if you are working and have health insurance on the job, nothing will change just because you now have HIV. Your employer can’t kick you off the insurance plan or charge you more. The insurance company can’t refuse to renew your employer’s insurance policy. But you should look closely at your insurance options next time there’s an open enrollment period. If your current plan charges very high co-pays for brand name prescription drugs, and there’s an option with lower co-pays, you may want 20

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to switch. If you’ve had a high-deductible plan with a health savings account, you may want to start putting more into your HSA or switch to a different plan.

If you are working but don’t have insurance available at work, or you’re selfemployed, starting in October 2013 you’ll be able to buy a private insurance plan either through the new health insurance marketplaces (also called the insurance “exchanges”) or by purchasing it directly from an insurance company not participating in the exchange. Insurance companies cannot charge a higher rate based on you having a pre-existing condition like HIV. This is one of the most important features of the health care reform law. They may charge different rates based only on your age, the area of the state you live in, and whether or not you smoke. The change is scheduled go into effect on January 1, 2014.

If your income is under 400% of the federal poverty level ($45,960 gross per year for a single individual), you may qualify for

subsidies to help pay the insurance premiums, though you will be expected to pay a percentage of your income (9.5% for those making 400%) as well as deductibles, copays, and co-insurance. The Kaiser Family Foundation also has a subsidy calculator— http://kff.org/interactive/subsidy-calculator/ —by which you can see what your cost will be for premiums. In many states, there will also be programs that will help pay the copays for HIV medications or provide additional assistance with premiums. Your local or state health department will be able to connect you to those programs. Many of the pharmaceutical companies also have co-pay and patient assistance programs (see the chart in Positively Aware’s annual HIV Drug Guide, also online at positivelyaware.com/copay).

One word of caution, though. You must buy insurance before March 31, 2014.

Otherwise, in most cases, you will have to wait until the next open enrollment period which will begin October 15, 2014, for

Your public health department knows about your HIV status, and, in an increasing number of states, learns your viral load and CD4 count every time you get lab work done.

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coverage that will start in 2015.

If you are near the Federal Poverty Level, with income below about $1,500 per month, in 26 states (as of July 2013) you are eligible for health insurance through Medicaid, effective January 1, 2014. A few states are implementing alternatives to Medicaid expansion, like buying private health insurance for people in this low-income group.

Enrollment for these programs is scheduled to begin in October 2013.

One important note: many of the private plans and state Medicaid plans will be HMOs or other managed care plans. You’ll need to carefully select a plan that allows you access to the doctors, specialists, and HIV medications you need.

Is this going to affect my job?

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ederal, state, and local laws make

it illegal to discriminate against people with disabilities, including HIV. You cannot be turned down for a job, or fired, because of your HIV status unless your condition poses a “direct threat” to others.

As a practical matter, this only becomes an issue if you are, for example, a surgeon. HIV is not spread by preparing or serving food, taking someone’s blood pressure, teaching students in a classroom, or working in a factory.

There is almost never any reason for your employer to learn your HIV status and most HIV lawyers would suggest that you should not volunteer that information except in some special circumstances discussed below.

It is also almost always improper for your employer to ask you about your HIV status, directly (“Are you HIV-positive?”) or indirectly (“What medications do you take?”). There are only a few exceptions.

First, if you have been offered a job but haven’t yet started working, an employer can require a physical and can inquire about (or test for) HIV. Unless you are applying for a job in health care, it is very unlikely that you will be given an HIV test during a pre-employment physical, although there may be a question about your HIV status in the medical history portion of the exam. In either case, if the job offer is withdrawn solely because you have HIV, the discrimination is clear and can be

challenged. If your employer does learn your HIV status, they are required to keep it confidential. The information is not even supposed to go into your personnel file.

Second, your employer can give you a drug test even before offering you the job.

The drug testing company will usually ask you to list your medications. Since some of the most commonly prescribed HIV drugs (including Atripla) may cause false-positive results for marijuana (there is a confirmatory test you can take if this happens), you should definitely list them. The good news is that drug-testing companies generally don’t turn those forms over to the employer. They just tell the employer whether you passed or failed the drug test. Most pre-employment physicals are also done by outside companies.

So when might you want to consider disclosing your HIV status to your employer? Sometimes HIV can make it harder for you to do your job. Perhaps you’re having complications that require an unusually high number of medical visits. Perhaps temporary medication side effects interfere with your usual schedule. Federal and state laws require most employers to give you some flexibility in these situations.

The Americans with Disabilities Act requires employers with more than 15 employees to provide “reasonable accommodations” for people whose disabilities make it difficult to fulfill their “essential job functions.” The law makes it very clear that this is not a “one size fits all” requirement.

Instead you and your employer have to discuss what would make your job easier without placing an “undue burden” on your employer. For example, say you’re having bad problems with diarrhea early in the morning and would like to start work later in the day. If you work for a large company with people who work lots of different shifts, it’s quite possible that your employer could move you to a later schedule. But if you’re a kindergarten teacher it’s probably

impossible for you to start work at 10 a.m. if class starts at 8 a.m.

If you need an accommodation at work, you have to prove you are disabled under the Americans with Disabilities Act, so you will probably have to disclose your status.

We at the AIDS Legal Council recommend that you discuss your situation with an attorney familiar with employment law before you ask for an accommodation.

The other federal law that may help you if your health issues are interfering with your job is the Family and Medical Leave Act (FMLA). That law gives you up to 12 weeks of unpaid leave each year but only if you’ve been working close to full-time for at least a year and only if your company has at least 50 employees. You do not necessarily have to disclose your HIV status to get FMLA leave: your doctor can just sign a form stating that you have a “serious health condition.” Your HR office, if you have one, should be able to give you the information and forms you need to request FMLA leave.

These are just a few of the legal issues that may come up in connection with your HIV status. It’s always a good idea to talk to a lawyer about your specific situation. In Chicago, the AIDS Legal Council has regular office hours both at Chicago’s largest HIV health care provider, the Ruth M. Rothstein CORE Center, and also at TPAN, where many people with HIV go for support groups and case management. Even if the legal services program at your clinic or in your community is not HIV-specific, they will probably be able to answer many of your questions or direct you to the right local resources.

Sometimes people are anxious about talking to lawyers because they think they won’t understand what the lawyer tells them. But just like doctors, lawyers can speak plain English when you tell them you don’t understand! So don’t be afraid to call.

Any lawyer would rather talk to you before things go wrong than to try to straighten out the problems afterwards.

Ann Hilton Fisher, JD, has been the executive director of the AIDS Legal Council of Chicago (ALCC) since 1997, representing people living with AIDS and HIV on a wide range of legal issues. She and ALCC provide training for providers, case managers, and consumers. Fisher has been a strong advocate for voluntary HIV testing and laws that ensure confidentiality and HIV non-discrimination. She also sits on the American Bar Association’s AIDS Coordinating Committee.

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CONFERENCE UPDATE IAS 2013 KUALA LUMPUR

Cure at IAS 2013 HIV cure research a hot topic at this year’s conference

By Jeff Berry

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here continue to be incremental steps forward in HIV cure research, some of which were presented at the 7th IAS Conference on HIV Pathogenesis, Treatment and Prevention which took place June 30–July 3 in Kuala Lumpur, Malaysia.

The “Towards an HIV Cure” two-day pre-conference workshop sponsored by the International AIDS Society (IAS) has become increasingly popular each year.

Three hundred scientists, clinical researchers, funders, and community activists came together to discuss the latest findings. In an opening talk, Carl Dieffenbach, Director of the Divsion of AIDS at the NIH, made it clear that despite the current era of funding cutbacks, the Office of AIDS Research is still committed to cure research.

One point of discussion that came up during the symposium was whether we should even be using the word “cure” when talking about HIV eradication research. During a panel on ethics, amFAR’s Rowena Johnston speculated that maybe we should be using the word cure only when talking about a “sterilizing” cure (where there is no longer any sign of HIV in the body) and perhaps a different word to describe “functional” cure (where there is still some trace of HIV but none that is virus-producing). Gus Cairns, AIDSmap Editor and U.K. advocate, proposed a moratorium on the use of the 22

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word cure altogether, opting instead for something akin to “remission.”

The Boston Patients

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ne of the biggest stories to come out of this year’s conference was regarding two patients who are being referred to as the Boston Patients.

Both men had HIV and lymphoma and had previously undergone a bone marrow transplant using a “gentler” conditioning than the fully myeloablative therapy (stronger chemo plus radiation) used in the case of Timothy Ray Brown (the Berlin Patient). Brown, who had leukemia and received two transplants, is still cancerfree and considered functionally cured of HIV after six years. Unlike the Brown case, where the donor had a rare genetic mutation that provides natural resistance to HIV, the Boston patients received marrow from donors who did not have the CCR5 delta 32 mutation.

Both patients were kept on ART before, during, and after the transplant (a third patient died when his cancer returned).

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Several years (4.3 and 2.6) post-transplant, with no sign of HIV in blood and cell samples, researchers felt it was justified to do an analytic treatment interruption (ATI) and have the two go off HIV treatment.

As of early July, after eight weeks for one patient and almost four months for the other, they were unable to find any trace of virus in the blood or in cells, and at least for one of the patients, HIV was completely undetectable using even the most sensitive tests. Study author Timothy Heinrich said at a press conference that the virus could come back next week, next month, or even in one to two years. It will probably be up to five years before the two patients could be considered functionally cured, if ever, so for now, they are said to be in remission.

These strategies are being conducted in patients with cancer, and are expensive, risky, and not feasible on a larger scale. As Heinrich points out, some would ask why rock the boat? Physicians spent months discussing the informed consent document and potential risks with the patients, as they should. In the end, however, it was the patients’ decision to go off of treatment—one of them stated that not many people are doing transplants in PWHIV, so he wanted to help by “giving back.” Ethics and informed consent are critical components of cure research as studies continue to move forward. As more people choose

Sharon Lewin, Cécille Goujard, and Laurent Hocqueloux leading a panel discussion.

to enter these clinical trials, it will be necessary for them to fully comprehend that there may be little, if any, clinical benefit, and potentially much risk.

Other cure news

Photos: © IAS/Marcus Rose-Workers’ photos

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lso at the conference was a report of a 67-year-old man in Germany who was treated early with ART (three months after exposure and one month after sero-conversion) for a total of 5.5 years. Therapy was stopped in 2004 and the man currently has normal CD4 counts and distribution (ratio), and no sign of viral RNA or DNA has been found using ultra-sensitive tests, suggesting a functional cure.

In another study, French researchers looked at whether treatment during primary HIV infection (within weeks of being infected) could help limit the establishment of HIV reservoirs, those tissues in the body outside of blood and plasma where resting CD4 cells infected with HIV lie dormant until reactivation and replication. The OPTIPRIM study randomized 90 participants 1:1 to either a three-drug (boosted Prezista/Truvada) or a five-drug (boosted Prezista/Truvada plus Isentress/ Selzentry) regimen for 24 months. After 12 months, CD4 counts rose by a median (half in the study were above this number, half

below) of 235 cells, and viral load dropped substantially by a median of 1.43 logs.

Study author Antoine Chéret proposed that treatment as soon as three months after infection might prepare patients to be good candidates for treatment of latent infection, and concluded that “this is the first trial showing such a rapid and intense decrease in cell-associated HIV-DNA in one year.” The plan is to conduct a six-month analytic treatment interruption at the end of the 24 months of treatment.

Danish researcher Martin Tolstrup of Aarhus University presented early data on panobinostat (an HDAC inhibitor similar to vorinostat), a cancer drug being developed by Novartis that is also being studied as part of what’s being referred to as the “kick and kill” strategy in HIV cure research. Latent reservoirs of HIV are established early during infection, and although ART can bring the level of HIV in the blood to undetectable, latent reservoirs continue to survive. When a latently infected cell is reactivated, such as if a person were to stop treatment, the cell begins to produce HIV again. The idea is that the virus in the latent HIV reservoirs would first be “kicked” out of its hiding place and then “killed” using another drug, vaccine, or a combination thereof.

Researchers wanted to know if 20 mg of oral panobinostat led to viral reactivation

in virologically suppressed patients (the “kick”), and whether cyclic dosing could lead to a more efficient viral kick and a reduction in side effects. The hope was that after the “kick,” there would be more HIV found in the blood, indicating that the panobinostat was successful in reactivating the virus, and indeed, only one of the 15 treated patients remained undetectable in blood following dosing. Participants remained on antiretroviral therapy during the entire study. The panobinostat dose, 20 mg three times per week, taken every other week for a total of eight weeks, was well tolerated.

Fatigue was the most common adverse event, and no adverse effect on CD4s was observed, although an initial drop was seen in neutrophils—a type of white blood cell (the lower your neutrophil count, the more vulnerable you are to infection) Tolstrup recently said via email that the degree of low-level viremia that they were able to detect has not caused any “viral blips” above 20 copies/mL at the regular outpatient visits after completion of panobinostat dosing, and they have extensive samples that they intend to quantify to see whether plasma virus levels go above 20 copies/mL during panobinostat, but that data is not yet available.

To read more abstracts and view

session webcasts go to ias2013.org.

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CONFERENCE UPDATE IAS 2013 KUALA LUMPUR

By Enid Vázquez

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he World Health Organization (WHO) issued new HIV treatment guidelines recommending that therapy start earlier, at 500 or fewer CD4+ T-cells for everyone living with the virus.

Previously, the guidelines suggested starting therapy for people who had less than 350 T-cells. More viral load monitoring, at greater expense, however, is now recommended, not good news for areas with limited resources.

“Recent evidence indicates that earlier ART will help people with HIV to live longer, healthier lives, and substantially reduce the risk of transmitting HIV to others,” the organization reported in a press release. “The move could avert an additional three million deaths and prevent 3.5 million more new HIV infections between now and 2025.”

“These guidelines represent another leap ahead in a trend of ever-higher goals and ever-greater achievements,” said WHO Director-General Dr. Margaret Chan in the release. “With nearly 10 million people now on antiretroviral therapy, we see that such prospects—unthinkable just a few years ago—can now fuel the momentum needed to push the HIV epidemic into irreversible decline.”

The new recommendations also include providing antiretroviral therapy to all HIVpositive people in the following categories: children under the age of five, pregnant and breastfeeding women, and partners in a serodiscordant relationship (their partner is HIV-negative). Children over five should also be treated when they have 500 or fewer CD4 T-cell counts. The organization continued to recommend that all HIVpositive people with active tuberculosis or hepatitis B receive antiretroviral therapy.

Another new recommendation is starting people on a single, fixed dose pill, which WHO said is “easier to take and safer than alternative combinations previously recommended and can be used [by] adults, pregnant women, adolescents, and older children.”

The regimen recommended is technically contraindicated for pregnant women because of the potential for birth defects with one of its components, efavirenz.

WHO followed several reports of efavirenz safety in pregnancy and based its recommendation on a systemic review which found no increased risk of overall birth defects among women exposed to the drug during the first trimester of pregnancy compared with exposure to other HIV medications. Advocates said that WHO should address this contradiction, especially before making recommendations.

WHO also recommends decreasing out-of-pocket costs for patients and starting community-based HIV counseling and testing programs in areas where there is a high prevalence of HIV, as well as offering services such as peer support, use of mobile phone text messages to promote medication and doctor visit adherence, and nutritional support in areas where there is a high degree of food insecurity.

UNAIDS reported that the cost of the new WHO recommendations could be met through the global budget for HIV treatment by making improvements in three specific areas: “a reduction in costs of medicines and medical supplies, particularly as volumes increase; simplifying delivery systems; and increasing efficiencies within the overall AIDS response.”

“For example,” the organization stated in a press release, “the price of medicines to prevent mother to child transmission of HIV was reduced from $800 in 2011 to below $100 in 2013. Through a more

competitive bidding process, South Africa has reduced the cost of procurement of antiretrovirals to the lowest price anywhere in the world at $127 per person per year for the fixed dose combination recommended in the new guidelines. This has resulted in a 53% reduction in expenditure on antiretroviral treatment for South Africa.”

“Today nearly 10 million people have access to lifesaving treatment,” said Michel Sidibé, Executive Director of UNAIDS. “This is a true development triumph. But we now have a new challenge—ensuring that all 26 million people eligible for treatment have access, not one person less. Any new HIV infection or AIDS-related death due to lack of access to antiretroviral therapy is unacceptable.”

The human rights group Doctors Without Borders, however, warned that drug company pricing rights were keeping newer medications out of reach for developing countries. The group said newer and more effective antiviral medications cost up to 15 times what the older drugs with generic formulations, mostly available abroad, are costing. “We need the newer treatments for people that have exhausted all other options, but patents keep them priced beyond reach,” said Jennifer Cohn, medical director of the organization’s access campaign, in a press release.

Tivicay (dolutegravir) superior to Isentress

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here was a great deal of interest in results of the SAILING study, comparing the popular HIV drug Isentress to a similar, newly approved medication on the market, called dolutegravir, brand name Tivicay.

Dolutegravir was reported to be superior to Isentress at 48 weeks of treatment.

In previous findings, from the VIKING-3 study, dolutegravir was found to be effective in people who had developed drug resistance to integrase inhibitors, making it an important new second-generation drug in this class, able to help those individuals.

The 715 SAILING study participants were HIVtreatment experienced people who’ve never Newly approved: TIVICAY

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TIVICAY: COURESY OF VIIV HEALTHCARE

New global treatment guidelines

before used an integrase inhibitor, the class of drugs Isentress and dolutegravir belong to. (The class is sometimes referred to as “integrase strand transfer inhibitors,” or INSTIs.) Moreover, their HIV had developed resistance to at least two other classes of antiviral medications, meaning that those drug classes no longer worked as well against their virus, if at all. Half of them actually had HIV that was resistant to three drug classes (there are currently only five classes on the market).

For those given dolutegravir, 71 percent had viral loads under 50 copies per mL (considered “undetectable”) vs. 64 percent of those on Isentress. The difference was statistically significant.

Undetectable viral load was the same between the two groups, however, for those who were able to add Prezista to their regimen, meaning that their virus was not resistant to this protease inhibitor drug.

For those who did not have Prezista added to their therapy or who had drug resistance to the protease inhibitor drug class, however, the difference in undetectable viral load was even greater, 71 percent for dolutegravir, 62 percent for Isentress.

Side effects were about the same for each drug, with diarrhea being the most common drug-related adverse event for each (20% for dolutegravir vs. 18% for Isentress). Overall, drug-related adverse events occurred in 20 percent of the dolutegravir group and 23 percent of the Isentress group.

HIV specialist Paul Sax said on his blog, HIV and ID Observations, that while Isentress is “one of our very best antiretrovirals,” the SAILING results will “probably” make dolutegravir the go-to drug for people with treatment failure and INSTI drug resistance. “In the hardestto-treat sub-groups—those with no active [Prezista] in their OBR [optimized background regimen], or the higher viral load stratum—the differences favoring dolutegravir over [Isentress] were even greater than in the study overall.” See his comments at http://feeds.feedburner. com/HivAndIDObservations. “[Dolutegravir] statistical superiority was driven by fewer withdrawals due to lack of efficacy, lower number of

Kuala Lumpur, capital of the island nation of Malaysia, hosted the 7th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2013).

protocol- [study] defined virologic failure [not reaching undetectable levels], and lower treatment emergent resistance,” the SAILING team reported. Failure to reach undetectable viral load level occurred in 12 percent of the Isentress group vs.

6 percent of the dolutegravir group.

Significantly fewer of the failures with dolutegravir, however, occurred with drug resistance (1% for dolutegravir vs. 5% for Isentress).

The findings were published in the July 3rd issue of the Lancet.

In August, the FDA approved dolutegravir for use in a broad population of HIV-positive people, including those never on treatment before, the treatment-experienced, those who’ve taken other integrase inhibitors, and children 12 or older who haven’t had integrase inhibitors before.

Once-a-month dose

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wo drug companies that produce HIV medications are teaming up to explore a long-lasting injection that can be taken once a month.

GSK1265744 (744), the long-acting parenteral (LAP) from GlaxoSmithKline (GSK) and the rilpivirine (TMC278) longacting formulation from Janssen were reported to be “generally safe and well tolerated” in a very early, Phase 1 study with 40 HIV-negative individuals. The combination is now moving forward into Phase 2 research with HIV-positive individuals.

The hope is that the once-monthly injection can be used as a maintenance

dose after initial therapy with a standard triple-combination regimen brings the virus down to undetectable levels. There’s also hope that the injection can be used for HIV prevention. 744 is similar to an integrase inhibitor called dolutegravir (see above) and the rilpivirine oral formulation is on the market as the non-nuke Edurant and as part of the single tablet regimen Complera.

Lower dose, same results

R

esearchers from the University of New South Wales in Australia tested efavirenz, or EFV, at a lower dose. They were particularly interested in the effect on behalf of poorer countries.

“An effective and safe reduced dose could yield meaningful cost savings” with “this globally important ARV [antiretroviral],” the ENCORE1 research team noted.

Efavirenz is available under the brand name Sustiva, and is part of the single dose regimen Atripla. Efavirenz was compared at its usual dose of 600 mg once daily to a dose of 400 mg once a day. A total of 630 individuals on HIV treatment for the first time were divided into the two study groups, and were given tenofovir DF/emtricitabine (available under the brand name Truvada) along with the efavirenz. These drugs are available combined in Atripla, but both groups received four pills taken once a day (for placebocontrolled double-blinding).

The strategy was successful: at 48 weeks, the lower dose of efavirenz was found to be non-inferior to the regular dose. More than 85% of participants

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CONFERENCE UPDATE IAS 2013 KUALA LUMPUR achieved an undetectable viral load of less than 200 copies per mL (as per the test used).

Although there were fewer adverse events with the lower dose, the difference was not statistically significant. There was, however, a higher drop-out rate due to adverse events with the 600 mg dose. There was a 1.9% drop-out rate for the lower dose compared to 5.8% for the higher one. The difference was statistically significant.

The team concluded, “400 mg EFV should be considered for initial ARV treatment.”

Statins help cut cancer risk

W

hile not intending to delve into the possibility that statins could reduce not just cholesterol, but also the risk of cancer, a team of Italian researchers reported that they’d found that was indeed the case. The use of statins in the general population has been associated with a reduced incidence of cancer-related mortality—the team found that in HIV patients, statins have been shown to play a protective role in the occurrence of and mortality from non-Hodgkin’s lymphoma, an AIDS-defining cancer.

Looking at the records of more than 5,000 patients on HIV therapy, over a period of about 10 years, the researchers found fewer cases of cancer in those taking statins (12 out of 740 individuals) vs. those not using the medication (363 out of 4,617).

They concluded that, “In this retrospective study on HIV-infected, treated patients, the use of a statin was associated with reduced risk of cancer.”

Destination: Kuala Lumpur While in Kuala Lumpur, Jeff Berry was able to take in some of the culture and sights. Clockwise from top: The Kuala Lumpur Convention Centre, with the famous Petronas Twin Towers looming in the background; the Petronas Towers at night; the world’s tallest statue of Murugan, a Hindu deity, at the Batu Caves outside Kuala Lumpur; and Malaysia’s National Monument, Tugu Negara.

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P OSITIVE LY AWARE

Some Thoughts On living with HIV Lessons learned by someone living with the virus

By Dan Gebhardt

A

llow me to introduce myself. My name is Dan. I have been positive for over 20 years and I have lived the history of the AIDS epidemic. There have been lots of ups and downs emotionally, spiritually, and physically. I’ve lost many friends along the way. But somehow I have always been able to pull myself up by the bootstraps and face the next challenge the disease has to offer.

There are actually several things about having this disease that I consider gifts. It has allowed me to feel more compassion for others, to feel oneness with everyone else who is also infected, and to realize that for all our perceived and/or imagined differences, what we have in common as living beings is more important.

My medication groove

I

started out on dual therapy—AZT/3TC— and have been on many of the other antiretroviral (ART) meds as they came out.

Some of those early HIV medications were very difficult to take. Maybe it was the sheer amount of pills, or the timing before and after food, or the awful side effects. But

regardless, I knew if I stopped, I would die.

Realizing that missing a few doses can mean that the meds no longer work has always put an enormous amount of pressure on me. For years I checked and doubled checked to make sure I had not unintentionally missed a dose. It was like being in a state of constant hyper-vigilance, not ever really being able to totally relax for fear of forgetting to take my meds.

After being on meds for so long now, I finally feel like I can trust myself to remember to take my meds without having to think about it too much, that I’ve gotten into my “medication groove” and yes, possibly allow myself to even relax a bit. It has taken me a long time to realize that I am bigger than this. I cannot allow my life to be

overrun by medication schedule worries. I fully understand that my HIV meds are vital for my continued well-being and health, but I also realize I cannot allow this stress to drive me crazy.

Find your HIV med groove or your HIV med rhythm. That means finding ways to put your meds in the path of your daily routine so taking them becomes as mundane as brushing your teeth (ever think of putting your pill box by your toothbrush?).

Try to find your own way to make your medication adherence as natural as any of your daily routines.

The much, much more of touch

M

y body is not a fence to keep oth-

ers away. It is not a brick wall I constructed to hide my inner self.

When I first got my HIV diagnosis, it was easy getting to a place of disgust when thinking of my infected, diseased body. In my mind, my body had become something less than whole. It was messed up. It was defective.

There were days when it was hard to look in the mirror, especially as my body

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started to change beyond my control from some of the meds I was taking: too little fat here, too much fat there.

I was very educated on how HIV spreads; nevertheless I wanted to keep people away from me and from touching me. I didn’t want hugs. I didn’t want a peck on the cheek. I didn’t want to get too close to anyone just in case some of those HIV cooties jumped off me.

It has taken some time, but as I age, I have come to respect and appreciate my body and all that it has gone through to keep me alive. At the same time, I realize that I am not just a body but something much, much more.

Sometimes it is very nice to express that something much, much more by getting close to other people and sharing the wonderful sense of touch that my body allows.

Of course, I still have to be vigilant about never infecting someone else, but there are many ways of experiencing touch that don’t involve that risk.

I have come to understand and not be afraid of my body and the virus it unwillingly shelters. It’s nice to know I can’t endanger anyone by a hug or a peck on the cheek, that I can still touch others and feel the warmth of their skin and feel alive.

condition doesn’t mean resignation to the disease. In his mind, it means, “something is what it is, and that there is a way to get through it.”

I think that is the problem many of us face in living with HIV, including me—finding the way through it; finding the way to make sense of it and keep living; finding the way to resist resigning to the disease and keep on with that thing called life. For me, this has been a process of changing the way I look at things.

I used to get really sick and tired of the many doctor appointments. Now I look forward to seeing familiar faces of people who care about me. I used to get agitated at trying to keep my growing med list straight and managing it well. Now I am thankful to even have access to meds. I used to be fearful of what the next test or screening would uncover. Now I try, although not always successfully, to hope for the best and prepare for the worst, knowing that I will do my best to get through it.

Some of the things I do to try to find my way through it: n

Many paths

T

here is a saying in Hinduism, “Truth

is One, but the Paths are Many.”

It struck me that there are many paths on my journey, wherever it is going.

Sometimes I may be stuck on an obstructed path where I have to fight my way through to make any progress. Other times I may get to skip along a straight, easy path, having a vision of a distant place I am going to on the horizon. Either way, I am confident that I will end up at the same place.

For me, having a chronic illness like HIV has forced me to trust more in the flow of life. There are many things I cannot control.

I cannot control, for the most part, when a new health challenge appears or when my body can no longer sustain itself. But I can try to learn and grow from these experiences, knowing I am still moving on my journey toward that wonderful place on the horizon.

I recently read a commentary from Michael J. Fox on living with Parkinson’s disease. He said that accepting one’s 28

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Prepare pill boxes for several weeks at a time. This way I can see if I am going to run out of anything soon and make sure I have requested a refill in plenty of time if necessary.

n

Keep a doctor appointment calendar that I check at the beginning of each month to see what is coming. Without a calendar where I write each appointment as I get them, I would miss a lot of them!

n

Communicate with my doctor about understanding screenings and tests for my particular situation. This way, if something is discovered, hopefully it will be early enough that it can be treated easily.

The tapestry of my life

C

orrie ten Boom, the author of The Hiding Place, a book about her experiences helping Jews escape the Holocaust and her own concentration camp survival, used a tapestry as a visual aid in talks about her experiences. She always showed the tapestry backside out.

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On the back of any tapestry is a mess of threads, knots and scraps of light and dark colors that make no sense or pattern. After talking about the many different colors of threads used in the tapestry, she would turn it over and show the beauty on the other side.

Her point was that our lives are much like the weaving of a tapestry. We go through dark and bright times and times of every shade in between. Each one of the threads of experience is important to the intricacy and beauty of the finished tapestry of our lives. This strong image has helped me realize that I can’t expect everything to always be light and easy and fun and pleasant. There also need to be other, darker threads of experience because that is how life works and without them, the tapestry is incomplete.

When I was first diagnosed with HIV, I couldn’t even imagine living very long, much less getting to where I am now. At that point, if I could have imagined a tapestry, it would have been very small and not much to look at. Through the years of living with HIV, I have added to the tapestry of my life to the point where I am proud of what has been created.

Thoughts on disclosure

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here are two kinds of disclosure for those of us who are HIV-positive— the “I-have-no-choice” situation and the “do-I-want-to-show-this-side-of-me?” situation.

The first circumstance is very straightforward. In any situation where there is the possibility of having sex with another person—any kind of sex—I believe we must clearly inform that person of our status before anything further happens. This is not only our legal obligation in many states (see Questions of Law, page 19), but it is also, in my opinion, our moral and ethical responsibility. This is usually not an easy or comfortable thing to do. But it should be done.

Unfortunately, you may also have to be able to prove that you did indeed disclose.

In some cases, people have gone to prison for not disclosing, even when the other sexual partner didn’t become infected or condoms were used. It is always advisable to get something in writing—be it on paper,

Asking for help is not a sign of weakness but of determination and strength.

in email, or in a text message—that proves the other person has been informed. But be careful—once your status is out there, it is impossible to control where it goes.

Of course, sometimes you do have a choice. It is immensely liberating to be totally open about your status. This openness will certainly help in reducing stigma for all of us who are HIV-positive. But we can’t always predict the response of others when they learn of our status. Sometimes they are more accepting than we had anticipated, but sometimes people may sever ties with us and it’s best to be prepared for either type of reaction. So you may want to think twice about disclosing, especially at work or in other situations where the ramifications can be many and long lasting.

get into care, the better off you’ll be. Before you go, make a list of questions to ask your health care providers. Before you leave the doctor’s office, make sure you have contact numbers for your health care team.

Stay in care. Keep a calendar for medical and lab work appointments. If you miss an appointment, try to reschedule as soon as possible.

Get on HIV meds. Your doctor will discuss with you when it is time to start HIV medications. Once you do start meds, if you are having problems taking them and are missing doses, get help to figure out a system that works for you. Missing doses can lead to drug resistance resulting in the meds you’re taking no longer working.

Get counseling. Coming to terms with being HIV-positive can be hard. Asking for help is not a sign of weakness but of determination and strength. Maybe there are also other issues that you need to figure out.

Your health care team can recommend an experienced counselor that can help you.

Decide on disclosing. If you are going to have sex with someone, I personally believe you must disclose. In other situations, it is your choice. Disclosing to those you love and care about can make living with HIV much easier.

Find support groups. There are many different support groups and programs for people living with HIV. Find some that work for you. It can be reassuring and comforting to hang out with others who are also HIV-positive. It can also be a place to learn how to deal with issues we are going through. Participating in these groups reminds us that we are not alone.

Get your life in order. Help your body to live with the virus. Once your doctor gives you the OK, start an exercise program. Work on eating healthy food. Make an effort to get enough good sleep. Get help to stop harmful habits. These things will help to improve the quality of your life and make living with HIV easier.

Stay involved in your HIV care. Make your HIV health an ongoing part of your life. Track your labs. Ask your doctor what screenings you need. Go to the dentist. Make it a habit to read magazines or websites for positive people. You need to be able to talk to your doctor about anything. If you do not have that kind of relationship with your doctor, it may be time to ask about your options for switching doctors. Staying informed and having an open and trusting relationship with your health care team can only impact your health in a good way.

Give back. No one can know what it is like living with HIV, unless you are living with HIV. Sometimes it is important to talk with someone else who is positive.

Volunteer and be a peer support buddy.

Your experiences may be just what someone else needs to adjust to living with HIV. Get on with living. The whole process of finding out you are positive, and then coming to terms with it, usually means everything else gets put on hold for awhile.

Once you come to terms with your HIV, it’s time to get back to pursuing your dreams and goals, or break past bad habits and figure out where you want to go, to make the change you couldn’t make before. Figure out what will make you excited about getting out of bed every morning.

Be happy. If you had tested positive in the early days of the epidemic, you would most likely have died soon after. No one wants to be HIV-positive. It is a difficult and complicated living situation in very many ways. The good news is that those of us with HIV can expect to live an almost normal life span now. And who knows what future medical breakthroughs will bring.

Although I would not wish for anyone to have HIV, I am grateful for the experience.

It has helped to make the tapestry of my life so incredibly rich and profound. And to all those who helped me along the way with my weaving and the weaving still to come, I say thank you!

Dan’s to-do list

S

Dan Gebhardt works in the AIDS Clinical Trials Unit of Case

o you’ve tested positive. What should

you do now?

Get into care. That first doctor appointment after you test positive can be a scary thing, but don’t put it off. Make the appointment and keep it. The sooner you

Western Reserve University School of Medicine in Cleveland, Ohio. He is also an AIDS Clinical Trials Group (ACTG) Community Advisory Board Staff Representative and works in patient outreach and linkage to care at MetroHealth Medical Center. Dan writes the POZabilities blog on the MetroHealth website for the Compass Services Program.

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The Rides of a Lifetime Friends take part in two AIDS rides to help fight stigma and raise awareness STory and photography By David Duran

R

iding for a cause. It’s a phrase we’ve all heard or seen first hand with cyclists on the road or on the television screen riding to raise money for a cause. But it’s not just the money they are raising; it’s also awareness they are spreading. With over 30 years of HIV/AIDS, and countless lives lost to the disease, now more than ever is the time to remind everyone that it’s not over yet, and the time to end AIDS is now.

With such incredible medical advancements in the world of pharmaceuticals, it’s easy to brush off the severity of HIV in 2013. We see it all the time now in magazines and billboards—one pill a day. Yes, it’s true, there are some treatments that only require someone with HIV to take a single pill once a day. But what about those who can’t afford that pill, or don’t have the proper insurance or benefits to get it? And more importantly, what about the person who doesn’t even know they are HIV-positive or refuses to find out?

HIV awareness is more about putting all of what we know about HIV/AIDS out there and letting the masses absorb it. As cliché as it sounds, knowledge truly is power. By putting it all out there for people to see, hear, and read, it’s also empowering those living with HIV to be more open about being HIV-positive and helping to take away the stigma that is often unnecessarily associated with the virus.

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Helping to raise money, awareness, and end stigma are two organizations, in two parts of the country—California and Chicago— both with two different types of cycling events, but one singular mission—to bring an end to AIDS.

AIDS/LifeCylce

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he AIDS/LifeCycle in California, which is organized by the San Francisco AIDS Foundation and the L.A. Gay & Lesbian Center, is a seven-day, 545-mile bike ride from San Francisco to Los Angeles. This year marked AIDS/LifeCycle’s 11th year and the 19th for the event overall. During the week of June 2–8, over 2,200 riders and 550 roadies raised a record-breaking $14.2 million dollars. This mega-event in California is the principle fundraiser for both organizations each year. Money raised from the ride goes to provide critical

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services and education in San Francisco and Los Angeles, as well as surrounding communities.

Ride for AIDS Chicago

E

qually as important, but on

a smaller scale is Ride for AIDS Chicago (RFAC). RFAC reached its 10th anniversary this year and is produced by Test Positive Aware Network

Joy riders: (from left) Jaime Arroyo, Jorge Partida, and Keith Stryker have participated in the San Francisco-to-Los Angeles AIDS/LifeCycle and the 200-mile Ride for AIDS Chicago.

volunteers, RFAC raised over $750,000, the most in its 10-year history.

Both fundraisers not only produce money in the end, but help form everlasting friendships between riders.

Cycling those long distances takes strength, courage, and a lot of encouragement from fellow riders. The bonds that are created from both events last a lifetime. Each ride is designed to raise money for their respective community, and although both rides attract cyclists from all over the country, and even the world, the bulk of the dedicated riders come from within the beneficiary communities. And sometimes, the strongest of the strong do both rides, back to back.

Three friends, two rides

J

orge Partida, Jaime Arroyo,

(TPAN), the publisher of Positively Aware, and is a two-day, 200-mile event

that raises money for TPAN and community partners. Ride for AIDS Chicago is committed to returning 100% of pledges to the beneficiaries. This grassroots event, which took place this year July 13–14, does its best to keep costs as low as possible, using registration fees along with corporate sponsorship dollars to help offset the cost of producing the ride. This year, with 233 riders, 75 crew members, and hundreds of

and Keith Stryker are all friends who each have their own reasons to get on a bike and raise money.

The Chicago-based friends all started their cycling fundraising with RFAC. This year marked Partida’s fourth year doing the RFAC. “I was sitting in a bar one day and this guy was talking about the Ride and telling me all about it, and how amazing the experience was,” he said. “At the time, I wasn’t associated with any of the services in Chicago and was going through a really messy breakup, and I thought this would be a great way to get my mind off of it.”

Partida, who is HIV-negative, says that on his first ride he met so many amazing people who helped him get through that time in his life. “That’s why I continue to do it each year,” he said. “My friends mean a lot to me and if I can do anything to keep them around for as long as possible, I will.” Since his first ride, Partida has been involved as a volunteer for various events and does what he can to raise money for TPAN. 2013

marked the first year that Partida joined his two friends on both rides. “I was supposed to do it last year with my friends and wasn’t able to, but this year I made sure I was able to join them,” he said. “I told myself that nothing was going to get in the way of having the experience with them.”

Arroyo, who originally had the idea for doing both rides, said he started riding in RFAC because TPAN set him up with his medical doctor and prescription medications. “They kind of changed my life and helped me when I was in need, and I do the ride to give back,” he said. Arroyo has been HIV-positive for eight years and didn’t truly accept it or take control of it until he first got involved with TPAN. Partida was the one who helped him sign up for his first RFAC and got him set up with his initial services at TPAN. Arroyo was the first of the three to sign up for AIDS/LifeCycle. “I signed up for ALC last year for the challenge, and I signed up this year because of the community you get to be a part of, and the amazing feeling I get from the opening and closing ceremonies of ALC,” he said.

Joining Arroyo on his second ALC was Keith Stryker. Stryker, who was diagnosed with HIV in 2003, is on the executive committee for RFAC and attributes his first ALC ride to Arroyo who “convinced” him to register. “I started with the Chicago ride in 2011 because I needed something to refocus on and a new direction in my life,” he said. “I am doing ALC for myself, number one, because I have HIV, and number two, because I wanted to give back to my community.”

The three friends all plan to participate in both rides in 2014.

To find out more go to rideforaids.org

and aidslifecycle.org.

DAVID DURAN is an LGBT-focused free-

lance journalist who frequently contributes to publications such as the Advocate, Out magazine, Instinct, and the Huffington Post.

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Nothing Small

About Microaggression How we can hurt and be hurt and never know it

by Jeff Levy, LCSW and Amber Jones, AM

W

ith advances in HIV medications, the U.S. Supreme Court’s overturning (in part) the Defense of Marriage Act (DOMA), and the expanding diversity of people living in this country, it is easy to be lulled into thinking that acceptance of difference is on the rise and the stigma that has been associated with so many of our marginalized identities has diminished. In some instances, this is true. For others, it’s more complex. Jacob’s story is a composite of many stories and experiences of people who have traumatic histories and also live with stigma and marginalization. His life highlights the entanglement of marginalization and the experience of trauma.

Jacob’s story

B

orn in the early 1970s in Mississippi, Jacob’s parents divorced when he was 10 years old. His mother remarried a pastor who adhered to literal interpretations of the bible and who was never fond of Jacob. When Jacob disclosed he was gay to his mother and stepfather at age 17, he was beaten, denigrated, thrown on the street, and shunned by his family and church community. Most would agree that Jacob experienced major trauma and even wonder how these early experiences impacted Jacob in adulthood.

Ironically, it is not these major traumas that have caused Jacob the most pain and confusion. Those traumas were clearer for Jacob to acknowledge and discuss with others. Trauma he experienced as a result of difference and marginalization, however, was harder to identify, and harder to separate from distinct traumatic life events.

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Jacob often felt unsafe navigating life as an openly gay, African American teenager in rural Mississippi. In the late 1980s he relocated to Chicago where, unemployed and without an education, he lived on the streets, engaged in sex for survival, and was hospitalized at age 21 for his first episode of depression. What stands out most for Jacob regarding his hospitalization was his lack of visitors. Hospital staff noticed and brought this to his attention with concern, which for Jacob felt like an emphasis on his “aloneness” in the world.

Upon discharge from the hospital, he was connected with several community resources that supported him in completing his GED (high school equivalency exam) and he began working as a sales assistant for a large public relations firm.

Soon thereafter, Jacob met a man with whom he felt safe and they maintained a life together for 15 years. Jacob did not find out until five years into the relationship that

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he was HIV-positive and he began treatment. He was initially successful at work and the only people who knew of his HIV status were his partner and his therapist.

As the years progressed, however, he noticed he was struggling at work, feeling more depressed, and was having trouble remembering even simple instructions.

After having HIV for 20 years, he was diagnosed with cognitive impairments and dementia and could no longer function at work. Eventually, he had to leave his job and file for long-term disability.

During the same 20-year period, he reconnected with his mother and some of his siblings. After a series of health crises, his family learned he was living with HIV; the only way Jacob was able to maintain any relationship with his mother was to deny being gay, exclude his partner from all family gatherings, refrain from discussing his HIV status, and keep his dementia diagnosis secret.

Along with navigating the transition to being on long-term disability, Jacob had to find ways to protect himself against the judgment and rejection he experienced from acquaintances, friends, and extended family while also managing his compromised immune system, dementia, and mounting depression.

Everyone has multiple identities

A

s complex beings like Jacob, each

of us has multiple “identities,” or parts of who we are. Most of us

ression begin to shape our identities at a young age with help from our families, peers, and communities. As we grow and mature, we continue to evolve and rediscover ourselves by exploring, inhabiting, and sometimes renouncing one or more of our identities.

They are a central component to understanding ourselves both independently and in relationship with others.

Our identities may be visible or invisible, but regardless of visibility, they serve to characterize the ways that we experience the world. For Jacob, his visible identities include his race, gender, and age. Invisible identities are parts of ourselves that are not as easily discerned by the outside world without some form of self-disclosure, such as sexual orientation, socio-economic background, or medical conditions, such as living with HIV. For Jacob, such invisible identities include being gay, having depression, living with HIV, and having dementia.

These marginalized identities, experienced together, may overlap and magnify stigma and shame. In addition, he continued to identify with some aspects of his religious upbringing, another invisible identity, but struggled with the negative messages he received from family that were so integral to their religious practices.

For Jacob and the rest of us, our multiple, complex, and ever-evolving identities play an important role in the ways that we experience ourselves, our relationships, and the world at large. Within any social group, certain identities are considered less desirable and as a result are relegated to

the margins of mainstream consciousness and social life. Being marginalized often means having less or lower social status, being negatively perceived by others, and regularly experiencing exclusion, injustice, and inequality within social, cultural, political, and economic systems.

Some examples of marginalized identities in our society include people of color, women, lesbian/gay/bisexual/transgender people, the differently abled, religious minorities, the elderly, people living with HIV, and others who may hold identities that are stigmatized or devalued.

Like Jacob, many of us hold multiple marginalized identities that intersect with one another, each contributing to our firsthand experiences and impressions of living as a member of a minority or oppressed group(s).

The experience of microaggression

W

hen we have one or more

marginalized identities, we may experience both intentional and unintentional discrimination and prejudice in daily life. Often this prejudice is expressed as a “microaggression,” as described by researcher Derald Wing Sue. Microaggressions are everyday verbal, behavioral, and environmental indignities that communicate hostile, derogatory, or negative attitudes toward those of us who are part of one or more marginalized groups. Microaggressions can invalidate the experiential reality of those impacted

by them, demean them personally or communally, communicate that they are lesser human beings, and signify that they are different from the mainstream or majority culture.

Experiencing a microaggression can also leave someone feeling threatened, intimidated, and unsafe, both physically and emotionally.

Any group that is marginalized in society is vulnerable to microaggressions and many people with multiple marginalized identities, like Jacob, may experience microaggressions in many different aspects of their lives and experiences.

Some may hear the term microaggression and think that it’s something very small, but this could not be farther from the truth. Often people do not recognize that a microaggression can have a lasting impact because of its insidious nature—superficially it may seem harmless or trivial, but in actuality, microaggressions build and accumulate so that over time they have a strong impact on the psychological state and wellbeing of those affected by them.

Microaggressions carry with them meanings that often remain out of the range of consciousness for those who perpetrate them, but the societal messages they convey can have lasting negative effects on those who are targeted and reinforce the structural inequalities faced by these individuals in their everyday lives.

For Jacob, while never stated explicitly, he knew that he was not “allowed” to bring his partner to any family event.

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The unspoken microaggression and not so invisible message is, “Your relationship and displays of affection with another man are offensive and abnormal; therefore, you should keep them to yourself.”

Repeated often enough, victims of microaggression begin to believe these messages and being devalued becomes internalized—it becomes part of how someone like Jacob sees himself.

Although many microaggressions are committed unintentionally, it does not diminish their damaging effects. In fact, the most psychologically and emotionally harmful microaggressions are perpetrated by individuals who are well-intentioned and unaware that they have acted in an offensive manner toward a person with a marginalized identity.

Microaggressions occur daily—for example, when two white women walk across the street when they see an African American teenage boy walking toward them (possible hidden message: All black men are dangerous), or when a straight couple discusses their wedding, not considering how it might impact their two gay friends who cannot marry and are listening to the conversation (possible hidden message: We are completely unaware that others in this country do not have the rights we have, that being gay and in a long-term relationship doesn’t merit acknowledgment).

In both examples none of the “perpetrators” are particularly aware that their behavior has hurt someone, though unintentionally they may have conveyed messages of fear, shame, and privilege.

Microaggressions come in three forms: microassaults, microinsults, and microinvalidations, again as described by Sue.

Microassault

A

microassault is a consciously

held bias or belief that is intentionally expressed verbally or non-verbally by an individual to hurt the intended target. A microassault can be acted out overtly, such as through derogatory namecalling or discriminatory behavior, or covertly, through avoidant behaviors and subtle mistreatment of those with marginalized identities.

34

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While never explicitly communicated, Jacob knew that he would be rejected if he tried to include his partner in family events.

The absence of questions about his relationship and the lack of any demonstrated interest in his partner served as a constant reminder that his relationship was “less than” other relationships in his family.

Microassaults are often characterized as what we have historically known as prejudice and discrimination, for example, using racial slurs to refer to people of a different race. People who commit microassaults, much like Jacob’s stepfather, are conscious of the biases they hold toward a marginalized group, but feel they are justified and may express this bias publicly and directly or act it out through a number of ways, such as bullying, hate speech, and supporting unjust legislative policies.

Microassaults are explicit attacks on an individual’s personhood and are meant to be threatening and to instill a sense of inferiority. At one point, Jacob’s mother told him his HIV was God’s punishment for being gay.

Despite logically knowing this to be untrue, his family experience created an internalized sense of shame so that his mother’s microassault maginified her comment; “not only is being gay wrong, but God punished this wrong with a serious illness.”

Microinsults

A

microinsult is more likely to

be committed unconsciously.

Microinsults are subtle attacks on one’s personhood that are usually disguised as compliments or positive statements, but are undermined by an insulting or offensive metacommunication or hidden message.

Microinsults communicate insensitivity, rudeness, or snubs that demean aspects of a person’s identity.

In many social situations, while others described their jobs, Jacob feared the inevitable question of being asked what he does for a living. An honest question, for Jacob it created the dilemma of how much to disclose. If he shared he was not working

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Many of us hold multiple marginalized identities that intersect with one another, each contributing to our first-hand experiences.

due to disability, the follow-up from many was to ask what had happened to him. The assumption that his disability was due to injury further pressured Jacob and created doubt about whether he was truly “entitled” to receive disability compensation, especially because the dementia he experienced was elusive and intangible.

As mentioned earlier, well-meaning hospital staff asked why no one had come to see him. Seemingly a simple question, for Jacob it served to emphasize his isolation and his fear of judgment if he shared the reason(s) his family had not visited.

Microinvalidations

M

icroinvalidations are

another form of microaggression. They also occur outside the level of consciousness.

This type of microaggression is particularly damaging and insidious because it directly attacks, denies, or minimizes the lived realities, thoughts, feelings, and beliefs of people with marginalized identities. Microinvalidations have potential to perpetuate denial around social privileges attached to those who do not experience marginalization and stigma.

Even in the context of a relationship that Jacob otherwise perceived as safe, his partner frequently minimized the importance of his connection to his church, as well as the cultural and racial influences which exacerbated his shame. He also challenged Jacob’s dementia, often claiming he exaggerated it to avoid accomplishing household tasks.

His partner’s statements failed to fully recognize the intersection of race, religion, and physical disability in Jacob’s reality and magnify his sense of shame. An unfortunately common microinvalidation occurs when a white individual says to his African American friend, “Slavery happened hundreds of years ago. Why can’t you get past it and just move on?” The metamessage communicated may translate to something like, “Slavery wasn’t significant enough to have lasting effects.”

Insidious trauma

T

he terms microaggression and insidious trauma are often used interchangeably. Some suggest that insidious trauma acts as a reminder in the lives of people with multiple marginalized identities of the potential for traumatization and the absence of safety in their daily lives, as raised by researcher Laura Brown. These are traumatic in a subtle way because they serve as constant reminders of the threat of physical, emotional, and psychological violence that underlies bias. For Jacob, everyday conversation and assumptions about marriage, employment, and health were paired with anxiety, shame, and a sense of worthlessness.

Symptoms of insidious trauma are the result of cumulative microaggressions; each may not be large enough to be a traumatic stressor on its own, but as microaggressions build over time, they can foster a complex form of traumatic responses not dissimilar to post traumatic stress disorder. While Jacob never demonstrated the symptoms associated with what we typically think of as traumatic, the accumulation of microaggressions created traumaassociated responses such as avoidance, personal devaluation, perceived loss of control, isolation, and a pervasive sense of shame. For Jacob and others, these feelings and responses are often indescribable and without intentional questioning from a compassionate friend or therapist, remain unacknowledged. The lack of acknowledgment, in itself, is a microinvalidation.

Moving toward acknowledgment

A

s part of our diverse and everchanging world, we cannot avoid being both victims and perpetrators of microaggressions. The insidious nature of microaggressions can make them difficult to identify when we perpetrate them, difficult to understand when they happen to us, and even more difficult to address or discuss. When we are made aware of a microaggression we have perpetrated, our guilt and immediate urge to apologize may interfere with fully listening to the impact of our behavior. The result may be additional insidious trauma and the subtle but

poignant message that microaggressions are really “micro” and don’t deserve to be considered traumatic.

When we experience a microaggression, we often don’t trust our own feelings because sometimes the subtle and underlying message can be difficult to clearly articulate. Or the message has been stated so many times that it is automatically accepted as a “truth” rather than something offensive.

If we don’t know when we have perpetrated a microaggression and can’t trust ourselves in knowing when we have experienced one, what do we do? An awareness of insidious trauma is a first step. If we are aware of and understand how a simple and seemingly innocent comment can magnify stigma and shame, we can make more informed and intentional decisions in our conversations, especially with those who may hold identities different from ours that may carry with them a history of marginalization and stigma. When we commit to an awareness of our own lived experiences and those of others, we can foster more compassionate relationships. And, when we are able to be gentle with ourselves about our own propensity to hurt another we can demonstrate that same gentleness toward those we hurt.

If we believe that compassion reduces insidious trauma, then through our compassion we diminish the forces behind marginalization, stigma, and shame.

To view the resources used in this article,

go to positivelyaware.com.

Jeff Levy is co-founder and CEO of Live Oak, Inc. He is also adjunct faculty at the University of Chicago’s School of Social Service Administration where he teaches an advanced seminar on violence and trauma.

Amber Jones is a recent graduate of this program with a concentration in traumainformed, culturally relevant practice.

Together, Levy and Jones have developed a graduate course proposal related to insidious trauma, microaggressions, and historical/intergenerational trauma.

For additional information, go to

liveoak.com.

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THE BUZZ

|

DANiel S. BERGER, MD

Aging Positively with HIV

I

t was nearly 24 years ago that I started an HIV-focused medical practice (Northstar Healthcare in Chicago) with patient #001. Today, at the time of this writing, we are at patient #7665 and counting. I still see more than a full load of patients, some of whom I’ve been treating for 20 years. There is scarcely enough time to see all the patients out there, so I’m thankful to the many HIV doctors that have devoted their lives and share in the work of treating patients with this disease.

Patient #001

I

am still taking care of my HIV-positive patient whose chart is #001, who I will call “AB.” He is now 65 years old and like many African Americans, is also battling diabetes, kidney problems, and hypertension, along with heart disease and occasional bouts of depression. This may not be terribly unusual for a person who has aged and has lived with diabetes from a very early age but became HIV-positive 25 years ago.

AB was only 40 years old when he first walked into my office with his partner, who was also suffering from HIV/AIDS. There was no AIDS cocktail in existence yet and few treatments for various opportunistic infections. These days, as I have little problem constructing excellent antiviral regimens, having access to many classes of drugs that are generally easy to take and with relatively few side effects, my focus has changed to more internal medicine, aging, and prevention issues. Today, AB takes his ARVs along with other pills that treat his heart disease and diabetes.

Unfortunately, he also needs dialysis three times a week.

Our long-term close doctor-patient relationship allows us to have frank and open conversations about many of the harder 36

S eptem b er+ o c to b er 2 013

issues relating to getting older with HIV. Although some of these sessions may be difficult, I take pleasure in seeing him every visit, often with a smile on his face. It’s hard to believe that I’ve been seeing him and others for nearly a quarter of a century. I’m proud to say AB is doing rather well and much better than last year when overcoming some health hurdles.

Getting older

A

ging with HIV is not a happy, feelgood subject to write about; however, having a greatly improved life expectancy and quality of life should be.

From the latest data, life expectancy for HIV-positive adults has increased dramatically. Individuals who get started on ART at age 20 can now be expected to live an additional 53 years; 73 years of age is not far away from normal life expectancy. As a doctor specializing in HIV, my focus is now aimed at delivering the best treatments, often utilizing improved characteristics associated with newer drugs. Improving long-term safety, tolerability, and ease of dosing are paramount. Focusing on metabolic issues and prevention of other possible complications is high on the list.

These days, it’s conceivable that a doctor can walk into an exam room, spend no

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more than five minutes with a patient, and then say, “You look fine” as he rattles off the stable CD4 count numbers and continued undetectability facts. What does take some time is to start patient appointments with open-ended questions such as “How are you doing?” combined with focused questions such as “What are you up to when you’re not working? How are you dealing with your depression? How is your memory?” Or, “How is your libido?”

If you ask some of these questions, rather than thinking an individual is doing very well, you might find out otherwise. You may find that other than work, your patient could be spending major time on the toilet dealing with watery diarrhea side effects.

Discussing issues related to living with HIV long-term with our patients is important.

It would be impossible to discuss every age-related issue in one article, but I will try to touch on some major ones here.

Cardiovascular risk

O

ne issue we focus on heavily is the prospect of developing cardiovascular disease as one gets older. Cardiovascular disease (CVD) is the most common cause of death in the United States and as HIV-positive patients age, they are also at risk for CVD, probably more so than the general public. Some risk factors can be related to the direct effect of HIV causing increased inflammation and immune system activation, as well as

increased lipids that are often associated with HIV medications and a host of other factors.

One such factor, often overlooked, is the development of visceral adiposity (increased belly fat), which is part of the syndrome of lipodystrophy and is associated with some antiretrovirals and possibly with HIV infection as well. Visceral adiposity is not generally added as a risk factor, but I believe it should be, as studies have shown that it contributes to further CVD risk. We know from some studies in normal uninfected individuals that visceral fat increases the risk for a major cardiovascular event such as myocardial infarction (heart attack). Likewise seen in studies of HIV-positive individuals, patients with lipodystrophy have a higher incidence of CVD risk and greatly elevated risk of myocardial infarction. Though unproven at present, one can surmise that reducing visceral fat can reduce CVD risk. Though published studies have shown that patients on Egrifta, an injectable medication approved for decreasing belly fat in HIV disease, showed improved levels of cholesterol, triglycerides, and HDL (good cholesterol), we are waiting for completed research investigating whether there is a link between

treatment with Egrifta and the possibility of it affecting or lowering CVD risk, which will take many years of observation.

As patients reach middle age, efforts to minimize risk factors that can be controlled deserve more attention. Close monitoring of cholesterol (both HDL and LDL) and other blood fats is the standard, and achieving normalization of those levels is crucial to reducing CVD risk. However, 50% of heart attacks occur in patients with normal cholesterol.

Standard inflammatory markers such as CRP (C-reactive protein) are sometimes used to indicate risk, but another marker that is more specific to blood vessel inflammation, though not used as much, is called Lp-PLA2. I find it helpful because it indicates that actual disease is already present, which can motivate our patients to be more adherent to our recommendations. It also gives us, as physicians, a good reason to be more aggressive with risk management.

Finally, one should not ignore the tremendous risk that smoking adds to the development of stroke and heart disease.

More than 50 percent of our HIV-positive patients smoke. Dr. David Wohl, a wellrespected HIV specialist from Chapel Hill, North Carolina, says he “plays with the Framingham Risk Score” (an algorithm used to estimate the 10-year cardiovascular risk of an individual) with his patients. He’ll calculate it and then show the sharp and dramatic reduction in risk when one stops smoking, which he reiterates “has the biggest influence [on heart disease risk], and it’s dramatic.” Physicians should make an extra effort to support our patients with suggestions for quitting smoking.

By the way, aside from cardiovascular risk, smoking carries the risk of chronic

obstructive pulmonary disease (COPD), now the fourth leading cause of death in the U.S. Another risk factor is being overweight.

One should not understate the improvements to be gained through routine exercise and proper nutrition. Moreover, exercise and nutrition are important for everyone living with HIV. Related to my philosophy of healthy lifestyle, I try to encourage patients to do some form of aerobic or “cardio” exercise and reduce consumption of processed foods and food that is high in starch and fat. A healthy lifestyle can also slow the propensity to develop visceral adiposity.

Depression

D

epression is a common problem—among our HIV-positive patients, perhaps more than 50 percent are taking medications for either anxiety, depression, and/or insomnia. I am comfortable with prescribing medications for depression, but find myself acting as a part-time therapist for patients in the exam room. I have added an additional PhD psychologist to our clinic psych staff to provide more support, as depression and anxiety have become so common.

Additionally, very common among the MSM (men who have sex with men) or gay population is recreational drug use. Crystal methamphetamine has been shown to be linked to depression and what sometimes ensues is a form of depression that can be irreversible and hard to treat.

Depression is often genetic and many studies have shown this to run in families. I also believe that depression is biologically based and often related to a hormonal imbalance, such as with serotonin—thus,

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37

treatment with pharmacologics is very helpful. Also biologically, low testosterone can predispose patients to depression as well, and thus correcting for deficiency is indicated. I think that whatever one can do to promote a healthy lifestyle, such as good diet and exercise, as well as forming good support systems with friends, partners, and family, should be harnessed, along with professional help.

Low testosterone

T

estosterone, known as the

male sex hormone, is important for many physiological and metabolic functions. Low and deficient levels may be associated with low libido, as well as generalized fatigue, depression, irritability, bone thinning and, especially in older men, reduced cognitive function. Not uncommonly, patients make doctor appointments complaining of very general symptoms such as fatigue and depression (in addition to low libido), that are often typical of low testosterone levels. We use the term “hypogonadism” to describe this syndrome.

Laboratory testing of testosterone levels is generally done to document deficiency and often patients show levels below the range of normal. Normal for younger men at our lab is from 300–1090 ng/mL (there are no standardized levels for testing testosterone, so it differs from lab to lab, as does age range). Unfortunately, if a young patient has symptoms and their levels are, for example, 350 ng/mL, they may be told that their levels are “fine,” even if low for their age range and accompanied by symptoms. A value in the normal range may not be normal for an individual, as levels may have decreased with development of symptoms. Moreover, we often have no baseline or previous levels to compare. I believe that the above example is a patient who warrants a trial of physiologic replacement of testosterone.

Originally, it was several HIV specialists that began recognizing the importance of testosterone replacement. Back in the early ’90s, we began offering our patients “physiologic replacement” by intramuscular injection. In other words, we administered dosages of testosterone that are consistent

with what the body should normally have to maintain its normal levels and function.

While testosterone has no direct effect on the virus, treatment has resulted in greatly improved energy levels, reduced anxiety and depression, and improved weight.

Often these effects are dramatic. I believe the prevalence of hypogonadism in the HIV-positive population is underestimated.

Consistent symptoms warrant discussion with a doctor.

HIV-associated neurocognitive disorder

L

ong before HIV-associated neu-

rocognitive disorder (also known as HAND) showed up on our radar, another brain complication called AIDS dementia was a long-feared condition.

Thankfully, with the widespread and early use of antiviral therapy, AIDS dementia is relatively rare.

Currently, HAND is something we often see in the clinic. It sometimes goes undetected because it can be so subtle.

But sometimes patients themselves notice

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the symptoms that predominantly affect memory loss. A patient may state that they’re noticing loss of vocabulary, or forgetting their train of thought, forgetting names of some friends, but there are many other examples of short-term memory loss.

Neurocognitive and psychological testing can be used to diagnose the problem. MRIs of the brain are often useless because they fail to show any abnormality.

The etiology (cause) is not well understood. Some studies showed that the type of antiviral agent used, even if better at penetrating the blood/brain barrier (BBB), does not affect or reduce the propensity to develop HAND, nor does switching to those BBB medications improve the problem if it is already present. Moreover, HAND is often seen in patients who have been undetectable on long-standing therapy and it can begin to develop after many years of being on antiretrovirals.

However, one association is low CD4 nadir (the lowest ever number of T-cells)— in other words, patients who start on therapy who have had lower CD4 counts tend to have a greater propensity to develop HAND, and this is just one reason that one should start HIV treatment early.

Current thinking is that either inflammation or immune activation when becoming infected with HIV, and during periods of non-treatment, contributes to this subtle damage within the brain that may manifest later. It is also known that beginning HIV treatment is followed by a period of immune activation, another doorway for HAND to develop.

Patients can reduce the propensity or severity of later developing HAND by beginning HIV treatment early. Additionally, reducing any substances or medications that affect memory and neurological functions, including recreational drugs, alcohol, and some sedatives, can be important.

Often exercise and using the brain to learn new skills, such as a new language, can improve and sharpen memory.

Premature cancers

A

major cause of death in this country is cancer. About 1.6 million new cancer cases are expected to be diagnosed in 2013, and more than 580,000 Americans are projected to die of

cancer this year. As individuals with HIV live longer they have an added chance of developing malignancies; some specific cancers pose an even greater risk to patients with HIV compared to the population at large.

Early studies showed that having HIV raises the risk of lung cancer by 70% and men with HIV have twice the risk of developing non-AIDS-related cancers.

Many of the non-AIDS-related cancers are linked to viral infections, which often have similar routes of transmission as HIV. Although patients with HIV on treatment have an improved or reconstituted immune system, studies have shown that their immune system function is not completely normalized. In a less protective immune system, these viruses can cause cells to mature or develop abnormally, which may transform those cells into cancer (neoplasia). Examples of viruses and their specific associated cancers are the following: hepatitis B and hepatitis C virus infection are linked to liver disease and cancer (hepatoma). Epstein-Barr virus, a member of the herpes virus family, is linked to cancers of the lymphatic system called lymphoma.

HHV-8 or human herpes virus-8 was shown to cause Kaposi’s sarcoma (KS) and a cancer-like (lymphomatous) condition called Castleman’s disease. Finally, HPV or human papillomavirus is the cause of anal and genital warts; some strains can lead to cancer of the anus and penis in men and cancers of the anus, cervix, and vulva in women. Recent research findings showed that some strains of HPV are also linked to cancers of the mouth, lips, and throat, perhaps linked to oral sex.

Previously, research showed that prior to the widespread use of ARVs, cases of anal cancer were twice as high among HIVpositive MSM compared to HIV-negative MSM. Currently, compared to the average HIV-negative man, the relative risk of anal cancer is many times greater for HIVpositive men who are not MSM (37-fold) and even greater for HIV-positive MSM (60-fold).

There is little consensus of what should be the standard of care for cancer prevention in HIV-positive people, but common sense rules. Here are some ideas for prevention: n

People with HIV who start on treatment

earlier, with higher CD4 counts, have been shown to have a much lower risk of cancer many years later. Thus, I believe that treatment should be initiated sooner rather than waiting for CD4 count decline. Additionally, early initiation of treatment has also been shown to reduce the propensity to develop HIV-associated neurocognitive disorder (HAND). n Individuals

with HIV should undergo routine anal Pap smears and women should have routine cervical Pap smears as well.

n

When genital or anal warts are discovered, they should be destroyed and a careful inspection of the anal canal utilizing an anoscope should be done.

Anoscopic exams are simple procedures that can be performed in the exam room.

n Avoid

high-risk behavior that may increase the chance of becoming infected with hepatitis B or C.

n

Finally, avoid smoking or get your physician’s help in quitting.

Taken together the multitude of complications affecting people aging with HIV may seem daunting. However, arming yourself with the most current information and an understanding of the issues at hand can help to ensure a better quality of life for those living with HIV. Daniel S. Berger, MD is a leading HIV physician and is Clinical Associate Professor of Medicine at the University of Illinois at Chicago. He is founder and medical director of Northstar Healthcare, where he also currently serves as principle investigator. He has published extensively in journals such as the Lancet and the New England Journal of Medicine, and has been honored by TPAN with the Charles E. Clifton Leadership Award. Dr. Berger had taken a break from writing this column for more than a year, but The Buzz has been a fixture in PA since November 2000; this is its 39th installment. Dr. Berger can be reached at DSBergerMD@gmail.com and Nstarmedical.com.

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2 013 R e a d e r S u rv e y

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