JAN+FEB 2013

runway design to AIDS activism Mondo From A conversation men need to have PrEP gay

Ja n ua ry+ F e b r ua ry 2 0 1 3

BREAKTHROUGHS How advances in science and technology are changing the way we live with— and fight—HIV

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CONTRIBUTORS

Bran LeFae has worked as a technician in cancer and HIV research and in research administration. With the shifting tides of the economy and career interest, she is co-owner of Bramblethorn Studios. Located just north of Seattle, she spends her time as a photographer and writing and editing health care articles. As a queer, genderfluid individual, Bran is pleased to contribute to her community through her work with POSITIVELY AWARE. What particular skill or trait helped you to cover this story?

This story covers a wide range of information and opinions. During the course of writing the article, I interviewed several research and health care professionals. Being organized and able to listen well and guide the conversations in certain directions helped me get the information I needed during these interviews, which is my favorite part of working as a writer. I love talking to people and hearing their opinions and learning more about what they do in their field.

In writing this article, what did you learn that you didn’t know before?

Photo: Bran LeFae

As always, I learned a lot of things that I didn’t know while researching this topic! I learned how much time it takes away from physicians to be constantly tapped in to their work through technology and how little they are compensated for their time. I learned that people can use technology to help them get involved in their health care, but that it’s not something that’s available to everyone, because we all have different resources. And I learned—again—that very busy people can be very generous with their time to get the word out about their work and experiences. I’m grateful to all of them.

An LGBT-focused freelance journalist, David Duran frequently contributes to publications such as Out, The Advocate, the Bay Area Reporter and the Huffington Post. He covers news, entertainment interviews, reviews, travel features, and personal opinion. He also has a biweekly business column that features successful LGBT entrepreneurs and is currently developing a column about dating in New York City that will be published in the UK.

What particular skill or trait helped you to cover this story?

What most helped me cover this story was my familiarity with using mobile apps for resources, information, and dating. As an HIV-positive man, I am constantly out there, discovering what is available to me.

In writing this article, what did you learn that you didn’t know before?

Photo: © Troy Dean Photography

The most important thing I learned from covering this story is the fact that the creators and employees at these gay dating apps are so passionate about HIV disclosure. I honestly assumed it was just a minor piece of their agenda, but in fact, they are dedicated to informing their users and ending stigma. I was truly impressed.

J A N U A R Y+ F E B R U A R Y 2 0 1 3 | P o s i t i v e lyA w are . c o m

5

Seize the

DaY. Seize the DaY.

JOURNALISM. INTEGRITY. HOPE. editor-in-Chief Jeff Berry Guest editor Rick Guasco associate editor Enid Vázquez copy Editor Sue Saltmarsh proofreader Jason Lancaster Web Master Joshua Thorne Creative director Rick Guasco contributing writers Keith R. Green, Liz Highleyman, Sal Iacopelli, Laura Jones, Jim Pickett, Matt Sharp photographers Chris Knight, Joshua Thorne Medical advisors Daniel S. Berger, MD Gary Bucher, MD Michael Cristofano, PA Joel Gallant, MD Swarup Mehta, PharmD

Select pictures from A Day with HIV’s 2012 campaign are featured in a new book published by Positively Aware.

Keep for yourself some of the most compelling images of our anti-stigma project. Limited supply.

advertising inquiries Lorraine Hayes

l.hayes@tpan.com

Order your book for a $20 donation to cover the cost of printing, plus $2 for shipping.

Subscription coordinator Ian Ponsetto

distribution@tpan.com

To order, go to www.adaywithhiv.com/book

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

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.

© 2013. Positively Aware (ISSN: 1523-2883) is published bi-monthly by Test Positive Aware Network (TPAN), 5537 N. Broadway St, Chicago, IL 60640. TPAN is an Illinois not-for-profit corporation, providing information and support to anyone concerned with HIV and AIDS issues. Positively Aware is a registered trademark of TPAN. All rights reserved. Circulation: 100,000. For reprint permission, send email to inbox@tpan.com. Six issues mailed bulk rate for $30 donation; mailed free to those living with HIV or those unable to contribute.

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Although Positively Aware takes great care to ensure the accuracy of all the information that it presents, Positively Aware staff and volunteers, TPAN, or the institutions and personnel who provide us with information cannot be held responsible for any damages, direct or consequential, that arise from use of this material or due to errors contained herein. Opinions expressed in Positively Aware are not necessarily those of staff or 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.

J A N U A R Y+ F E B R U A R Y 2 0 1 3 | P o s i t i v e lyA w are . c o m

JAN+FEB 2013 VOL U ME 2 5

N U M B ER 1

co v e r F e a tur e S

Breakthroughs How science and technology are changing the way we live with—and fight—HIV

22 Take two apps and call me in the morning

27 Model behavior

Technology is changing medicine, even in the examination room.

Doctors and patients are increasingly making use of an array of gadgets and widgets.

Computer simulations are used to predict things such as how quickly drug resistance will develop and the best way of controlling the HIV epidemic. What are the limits of computer modeling?

31 ‘Hooking up’ to social media Apps and websites are the new tools of awareness and prevention campaigns. How effective are social media in changing behavior?

D e p a rt m e nts

F e a tur e s

8 In Box

17 Preview: Mondo’s mission

8 Readers’ Poll What do you think is the biggest cause of stigma?

9 Guest editor’s Note

Excerpt from the online interview with designer and AIDS activist Mondo Guerra.

35 A pill to prevent HIV A conversation gay men need to have.

The power to change your life.

O n l in e e x tr a s

14 Briefly

Go to

800 mg Prezista. Hep C drug shows promise. African American women and HIV/HCV co-infection.

39 Ask the Doctor It’s not just a river in Egypt.

40 Wholistic Picture Siri-ously?

www.positivelyaware.com

I Design (and speak out) An interview with fashion designer and AIDS advocate Mondo Guerra.

www.positivelyaware.com/2013/13_01/mondo.shtml ON THE COVER: Photography and image compositing by Chris Knight. computer image: istockphoto.com/alengo J A N U A R Y+ F E B R U A R Y 2 0 1 3 | P o s i t i v e lyA w are . c o m

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I n bo x

join the conversation: inbox@tpan.com + @posaware

R e a d e rs ’ p o l l In the NOV+DEC issue, we asked

Reflecting on stigma

What do you think is the biggest cause of stigma?

I found the message of “Spoiled Identity” [Nov+Dec issue] to be so incredibly true. I liked the author’s distinction between felt and perceived stigma. I also have to agree that there is a stigmatization within the gay community that is going on. I have often heard many of the false stereotypes of HIV-positive men, which further increase the stigmatization. Pointing it out helps create conversation and change attitudes. The author’s presentation of social hierarchies within the gay community is both true and powerful. The practical suggestions of how to overcome all this is just as, if not more, powerful and true.

Thanks for this great article!

—Ben

Ignorance: 42%

Fear: 23%

Bigotry:

19%

Religion: Other:

8%

8%

Your comments:

via the Internet

Just today I changed my meds from Sustiva and Combivir to Atripla, thanks to Dr. Doug Cunningham of Pueblo Family Physicians, LTD in Phoenix, AZ. That is where I picked up a copy of the NOV+DEC issue of POSITIVELY AWARE and cried at the picture and story of David Walker. It broke my heart to think he was separated from his three siblings because their adoptive family didn’t want an HIV-positive child. It was clear from his photo that he does indeed have “the spirit of an angel.”

His daddy is a lucky man.

I would LOVE to distribute POSITIVELY AWARE along with the condoms I have volunteered to distribute for Project Hardhat! I think people need to read this

because your magazine contains so much information, whether you’re poz or neg. I am so impressed with all the Information you have put together on life with HIV and the meds we take. I will be reading most of these articles to all my friends, family, and anybody who will listen. We all have to be advocates to educate others.

I am also going to post this on my Facebook wall. I want people to cry along with me, not out of sadness, but because of what others, including children, have to go through to stay healthy and cope with the stigma. I see so much, every day, of what you have written, and on a scale of 1 to 10, I give PA a 20! Please keep it up— you’re making it better.

—Dale Ferguson

“I think each plays a role, but ignorance is the biggest cause of stigma. If the population were educated about HIV then a lot of the stigma would go away.”

“All of the above!”

“FEAR, ignorance and cultural background!”

“I personally think it is both fear and ignorance. As a gay man living with HIV (undetectable viral load and healthy CD4 count), I find that gay men usually don’t want to talk about anything, but just want to have sex.

However, when I mention that I am HIVpositive, it’s automatic rejection without getting to know me and without talking about safer sex practices.”

Phoenix, AZ this issue’s poll question:

C o nne c t to Positi v e ly Awa r e Email: inbox@tpan.com Facebook: www.facebook.com/PositivelyAware Twitter: @PosAware Letters: Positively Aware, 5537 N. Broadway St., Chicago, IL 60640. Positively Aware treats all communications (letters, email, etc.) 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.

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How comfortable are you with using computer technology to keep track of your medical records? cast your vote at

positivelyaware.com

J A N U A R Y+ F E B R U A R Y 2 0 1 3 | P o s i t i v e lyA w are . c o m

G u e st Editor ’ s not e Rick guasco @rickguasco

The power to change your life

PHOTO: Joshua Thorne

It was the week before Christmas 1992 when I tested HIV-positive, which meant that the more than 100 purplish blotches on my face and body were likely Kaposi’s sarcoma (KS), which at the time the Centers for Disease Control and Prevention (CDC) had classified as an end-stage, AIDS-defining illness. My post-test counseling consisted of nothing more than somberly being told, “Good luck,” as I was handed three publications. One of the them was POSITIVELY AWARE. The other two publications—an AIDS services directory and a newsletter—were also produced by TPAN. I had lost my job and had no insurance. But through the agency’s newsletter I found a clinical study that sent my KS into remission, and the services directory showed me that support services were available if I needed them.

It was PA, though, that educated me. The magazine’s information was so vital, I decided to volunteer at POSITIVELY AWARE and eventually became the magazine’s art director.

TPAN and POSITIVELY AWARE taught me that information is power. The power to survive. How we connect to that information is what the theme of this issue, Breakthroughs, is about. When I presented the concept to PA editor-in-chief Jeff Berry, he very graciously allowed me to take the lead in developing it for this issue.

I have always been fascinated by science and technology. Truth is, I’m a geek. I’m not all that good at science, but I have always been fascinated by technology.

Sure, the gadgets are cool (I’m an Apple fan boy) and I love science fiction (I can recite scenes of dialogue from Star Trek), but science and technology excite me because of their ability to help us understand the world around us and to change our lives.

Advances in science and technology affect how we develop, gather, report, share, and consume information. Some of those changes would have been the stuff of science fiction just five or ten years ago. Other changes are taking place and we might not even be aware of their impact.

Writer Bran LeFae highlights how some of these advances are changing the doctor-patient relationship

with, “Take Two Apps and Call Me in the Morning.”

Technology has empowered patients to educate themselves and become more responsible for their treatment. Doctors can share lab results and other treatment information about a common patient. But, as Bran points out, technology can also come with a downside. And not everyone is comfortable with—or has easy access to—all this nifty technology.

Other people who are computer savvy, however, apply technology to the everyday aspects of their lives.

David Duran’s story, “Hooking Up to Social Media,” provides an overview of the role of social media websites and mobile applications. From anti-stigma campaigns to changing how gay men are dating, David demonstrates how social media are becoming socially conscious.

In “Model Behavior,” researchers and clinicians are creating virtual worlds to predict how and when HIV develops drug resistance in patients, to determine how to best curb the spread of HIV among injection drug users in New York, and to track how the virus spreads among various villages in Botswana. In writing this article, I was surprised to discover that the simulations used to develop strategies in the fight against HIV are very much like the war games run by military computers.

Such developments touch all our lives, especially those of us living with HIV. I hope that you find our attempt to address them in this issue to be informative and useful. My deep appreciation to Jeff for letting me share with you my interest and excitement in technology and the power of information. It’s not an exaggeration to say that POSITIVELY AWARE changed my life, if not actually saved it. I’d like to believe that every issue of this magazine touches at least one life the same way.

I’m proud and grateful to be a part of PA, because I am hopefully paying back the favor it has done for me.

Peace and long life.

J A N U A R Y+ F E B R U A R Y 2 0 1 3 | P o s i t i v e lyA w are . c o m

Truth is, I’m a geek.

I’m not all that good at science, but science and technology excite me because of their ability to help us understand the world around us and to change our lives.

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ABOUT PREZISTA

®

PREZISTA® is always taken with and at the same time as ritonavir (Norvir ®), in combination with other HIV medicines for the treatment of HIV infection in adults. PREZISTA® should also be taken with food.

• The use of other medicines active against HIV in combination with PREZISTA®/ritonavir (Norvir ®) may increase your ability to fight HIV. Your healthcare professional will work with you to find the right combination of HIV medicines • It is important that you remain under the care of your healthcare professional during treatment with PREZISTA® PREZISTA® does not cure HIV infection or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using PREZISTA.® Please read Important Safety Information below, and talk to your healthcare professional to learn if PREZISTA® is right for you.

IMPORTANT SAFETY INFORMATION What is the most important information I should know about PREZISTA®?

• PREZISTA® can interact with other medicines and cause serious side effects. See “Who should not take PREZISTA®?”

• PREZISTA® may cause liver problems. Some people taking PREZISTA,® together with Norvir ® (ritonavir), have developed liver problems which may be life-threatening. Your healthcare professional should do blood tests before and during your combination treatment with PREZISTA.® If you have chronic hepatitis B or C infection, your healthcare professional should check your blood tests more often because you have an increased chance of developing liver problems • Tell your healthcare professional if you have any of these signs and symptoms of liver problems: dark (tea-colored) urine, yellowing of your skin or whites of your eyes, pale-colored stools (bowel movements), nausea, vomiting, pain or tenderness on your right side below your ribs, or loss of appetite • PREZISTA® may cause a severe or life-threatening skin reaction or rash. Sometimes these skin reactions and skin rashes can become severe and require treatment in a hospital. You should call your healthcare professional immediately if you develop a rash.

However, stop taking PREZISTA® and ritonavir combination treatment and call your healthcare professional immediately if you develop any skin changes with these symptoms: fever, tiredness, muscle or joint pain, blisters or skin lesions, mouth sores or ulcers, red or inflamed eyes, like “pink eye.” Rash occurred more often in patients taking PREZISTA® and raltegravir together than with either drug separately, but was generally mild Who should not take PREZISTA®?

• Do not take PREZISTA® if you are taking the following medicines: alfuzosin (Uroxatral®), dihydroergotamine (D.H.E.45,® Embolex,® Migranal®), ergonovine, ergotamine (Cafergot,® Ergomar ®), methylergonovine, cisapride (Propulsid®), pimozide (Orap®), oral midazolam, triazolam (Halcion®), the herbal supplement St. John’s wort (Hypericum perforatum), lovastatin (Mevacor,® Altoprev,® Advicor ®), simvastatin (Zocor,® Simcor,® Vytorin®), rifampin (Rifadin,® Rifater,®

Rifamate,® Rimactane®), sildenafil (Revatio®) when used to treat pulmonary arterial hypertension, indinavir (Crixivan®), lopinavir/ ritonavir (Kaletra®), saquinavir (Invirase®), boceprevir (Victrelis™), or telaprevir (Incivek™) • Before taking PREZISTA,® tell your healthcare professional if you are taking sildenafil (Viagra,® Revatio®), vardenafil (Levitra,® Staxyn®), tadalafil (Cialis,® Adcirca®), atorvastatin (Lipitor ®), rosuvastatin (Crestor ®), pravastatin (Pravachol®), or colchicine (Colcrys,® Col-Probenecid®). Tell your healthcare professional if you are taking estrogen-based contraceptives (birth control). PREZISTA® might reduce the effectiveness of estrogen-based contraceptives. You must take additional precautions for birth control, such as condoms This is not a complete list of medicines. Be sure to tell your healthcare professional about all the medicines you are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

What should I tell my doctor before I take PREZISTA®?

• Before taking PREZISTA,® tell your healthcare professional if you have any medical conditions, including liver problems (including hepatitis B or C), allergy to sulfa medicines, diabetes, or hemophilia • Tell your healthcare professional if you are pregnant or planning to become pregnant, or are breastfeeding — The effects of PREZISTA® on pregnant women or their unborn babies are not known. You and your healthcare professional will need to decide if taking PREZISTA® is right for you — Do not breastfeed. It is not known if PREZISTA® can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV should not breastfeed because HIV can be passed to your baby in the breast milk What are the possible side effects of PREZISTA®?

• High blood sugar, diabetes or worsening of diabetes, and increased bleeding in people with hemophilia have been reported in patients taking protease inhibitor medicines, including PREZISTA® • Changes in body fat have been seen in some patients taking HIV medicines, including PREZISTA.® The cause and long-term health effects of these conditions are not known at this time • Changes in your immune system can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden • The most common side effects related to taking PREZISTA® include diarrhea, nausea, rash, headache, stomach pain, and vomiting. This is not a complete list of all possible side effects. If you experience these or other side effects, talk to your healthcare professional. Do not stop taking PREZISTA® or any other medicines without first talking to your healthcare professional 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 refer to the ritonavir (Norvir ®) Product Information (PI and PPI) for additional information on precautionary measures.

Please read accompanying Patient Information for PREZISTA® and discuss any questions you have with your doctor.

28PRZDTC0288R8

PREZISTA® (darunavir) is a prescription medicine. It is one treatment option in the class of HIV (human immunodeficiency virus) medicines known as protease inhibitors.

IS THE PREZISTA

®

EXPERIENCE RIGHT FOR YOU?

There is no other person in the world who is exactly like you. And no HIV treatments are exactly alike, either. That’s why you should ask your healthcare professional about PREZISTA® (darunavir).

Once-Daily PREZISTA® taken with ritonavir and in combination with other HIV medications can help lower your viral load and keep your HIV under control over the long term.

In a clinical study* of almost 4 years (192 weeks), 7 out of 10 adults who had never taken HIV medications before maintained undetectable† viral loads with PREZISTA® plus ritonavir and Truvada.® Find out if the PREZISTA® EXPERIENCE is right for you.

Ask your healthcare professional and learn more at DiscoverPREZISTA.com Please read the Important Safety Information and Patient Information on adjacent pages.

Snap a quick pic of our logo to show your doctor and get the conversation started. *A randomized open label Phase 3 trial comparing PREZISTA®/ritonavir 800/100 mg once daily (n=343) vs. Kaletra®/ritonavir 800/200 mg/day (n=346). †Undetectable was defined as a viral load of less than 50 copies per mL. Registered trademarks are the property of their respective owners.

Janssen Therapeutics, Division of Janssen Products, LP © Janssen Therapeutics, Division of Janssen Products, LP 2012 06/12 28PRZ12036G

IMPORTANT PATIENT INFORMATION PREZISTA (pre-ZIS-ta) (darunavir) Oral Suspension PREZISTA (pre-ZIS-ta) (darunavir) Tablets Read this Patient Information before you start taking PREZISTA and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Also read the Patient Information leaflet for NORVIR® (ritonavir).

What is the most important information I should know about PREZISTA? • PREZISTA can interact with other medicines and cause serious side effects. It is important to know the medicines that should not be taken with PREZISTA. See the section “Who should not take PREZISTA?” • PREZISTA may cause liver problems. Some people taking PREZISTA in combination with NORVIR® (ritonavir) have developed liver problems which may be life-threatening. Your healthcare provider should do blood tests before and during your combination treatment with PREZISTA. If you have chronic hepatitis B or C infection, your healthcare provider should check your blood tests more often because you have an increased chance of developing liver problems.

• Tell your healthcare provider if you have any of the below signs and symptoms of liver problems.

• Dark (tea colored) urine • yellowing of your skin or whites of your eyes • pale colored stools (bowel movements) • nausea • vomiting • pain or tenderness on your right side below your ribs • loss of appetite PREZISTA may cause severe or life-threatening skin reactions or rash.

Sometimes these skin reactions and skin rashes can become severe and require treatment in a hospital. You should call your healthcare provider immediately if you develop a rash. However, stop taking PREZISTA and ritonavir combination treatment and call your healthcare provider immediately if you develop any skin changes with symptoms below: • fever • tiredness • muscle or joint pain • blisters or skin lesions • mouth sores or ulcers • red or inflamed eyes, like “pink eye” (conjunctivitis) Rash occurred more often in patients taking PREZISTA and raltegravir together than with either drug separately, but was generally mild.

See “What are the possible side effects of PREZISTA?” for more information about side effects.

What is PREZISTA? PREZISTA is a prescription anti-HIV medicine used with ritonavir and other anti-HIV medicines to treat adults with human immunodeficiency virus (HIV-1) infection. PREZISTA is a type of anti-HIV medicine called a protease inhibitor. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

When used with other HIV medicines, PREZISTA may help to reduce the amount of HIV in your blood (called “viral load”). PREZISTA may also help to increase the number of white blood cells called CD4 (T) cell which help fight off other infections. Reducing the amount of HIV and increasing the CD4 (T) cell count may improve your immune system.

This may reduce your risk of death or infections that can happen when your immune system is weak (opportunistic infections).

PREZISTA does not cure HIV infection or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using PREZISTA. Avoid doing things that can spread HIV-1 infection.

• Do not share needles or other injection equipment.

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

• D o not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.

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

Who should not take PREZISTA? Do not take PREZISTA with any of the following medicines: • alfuzosin (Uroxatral®) • dihydroergotamine (D.H.E. 45®, Embolex®, Migranal®), ergonovine, ergotamine (Cafergot®, Ergomar®) methylergonovine • cisapride • pimozide (Orap®) • oral midazolam, triazolam (Halcion®) • the herbal supplement St. John’s Wort (Hypericum perforatum) • the cholesterol lowering medicines lovastatin (Mevacor®, Altoprev®, Advicor®) or simvastatin (Zocor®, Simcor®, Vytorin®) • rifampin (Rifadin®, Rifater®, Rifamate®, Rimactane®) • sildenafil (Revatio®) only when used for the treatment of pulmonary arterial hypertension.

Serious problems can happen if you take any of these medicines with PREZISTA. What should I tell my doctor before I take PREZISTA? PREZISTA may not be right for you. Before taking PREZISTA, tell your healthcare provider if you: • have liver problems, including hepatitis B or hepatitis C • are allergic to sulfa medicines • have high blood sugar (diabetes) • have hemophilia • are pregnant or planning to become pregnant. It is not known if PREZISTA will harm your unborn baby.

Pregnancy Registry: You and your healthcare provider will need to decide if taking PREZISTA is right for you. If you take PREZISTA while you are pregnant, talk to your healthcare provider about how you can be included in the Antiretroviral Pregnancy Registry. The purpose of the registry is follow the health of you and your baby.

• are breastfeeding or plan to breastfeed. Do not breastfeed. We do not know if PREZISTA can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.

Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Using PREZISTA and certain other medicines may affect each other causing serious side effects. PREZISTA may affect the way other medicines work and other medicines may affect how PREZISTA works.

Especially tell your healthcare provider if you take: • medicine to treat HIV • estrogen-based contraceptives (birth control). PREZISTA might reduce the effectiveness of estrogen-based contraceptives. You must take additional precautions for birth control such as a condom.

• medicine for your heart such as bepridil, lidocaine (Xylocaine Viscous®), quinidine (Nuedexta®), amiodarone (Pacerone®, Cardarone®), digoxin (Lanoxin ®), flecainide (Tambocor ®), propafenone (Rythmol®) • warfarin (Coumadin®, Jantoven®) • medicine for seizures such as carbamazepine (Carbatrol®, Equetro®, Tegretol®, Epitol®), phenobarbital, phenytoin (Dilantin®, Phenytek®) • medicine for depression such as trazadone and desipramine (Norpramin®) • clarithromycin (Prevpac®, Biaxin®) • medicine for fungal infections such as ketoconazole (Nizoral®), itraconazole (Sporanox®, Onmel®), voriconazole (VFend®) • colchicine (Colcrys®, Col-Probenecid®) • rifabutin (Mycobutin®) • medicine used to treat blood pressure, a heart attack, heart failure, or to lower pressure in the eye such as metoprolol (Lopressor®, Toprol-XL®), timolol (Cosopt®, Betimol®, Timoptic®, Isatolol®, Combigan®) • midazolam administered by injection • medicine for heart disease such as felodipine (Plendil®), nifedipine (Procardia®, Adalat CC®, Afeditab CR®), nicardipine (Cardene®)

IMPORTANT PATIENT INFORMATION • s teroids such as dexamethasone, fluticasone (Advair Diskus®, Veramyst®, Flovent®, Flonase®) • bosentan (Tracleer®) • medicine to treat chronic hepatitis C such as boceprevir (VictrelisTM), telaprevir (IncivekTM) • medicine for cholesterol such as pravastatin (Pravachol®), atorvastatin (Lipitor®), rosuvastatin (Crestor®) • medicine to prevent organ transplant failure such as cyclosporine (Gengraf®, Sandimmune®, Neoral®), tacrolimus (Prograf®), sirolimus (Rapamune®) • salmeterol (Advair®, Serevent®) • medicine for narcotic withdrawal such as methadone (Methadose®, Dolophine Hydrochloride), buprenorphine (Butrans®, Buprenex®, Subutex®), buprenorphine/naloxone (Suboxone®) • medicine to treat schizophrenia such as risperidone (Risperdal®), thioridazine • medicine to treat erectile dysfunction or pulmonary hypertension such as sildenafil (Viagra®, Revatio®), vardenafil (Levitra®, Staxyn®), tadalafil (Cialis®, Adcirca®) • medicine to treat anxiety, depression or panic disorder such as sertraline (Zoloft®), paroxetine (Paxil®) This is not a complete list of medicines that you should tell your healthcare provider that you are taking. Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine. Do not start any new medicines while you are taking PREZISTA without first talking with your healthcare provider.

How should I take PREZISTA? • Take PREZISTA every day exactly as prescribed by your healthcare provider.

• You must take ritonavir (NORVIR®) at the same time as PREZISTA. • Do not change your dose of PREZISTA or stop treatment without talking to your healthcare provider first.

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

• Swallow PREZISTA tablets whole with a drink. If you have difficulty swallowing PREZISTA tablets, PREZISTA oral suspension is also available. Your health care provider will help determine whether PREZISTA tablets or oral suspension is right for you.

• PREZISTA oral suspension should be given with the supplied oral dosing syringe. Shake the suspension well before each usage.

• If you take too much PREZISTA, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I do if I miss a dose?

People who take PREZISTA one time a day: • If you miss a dose of PREZISTA by less than 12 hours, take your missed dose of PREZISTA right away. Then take your next dose of PREZISTA at your regularly scheduled time.

• If you miss a dose of PREZISTA by more than 12 hours, wait and then take the next dose of PREZISTA at your regularly scheduled time.

People who take PREZISTA two times a day • If you miss a dose of PREZISTA by less than 6 hours, take your missed dose of PREZISTA right away. Then take your next dose of PREZISTA at your regularly scheduled time.

• If you miss a dose of PREZISTA by more than 6 hours, wait and then take the next dose of PREZISTA at your regularly scheduled time.

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

What are the possible side effects of PREZISTA? PREZISTA can cause side effects including: • See “What is the most important information I should know about PREZISTA?” • Diabetes and high blood sugar (hyperglycemia). Some people who take protease inhibitors including PREZISTA can get high blood sugar, develop diabetes, or your diabetes can get worse. Tell your healthcare provider if you notice an increase in thirst or urinate often while taking PREZISTA. • Changes in body fat. These changes can happen in people who take antiretroviral therapy. The changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the back, chest, and stomach area. Loss of fat from the legs, arms, and face may also happen. The exact cause and longterm health effects of these conditions are not known.

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

• Increased bleeding for hemophiliacs. Some people with hemophilia have increased bleeding with protease inhibitors including PREZISTA. The most common side effects of PREZISTA include: • diarrhea • headache • nausea • abdominal pain • rash • vomiting Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of PREZISTA. For more information, ask your health care provider.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store PREZISTA? • Store PREZISTA oral suspension and tablets at room temperature [77°F (25°C)].

• Do not refrigerate or freeze PREZISTA oral suspension.

• Keep PREZISTA away from high heat.

• PREZISTA oral suspension should be stored in the original container.

Keep PREZISTA and all medicines out of the reach of children.

General information about PREZISTA Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use PREZISTA for a condition for which it was not prescribed. Do not give PREZISTA to other people even if they have the same condition you have. It may harm them.

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

For more information, call 1-800-526-7736.

What are the ingredients in PREZISTA? Active ingredient: darunavir Inactive ingredients: PREZISTA Oral Suspension: hydroxypropyl cellulose, microcrystalline cellulose, sodium carboxymethylcellulose, methylparaben sodium, citric acid monohydrate, sucralose, masking flavor, strawberry cream flavor, hydrochloric acid (for pH adjustment), purified water.

PREZISTA 75 mg and 150 mg Tablets: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose. The film coating contains: OPADRY® White (polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide).

PREZISTA 400 mg and 600 mg Tablets: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose. The film coating contains: OPADRY® Orange (FD&C Yellow No. 6, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide).

PREZISTA 800 mg Tablets: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, hypromellose. The film coating contains: OPADRY® Dark Red (iron oxide red, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide).

This Patient Information has been approved by the U.S Food and Drug Administration.

Manufactured by: PREZISTA Oral Suspension PREZISTA Tablets Janssen Pharmaceutica, N.V. Janssen Ortho LLC, Beerse, Belgium Gurabo, PR 00778 Manufactured for: Janssen Therapeutics, Division of Janssen Products, LP, Titusville NJ 08560 NORVIR® is a registered trademark of its respective owner.

PREZISTA® is a registered trademark of Janssen Pharmaceuticals © Janssen Pharmaceuticals, Inc. 2006 Revised: November 2012 10101718P

Briefly Enid Vázquez @ENIDVAZQUEZPA

“Can HIV-negative gay men stay negative by taking Truvada and not using condoms?

I say yes—maybe. My buddy and long-time activist Joey Wynn says no. Absolutely not.”

Read Enid Vázquez’s new blog at www. positivelyaware.com.

‘Point of sex’ testing, using the new ‘Quad,’ and more doctor talk You can listen in as HIV specialists from around the country discuss online the trials and tribulations of medical advancements at Clinical Care Options HIV (www.clinicalcareoptions.com/hiv).

Some of the items are clinical, but many are quite understandable. Among the topics is a discussion of the rapid home HIV test by Donna Sweet, MD, including use right before sex takes place, and comments about prescribing the new medication Stribild (formerly the Quad) by Joel E. Gallant, MD, MPH. Other doctors respond with their comments.

Registration is free.

Protecting younger men Men can greatly reduce the risk of getting HIV by taking Truvada, but will the pills help teen boys and other young males from becoming infected?

Project PrEPare seeks to find out how youth can take and benefit from Truvada for pre-exposure prophylaxis (PrEP). Medication, condoms, lab work, and treatment of sexually transmitted infections (STIs) are free, and financial compensation is provided.

Clinical sites are located in Baltimore, Boston, Bronx, Chicago, Denver, Houston, Los Angeles, Memphis, Miami, New Orleans, Philadelphia, Tampa, and Washington, DC. To find out more, go to www.projectprepare.net.

Investigational hep C drug shows good results Janssen Pharmaceuticals reported high levels of sustained virologic response (SVR) in study participants using its investigational hepatitis C medication simeprevir (TMC435). The once-daily pill was given with pegylated interferon (PEG-IFN) and ribavirin, the current standard of care.

Participants in the Phase 2b studies had Metavir scores (a method for assessing liver damage) F3 and F4, signs of advanced liver disease. An F3 score means the patient has numerous septa (fibrous tissue bands that can decrease the flow of blood through the liver), while an F4 score means the patient has cirrhosis (the final phase of chronic liver disease).

All had genotype 1 HCV, the hardest to treat.

In the PILLAR study with treatment-naïve (never before on hep C therapy) participants, 79% of those with an F3 score taking the simeprevir regimen saw an SVR at 24 weeks vs. 72% of those on PEG-IFN and ribavirin alone.

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In the treatment-experienced patients seen in the ASPIRE study, however, the difference was much greater: 48% of the F3 participants on the simeprevir regimen saw an SVR at 24 weeks compared to 8% of those on PEG-IFN and ribavirin. For those with cirrhosis, 62% achieved SVR on simeprivir vs. none of the patients on the dual therapy.

While none of these patients had HIV, hep C advancements are important because a large percentage of people with HIV are estimated to be co-infected with HCV. Fortunately, a slew of new, and more tolerable, hepatitis C treatments are on their way. Simeprevir is an NS3/4A protease inhibitor. It is also being studied in all-oral, interferon-free regimens.

The results came from post hoc (done after the study) analyses of patients on 150 mg of simeprevir and were presented at the annual Liver Meeting of the American Association for the Study of Liver Diseases (AASLD) in November.

J A N U A R Y+ F E B R U A R Y 2 0 1 3 | P o s i t i v e lyA w are . c o m

Enid Vázquez: Joshua Thorne | Young Man: iStockphoto.com/ Erik Khalitov

Tell it to Enid

In 2010, about 12,000 young people became newly infected with HIV: Nearly 60% were African American.

20% were white. 20% were Latino.

Disclosure among teens born positive

PreziSTa courtesy of Janssen Pharmaceuticals | additional images: istockphoto.com

Changes in Viramune XR tablets for kids The FDA approved changes to the Viramune (nevirapine) Extended-Release (XR) tablet label to include the 100 mg tablet and dosing information for children ages six to 18 years. Previously, only 200 mg immediate release (IR) tablets or 400 mg extended release (XR) tablets were available.

The Dosage and Administration section was updated to include the following: n Viramune XR tablets must be swallowed whole and must not be chewed, crushed, or divided. n Children should be assessed for their ability to swallow tablets before prescribing Viramune XR tablets. n Viramune XR can be taken with or without food.

No recommendations were made regarding substitution of four Viramune XR 100 mg tablets for one Viramune XR 400 mg tablet.

Dosing information in the Pediatric Patients section states that pediatric patients may be dosed using Viramune XR 400 mg or 100 mg tablets, still twice daily (adults get a once-daily dose with either IR or XR tablets). They must also follow the same special directions that adults do for taking Viramune: a lead-in dose of one 200 mg IR tablet a day for two weeks before starting their full dose (critical for preventing rash, which can be dangerous). The total daily dose should not exceed 400 mg for any patient.

Condoms in porn After Los Angeles County voters passed Measure B in November, requiring condoms to be used in locally-produced porn films, opponents announced plans to stop it in the courts. The No on Government Waste Committee issued a press release saying it expects the measure to be found unconstitutional. The committee also asked the Los Angeles County Board of Supervisors to delay implementation pending a court rulling and reported that film company representatives are talking of plans to move production away from the county.

New 800 mg Prezista The long-awaited 800 mg Prezista tablet has been approved by the FDA. Previously, people on Prezista took two 400 mg tablets once a day (with Norvir).

Prezista must still be taken with Norvir and food, but now only one pill once a day.

Kudos to Janssen Pharmaceuticals for reducing pill burden for Prezista patients.

Janssen plans to phase out the 400 mg pills. Still in the works is a co-formulated pill with a drug level booster built right in, combining Prezista with the PK (pharmacokinetic) enhancer cobicistat.

This would eliminate the need for taking Norvir. Cobicistat by itself is not yet on the market, but is part of the recently FDA approved single tablet regimen Stribild.

The new tablet will be covered by the Janssen Patient Savings Program and the Johnson & Johnson Patient Assistance Foundation.

A study published by the Pediatric HIV/ AIDS Cohort Study (PHACS) shows that, as with adults, disclosure of a positive HIV status to potential sex partners can be difficult for teenagers who were born HIVpositive. Of the 330 teens in this report, however, 18% did not know that they were HIV-positive.

Among the teens, 28% had engaged in sexual intercourse. Of these, 62% reported unprotected sex, while 33% disclosed their HIV status to their first sexual partners.

Of the 92 teens engaging in sexual intercourse, 42% had an HIV viral load greater than 5,000 copies/ml (uncontrolled infection). One of the research authors, George R. Seage III, DSc, MPH, of the Harvard School of Public Health, said that it may help youth adhere to their HIV therapy if it was explained to them “that ART [anti-retroviral therapy] can dramatically reduce the likelihood of sexual transmission of HIV.” The study concluded that, “As PHIV+ [perinatally HIV-positive, or infected at birth] youth become sexually active, many engage in behaviors that place their partners at risk for HIV infection, including infection with drug-resistant virus. Effective interventions to facilitate youth adherence, safe sex practices, and disclosure are urgently needed.”

The full-text PHACS study, “Sexual Risk Behavior Among Youth with Perinatal HIV Infection in the United States,” published in Clinical Infectious Diseases, is available at http://oxfordjournals.org/our_journals/cid/prpaper.pdf. The study also pointed to guidelines for making children and teenagers aware of their HIV infection, from the American Academy of Pediatrics; see http://pediatrics.aappublications.org/content/ 103/1/164.full.html.

J A N U A R Y+ F E B R U A R Y 2 0 1 3 | P o s i t i v e lyA w are . c o m

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B r i e f ly

African American women with HIV/HCV less likely to die from liver disease University of California San Francisco (UCSF) researchers have found that among women coinfected with HIV and hepatitis C virus (HCV), African Americans were less likely to die of liver disease. Of nearly 800 women enrolled in the Women’s Interagency HIV Study (WIHS) at UCSF, 438 deaths occurred over a period of nine years.

Of these, 37% were due to HIV/AIDS and 11% to liver-related disease. Liver-related disease was responsible for 21% of deaths among Latinas and 14% of deaths among whites, but only 8% of deaths among African Americans.

Overall, the incidence of death among the three groups was similar: 56% of African Americans and whites, and 52% of Latinas. The findings were published in the November 2012 issue of Hepatology.

Racial differences in liver disease are already known. Among these, the study noted that African Americans have lower spontaneous HCV clearance than whites, yet slower rates of liver fibrosis once chronically infected.

HIV testing urged for ages 15–65 Six years after expanded HIV testing was recommended by the Centers for Disease Control and Prevention (CDC), the U.S. Preventive Services Task Force (USPSTF) issued a draft statement “strongly recommend[ing] that clinicians screen all people aged 15 to 65 for HIV infection . Younger adolescents and older adults who are at an increased risk for HIV infection should also be screened. The Task Force also strongly recommends that clinicians screen all pregnant women for HIV, including women in labor whose HIV status is unknown.”

“The draft recommendation reflects new evidence that demonstrates the benefits of both screening for and earlier treatment of HIV,” said Task Force member Douglas K. Owens, MD, MS, in a press release.

“Because HIV infection usually does not cause symptoms in the early stages, people need to be screened

What good health care—and Ryan White funding—can do “Proper care and funding from sources like Ryan White may significantly shift health outcomes for HIV patients despite risk factors,” reports the Johns Hopkins University HIV clinic. “The results from the 15-year analysis of patients at [our] clinic serving a primarily poor, African American patient population with high rates of injection drug use demonstrate what state-of-the-art HIV care can achieve, given appropriate support.” The clinic’s report noted, however, that patients must show up for care—in other words, you can’t expect equal benefits by staying away from medical care.

“Contemporary HIV care can markedly improve the health of persons living with HIV regardless of their gender, race, risk group, or socioeconomic status,” said study author Richard D. Moore, MD, MHS, of the Baltimore-based university, in a press release. According to the release, this is the first study to directly compare outcomes for patient groups defined by these variables, “often the groups affected most by healthcare disparities.”

Michael S. Saag, MD, of the University of Alabama at Birmingham, a longtime advocate for HIV health care funding, noted in a related editorial titled “Viva No Difference!,” “The lesson learned from the remarkable outcomes within the HIV clinic at Johns Hopkins and other Ryan White-supported clinics in the U.S. is that supplemental funding for primary care is needed to overcome health disparities widely evident in our current system.”

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to learn if they are infected.” The Task Force also noted that HIV treatment has been shown to decrease the chance of transmission of HIV. “The task force’s draft recommendation, if fully adopted, is potentially game changing in helping to identify the nearly 20 percent of individuals infected with HIV in this country who do not know they are infected and connecting them with lifesaving HIV care and treatment,” said Michael Horberg, MD, MAS, chair of the HIV Medical Association, in a press statement. He added that up to a third of people with HIV in the U.S. are diagnosed too late to fully benefit from therapy and furthermore, that less than 40 percent are in regular care.

Of note, the recommendation, if adopted, would allow for insurance coverage of an HIV test. Visit www. uspreventiveservicestaskforce.org.

Treating pneumonia in the immunocompromised The Centers for Disease Control and Prevention (CDC) reports on updated recommendations for the use of pneumonia vaccination in people who are immunocompromised, including people with HIV, in its October 12, 2012 Morbidity and Mortality Weekly Report (MMWR). The report discusses the June recommendations of the Advisory Committee on Immunization Practices (ACIP). According to the report, “Streptococcus pneumonia remains a leading cause of serious illness among adults in the U.S., including bacteremia, meningitis, and pneumonia. An estimated 4,000 deaths due to pneumococcal infection occur in the U.S. each year, primarily among adults.” Go to www.cdc.gov/mmwr/preview/mmwrhtml/ mm6140a4.htm.

J A N U A R Y+ F E B R U A R Y 2 0 1 3 | P o s i t i v e lyA w are . c o m

O N L I N E P R EV I EW

Mondo’s

Mission

by Sue Saltmarsh

Photo: Andrew Walker/Getty images

He’d never planned to go on Project Runway and talk about his HIV status. Mondo Guerra had kept it secret, even from his family, for a decade. But he found himself on that runway lying about the inspiration behind his work and feeling the emptiness of betraying himself and wishing the judges (and everyone else) could know the whole story. What happened as he pointed to the plus signs in the fabric of the pants he’d designed and told the world he’d been HIV-positive for 10 years changed his life irrevocably in many ways: “During Season 8, two years ago, I disclosed my status through a challenge on the runway. I never planned on going to Project Runway and talking about my HIV status. It was influenced by this particular challenge, an emotional challenge that was inspired by childhood photographs. I really wanted to pull something from the past, the present at the time, and the future so I designed a very geometric pattern of a plus sign.

When I was on the runway presenting it, I sort of danced around the subject of what I was really inspired by. It wasn’t until one of the judges said, ‘This pattern is so perfect.’ And I thought, ‘No one really knows how perfect it is.’ I was really taking away from myself at this point, because not only have I been keeping this secret for 10 years, but now I was lying about the inspiration behind my work.

And the work is so important to me—it’s kept me alive since I was a kid. It’s always been such an influence, such an encouraging friend, really, to me and so when I was lying about my work, I felt very empty…and it came out. I told them what it really represented and that moment was a turning point in my life. It came out in about a minute and a half and it changed the course of my whole future.”

Read more about Mondo’s journey, his advocacy work and Project I Design, his latest effort to raise awareness and fight stigma: www.positivelyaware.com/2013/13_01/mondo.shtml

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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 contraceptives (birth control pills and patches).

• 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.

NEW 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 contraceptives (birth control pills and patches) - 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. © 2012 Gilead Sciences, Inc. All rights reserved. QC15172 11/12

Bre ak throughs

Take two app and call me in the mornin An ever increasing array of gadgets and widgets is changing the doctor-patient rel

by Bran LeFae

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s technology advances and becomes more common in our lives, it is transforming modern medicine. From diagnostic equipment to increasingly accessible health care records, technological advances are providing new tools for researchers, medical providers, and patients. Instead of being confined to the office visit, patients now have the option of using electronic health (eHealth) resources to address their health needs through technology. Email, smartphones, tablets, and other devices are changing the face of health care. How has this transformation changed the patient-doctor relationship and the face of HIV/AIDS patient care—and how will that impact be felt in years to come? eHealth

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ust like other people living with ongoing health care challenges, people living with HIV and AIDS can benefit from the use of eHealth resources. Computer software and mobile apps can help them keep track of symptoms, medications, and appointments. Patients can even create reports to take to their appointments or email directly to their health care providers.

Education is a key component of living well with a chronic disease, and many eHealth applications have an easily used 22

education component built into them.

When this is combined with accessing personal health records online, patients can have a much better understanding of their health and the different ways they can live successfully with HIV. An example of easy-to-use online tools comes from the largest single health care provider for HIV-positive people in the U.S., the Veterans Administration (VA).

As of 2009, the VA estimated that at least one in every 250 veterans receiving health care from the VA was HIV-positive. The VA has a number of online resources for

their HIV-positive patients. Among them is the Drug Dosing Toolkit, a website that provides information on commonly used HIV medications, dosage schedules, and potential side effects. The site also offers information on how to get tested, treatment options, understanding lab tests, alternative therapies, and other aspects of daily living with HIV. VA patients benefit from a nationally integrated electronic health record (EHR) system. Dr. Pandora Lucrezia (“Luke”) Wander, currently a postdoctoral research fellow at the University of Washington, finds this very useful. “The VA connects across the nation. This is super helpful! I was working with a patient the other day and looking at what he had told the nurse in triage. I was thinking about what could cause his symptoms. I noticed that he had records in other places. It turns out he’s HIV-positive. I could access all of his information—CD4 count, viral load—in the EHR system. That put his symptoms into a different perspective,” said Wander.

In addition, the VA offers the Blue Button program as part of its “My HealtheVet” services. Blue Button allows patients to view electronic health information and save, print, or download it. There

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ng ationship

Technological solutions for HIV/AIDS global health care

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cross the United States, eHealth has changed systems and, just like HIV, it has changed the face of health care across the globe. The South American nation of Peru provides an excellent example of technology working with a national health care system to ensure better patient support. A website offering access to 220 peer-reviewed science, technical, and medical journals, BioMedCentral.com, published an article from 2009, “Medical Informatics and Decision Making,” by Patricia J. Garcia

PHOTO: iStockphoto.com/ Erik Khalitov

are three free account types for patients which offer different levels of information and functionality. The Premium account, which requires authentication of the patient’s identity before access, allows a patient to participate in secure messaging with their health care team and access to a wide range of personal health information. Patients can get chemistry and hematology lab results and information on appointments, including reminders.

By using Blue Button, patients can have a greater level of participation in their health care management.

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et al., describing how the development of a secure data system has helped care providers track treatment efficacy across the nation. With 76,000 people living with HIV in Peru as of 2007, researchers created NETLAB to track lab results, medication use, and other health information.

The system has a registration component that tracks data from sample acquisition to test results, a reporting component where results are reported to users, and an educational component. Each sample is tracked using a barcode that moves with it throughout the process. Patient information is similarly tracked with an identification code. NETLAB is fairly sophisticated and can detect duplicate data or data that should have been included but wasn’t. It can even contact the health care provider, medical center, or lab that sent the sample

to get the correct patient information.

Before results are given to the patient, they are verified by lab personnel.

Users can access NETLAB over the Internet. All results can be accessed regardless of where the test was taken and providers can easily look at the historical data for patients in the system. Results are presented through text and simple graphs that show the results over time.

The educational component is available to anyone on the main screen, prior to entering the secure database through username and password entry. This part of NETLAB explains CD4 cells, CD4 counts, and viral loads through text and graphics. It also includes links to resource pages. NETLAB has been designed to be useful for both patients and physicians. Providers and other health care personnel can access

the latest information on HIV/AIDS clinical care, research, and primary literature through scientific journals, as well as patient data. Because of its attention to detail and commitment to responding to user feedback, NETLAB seems a good example of how technology can meet the health care needs of a specific population on both sides of the clinic desk.

Technology and health education— benefits and challenges

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he way that technology affects patients and doctors is in part an individual experience. Dr. Wander has generally found patient use of online health information helpful in her hospital practice. “There was this concern that people would read

FINDING THE Appropriate app

My Health Matters Created by Merck & Co, Inc., this is an app designed for iPhone, iPod touch, and iPad. 24

It helps people with HIV track symptoms and set reminders for medications. The app can create reports to display the symptoms a patient has experienced and email the reports to their health care providers.

The medication reminders also keep track of when medications have been taken. These reminders are customizable so the patient can enter the name of the medication they are taking. https://itunes.apple.com/ us/app/my-health-matters/ id512943758?mt=8

The NIH AIDSinfo Glossary of HIV/AIDS-Related Terms This app for iPhone, iPad and iPod Touch contains both English and Spanish definitions of more than 700 HIV/AIDSrelated terms. It is offered as part of aidsinfo.nih.gov. http://aidsinfo.nih.gov/apps

Airstrip Physicians can use this app to securely route information from monitoring systems in the hospital, various bedside devices, and EHRs to the provider’s mobile device.

Compatible with many smartphones and tablets. www.airstriptech.com/ Portals/_default/Skins/ AirstripSkin/Home.aspx Mobile MIM This mobile app provides access to diagnostic imaging for clinicians. It’s available for iPad, iPhone, and iPod touch, and can access images such as x-rays and ultrasounds.

The app allows physicians to have images on hand for consultations with patients and colleagues while on the go. Mobile MIM also offers cross-platform, secure, cloudbased image data storage.

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All personal health information is encrypted for transfer and storage and the system is compliant with the Health Information Portability and Accountability Act (HIPAA).

Cloud-based storage is essentially like storing files on the Internet, instead of on your computer’s hard drive, so it can reach across institutions and physical limitations. Mobile MIM can also be used to collect images or data for clinical trials. People without Mobile MIM can view data using desktop software downloaded from MIMSoftware.com. www.mimsoftware.com/ products/mobile

Fooducate This consumer-focused set of apps helps users navigate nutritional health. These apps aim to act as a personal grocery advisor, so people can

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HealthyWithHIV.com HealthyWithHIV.com offers My Positive Agenda, downloadable software for both PC and Mac, with mobile apps for iPhone and Android. The software allows HIV-positive people to track their health, symptoms, CD4 counts, current viral load, and medications. Information can be printed and shared with medical providers. It also has medication reminders. The software offers an educational component to help patients learn more about HIV therapy, the virus, other resources, and other conditions that might affect people with HIV. www.healthywithhiv.com/ healthy-with-hiv/healthywithhiv/hiv_healthy/index.jsp

things online and misconstrue them,” she said. “That’s not been my experience.

People don’t necessarily believe what’s on the Internet. They come with more thoughtful and educated questions,” she explained. “In general when people are more informed about their health, they can participate more in their care.”

Technology can help patients take a step to become more empowered in their health care. With the increasing use of smartphones, many patients have instant Internet access at almost all times. While apps, gadgets, and websites are appealing to tech-savvy folks, the balance of benefit versus cost remains uncertain. Online information is only useful if it’s understandable. Dr. Perry Halkitis, Professor of Applied Psychology, Public Health, and Medicine at NYU Steinhardt, sees health

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make healthy food choices when shopping. The basic app is free for iPhone and Android, with paid versions available for people who have certain food allergies or diabetes and need more in-depth information.

They also offer a daily educational tip. The group behind the technology is composed of parents, dietitians, and technology specialists. The app allows you to scan a product barcode, see the good and bad highlights for the product, compare it with other products, and also learn more about food and nutrition. It also works on iPod touch and iPad. www.fooducate.com

iTriage Health Founded by two emergency medicine physicians whose vision is to “help the world make better health care decisions,” with a focus on helping

literacy as a central challenge. “Is technology really solving the problem or only providing the information in a different way?”

Halkitis wondered. “Is it being tailored to be meaningful to people?”

The more a patient understands about their own health care, the better chance they have of being healthy. While physicians provide key support in the health care needs of their patients, many of those needs must be met outside of the clinic within the context of the patient’s daily life.

Many patients rely on the support of family members, partners, friends, coworkers, and other community members. Their lives are played out at their homes, in their workplace or school, in their churches, or at communal gathering places. The physician is only one piece of this puzzle. As eHealth resources become more available, patients

the patient move from symptom to provider. Their apps for Android and iPhone are oriented to answer the questions “What could be wrong?” and “Where should I go for treatment?” When hospital emergency rooms participate in the ER Check-in feature, patients can use their smartphones to let the emergency department know that they are on their way to the hospital. This can save valuable time and allow the hospital staff to prepare for their medical needs even before they arrive on site. www.itriagehealth.com

WebMD One of the most popular resources online is WebMD. The site is well known for providing credible medical news and reference material and is reviewed by an independent Medical Review Board for

can participate more in their own health care on a deeper level.

If patients have the resources, they can become well educated about their illness or possible treatments through the Internet.

They can research options and learn about viable health care choices even before they see their doctor. Patients can now send their doctors and care providers questions via email. They can use software and smartphone applications to set up medication and appointment reminders for themselves and record important symptom and health information for their providers. It’s important to remember, however, that these options only exist for people who have the resources to use them. On top of that, the challenge of reaching across literacy barriers must be met. No matter how accessible the technology, if the information isn’t

accuracy. WebMD offers a number of mHealth options.

WebMD Pain Coach for iPhone is helpful for people living with chronic pain, offering tips, articles, and symptom/treatment trackers, among other features. iPad users can get WebMD the Magazine on their iPad for free.

The basic WebMD app has a symptom checker, drug and treatment information section, basic first aid information, and allows the user to check local health listings. Available for iPhone, iPad, and Android.

Medscape, a medical resource often used by students, nurses, and health care professionals for clinical information, is available for iPhone, Android, Blackberry, iPad, and the Kindle Fire. TheHeart.org is available as an app for the latest information and developments in cardiology and cardiovascular research.

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www.webmd.com and www. webmd.com/mobile

DocbookMD DocbookMD is a physicianoriented mHealth communication platform that is HIPAA-compliant and available for both smartphones and tablets. It has a secure network that allows providers to share confidential patient information with their colleagues for collaboration and analysis. It has been developed by physicians and is growing in size, although still small and only available in 28 states. One way data is secured is by keeping patient details and images on DocbookMD servers and not on the mobile devices. Its encryption exceeds current HIPAA requirements, and devices can be remotely disabled if lost or stolen. www.docbookmd.com 25

Bre ak throughs

Increasing health literacy is critical in reaching across the power divide between patient and physician.

Without a basic understanding of the issues at hand, it’s impossible for patients to be truly empowered. provided in a way that’s truly useful to the patient, it means little, whether on paper or online.

Though physicians and other health care providers are accustomed to working with highly technical systems, patients have a wide range of technical skills. Dr. Halkitis has worked in research for almost two decades, and interacts with both younger and older HIV-positive individuals.

“There is a huge difference in technical skill by age,” Halkitis explained. “It’s not that older positive men aren’t using technology—they are—but there isn’t the same ease around it that the younger guys have. For them, it’s like an extension of their hand.”

While technology has the potential to offer great advantages to the population of gay and bisexual men that he studies, Halkitis finds that health literacy is a real issue in his work. “Many of the men in the younger cohort don’t understand the limitations of the antibody test we use for HIV. We would like to develop a software application that would show these men the window of time between infection and when HIV can be detected,” said Halkitis.

His emphasis on increasing health literacy is critical in reaching across the power differential that exists between patient and physician. Without a basic understanding of the issues at hand, it’s impossible for patients to be truly empowered in their health care choices.

Instant access, constant communication

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ome changes in health care seem to carry obvious benefits, at least on the surface. For example, EHRs provide instant access to patient information that is available 24 hours a day, seven days a week.

Physicians can more easily gain access to a comprehensive medical history for a patient than ever before—sometimes even if they’ve never seen that patient in that

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clinic. But even this benefit holds challenges. Dr. Keith Henry, Professor of Medicine at the University of Minnesota, says that the amount of time he spends in the medical records system actually reduces his face-to-face time with patients. “My patient interactions are depersonalized because I have to pay attention to the computer,” Henry explained. “People already complain that they don’t get enough time with their doctors.” As director of HIV research at Hennepin County Medical Center in Minneapolis, Dr. Henry has been involved in caring for HIV patients since the early 1980s. He has seen the impact of technological changes in the health care industry firsthand and speaks from experience about both the benefits and the costs of electronic systems.

Another benefit of technological advances in health care comes from the ability to communicate across distances with greater ease. Most patients no longer rely on a single physician system, often seeing multiple providers at different clinics. To provide integrated health care, these providers need to stay in touch, which eHealth makes more possible than ever before. Providers can use secure data transfer software to ask for a review of patient information by a colleague.

They can touch base by email or receive a health summary before a patient’s appointment. Keeping these lines of communication open and accessible provides great benefits for patients, because their providers can stay up to date with their treatment progress, even outside of their own practice. Time is finite, however, and constant connection brings its own issues.

In Dr. Henry’s practice, he’s finding that he spends more and more time using electronic communication, and less time talking with colleagues as well as patients.

“You’re always basically connected,” he explained. “It’s very hard to get away for a break or free time.”

The changes brought by technology are permanent; there won’t be any backwards movement without a serious change in circumstances. The transition from paper to electronic records isn’t temporary. EHRs are here to stay. The Federal government has mandated that EHRs must be available for “meaningful use” by 2014. Patients should receive better care since EHRs can be accessed by multiple clinics and providers within any given system. Patients can also become more informed by having access to their medical records online.

Unfortunately, there’s no mandate that requires communication across different systems, and this can reduce how effective they are for a health care provider.

In Minneapolis and St. Paul, there’s been a movement to integrate the medical systems across most of the hospitals there.

“When patients come see me, I can more often than not get into their records elsewhere. I can see their labs or x-rays and see what needs to be done,” said Henry.

But even the benefit of quick online communication can eat up time that could be spent with patients instead. It comes down to finding the balance between face time and time online for physicians in the clinic and at home after hours. This balance is challenged by many of the rules and regulations in the health care industry.

always room to grow

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he patient-doctor relationship is continuously evolving. How does technology affect the pace of that evolution? The relationship will be enhanced, hindered, or unaffected, depending on region, resources, and the way that technology is being used.

Different people face different challenges and only through strategic application can technology be useful for any individual.

With mindful development and careful research, technical advances can be powerful resources that have the potential to take us further into useful health care for both patient and provider.

Bran LeFae has worked as a techni-

cian in cancer and HIV research, and in research administration. She is co-owner of Bramblethorn Studios.

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Model BEHAVIOR Photo: iSTOCKPHOTO.COM/alengo

Creating virtual worlds to solve real world problems

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By Rick Guasco

he fight against HIV is now being waged in virtual worlds that exist only inside a computer. Making use of statistics and other data, these simulations recreate real world conditions to help us better understand drug resistance, predict the outcome of prevention and treatment efforts, and determine the best use of resources. They can’t predict the future, but computer models are helping us to answer the question, What if?

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Mixing a better cocktail or a person on HIV medication, strictly following their drug regimen is critical to treatment success. Research has shown that the relationship between adherence and the resistance the virus can develop is different for each medication in a patient’s regimen. A new computer model

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These sims, however, act like real people— they have sex, sometimes engage in risky behaviors, and sometimes contract or transmit HIV. developed by Harvard grad students in collaboration with a similar team at Johns Hopkins School of Medicine is the first to predict drug resistance that takes adherence into account.

“The mathematical model we built looks at the growth rate of the virus in a person who’s being treated,” said Daniel Scholes Rosenbloom, one of the students who developed the model. “To know whether viral load will grow or decay, you need to know both how strong each drug in the regimen is and how often the patient is taking or skipping their pills.”

The Harvard simulation builds on years of accumulated data and mathematical models explaining how viral load changes over time and at different phases of infection. Rosenbloom and his colleague, Alison Hill, a student of biophysics at Harvard, made use of another research team’s work.

At the Johns Hopkins School of Medicine, Robert F. Siliciano, MD, PhD, worked with graduate student Alireza Rabi to study how HIV reacts to varying doses of medications.

Using data from Johns Hopkins, the Harvard team created a simulation that predicts whether the virus was growing or if different strains were emerging, based upon a patient’s adherence level. If drug levels are very low, the virus is able to grow even without being resistant to medication, and so drug resistance does not emerge.

If drug levels are very high (as they are in a patient taking 100% of their pills), then even a drug-resistant virus may not be able to grow. However, there is a “danger zone” of intermediate drug levels where drug resistance emerges. The new model computes the size of this danger zone, which is different for each drug. (Rosenbloom noted that boosted protease inhibitors 28

tend to have a very small danger zone.)

The Harvard students fed the data and their equations that simulated more than 1 million patients—about 50,000 for each of 23 HIV medications—into the school’s computer cluster. These virtual patients varied in adherence and viral load over the course of 48 simulated weeks. “We tried to simulate a diverse cohort [that] might participate in a real-world clinical trial,” said Rosenbloom. It took the computers up to two days each time the simulation was run.

Rosenbloom notes that the model focuses on monotherapy and that only some simple drug combinations were simulated. However, it proves that resistance can be predicted. While the current model only examines concentrations of drug in blood plasma, Rosenbloom says future models will look at drug concentrations in other parts of the body, as well as simulating combination therapies. The hope is that their computer model will lead to better, cheaper, and more effective HIV medications.

Led by Martin A. Nowak, PhD, professor of mathematics and biology and the director of Harvard University’s Program for Evolutionary Dynamics, the Harvard model is discussed in a paper appearing in the September 2, 2012 issue of Nature Medicine.

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Sim City, New York ublic health officials and policymakers need to identify the best strategies for combating the spread of HIV, especially in a world of limited resources.

However, determining the effectiveness of these strategies, either separately or in combination with others, can take years.

Brandon Marshall, PhD, assistant professor

of epidemiology at Brown University, presented a computer model at the AIDS 2012 conference last summer that accurately recreates the spread of HIV in New York and can make predictions into the year 2040 based on a given scenario.

New York City data about drug use, sexual orientation, access to treatment, treatment effectiveness, probabilities regarding risk behaviors, and information about other behavioral, social, and medical factors were used to create the model. The simulation was run and constantly adjusted until it could match actual infection rates that were known to have occurred in New York between 1992 and 2002 among injection drug users.

“With this model you can really look at the micro-connections between people,” Marshall said in a Brown press release about his work. “It reflects what’s seen in the real world.”

Marshall’s model of New York is a virtual reality of 150,000 “agents”—simulated individuals derived from statistical data.

These sims, however, act like real people— they have sex, sometimes engage in risky behaviors, and sometimes contract or transmit HIV. Six scenarios, each featuring a different HIV prevention policy, was tested by the model: expanding needle exchange programs, expanding substance abuse treatment programs, expanding HIV testing, starting people on HIV treatment earlier, a combination of these strategies, and not changing the current policies.

Simulating one year’s time with the six scenarios and the 150,000 agents took Brown University’s massive computer array 72 hours to run. To ensure accurate results, each scenario was run several times, providing predictions through 2040.

The single most effective strategy was to start HIV treatment earlier, which lowered the rate of new infections by 45%.

Increasing the number of people who get tested for HIV by 50% would reduce new infections among injection drug users only

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Role model: Representation of HIV, made of HIV medications. A version of the image was used to illustrate the cover of Nature Medicine which featured a paper by Daniel Rosenbloom and his colleagues on their model for predicting drug resistance.

by about 12% through 2040, according to the model.

Combining all four strategies would cut infections by 62%.

Marshall was disappointed that the strategies, as shown by the model, would not lead to a greater drop in the infection rate.

“I actually expected something larger,” he said. “That speaks to how hard we have to work to make sure that drug users can access and benefit from proven interventions to reduce the spread of HIV.” Marshall plans to expand work on his model. “What we are moving towards now is actually implementing costing data into the model so we can examine the cost-effectiveness of various scenarios,” Marshall told Rhode Island Public Radio.

“That’s the next step that I think will be of most interest to policy makers.”

The National Institutes of Health (NIH) and the Lifespan/Tufts/Brown Center for AIDS Research are providing financial support for the model’s continued development.

I ILLUSTRATION: KAREN VANDERBILT

This means war f the fight against HIV is a war, then the computer models being developed are the war games of this fight. And Ravi Goyal is a living metaphor. Fresh out of the University of Pennsylvania, Goyal was recruited in 2002 by the National Security Agency (NSA) for its rapidly expanding counter-terrorism unit. As an applied research mathematician, Goyal used his exceptional math and computer skills to analyze the flow of information within and between terrorist networks.

Assigned to find new ways of utilizing information, he was sent to Baghdad.

“It was important to see not just data, but how it was collected,” Goyal said. “That really impacts how you adjust for uncertainties and biases that

come with various kinds of data collections.”

When Goyal’s wife, a nurse, suggested he could apply his skills to public health, he left the NSA and enrolled at the Harvard School of Public Health.

Today, Goyal models how HIV grows within an individual and spreads across communities.

Goyal is currently working on the epidemic in Botswana. According to the World Health Organization (WHO), one of four people there is HIV-positive. An ambitious, four-year project aims to assess the impact and cost effectiveness of a unique combination of prevention strategies in this southern African country.

Max Essex, principal investigator, professor of health sciences, and chair of Harvard’s School of Public Health AIDS Initiative, and co-principal investigator

Victor De Gruttola, professor of biostatistics and chair of the school’s Department of Biostatistics, believe their computer model can help cut Botswana’s infection rate by at least half. Essex thinks this can be done by focusing on people with a high viral load.

“This is the subset of people most likely to transmit the virus,” Essex said in a Harvard press release.

The Centers for Disease Control and Prevention (CDC) is funding the Botswana Combined Prevention Project (BCPP) with a $20 million grant. The BCPP is a collaboration between the CDC and the Botswana Harvard AIDS Institute, a joint research and training initiative begun in 1996 by Harvard’s AIDS Initiative and the Botswana Ministry of Health.

Researchers will conduct a randomized study, monitoring 20% of the population of the village of Mochudi and 16 nearby rural

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communities on a yearly basis. In addition to treating patients who have a high viral load, the BCPP will provide antiretroviral therapy to more than 90% of HIV-positive adults and 95% of HIV-positive women who are pregnant. Testing and counseling for adults and voluntary circumcision for men who are HIV-negative will also be offered.

In another key aspect of the BCPP, viral genetic sequencing of new infections is being conducted.

“Fingerprinting” the virus of each new patient will help indicate whether infections originated from within a community.

Evaluating these strategies will be a computer model developed in part by Goyal, who is now a research associate at Harvard’s Department of Biostatistics. Goyal and his team will simulate how HIV spreads within a village. To do so requires an enormous amount of data from a variety of sources. Demographic and medical data on the tens of thousands of study participants have been combined with information provided by those who answered a 17-page questionnaire.

“Getting data on sexual histories can be very challenging as people are reluctant to divulge such personal details,” Goyal noted.

The BCPP model allows researchers to organize and interpret this data. The biostatistics team, led by De Gruttola, will use algorithms and mathematical techniques to simulate how the virus evolves inside an individual while simultaneously building a model of how HIV moves from one person to the next in a growing network of sexual contacts.

“Geography has an interesting role in treatment as prevention,” Goyal said, noting how personal relationships add an unknown variable to the model. “People 30

have relationships outside of their community. Think of the ‘agent’-based model.

Everyone in a community is modeled.

Individuals are represented as dots, or nodes, on a network and relationships are lines, or edges, connecting two individuals. Relationships last a certain amount of time, then disappear from the network.”

Computer modeling will allow researchers to follow participants and explore options that would have been too expensive in the real world.

“It wouldn’t be practical or ethical to run a whole bunch of experiments over and over again on a group of people,” Goyal said, “but a model allows us to test different kinds of interventions and

how they would work under various conditions.”

Once completed, the BCPP model will be adaptable for use in other countries, even where the nature of the HIV epidemic is different. However, Goyal cautions that computer modeling is not a one-size-fitsall solution to the many aspects of HIV. “Computer modeling can help guide decisions and give an idea what the best types of interventions are,” he said, “but there are limitations. It can’t give you the correct answer all the time. It can only tell you what the realistic goals are or what the important things are that we should focus on.”

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Image: The Harvard School of Public Health

Social Network: This visualization of a computer model depicts individuals (yellow circles) and their sexual relationship (red line) to another person.

Hooking Up

to Social Media How apps and social media are changing life with HIV

Photo: iStockphoto.com/ Visiofutura

By David Duran

T

he emerging role of technology is evident in the mobile phones most of us use on a daily basis. It’s practically impossible not to do everything via your device at this point. Mobile applications (apps) have dominated every corner of the market and in some cases are revolutionizing the ways users get pertinent information, as well as changing the way gay men date as we know it. Apps are making it easier for men to pre-screen their potential partners as well as set up quick, casual encounters. Social media has also become a strong presence in advocacy and is being utilized left and right to promote, educate, and recruit.

‘There’s an app for that’

P

ozTracker is a secure health management tool for people living with HIV/AIDS. The website states that it is designed to help users track their medication, record test results, and monitor progress.

HIV and Your Heart is an app that encourages HIV-positive people to make changes in their life to achieve better heart health. Produced in conjunction with the American Heart Assoication, the app’s companion website notes that

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Bre ak throughs

cardiovascular disease is now one of the top causes of death for people who are HIV-positive. The app includes both heart health and HIV wellness goals, and suggests ways to reach each goal. iStayHealthy lets users store lab results, HIV medications, and supplementary medications, as well as review CD4 and viral load results in simple charts. The app also provides a glossary of HIV terms and has a user-friendly interface to send results and charts via email.

For those who want concise and easy to understand definitions, AIDSinfo HIV/ AIDS Glossary provides more than 700 HIV-related terms in English and Spanish. It also includes an audio feature to hear the pronunciation of terms in both languages.

Although not specifically designed for people with HIV, Dosecast is an app for people who take multiple doses of medications on a daily basis. Users enter basic information about each drug they take, including dosage, and can set up reminders on a daily, weekly, or monthly schedule. The app also tracks remaining quantities and can send refill reminders and log drug adherence.

Social media

S

ocial media have also taken a greater role in HIV awareness and prevention.

AIDS service organizations (ASOs), governmental agencies, and even pharmaceutical companies now actively post on sites such as

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Facebook, Twitter, Tumblr and Instagram.

These online communities and public discussion boards provide an outlet for people living with HIV to connect with others in similar situations. Posts encourage an open dialogue between users and give them the confidence to re-post certain articles, threads, or images to their personal pages or Twitter feeds, which leads to HIVnegative individuals learning more about HIV stigma and most importantly, prevention. Online social communities are formed and bonds are made. Twitter is inundated with individuals telling their daily life struggles and successes living with the disease.

For some, it helps to vent what they have to deal with and for others, topics of dating or sex are prevalent on their feeds. These individual life stories are encouraging and inspiring to others. The use of hashtags such as #HIV or #AIDS helps users quickly search for relevant posts.

Stigma

A

number of organizations have taken to social media to promote their campaigns.

Many are focused on the effort to end stigma against HIV and those affected by it.

Greater Than AIDS promotes images of individuals telling their story. The U.S. Centers for Disease Control (CDC) has a similar campaign, Act Against AIDS. Even regional organizations such as the San Francisco AIDS Foundation are currently developing campaigns around personal stories.

“Our message has to compete against the professional marketing and advertising campaigns to get that 15 seconds of the public’s attention.�

Positively Aware’s photographic anti-

stigma campaign began in 2010 as A Day with HIV in America. In 2012, it expanded to include submissions from as far away as Brazil, Cyprus, and New Zealand and is now known as A Day with HIV. Promoted through social media, photo submissions are displayed in an online photo gallery.

‘HIV Neutral’

Dating and HIV

M

obile geo-location gay dating apps are popular among men looking for sex and/or a relationship.

There are a handful of options. At first glance, many of these “hookup” apps don’t

about HIV testing, disclosure, and having these become standards in the gay community. “Being responsible means talking about your status—positive or negative,” Howell said.

Hornet is currently the only app that offers HIV status on their mobile app.

However, users can leave their HIV status blank, not disclosing whether they are positive or negative. The app also reminds users to get tested every six months. For those who claim they are “negative,” there is the option to enter the date of their most recent test.

Asked why they allowed users to opt out of answering, Howell explained, “Hornet isn’t just for people who are sexually active, so they might not have been tested lately or feel they need to be.

Approximately six months after their last stated test date, if indicated, we prompt them to pick an option, and insert their new test dates, but the categories might not be so black and white. We don’t want to force someone to put that they’re ‘unsure’ about their status just because our belief is that sexually active users should test every six months.”

In Howell’s view, there are no current campaigns that are successfully reaching youth and males aged 35–55 among the groups most at risk. “Old print media is dead, and this is why Hornet works well,” Howell said. “Users are on the app, making friends and talking about these issues.”

MISTER

M

ISTER is leading the way in getting members to think about health, HIV, and dating. CEO Carl Sandler is outspoken on issues related to HIV and dating. A contributing writer for the Huffington Post, Sandler also discusses

Photo:

Photo: iStockPhoto.com/KBF Media

T

he Stigma Project seeks to create an “HIV Neutral” world—free of judgment, fear, discrimination, and alienation— by educating both positive and negative individuals about the “constantly evolving state of the epidemic” in order to end the distinction between positive or negative.

With the rise of HIV infections among young people, the Stigma Project is reaching out to them through the channels of communication that they use.

“Our message has to compete against the professional marketing and advertising campaigns of the public and private sector, and in order to get that 15 seconds of the public’s attention, we use targeted ads, thought-provoking and trend-setting memes with branded, appealing graphics that stand out in social media,” said Chris Richey, founder and president of The Stigma Project.

seem concerned with the disclosure of HIV status. But after further research, it turns out that many companies actually have their own strategic and logical plans regarding HIV disclosure and how they incorporate them into their apps and websites.

Hornet has spent time developing its Know Your Status (KYS) campaign and the language surrounding it. The smartphone app’s emphasis on users’ selfdisclosure is an essential feature—it’s one of the first options when registering a new account.

“For many of the members, our research showed they wanted the ability to let people know before they even started conversations that they are poz; that way, it is already on the table and they can feel safe talking about it and move on to additional meaningful conversations,” said Sean Howell, Hornet co-founder and chief marketing officer.

The app allows use of the abbreviation “KYS” as a discreet signal that doesn’t reinforce stigmatizing attitudes. According to Howell, fear of stigma is a major reason why people don’t get tested. This lack of testing by people who think they are negative but in fact are positive is perpetuating the spread of the virus.

“It’s easy to think that we are past the HIV epidemic, but we are not,” said Howell. “Numbers are on the rise.”

Howell and his team at Hornet are looking to the community to help build a culture of doing good—having health advocates who are HIV-positive and others making it normal to talk

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Bre ak throughs

“When it comes to safer sex, we believe that all members, regardless of status, need to adapt risk reduction strategies that protect themselves and their partners.”

HIV in his role as the relationship and dating expert on Sirius XM Radio. Some of his articles, such as “Fear and Dating in the Age of HIV” and “I’d Like to Sleep with You and I’m HIV+,” are sent to hundreds of thousands of MISTER members, who are encouraged to comment and discuss the challenges of dating apps and HIV status.

Sandler’s article on the meningitis outbreak in New York City was a call to action for HIV-positive members to protect themselves through vaccination. “MISTER is active in helping users to understand the options available to them for protection, and MISTER is leading the way in the use of Truvada for pre-exposure prophylaxis [PrEP],” said Sandler. (See “A Pill to Prevent HIV,” on next page.)

Through its app and website, MISTER encourages users to talk honestly about HIV and their status (see the Online Extra “Surface vs. Substance” at positivelyaware.com). “We have created an environment where honesty and tolerance are valued and encouraged,” said Sandler. The app actively discourages any type of language that might discourage users to reveal their HIV status—such as negative users describing themselves as “clean.” “MISTER members are adults who understand that dating in the age of HIV requires maturity, conversation, and compassion,” he added.

“We don’t see people as HIV-positive or negative, but as one community,” Sandler said. “When it comes to safer sex, we believe that all members, regardless of status, need to adapt risk reduction strategies that protect themselves and their partners.

This ranges from seroadaptive practices negotiated safely, suppressive HIV therapy, PrEP, condoms, HPV/HBV vaccinations and herpes suppression.” According to Sandler, an upcoming version of the app will address disclosure in a new way.

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Grindr

O

ne of the first geolocation dating apps, Grindr is still one of the most popular. Currently, users do not have an option to indicate HIV status, but the company has plans for a new “community.”

“When we launch the new Grindr, users will be able to identify with an HIV-positive community called ‘Poz’,” said Joel Simkhai, founder and CEO. “We’ve decided to do this instead of providing an HIV status field in their profile, since [a status field]… might lead to some people unknowingly stating that they’re negative in a world where nearly half of HIV-positive gay men don’t even know that they’re HIV-positive.”

The Poz community is just one of many communities expected to appear on the app’s new version set for release in early 2013.

Volttage

V

olttage.com is a social networking and dating website exclusively for HIVpositive gay men. Launched in October 2012, the site offers free profiles and has been quickly gaining members.

Co-creator, AIDS activist, and Project Runway star Jack Mackenroth states, “Sex sells, but we are much more than a hookup site.”

The site plans to combat stigma by creating a database of information, support, and resources for users. “We provide an alternative for HIV-positive men who often feel stigmatized and discriminated against on the other sites,” Mackenroth said. No longer do poz guys have to worry about disclosure—it’s not a topic that needs to be discussed on Volttage as all users are presumed to be HIV-positive. “As the site develops and grows, we will incorporate

features such as forums and blogs that will strengthen a sense of community and acceptance,” said Mackenroth. “Volttage will be amazing for creating a very specialized target audience, one we expect to number over 50,000 within its first year.”

The three-man operation has also partnered with Frank Spinelli, MD, FACP, a licensed and board-certified internist working at Chelsea Village Medical in Manhattan. Dr. Spinelli is the author of The Advocate Guide to Gay Men’s Health and Wellness and is an associate clinical professor of medicine at New York Medical College. In addition, Volttage is currently talking with other organizations and professionals about adding content to their site. They are constantly updating the site and adding new features and expect to have a multitude of guest bloggers by early 2013.

How far can we go?

A

s with all aspects of modern life, the world of technology is ever-evolving and seems limitless in the ways it can affect our lives. For those living with HIV and any other chronic illness, access to the Internet, mobile apps, and social media is not only vital but can provide benefits in a much broader way than the resources of our past. Of course, for many HIV-positive people the issue of access—whether to health care, treatment, computer time, or a smartphone—can be a deciding factor in how, or if, technology can affect their lives.

As technology continues to dominate and make its way into our daily routine, doctors, patients, caretakers, and anyone affected by HIV will be forced to adapt and embrace the awesomeness of what the future in HIV care and prevention has to offer.

David Duran is an LGBT-focused free-

lance journalist who frequently contributes to publications such as Out, The Advocate, The Bay Area Reporter, and the Huffington Post.

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A pill to prevent HIV A conversation gay men need to have

Photo: iStockPhoto.com/Alashi

By Carl Sandler

Last week a friend posted on Facebook: “It’s been an interesting life. HIV+ (positive). 10/9/2012.” He is 24.

Later, I asked my young friend if he had heard of Truvada, the drug recently approved by the FDA for use as preexposure prophylaxis, or PrEP, against HIV. A pill to prevent HIV transmission. Like most people I know, he hadn’t ever heard about PrEP and didn’t understand it was an option available to him.

Sadly, I’m not surprised. The information that has come out about PrEP over

the past year has been so vague or confusing that millions of gay men at risk for getting HIV may not understand it. The fact is, a daily dose of Truvada can statistically protect against contracting HIV. If taken properly and consistently over a period of time prior to an exposure, an HIV-negative person is protected in roughly equivalent rates of protection provided by a condom, or over 90%.

Researchers have estimated that for gay men, taking Truvada daily (seven pills per week) may be 99% effective; four pills a week might be as good as consistent condom use (96%).

So why isn’t there a more expansive conversation happening in the gay community about this drug? Where are the front-page headlines? I spoke to some of my own friends about PrEP and quickly realized that many people, both HIV-positive and HIV-negative, have a knee-jerk negative reaction to PrEP—a

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I asked my own doctor’s assistant about PrEP and he admitted he didn’t know much about it— and I live in New York City, arguably a health and medical treatment capital of the world. combination of healthy skepticism, fear, misinformation, and confusion.

I’m writing this article because I don’t want to read any more Facebook postings like that of my young friend. I want people of all ages to have the information they need to decide for themselves about the risks and benefits of Truvada and PrEP.

The condom conundrum Despite decades of safer sex

messages, over 50,000 Americans are still newly infected with HIV every year. Gay men, who represent less than 2% of the U.S. population, account for over 60% of new infections.

With statistics like these, you might think that public health departments and HIV organizations would be doing much more to educate the public about this powerful, new tool in the fight against HIV. I asked my own doctor’s assistant about PrEP and he admitted he didn’t know much about it—and I live in New York City, arguably a health and medical treatment capital of the world.

I can’t help but wonder if the reluctance to promote PrEP may be that there are real limits to what PrEP can and cannot do. PrEP is not a vaccine that can give you 100% protection. It is not Viagra that can be taken 15 minutes before intercourse. It is not a cure for HIV. And it cannot protect you against hep B or C, herpes, syphilis, Chlamydia, or gonorrhea.

And still, for many of us, PrEP could be a game-changer.

For as long as I can remember, the only real protection we have had against HIV, other than abstinence, has been condoms.

But as protective as they are, condoms are also imperfect. They break. They are used incorrectly. They are at every bar when you don’t need them, and nowhere to be found when you do.

36

I also don’t know a lot of people who are able to use condoms “100%” of the time. Do you? Like anything we try to do 100% of the time, it’s actually human to be less than 100% successful. That being said, I am constantly amazed at how many presumably negative people I encounter who seem to think nothing of having sex without a condom. Something else is going on—namely that people are inherently unable to adhere to the “wear a condom every time” warnings. How many times did you slip in the past year? Once? Twice?

Too many to count?

It’s high time for a different approach.

A new approach to prevention

people at some points in their lives when condoms are either impractical, unavailable, or insufficient protection.

For those of us who live in relatively affluent, urban centers, it’s sometimes easy to forget that safer-sex strategies and condoms are not “one size fits all.” There are many, many people at risk for HIV who don’t have the voice and power to always demand a condom during sex. There are people in serodiscordant relationships who could benefit from the practical and emotional protection of PrEP. Some people have fears around HIV that prevent them from loving. People with unfaithful and dishonest husbands and partners could be protected.

People who “party” and take bigger risks, people who, for one reason or for many reasons, cannot “simply” use a condom 100% of the time. If you are one of those people, and you are lucky enough to have access to PrEP, you might decide that PrEP is a ray of light in an otherwise very dark place.

PrEP has the potential to

PrEP vs. condoms

dimensionalize our approach to HIV prevention, principally because taking a drug daily, as a woman might take birth control, more accurately addresses sex in the real world. The same world where people slip up and condoms break.

In reproductive health for heterosexuals, men and women have many options to protect against unwanted pregnancy, from condoms and birth control to the morningafter pill. PrEP as pre-exposure prophylaxis and PEP as post-exposure prophylaxis are both powerful, valuable tools that give gay men, and anyone worried about contracting HIV, additional avenues of protection. Perhaps most important is that like oral contraception for women, but unlike condoms for protection against pregnancy or HIV, PrEP is not taken at the same complicated moment when sexual intimacy occurs; it can be taken at routine daily times before and after those less predictable moments. That is what most makes PrEP a unique addition to condoms in our struggle against HIV: It is neither better nor worse as much as it is a different strategy, one that may protect some

A new ad campaign from prep-

facts.org eloquently proclaims: Love has another form of protection. We’d like to think this means, universally, that people will use PrEP in conjunction with condoms to provide a second level of protection.

That would make the most sense from a public health perspective, but PrEP presents us with a fundamental challenge to our way of thinking about protection and safer sex, namely that some people may use PrEP as a substitute for condoms although it does not provide all the same protections.

I spoke with Jeff McConnell of the Gladstone Institutes—he is a sociologist on the trial that showed Truvada effective against HIV infection in gay men. Mr. McConnell pointed out that a person who is taking Truvada consistently as recommended (daily) and having sex without a condom can no longer be considered to be having unprotected sex, at least for HIV. It’s taken several weeks for me to wrap my head, and heart, around the idea espoused by sites like prepfacts.org and Mr. McConnell that taking PrEP daily and

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not using condoms could be considered, for some people, safer sex. This goes against everything I’ve been taught about HIV. Could it be that the language of safer sex, and perhaps sex as we know it, is fundamentally changing with PrEP? The fear among many of us in the gay community and in public health is that people on PrEP will start taking more risks, risks they would not have taken otherwise.

I understand these fears. And share them.

But so far there aren’t data to support this fear. It could also be that the protection offered by this drug, when used properly, might actually offset any “riskier behavior.”

Only time will tell. As mentioned earlier, condoms offer protection against a wider variety of sexually transmitted infections than just HIV, and have plenty of other advantages as well.

Caveat emptor (Let the buyer beware) I have never known a world

without HIV. I came to sexual maturity in the late ’80s, at a time when HIV, sex, and gay identity were smashed into one. For me, the concept of sexual freedom without the fear and shame associated with HIV is both liberating—and scary.

The epidemic has traumatized us through loss of our loved ones and in our shame around the disease. It has traumatized us in our prejudices against our HIVpositive brothers and sisters. And I wonder if the trauma of HIV, fears for our own safety and the safety of our community, and our own shame are holding us back from being able to objectively consider this new prevention method.

PrEP has the potential to liberate us because it gives gay men who have managed to stay negative an opportunity to sever the cord between sex and HIV, perhaps for the first time. To understand the scars that HIV has made, consider that HIV fear is present among many of us even when we are 100% safe, regardless of status. If PrEP can help positive and negative people feel safer and protected, then PrEP will have made a profound contribution to our emotional and physical well-being.

As anyone who has lived through the AIDS epidemic knows—when it comes to HIV there have been few “home runs.”

Only a series of singles, doubles, and more than our fair share of foul balls. Truvada is not the one ring to rule them all. And yet it might still be a game-changer for some of us—if we understand that PrEP is not a replacement for common sense.

Side effects Truvada has been around for

over a decade, used along with other drugs by HIV-positive people to reduce their virus to undetectable levels. When used alone and not as part of a cocktail by HIV-negative men to prevent HIV transmission, side effects are rare and often go away in weeks. Most common side effects are an upset stomach or nausea. In rare cases, there are significant kidney issues, but these side effects are reversible for people who simply stop taking the drug.

Resistance Drug resistance to antiretrovi-

rals like Truvada is an important issue. In fact, it is the reason HIV-positive people are given a combination of drugs in order to prevent HIV from developing resistance and escaping the meds.

However, if you are negative, and stay negative, according to the scientific findings reviewed by the FDA, drug resistance is not a significant issue. You must have HIV in order to have drug resistance to HIV (the virus becomes resistant, not the people). Translation: An HIV-negative person can go on or off Truvada during periods of their life when they are more or less sexually active. However, if someone is taking too little Truvada (less than recommended) and becomes infected, or is HIV-positive but does not know it when he begins taking PrEP, the virus could theoretically develop resistance to one or both of the drugs in Truvada.

In the clinical trial data reviewed by the FDA there was no evidence that an HIVnegative person developed resistance to both of the drugs in Truvada after taking it for prevention. It seems that resistance is

Additional Links What is PrEP?: www.cdc.gov/hiv/prep Interim guidance on PrEP for your doctor: www.cdc.gov/mmwr/preview/ mmwrhtml/mm6003a1. htm?s_cid=mm6003a1_w</a Truvada website: www.truvada.com HuffPost Live segment “A Pill to Save Lives,” hosted by Alicia Menendez. Guests: Carl Sandler; Damon Jacobs, licensed marriage and family therapist at Private Practice Psychotherapy; Jeff McConnell, sociologist and iPrEx investigator; Robert Grant, iPrEx protocol chair; Tom Myers, chief of public affairs and general counsel for the AIDS Healthcare Foundation: http://live.huffingtonpost.com/ r/segment/hiv-prevention-pill/ 5097f52802a7605939000154

The iPrEx Primary Report www.nejm.org/doi/pdf/10.1056/ NEJMoa1011205 “Emtricitabine-Tenofovir Concentrations and Pre-Exposure Prophylaxis Efficacy in Men Who Have Sex with Men” Science Translational Medicine: www.ghdonline.org/uploads/Sci_ Transl_Med-2012-Anderson-151ra125. pdf

“Preexposure chemoprophylaxis for HIV prevention in men who have sex with men.” The New England Journal of Medicine: http://www.nejm.org/doi/full/10.1056/ NEJMoa1011205

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How many more 24 year-olds need to get HIV before we are willing to consider that PrEP could be a viable part of a larger safer sex movement? not as serious an issue as people seem to think. At least not yet.

Mr. McConnell suggested that someone could even take a daily dose once a day for at least a week prior to a potential exposure (e.g., a “party” weekend) and continue daily dosing throughout the month to get good protection against the virus.

“As long as you stay negative,” he told me, “there is little problem going on or off the drug. You just need to test negative again before going back on.”

A tipping point Price and access issues have

yet to be resolved. Most insurance companies appear to be covering Truvada and drug companies may not want to risk the potential negative publicity associated

optimistic that if we are willing to look at this new strategy without prejudice and judgment we may be able to radically change the trajectory of new transmissions, as our queer brothers and sisters historically did in the 1980s. Perhaps with PrEP we can better protect the young men in their late teens and 20s (like my friend) and minority gay men who represent the largest and fastest growing segment of new HIV infections in the U.S. We could make history once again.

with denying a breakthrough drug to at-risk populations. But there is also the issue of those most vulnerable in our community who do not have insurance and are unable to get access through another avenue. [Editor’s note: Gilead, the maker of Truvada, has a patient assistance program for those who don’t have insurance and meet eligibility requirements.]

Truvada appears to be a powerful new weapon in our fight against HIV. You may still be skeptical of this strategy. You may still have fears around resistance, side effects, abuse, misuse and access. There is much we still need to learn about PrEP. And yet, how many more 24 year-olds need to get HIV before we are willing to consider that PrEP could be a viable part of a larger safer sex movement? I am

Carl Sandler has a degree in economics from Stanford University. He has spent the last 15 years designing, building, and using technology that helps gay men meet, first at Gay.com (later Planet Out Partners); then as Founder of Daddyhunt. com, a site for older guys; and most recently with the MISTER dating app. A version of this article originally appeared in the Gay Voices section of the Huffington Post.

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Ask the DOCTOR David Fawcett, P h D, LCSW

It’s not just a river in Egypt

M

y husband is HIV-positive. I found out about it five years ago, but he refuses to see a doctor to maintain his health. Recently he broke out with a bad case of shingles.

He’s complaining of tiredness and he’s not eating like he used to, which has led to weight loss. He’s in denial. Can you help?

PHOTO: iStockphoto.com/drbimages

T

hank you for writing. One common but obviously risky response to receiving a diagnosis of HIV is persistent denial and avoidance.

Denial is a protective mechanism against shock that is valuable in the short term.

However, people need to move through it into action, usually accomplished by getting more information, sharing feelings, and going through a process of acceptance. Sometimes, as in the case of your husband, this phase persists, and can be complicated by depression as well as anxiety. In such cases, it blocks the person from taking important medical actions.

Ironically, of course, the sooner one gets

on medication the better the outcome.

As time goes on, the impact of HIV becomes hard to ignore. Shingles is an opportunistic infection that indicates that your husband’s immune system is challenged. The fatigue and appetite changes may also be indicators, but they could be signs of depression as well.

I would recommend finding a support group (most places have agencies dealing with HIV/AIDS and can direct you) and encouraging him to attend. Sometimes the most powerful role models are others who share the experience. I would look for a group for yourself, as well. Caregivers/ partners experience a high level of stress

themselves and need to practice self-care on a daily basis.

If he is willing, I think he could also benefit from therapy. Trained professionals can often identify the specific barriers or beliefs keeping denial in place and provide tools to break through. He might also consider taking an antidepressant that could motivate him to further action. Remember, antidepressant medication combined with psychotherapy has the best outcomes.

Good luck to both of you.

David Fawcett PhD, LCSW is a psychotherapist and clinical hypnotherapist in private practice in Fort Lauderdale, Florida. He is active in the gay men’s health movement, writes regularly for TheBody.com, and is a national trainer for the National Association of Social Workers’ “HIV Spectrum Project.”

Find an HIV specialist near you.

Go to www.aahivm.org.

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Wholistic picturE

Sue Saltmarsh

Siri-ously?

I hope to turn my doctors on to Mobile MIM and Airstrip, seemingly amazing ways for those of us with complicated medical issues to keep track of everything we need.

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For the most part, Tandy and I lived together in nervous harmony, never expecting it to last forever.

Then her hardware gave out a few years later, just as Stefano DiMera had come back from the dead for the fifth or sixth time and I’d realized that if I didn’t slam the door on that chat room, I might also become one of the permanent citizens of cyber-Salem, where the residents never manage to use contraception or (gasp!) have the well chosen abortion, even in the case of rape, though thankfully, no incest.

Fast forward to today when the large majority of my time is spent at the computer, I bought myself a Nook last Christmas, and, even though I hate it, I forced myself to join Facebook so I could get hundreds of thousands of people demonstrating for universal healthcare (DUH). Despite all that, my relationship with technology is an uneasy one, sometimes downright adversarial.

First, it isn’t cheap. There’s the actual “hardware” you have to have. Then you need enough knowledge to be able to upload, download (overload) whatever “software” necessary to get the machine to do what you want it to do. And then you have to know what buttons to click on or tap to get it going. So if you have neither the money nor the brain function nor the patience necessary to put all the parts together, you will never benefit from the sum of those parts.

But the benefits are hard to deny. I love the facile convenience of email, being able to send a document or an idea to multiple people at once instead of having to make numerous phone calls. It’s great to be able to call up facts, statistics, and articles by “Googling” them,

and then there’s the shopping...well, I even order my groceries online.

And I hope to turn my doctors on to Mobile MIM and Airstrip, seemingly amazing ways for those of us with complicated medical issues to keep track of everything we need.

But for as much as computer technology gives us, it also taketh away. Of particular pain to me is what it is doing to the English language (and I assume others).

The use of punctuation symbols to convey something drives me crazy—I can figure out :) or :(, but what the hell does :$ mean? And I’m sorry, too many people already don’t know the correct application of “your” and “you’re”—“ur” only makes them lazier. I may have caved to Facebook, but Twitter will NEVER get me, simply because its absurd limiting of characters is destroying the written language I love.

The thing that worries me most, however, are the long-term effects of humans feeling more comfortable having “conversations” with some echoey female voice on their smartphones than they do speaking to each other face-to-face. Will the day come when many of our instincts are atrophied because we’re used to reading our communication, without the benefit of tone of voice, volume, physical cues, and gestures? Will couples have fights via text as they sit at the same café table?

Will it become de rigueur to ask Siri if you should see that guy or girl again?

From the refrigerator, to TV, to Tandy, to the iPad, human ingenuity is seemingly relentless in its determination to bring us a better, easier life. But all along the way, cautionary tales have accompanied technological advances—the visions of H.G. Wells, Frank Herbert, Isaac Asimov, Gene Roddenberry, and Stanley Kubrick have shown us that the lure of breaking our bounds is often mixed with the dangers of not knowing what we’ve gotten ourselves into.

By all means, let’s keep inventing, improving, and using technology to its highest potential, but let’s also remember that neither HAL 9000 nor Siri can ever replace a good talk and a hug with someone we love.

Breathe deep, live long.

J A N U A R Y+ F E B R U A R Y 2 0 1 3 | P o s i t i v e lyA w are . c o m

Photo: Cheryl MANN

I can still remember the night in 1998 when I signed up for a Compuserve account. I had purchased a computer based not on a rating from Consumer Reports, but rather on the least intimidating, most friendly brand name I could find—Tandy. Tandy was not exactly your gold standard in any way, but I did use “her” successfully to become a prolific emailer and to venture into the “chat room” of “Days of Our Lives” fans, a virtual clubhouse for sociopaths and those suffering from OCD.

A MESSAGE FROM YOUR IMMUNE SYSTEM

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