HIV Plus Magazine #91

How to Handle Bad News + Hip-Hop for HIV + International AIDS Conference Wrap-Up

H E A L T H + S P I R I T + C U L T U R E + L I F E

WHAT’S WRONG IN THE SOUTH?

How one teen group is fighting AIDS below the Mason-Dixon Line

Is Reality TV Good for America?

The Real World, Project Runway, RuPaul’s Drag Race, and more have changed how we see positive people

Criminalizing the Condom

Are police spreading HIV with their policies against sex workers?

Pauley She’s the heart of TV’s number 1 drama, but in her off hours, NCIS star Pauley Perrette is a full-time activist and advocate. Now she chats about overcoming fears, fighting complacency, and how churches like hers can lead the way in HIV education and outreach

november/december 2012

www.hivplusmag.com

in this issue

November+December 2012

healthy doses 8 Mother Teresa of africa An Episcopal priest finds God at the Good Shepherd Home for AIDS orphans.

10 How to survive a plague

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Three new docs tackle AIDS and HIV for a new generation.

11 Hip-Hop for HIV Two events in Texas make concertgoers get tested in order to get tickets.

11 Condom Criminals?

How police in some cities might be making HIV spread faster.

social networks 54 The stigma project One new group uses social media to change attitudes around the globe.

case studies 16 aids conference wrap-up New theories, treatments, and news from D.C.’s International AIDS Conference.

18 Affordable care act What so-called Obamacare will mean for people with HIV.

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20 News you can use All the latest news, studies, and more.

21 what is stribild?

A new four-in-one drug is shaking up treatment routines. Here’s why.

22 New theories on hiv Scientists still search for origins of AIDS.

columns

this pare, clock wise from top: courtesy CBS; photos.com; courtesy subjec t

48 mind + mood What do you say when you get that question? You know the one.

ALSO: 46 YOU 2.0: Advice on fighting thrush

naturally and handling bad news. Plus: the best new apps for HIVers.

56 The final word One positive kid wins a big settlement.

34 Along Came Pauley

NCIS star Pauley Perrette talks about HIV, church, and what it takes to get over fear.

38 What’s Wrong in the South?

Statistics are bad, but one group of teens is making big changes for everyone.

26 How Reality TV Stars Are Changing America

On Project Runway, Top Design, The Real World, RuPaul’s Drag Race, and more, cast members on reality TV are out and proud about their positive status, and their boldness is affecting how people with HIV see themselves.

Editor's Letter

Editor in chief

Diane Anderson-Minshall

managing Editor Neal

Broverman Scott McPherson digital Editor Michelle Garcia copy editor Trudy Ring ASSOCIATE ART DIRECTOR Boo Jarchow editorial interns Camille Beredjick, Lauren Jow, Daniel Reynolds

Svp, group publisher

Evp, publishing

Joe Valentino

Joe Landry

creative director

manager, editorial and marketing operations

Charles Culbert HERE MEDIA chairman

Stephen P. Jarchow ceo Paul Colichman cfo Tony Shyngle

INTEGR ATED advertising MANAGEr

senior manager, social media

Shamila Siddiqui

senior managers, integr ated marketing

Robbie Imes, Kevin Stec

Stephanie Block Robert Hébert

INTEGR ATED MARKETING MANAGER interactive art director

director, public relations & corporate communications

Mark Umbach

senior director, client services

executive vice presidents and General managers

Stephen Macias, Bernard Rook evp, publishing Joe Landry chief performance officer Robert Ames advocate group editorial director Matthew Breen senior vice presidents Christin Dennis, John Mongiardo, Alex Paul, Josh Rosenzweig vice presidents Matthew Breen, Greg Brossia, Eric Bui, Steven Capone, Mike Dubin, Justin Garrett lead web architect & developer Peter Di Maso creative director, digital media Dave Johnson director, digital media, development Lisa Brown senior online producer Christopher Harrity web production coordinator Joe Okonkwo

Steven O’Brien

Stewart Nacht

Director of circulation Jeff Lettiere

fulfillment manager Argus Galindo

Production Manager

John Lewis Heidi Medina

Advertising Production Manager

advertising & subscriptions offices 120 West 45th Street, 23rd floor, New York, New York 10036-4041 Phone (212) 242-8100 • Advertising Fax (212) 242-8338 Subscriptions (212) 242-8100, Ext. 19 • Subscriptions Fax (212) 242-1344 editorial offices 10990 Wilshire Blvd., Penthouse Suite, Los Angeles, California 90024 Phone (310) 806-4288 • Fax (310) 806-4268 • Email mail@HIVPlusMag.com DISTRIBUTE HIV PLUS FOR FREE AT YOUR OFFICE OR FACILITY AIDS service organizations, community-based groups, pharmacies, physicians’ offices, and other qualifying agencies can request bulk copies for FREE distribution at your office or facility. Log on to HIVPlusMag.com and select “organization copies” on the “subscribe” link at the top of the page to download a copy request form. There is a 10-copy minimum.

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Changing the World

B

Pauley Perrette plays spirited forensic specialist Abby on NCIS, America's most watched TV series. But in her spare time she's an HIV activist who works through her church, Hollywood United Methodist, to change the lives of people with HIV—something she thinks everyone should do. "I’m really grateful that I stuck with God and got away from the bigots," she says of her less progressive childhood church. "I know that each and every single person out there from the bigots to the LGBT community is a child of God." Indeed. Perrette is just one of the many people in this issue who is making a difference in the lives of HIVers. Hip-hop stars in Texas, a nun in Cameroon, a group of teens in D.C., reality stars in Hollywood, scientists at the AIDS conference, even the man in the White House—they've all done something fabulous recently that will reduce stigma, fight complacency, increase visibility, and help people with HIV live longer, healthier, happier lives.

I'm in awe. I hope you are too. y day

what’s your story?

HIV Plus (ISSN 1522-3086) is published bimonthly by Here Publishing Inc., 10990 Wilshire Blvd., Penthouse Suite, Los Angeles, CA 90024. HIV Plus is a registered trademark of Here Media Inc. Entire contents © 2012 by Here Publishing Inc. All rights reserved. Printed in the USA.

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Diane Anderson-Minshall Editor in Chief

KINA WILLIAMS

Do you have an interesting story about yourself or someone you know that you want to share? You might be a candidate for a profile in one of our departments or another section. We want to hear from you, and we want to know what you’ve been up to. So email us at mail@HIVPlusMag.com or write us at HIV Plus, 10990 Wilshire Blvd., Penthouse Suite, Los Angeles, CA 90024. We’ll even take faxes at (310) 806-4268.

healthy doses Your trip must have given you opportunity to consider how global poverty affects the transmission of HIV. The average living wage in Cameroon is less than $1 a day. When that is the reality, there is little energy left to focus on anything other than survival. When survival is the focus, there is little incentive to practice safe sex to prevent the transmission of an invisible virus. While some people are educated in Cameroon about how HIV is transmitted and are motivated to take preventative measures, they have limited access to condoms and little means to purchase them.

Lack of transportation infrastructure, along with inadequate health care and government programs, are all factors.

elizabeth geitz, an Episcopal priest and author of six books, has received praise from a broad range of people, including Archbishop Desmond Tutu and Sister Helen Prejean, for her ability to combine spirituality and matters of social justice. Her newest book, I Am That Child, is a riveting memoir of her journey to Cameroon’s Good Shepherd Home for Children, which serves those orphaned by the AIDS pandemic.

Geitz, who lives on Stony Brook Farm in the mountains of northeastern Pennsylvania, talks with us about that experience. —Diane Anderson-Minshall You went to a remote village in West Africa to work with an orphanage in Cameroon. What inspired that trip?

Seven years ago my family began sponsoring a 6-year-old boy in the [orphanage] named Nafi Ndika. I had been communicating with him once a year and took a real interest in his life, his background, and his country. When I was given a sabbatical, I literally took a leap of faith and traveled to see him. I had never been to a developing country before, so it was quite a challenge for me.

Tell me about Sister Jane Mankaa, who’s considered by many to be the Mother Teresa of Africa. One day Sister Jane was walking down the streets of Yaoundé, the capital of Cameroon, when a young child lifted his arms to her, beg-

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ging her to save his life. She asked him where he lived, and he told her the streets were his home. She went back the next day and there were 10 more children, all orphaned from the AIDS pandemic. She knew then that her life’s work was to care for these forgotten children who are the face of AIDS in Africa today. With a dream in her heart, a vision in her head, and $25 in her pocket, Sister Jane flew to America to learn how to establish an orphanage and an order of nuns to run it. Today, 140 children call her “Mama” in a home where all their food, shelter, health needs, and school fees are paid and where, most importantly, they are loved. Ten years after she established the home, it is 50% self-sustaining, with the largest chicken farm in the area, a bakery that produces 3,000 loaves of bread per day, a piggery, and three vegetable farms.

What can people learn from your experience? Too often people in developing countries are nameless faces, strangers we will never meet or know. It is easy then to depersonalize issues like global poverty and AIDS. My takeaway is that behind every statistic is a human being with the same feelings, needs, desires, and concerns that I have. We truly are all one, and we need to begin living that way.

You’re an Episcopal priest. Was this trip part of your ministry? Oh, yes, this was and is definitely part of my ministry. I worked in inner-city Trenton, N.J., for five years with women on welfare in the late 1980s, and this trip 25 years later was a continuation of that call. It strengthened my faith to be with Sister Jane and her children. They are more spiritual and faithfilled than any people I have ever been

courtesy subjec t (3)

Faith in Action

How does sexism impact HIV in Africa?

Sexism is a major factor in the propagation of HIV. Early and forceful marriages, polygamy, lack of decision-making power by women, widow cleansing [the practice of forcing a widow into sex or marriage with a relative of her dead husband in order to exorcise his spirit], neglect and abandonment of wives, tolerating male promiscuity, and condoning actions of rape all contribute to the spread of HIV. Women have little say over whether their partners use protection. A recent study in Africa has shown that forced sexual activity with drunken husbands was most often cited by women as times they felt they had been exposed to the virus, as many reported believing that their husbands had more than one sexual partner, either through polygamy or infidelity.

around. In the midst of abject poverty they are grateful for what they do have. They praise God for everything. I have never seen anything like it.

I hear you have a fan in Desmond Tutu.

Now, that question makes me smile. “Fan” might be overstating it, but he did write a ringing endorsement of my book Gender and the Nicene Creed, about feminism and Christianity. I had the pleasure of hosting him as a speaker for a clergy conference.

He unexpectedly asked me to drive him to a luncheon. I was so flustered I proceeded to get lost in downtown Trenton! He laughed and slapped his knee, while I on the other hand was about to die of embarrassment. To say he is unforgettable is an understatement. Talk about faith in the midst of incredible adversity.

A big topic recently has been the dangers of criminalization of HIV. The criminalization of HIV is an issue of growing and significant concern throughout Africa that is damaging to those with AIDS and exacerbates the spread of HIV. There is such a law on the books in Cameroon, but it is unclear whether or not it has ever been enacted. In a related area, there is a regularly enforced law in Cameroon against same-sex sexual activity.

Suspected homosexual men are arrested, beaten, and jailed. Women suspected of being lesbians suffer violence in their families, are forced to leave home, or their children are taken away from them. As a result, people who think they might have HIV refuse to get tested for fear that they will be accused of being homosexual and thrown in jail. This is a major factor in the spread of HIV. You’ve had a chance to really explore solidarity with people in developing countries. Did that impact how you deal with people back home? My time in Cameroon at the orphanage has impacted almost everything I do. I have had many more honest discussions with people of color about the role of racism in America today and have a different understanding of what it means to work in a partnership, in solidarity with those whose culture and reference point are very different from my own. Just as Westerners do not have the answers for people in developing countries, suburban or city people in the U.S. don’t have the answers for our brothers and sisters in the inner city. In each case, our role

Opposite page: Geitz and a new friend. Above: life at the Good Shepherd Home

is to listen and learn from the people who are experts on their own lives.

What was your most surprising experience in Cameroon? As odd as it sounds, my most surprising experience was the fact that we were the only white people in sight. For the first time in my life, I experienced what it is like to be surrounded by people of a different race.

Very few tourists travel to Cameroon, which I had not realized. One boy I met was scared to speak to me because he had never seen a white person before.

There are 300,000 orphans in Cameroon alone. What is their understanding of HIV/AIDS? The majority of the 140 children in the Good Shepherd Home lost one or both parents to AIDS. They

are well aware of how their parents died, although they do not discuss it because there is such a taboo and stigma associated with the disease. Many Cameroonians still believe AIDS is caused by witchcraft and that there is a spell on the children, even though very few of them are HIV-positive themselves. The children, on the other hand, are educated in how HIV/ AIDS is contracted and how to prevent it.

What do you most want readers to take away from your book? I most hope that the face of AIDS in Africa today—the estimated 15.7 million orphaned children left behind—will have a name and a personal story that touches readers, one human being to another. I share 14 different ways readers can…join the journey with me.

There is no substitute for it. ✜

november /december 2012 •

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STATUS SYMBOLS healthy doses

Scenes from a Plague

have been released this year to give the history of HIV an emotional, tangible context and remind us of both how far we’ve come and how far we still must go.

How to Survive a Plague: A film festival favorite, this documentary focuses on the controversial yet effective activist collective ACT UP! which was launched in the 1980s in reaction to a system that was failing to do much to address the growing HIV epidemic.

The story proves emotional yet empowering, as a group of highly motivated people find power in community. David France, the film’s director, says that while AIDS decimated populations in its early stages, ACT UP!’s work also drastically changed the way we view health care and the pharmaceutical industry. “Before ACT UP! it took 10 or 12 years for a drug to go from an idea to a medicine cabinet,” France told The Huffington Post. “That may have seemed appropriate before, but in a disease state where the average life span after diagnosis was just 18 months, there was not time for that sort of laconic, studious, almost academic approach to finding the answers about a new compound.” How to Survive a Plague should also be required viewing for present-day Occupiers and burgeoning grassroots activists. Now playing in theaters; visit SurviveAPlague.com for a schedule of screenings.

Documenting a Movement Thirty years after the first diagnosis of AIDS, three documentary films aim to educate some and honor others

to someone born in the mid 1980s and raised through the decidedly more HIV-conscious ’90s, the roots of the HIV/ AIDS crisis in America may sound somewhat foreign. By the time someone born during the Reagan administration reached grade school, an afternoon of cartoons on Nickelodeon often contained a public service announcement advising 8-yearolds that hugging an HIV-positive uncle

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or sharing food with a friend could not spread the virus. Though this sort of messaging has been integral to reducing stigma, younger people who did not live through the onslaught of AIDS may not be aware of the crisis that HIV ushered in during the 1980s, the rash of deaths across the country, and the mobilization of an army of new activists and caregivers. Fortunately, three in-depth documentaries

We Were Here: A handful of gay men and a lesbian nurse tell their personal experiences of San Francisco’s trials and tribulations with HIV. The documentary begins with the assassination of dynamic gay politician Harvey Milk, then goes into the first mysterious deaths and through the destruction AIDS brought to the city. Through darkness came light—several resources were born through that community’s need to come together, including the Names Project AIDS Memorial Quilt and the now-institutionalized humane care provided to HIV-positive patients at San Francisco General. Now available on DVD, iTunes, and Netflix Instant.

Positive Youth: This documentary follows four young adults whose lives are affected

by HIV, whether they’re positive themselves or have a family member who is. Importantly, this documentary gets into the everyday lives of people with HIV and the worlds around them. Now playing film festivals; visit Facebook.com/PositiveYouthDoc for a schedule of screenings. —Michelle Garcia

Criminally Insane Carrying too many condoms could get you arrested in four U.S. cities

opposite page: courtesy subjec t; this page: photos.com

in a handful of major U.S. cities, police are criminalizing condom possession as a way to crack down on sex work. In New York, Los Angeles, San Francisco, and Washington, D.C., police routinely stop suspected sex workers and search them for condoms, which are used against them as evidence of prostitution, according to a Human Rights Watch report titled “Sex Workers at Risk.” The report chronicles the substantial barriers to preventing the spread of HIV among several of the most at-risk populations, including sex workers, immigrants, gay and bisexual youth, and transgender people.

“If I took a lot of condoms, they would arrest me,” Anastasia L., a sex worker in New York City, told Human Rights Watch.

“If I took a few or only one, I would…not be able to protect myself. How many times have I had unprotected sex because I was afraid of carrying condoms? Many times.”

According to a 2012 report from Open Society Foundations, 52% of sex workers in the U.S. opted at times not to carry condoms because they were afraid doing so would cause problems with the police.

These efforts undermine decades of work

by HIV activists and countless public health campaigns that have worked to get free and affordable condoms into the hands of the most at-risk populations.

Even though condoms are legal in all 50 U.S. states, activists say police are using their mere presence as evidence of

prostitution. These policies fly in the face of federal and international law, including a United Nations treaty.

According to police officers, however, condoms are not used as sole evidence of prostitution. “There’s got to be other associated factors involved that lead us to believe that this person is out there engaging in some type of solicitation,” says Officer Carlos Manfredi, a spokesman for the San Francisco Police Department. Manfredi says there is no department-wide directive indicating how many condoms are “too many”—a person carrying one condom is as likely see that fact used as evidence against them as someone with 60, if there is additional evidence implying prostitution. Manfredi says he is familiar with the Human Rights Watch report and understands the organization’s position, but adds that police officers find themselves in a catch-22 when it comes to reporting condoms as evidence.

“Being law enforcement officers, we cannot lie,” Manfredi says. “We have to give them all the facts that we see what’s presented to us. Say we don’t disclose that information in court, then the defense can use that against us.”

The Human Rights Watch report concludes that sex workers, immigrants, and transgender people are particularly hard-hit by the strategy. The report surveyed sex workers, advocates, lawyers, and police officers.

—Sunnivie Brydum

Hip Hop for HIV Awareness

Houston and Fort Worth events tested and educated thousands of youth Two free hip-hop concerts this summer promised to be the social event young Texans did not want to miss. In order to get a ticket, however, concertgoers had to do one thing: Get tested for HIV. Held in Houston and Fort Worth two days apart, and sponsored by sister radio stations 97.9 the Beat and 97.9 the Box, the sixth annual Hip Hop for HIV Awareness concerts featured a host of well-known and up-andcoming musicians, including Juvenile, Yung Nation, Snow Tha Product, Dorrough, B Hamp, Kirko Bangz, Driicky Graham, Travis Porter, and Beat King.

Throughout the month leading up to the concerts, hundreds of volunteers in both cities provided free HIV, gonorrhea, syphilis, chlamydia, and hepatitis C testing for thousands of people. During last year’s screenings in Houston, one in nine attendees tested positive for chlamydia, while one in 193 tested positive for HIV. (Stats for 2012 aren’t available yet but, in the past, 0.6% of participants have tested HIV-positive.)

“It’s kind of like a health fair on steroids,” says Nike Blue, operations chief for the Houston event and the director of prevention services for AIDS Foundation Houston.

But this isn’t intended to be a onetime fix—volunteers discuss safe-sex practices, the prevalence of sexually transmitted infections, and the importance of getting tested regularly. Participants also had the opportunity to receive immunizations required for college and fill out preliminary paperwork for Medicaid and Medicare if they are eligible for those programs.

Most concertgoers are black youths from low-income neighborhoods who just want the free ticket, Blue says. For many of them, it’s their first time getting tested or even learning about these issues, as public schools in Texas typically provide abstinence-only sex ed.

“Our goal is to find and get those people who only go to the emergency room when their life is in danger to get them to actually come to us, so getting tested is a routine process,” she says.

Tim Jones, a risk reduction specialist at Houston’s Montrose Counseling Center, says he uses humor to make participants feel comfortable and engaged in the process.

Blue adds of the concerts, “We have young adults who are out in the audience who have just tested HIV-positive with us or they already are HIV-positive. It gives them encouragement: I might be positive, but I’m not alone.” —Lauren Jow

november /december 2012 •

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The

one

for me

Patient model. Pill shown is not actual size.

INDICATION COMPLERA (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate 300 mg) is a prescription HIV medicine that contains 3 medicines, EMTRIVA® (emtricitabine), EDURANT™ (rilpivirine), and VIREAD® (tenofovir disoproxil fumarate) combined in one pill. COMPLERA is used as a complete single-tablet regimen to treat HIV-1 infection in adults (age 18 and older) who have never taken HIV medicines before. ®

COMPLERA does not cure HIV and has not been shown to prevent passing HIV to others. It is important to always practice safer sex, use latex or polyurethane condoms to lower the chance of sexual contact with any body fluids, and to never re-use or share needles. Do not stop taking COMPLERA unless directed by your healthcare provider. See your healthcare provider regularly.

IMPORTANT SAFETY INFORMATION Contact your healthcare provider right away if you get the following side effects or conditions while taking COMPLERA: s Nausea, vomiting, unusual muscle pain, and/or weakness. These may be signs of a buildup of acid in the blood (lactic acidosis), which is a serious medical condition s Light-colored stools, dark-colored urine, and/or if your skin or the whites of your eyes turn yellow. These may be signs of serious liver problems (hepatotoxicity), with liver enlargement (hepatomegaly), and fat in the liver (steatosis) s If you have HIV-1 and hepatitis B virus (HBV), your liver disease may suddenly get worse if you stop taking COMPLERA. Do not stop taking COMPLERA without first talking to your healthcare provider. Your healthcare provider will monitor your condition COMPLERA may affect the way other medicines work, and other medicines may affect how COMPLERA works, and may cause serious side effects.

Do not take COMPLERA if you are taking the following medicines: s other HIV medicines (COMPLERA provides a complete treatment for HIV infection.) s the anti-seizure medicines carbamazepine (Carbatrol®, Equetro®, Tegretol®, Tegretol-XR®, Teril®, Epitol®), oxcarbazepine (Trileptal®), phenobarbital (Luminal®), phenytoin (Dilantin®, Dilantin-125®, Phenytek®) s the anti-tuberculosis medicines rifabutin (Mycobutin), rifampin (Rifater®, Rifamate®, Rimactane®, Rifadin®) and rifapentine (Priftin®) s a proton pump inhibitor medicine for certain stomach or intestinal problems, including esomeprazole (Nexium®, Vimovo®), lansoprazole (Prevacid®), omeprazole (Prilosec®), pantoprazole sodium (Protonix®), rabeprazole (Aciphex®) s more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate s St. John’s wort (Hypericum perforatum) s other medicines that contain tenofovir (VIREAD®, TRUVADA®, ATRIPLA®) s other medicines that contain emtricitabine or lamivudine (EMTRIVA®, Combivir®, Epivir® or Epivir-HBV®, Epzicom®, Trizivir®) s rilpivirine (Edurant™) s adefovir (HEPSERA®) In addition, also tell your healthcare provider if you take: s an antacid medicine that contains aluminum, magnesium hydroxide, or calcium

carbonate. Take antacids at least 2 hours before or at least 4 hours after you take COMPLERA s a histamine-2 blocker medicine, including famotidine (Pepcid®), cimetidine (Tagamet®), nizatidine (Axid®), or ranitidine hydrochloride (Zantac®). Take these medicines at least 12 hours before or at least 4 hours after you take COMPLERA s the antibiotic medicines clarithromycin (Biaxin®), erythromycin (E-Mycin®, Eryc®, Ery-Tab®, PCE®, Pediazole®, Ilosone®), and troleandomycin (TAO®) s an antifungal medicine by mouth, including fluconazole (Diflucan®), itraconazole (Sporanox®), ketoconazole (Nizoral®), posaconazole (Noxafil®), voriconazole (Vfend®) s methadone (Dolophine®) This list of medicines is not complete. Discuss with your healthcare provider all prescription and nonprescription medicines, vitamins, or herbal supplements you are taking or plan to take.

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

COMPLERA.

A complete HIV treatment in only 1 pill a day.

Ask your healthcare provider if it’s the one for you.

Before taking COMPLERA, tell your healthcare provider if you: • have liver problems, including hepatitis B or C virus infection • have kidney problems • have ever had a mental health problem • have bone problems • are pregnant or plan to become pregnant. It is not known if COMPLERA can harm your unborn child • are breastfeeding; women with HIV should not breast-feed because they can pass HIV through their milk to the baby Contact your healthcare provider right away if you experience any of the following serious or common side effects: Serious side effects associated with COMPLERA: • New or worse kidney problems can happen in some people who take COMPLERA. If you have had kidney problems in the past or take other medicines that can cause kidney problems, your healthcare provider may need to do blood tests to check your kidneys during your treatment with COMPLERA • Depression or mood changes can happen in some people who take COMPLERA. Tell your healthcare provider right away if you have any of the following symptoms: feeling sad or hopeless, feeling anxious or restless, or if you have thoughts of hurting yourself (suicide) or have tried to hurt yourself • Bone problems can happen in some people who take COMPLERA. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do additional tests to check your bones • Changes in body fat can happen in people taking HIV medicine. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms and face may also happen. The cause and long-term health effect 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. Tell your healthcare provider if you start having new symptoms after starting your HIV medicine

Common side effects associated with COMPLERA: • trouble sleeping (insomnia), abnormal dreams, headache, dizziness, diarrhea, nausea, rash, tiredness, and depression Other side effects associated with COMPLERA: • vomiting, stomach pain or discomfort, skin discoloration (small spots or freckles), and pain 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 COMPLERA. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects.

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.

Take COMPLERA exactly as your healthcare provider tells you to take it • Always take COMPLERA with a meal. Taking COMPLERA with a meal is important to help get the right amount of medicine in your body. A protein drink does not replace a meal • Stay under the care of your healthcare provider during treatment with COMPLERA and see your healthcare provider regularly

Please see Patient Information for COMPLERA on the following pages.

Learn more at www.COMPLERA.com

FDA-Approved Patient Labeling Patient Information COMPLERA® (kom-PLEH-rah) (emtricitabine, rilpivirine and tenofovir disoproxil fumarate) Tablets

COMPLERA may help: • Reduce the amount of HIV in your blood. This is called your “viral load”.

• Increase the number of white blood cells called CD4+ (T) cells that help fight off other infections.

Important: Ask your doctor or pharmacist about medicines that should not be taken with COMPLERA. For more information, see the section “What should I tell my healthcare provider before taking COMPLERA?”

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).

Read this Patient Information before you start taking COMPLERA 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 treatment.

What is the most important information I should know about COMPLERA?

COMPLERA does not cure HIV infections or AIDS. • Always practice safer sex.

• Use latex or polyurethane condoms to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood.

• Never re-use or share needles.

Ask your healthcare provider if you have any questions about how to prevent passing COMPLERA can cause serious side effects, including: 1. Build-up of an acid in your blood (lactic acidosis). Lactic acidosis can happen in HIV to other people. some people who take COMPLERA or similar (nucleoside analogs) medicines. Lactic Who should not take COMPLERA? acidosis is a serious medical emergency that can lead to death.

• Do not take COMPLERA if your HIV infection has been previously treated with Lactic acidosis can be hard to identify early, because the symptoms could seem like HIV medicines. symptoms of other health problems. Call your healthcare provider right away if you • Do not take COMPLERA if you are taking certain other medicines. For more get any of the following symptoms which could be signs of lactic acidosis: information about medicines that must not be taken with COMPLERA, see “What • feeling very weak or tired should I tell my healthcare provider before taking COMPLERA?” • have unusual (not normal) muscle pain • have trouble breathing What should I tell my healthcare provider before taking COMPLERA? • have stomach pain with Before you take COMPLERA, tell your healthcare provider if you: - nausea (feel sick to your stomach) • have liver problems, including hepatitis B or C virus infection - vomiting • have kidney problems • feel cold, especially in your arms and legs • have ever had a mental health problem • feel dizzy or lightheaded • have bone problems • have a fast or irregular heartbeat • are pregnant or plan to become pregnant. It is not known if COMPLERA can harm your unborn child Pregnancy Registry. There is a pregnancy registry for women who take antiviral medicines during pregnancy. Its purpose is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.

Call your healthcare provider right away if you have any of the following symptoms • are breast-feeding or plan to breast-feed. The Centers for Disease Control and of liver problems: Prevention recommends that mothers with HIV not breastfeed because they can pass • your skin or the white part of your eyes turns yellow (jaundice). the HIV through their milk to the baby. It is not known if COMPLERA can pass through • dark “tea-colored” urine your breast milk and harm your baby. Talk to your healthcare provider about the best • light-colored bowel movements (stools) way to feed your baby.

• loss of appetite for several days or longer Tell your healthcare provider about all the medicines you take, including prescription • nausea and nonprescription medicines, vitamins, and herbal supplements.

• stomach pain 2. Severe liver problems. Severe liver problems can happen in people who take COMPLERA or similar medicines. 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) when you take COMPLERA.

You may be more likely to get lactic acidosis or severe liver problems if you are COMPLERA may affect the way other medicines work, and other medicines may female, very overweight (obese), or have been taking COMPLERA or a similar affect how COMPLERA works, and may cause serious side effects. If you take certain medicines with COMPLERA, the amount of COMPLERA in your body may be too low and medicine containing nucleoside analogs for a long time. it may not work to help control your HIV infection. The HIV virus in your body may become 3. Worsening of Hepatitis B infection. If you also have hepatitis B virus (HBV) infection resistant to COMPLERA or other HIV medicines that are like it. and you stop taking COMPLERA, your HBV infection may become worse (flare-up). A “flare-up” is when your HBV infection suddenly returns in a worse way than before. Do not take COMPLERA if you also take these medicines: COMPLERA is not approved for the treatment of HBV, so you must discuss your HBV • COMPLERA provides a complete treatment for HIV infection. Do not take other HIV medicines with COMPLERA. therapy with your healthcare provider.

• the anti-seizure medicines carbamazepine (CARBATROL®, EQUETRO®, TEGRETOL®, • Do not let your COMPLERA run out. Refill your prescription or talk to your healthcare TEGRETOL-XR®, TERIL®, EPITOL®), oxcarbazepine (TRILEPTAL®), phenobarbital provider before your COMPLERA is all gone.

(LUMINAL®), phenytoin (DILANTIN®, DILANTIN-125®, PHENYTEK®) • Do not stop taking COMPLERA without first talking to your healthcare provider. ® ® • If you stop taking COMPLERA, your healthcare provider will need to check your health • the anti-tuberculosis medicines rifabutin (MYCOBUTIN ), rifampin (RIFATER , RIFAMATE®, RIMACTANE®, RIFADIN®) and rifapentine (PRIFTIN®) often and do regular blood tests to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking • a proton pump inhibitor medicine for certain stomach or intestinal problems, including esomeprazole (NEXIUM®, VIMOVO®), lansoprazole (PREVACID®), omeprazole COMPLERA. (PRILOSEC®), pantoprazole sodium (PROTONIX®), rabeprazole (ACIPHEX®) • more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium What is COMPLERA? COMPLERA is a prescription HIV (Human Immunodeficiency Virus) medicine that: phosphate • is used to treat HIV-1 in adults who have never taken HIV medicines before. HIV is the • St. John’s wort (Hypericum perforatum) virus that causes AIDS (Acquired Immunodeficiency Syndrome).

If you are taking COMPLERA, you should not take: • contains 3 medicines, (rilpivirine, emtricitabine, tenofovir disoproxil fumarate) • other medicines that contain tenofovir (VIREAD®, TRUVADA®, ATRIPLA®) combined in one tablet. EMTRIVA and VIREAD are HIV-1 (human immunodeficiency • other medicines that contain emtricitabine or lamivudine (EMTRIVA®, COMBIVIR®, virus) nucleoside analog reverse transcriptase inhibitors (NRTIs) and EDURANT is an EPIVIR® or EPIVIR-HBV®, EPZICOM®, TRIZIVIR®) HIV-1 non-nucleoside analog reverse transcriptase inhibitor (NNRTI).

• rilpivirine (EDURANT™) It is not known if COMPLERA is safe and effective in children under the age of 18 years. • adefovir (HEPSERA®)

Also tell your healthcare provider if you take: The most common side effects of COMPLERA include: an antacid medicine that contains aluminum, magnesium hydroxide, or calcium • trouble sleeping (insomnia) carbonate. Take antacids at least 2 hours before or at least 4 hours after you take • abnormal dreams COMPLERA. • headache • a histamine-2 blocker medicine, including famotidine (PEPCID®), cimetidine • dizziness (TAGAMET®), nizatidine (AXID®), or ranitidine hydrochloride (ZANTAC®). Take these • diarrhea medicines at least 12 hours before or at least 4 hours after you take COMPLERA. • nausea • the antibiotic medicines clarithromycin (BIAXIN®), erythromycin (E-MYCIN®, ERYC®, • rash ERY-TAB®, PCE®, PEDIAZOLE®, ILOSONE®), and troleandomycin (TAO®) • tiredness • an antifungal medicine by mouth, including fluconazole (DIFLUCAN®), itraconazole ® ® ® (SPORANOX ), ketoconazole (NIZORAL ), posaconazole (NOXAFIL ), voriconazole • depression (VFEND®) Additional common side effects include: • methadone (DOLOPHINE®) • vomiting Ask your healthcare provider or pharmacist if you are not sure if your medicine is • stomach pain or discomfort • skin discoloration (small spots or freckles) one that is listed above.

Know the medicines you take. Keep a list of your medicines and show it to your • pain •

healthcare provider and pharmacist when you get a new medicine. Your healthcare provider and your pharmacist can tell you if you can take these medicines with COMPLERA. Do not start any new medicines while you are taking COMPLERA without first talking with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for a list of medicines that can interact with COMPLERA. How should I take COMPLERA? • Stay under the care of your healthcare provider during treatment with COMPLERA. • Take COMPLERA exactly as your healthcare provider tells you to take it.

• Always take COMPLERA with a meal. Taking COMPLERA with a meal is important to help get the right amount of medicine in your body. A protein drink does not replace a meal.

• Do not change your dose or stop taking COMPLERA without first talking with your healthcare provider. See your healthcare provider regularly while taking COMPLERA. • If you miss a dose of COMPLERA within 12 hours of the time you usually take it, take your dose of COMPLERA with a meal as soon as possible. Then, take your next dose of COMPLERA at the regularly scheduled time. If you miss a dose of COMPLERA by more than 12 hours of the time you usually take it, wait and then take the next dose of COMPLERA at the regularly scheduled time.

• Do not take more than your prescribed dose to make up for a missed dose.

• When your COMPLERA supply starts to run low, get more from your healthcare provider or pharmacy. It is very important not to run out of COMPLERA. The amount of virus in your blood may increase if the medicine is stopped for even a short time.

• If you take too much COMPLERA, contact your local poison control center or go to the nearest hospital emergency room right away.

What are the possible side effects of COMPLERA? COMPLERA may cause the following serious side effects, including: • See “What is the most important information I should know about COMPLERA?” • New or worse kidney problems can happen in some people who take COMPLERA. If you have had kidney problems in the past or take other medicines that can cause kidney problems, your healthcare provider may need to do blood tests to check your kidneys during your treatment with COMPLERA. • Depression or mood changes. Tell your healthcare provider right away if you have any of the following symptoms: - feeling sad or hopeless - feeling anxious or restless - have thoughts of hurting yourself (suicide) or have tried to hurt yourself • Bone problems can happen in some people who take COMPLERA. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do additional tests to check your bones.

• Changes in body fat can happen in people taking HIV medicine. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms and face may also happen. The cause and long term health effect 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.

Tell your healthcare provider if you start having new symptoms after starting your HIV medicine.

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 COMPLERA. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088).

How do I store COMPLERA? • Store COMPLERA at room temperature 77 °F (25 °C).

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

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

Keep COMPLERA and all other medicines out of reach of children.

General information about COMPLERA: Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use COMPLERA for a condition for which it was not prescribed.

Do not give COMPLERA to other people, even if they have the same symptoms you have.

It may harm them.

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

What are the ingredients of COMPLERA? Active ingredients: emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate Inactive ingredients: pregelatinized starch, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, povidone, polysorbate 20. The tablet film coating contains polyethylene glycol, hypromellose, lactose monohydrate, triacetin, titanium dioxide, iron oxide red, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake.

This Patient Information has been approved by the U.S. Food and Drug Administration Manufactured and distributed by: Gilead Sciences, Inc. Foster City, CA 94404 Issued: August 2011 COMPLERA, the COMPLERA Logo, EMTRIVA, HEPSERA, TRUVADA, VIREAD, GILEAD, and the GILEAD Logo are trademarks of Gilead Sciences, Inc. or its related companies.

ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other trademarks referenced herein are the property of their respective owners. © 2012 Gilead Sciences, Inc. All rights reserved.

202123-GS-000 02AUG2011 CON11822 1/12

case studies

Clockwise from top left: Sir Elton John delivers a memorable speech about the battle against HIV stigma; activist Aaron Matthew Laxton raises awareness in front of the White House; former president Bill Clinton gives the keynote speech; the AIDS Quilt is laid out on display on the National Mall.

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• november /december 2012

Hope and Change Takeaways from the International AIDS Conference include new treatment guidelines and renewed hope for a cure

ge t t y images for the 19th international aids conference

this summer’s 19th International AIDS Conference, while acknowledging the still-great challenge of fighting the disease, was filled with talk of new battle strategies, such as early treatment and preventive drugs, and even hopeful discussion about research into a cure.

HIV remains a serious health condition and still claims lives around the globe, but several presenters at the Washington, D.C., event—held in the U.S. for the first time in 22 years—offered ideas that they say promise progress against the virus and its complications. Among the more interesting: 1. Early Treatment Rules One group of researchers unveiled new treatment guidelines that call for physicians to put HIVpositive individuals on medications as soon as they are diagnosed, instead of waiting until their immune system shows signs of deterioration (as measured by T-cell count), which has been a common approach.

The need for treatment does become more urgent as T-cell count decreases, said the researchers, but the availability of a variety of drugs and studies indicating the benefits of early treatment make it worthwhile to begin even before T-cell counts are affected.

The team, led by Atlanta physician Melanie Thompson, recommends a regimen of Truvada or Epizom plus either Sustiva,

Reyataz, Prezista, or Isentress.

These drugs can not only decrease the amount of HIV in the body, they can make it more difficult for an HIV-positive person to transmit the virus (although safer-sex practices are still called for). “The scientific community really recognizes how valuable they could be to prevent transmission,” Rowena Johnston, director of research for amfAR, told HealthDay. 2. A New Way of Preventing HIV The idea of “treatment as prevention” also informed the discussion of Truvada’s recent approval to be prescribed as a preventive measure for HIV-negative people at high risk of contracting the virus. Some conference attendees questioned the wisdom of using the drug for prevention, given its cost, the possibility of side effects, and the danger that people taking it may become lax about safer-sex precautions. Harvard University researcher and conference presenter Douglas Krakower said, however, that he considers it irresponsible “to withhold strategies that may be protective.”

3. Surprise Benefits of Antiretrovirals Cost is likewise a consideration with early initiation of treatment, as is the need to stay on the drugs faithfully; breaks in treatment can lead to the development of drugresistant strains of HIV. But one study presented at the conference

documented a group of patients in France who were treated early, went off their meds, and have seen the level of HIV in their bodies remain low. These results provide still more reason that “antiretroviral treatment should be started very early after infection,” said Charline Bacchus, lead researcher at the French National Agency for Research on AIDS and Viral Hepatitis.

4. The Cure Is Coming The French study and other developments, such as the report at the conference about suppression of HIV in two men who had received bone marrow transplants while on antiretroviral therapy (see HIV Plus, September/October), are leading some scientists to have new optimism about a cure. Toward that end, the International AIDS Society, which sponsors the conference, has put together a strategy for seeking a cure, identifying key areas for research to make this possible. It announced the strategy just prior to the conference.

“The science has been telling us for some time now that achieving a cure for HIV infection could be a realistic possibility,” said French scientist Françoise Barré-Sinoussi, who helped discover the virus, in announcing the project. “The time is right to take the opportunity to try and develop an HIV cure—we might regret never having tried.”

—Trudy Ring

november /december 2012 •

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17

What the Affordable Care Act Means For You

By Neal Broverman

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• m ay/J U N E 2 0 1 2

B

ack in June the Supreme Court narrowly upheld the landmark Affordable Care Act (nicknamed “Obamacare”), which has already helped millions get and keep health insurance. Importantly, the law made it illegal for health insurance companies to deny individuals coverage because of a preexisting condition, including HIV. But there are other changes and considerations that go along with the law, and Daniel Tietz, the executive director of the AIDS Community Research Initiative of America, helps flesh out what benefits (and possible drawbacks), it could bring you.

Are there immediate changes people need to be aware of with the Affordable Care Act? The expansion of coverage up to age 26 on your parents’ or family’s health insurance happened last year. It appears to be the only thing to explain the decreased number of young adults without insurance, according to Census data.

The end of preexisting condition exclusion has already happened. The end of lifetime caps on coverage already happened. With regard to women and preventative services, there’s now free HIV screening and counseling available, well-women exams, free HIV testing for women age 30 years and older, and other specific services in regard to HIV, HPV, and STI counseling.

The next big thing is January 1, 2014; that’s when Medicaid expansion happens in a big way.

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Do many receive HIV care through Medicaid, the federal insurance program for lowincome people?

Estimates are about half of people with HIV get their care through Medicaid. That number was initially expected to jump with the ACA—70% of those people who weren’t already getting their care through Medicaid would be eligible to do so. That number’s been lowered a bit.

The Supreme Court in the end of June said the Medicaid expansion could not be “coerced” by the Department of Health and Human Services.

That was the one thing that was removed from [the bill by the Supreme Court]. We’ve heard blather from some governors about whether they’re signing up for Medicaid expansion or not. I think they’re making that noise because it’s an election year. If the president wins reelection, I think they’ll get on board.

Why? The biggest reason is the money. The Medicaid expansion in the first two years—2014 to 2016—will have the federal government picking up 100% of the tab. Then it drops to 90% from 2020 forward. Medicaid is a federal-state split, as opposed to Medicare [which insures seniors

and the disabled], which is fully paid by federal taxes. Medicaid was always voluntary. States didn’t have to sign up. When Medicare and Medicaid were created in 1965, only a handful of states were clamoring to get on board. In fairly short order, they all took it. The deal offered then was much worse than the deal offered now. For example, the worst deal you could get from the federal government in regards to splitting the cost of Medicaid is 50/50. Well-off states, as in annual per capita income of its residents, have a 50/50 split. States that have the best deal in terms of how much the federal taxpayer picks up, well, the best in the country right now is Mississippi. Given that its per capita income is low, it has 73% of its Medicaid costs picked up by federal taxpayers. Before the Affordable Care Act, the best [any state] could ever get was 83%.

So states aren’t spending extra money by expanding Medicaid?

They are and they aren’t. There’s no one answer for that, there are 50 answers for that and the District of Columbia. States that already had a fairly generous Medicaid program, because of the expansion now paying so much of the services, could see their costs go down even as they expand the numbers eligible.

So it may benefit wealthier states that already contribute a lot.

Exactly. Admittedly, for states that had, in relative terms, lousy programs, like Mississippi, their costs are going to go up. Not as much as people think. Now their enrollment is going to go way up, but their costs won’t go up nearly as much. The Kaiser Family Foundation estimates, at the outside, a 4.8% rise in costs in some states, mostly in the South. But in the scheme of things, if you’ve got 40% or 50% increase in enrollment and you only have costs go up 4.5% or 5%, that’s pretty remarkable.

It’s funny the states making the most stink about it, Wisconsin, Texas, and Florida, aren’t very poor.

Texas has the worst numbers in the country in terms as the number of insured. More than a quarter of Texas’s population has no health insurance coverage. Wisconsin has a relatively expansive Medicaid program at present—it’ll see a tiny rise in its costs, according to KFF. Florida isn’t in as bad a shape in the number of uninsured as Texas.

Before the ACA, you wouldn’t qualify for Medicaid just by being low-income, you had to have a preexisting condition.

That’s right. In most states, if you were a childless adult, you had to be disabled to qualify. That will change. Essentially, now it’s just a measure

of your income. If you make under $14,000 a year, you’re going to be eligible for Medicaid, no matter who you are. What the Department of Health and Human Services is working on right now are essential health benefits, what the package looks like, and what they’re going to require of states…what Medicaid’s going to deliver, what private insurers are going to deliver in those state-based exchanges [online marketplaces that will be available for people to compare, choose, and buy affordable health insurance] for those who aren’t poor—what they require of that is going to make all the difference in the world. For example, there’s a low bar being set for drug coverage. You know how vital antiretrovirals are for people with HIV. Right now the HHS requires only one drug per drug class or category, but there can be a bunch of drugs in a single class of antiretroviral drugs.

If your state only offers up one, as far as HHS is concerned, they’ve met the requirement. We’re urging stronger protections at the federal level.

In the course of trying to reduce the criticism over the ACA, HHS has been rather generous in telling the states, “You can set this up the way you want.” For many advocates, particularly on the HIV side, we don’t like that. We were really hoping with the ACA, we would finally get to a consistent place about what kind of coverage folks would have for medications, primary care, and services.

Will the ACA change the cost of meds considerably?

If you’ve got Medicaid, your meds will be paid for. So it becomes literally what drugs that state is willing to pay for—either as part of the Medicaid expansion or part of the state-based exchanges. If you can believe it, those will be different. There’s a package of essential health benefits that come as part of the Medicaid expansion, and there’s a package of what the essential health benefits will be as part of the state-based exchanges. It’s confusing. The ACA is not quite the thing we had hoped for, at least not yet. It’s going to take more advocacy to get there. Activists are arguing that the HHS should make the essential health benefits with the drugs more consistent for Medicaid and the state-based exchanges.

Will there be chances to refine the bill?

All that action is literally happening right now.

There were comments due in September, there are decisions that the federal government will make between now and January 1. Everyone thinks those decisions will be made after the election.

For more information on the Affordable Care Act, visit ACRIA.org or HealthCare.gov.

November /december 2012 •

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case studies

News You Can Use

A Michigan man is arraigned on charges of exposing a partner to HIV, the CDC changes course on gonorrhea, persistent HIV stigma in Africa, and more. —Camille Beredjick

✚ A Clare, Mich., man was freed on bond after being arraigned on a charge of having sex without telling his partner he was HIV-positive.

Philip Bryan Manners, 25, was arrested in August after a person with whom he had sexual contact learned Manners is HIV-positive and notified police. He was charged with violating a 1989 Michigan law requiring HIV-positive people to inform prospective partners of their status before they have sex. ✚ Scientists from Oxford University discovered a compound that improves the effect of vaccines against viruses, including HIV, in mice. When added to a vaccine, a type of polymer called polyethyleneimine, or PEI, enhanced mice’s immune response and offered better protection against HIV, flu, and herpes, three of the most difficult viruses to combat with a vaccine. Researchers said it would likely be a few

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years before they could test PEI in a flu vaccine in clinical trials with humans. ✚ The Centers for Disease Control and Prevention no longer recommends the oral antibiotic cefixime for the treatment of gonorrhea.

Recent laboratory data indicates the drug is becoming less effective in treating the disease, leaving only one medication—the injectable antibiotic ceftriaxone—proven effective against gonorrhea. ✚ The first CDC study examining the proportion of HIV-positive Americans receiving treatment found that only one quarter of all HIV-positive people in the U.S. have the virus under control through antiretroviral therapy. African Americans and young people were the least likely to receive ongoing care and effective treatment. ✚ The LGBT advocacy organization Truth Wins Out in August blamed American evangelical Christian organizations for a spike in HIV cases in Uganda.

Fundamentalist Christian leaders such as Lou Engle and Rick Warren have visited Uganda in the past few years, promoting abstinence as the key to preventing the spread of HIV. According to a new American-financed survey, Uganda’s HIV infection rate increased to 7.3% in recent years from 6.4% in 2005. ✚ Women in rural Kenya avoid giving birth in hospitals or clinics for fear of being seen as HIV-positive,

• november /december 2012

according to a study published in PLoS Medicine in August.

Surveying young women in a province where only 44% of births take place in a medical facility, researchers found HIV-related stigma was a major factor keeping them away. Many of the women believe professional care is only for deliveries with complications, such as the mother being HIV-positive.

A similar study published in July found HIV stigma affects pregnant women in other parts of the world as well. ✚ A new policy brief from the Africa Initiative and the Centre for International Governance Innovation lays out strategies for increasing the number of pregnant women tested for HIV, so steps can be taken to reduce the possibility of mother-to-child transmission during delivery. Based on 129 interviews, “Increasing

the Uptake of HIV Testing in Maternal Health in Malawi” notes that many pregnant women do not know their HIV status. They avoid testing or counseling because of barriers to care, peer pressure, and fear of stigma. The brief recommends increasing the number of health care professionals, improving their training on HIV, and reducing misconceptions and stigma regarding the virus. ✚ Ten community-based AIDS organizations from around the world were honored in July with the 2012 Red Ribbon Award, recognized as the most prestigious award for innovative community work in response to AIDS. The winning organizations are from Egypt, Haiti, India, Iran, Kenya, Mexico, Myanmar, the Russian Federation, Sri Lanka, and Uganda. Each will receive a grant for $10,000.

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✚ Researchers at the University of California, Los Angeles may have discovered why certain people with a gene known as B57 progress to AIDS much more slowly than other HIV-positive people with the gene. The reason may be “a killer T-cell immune response that occurs early on in HIV infection and targets a section—or epitope—of the HIV protein called IW9,” according to a UCLA press release. Researchers are hoping more information on the B57 gene will eventually lead to an HIV vaccine.

The All-Four-One Drug A new combination treatment means some HIVers will only take one pill a day people taking medication for the first time have a new option now that the Food and Drug Administration has approved Gilead’s Stribild, which fuses four drugs into one pill.

Stribild (previously known as Quad) combines elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate into a single daily dose for people who have not previously been treated for HIV. Paul Sax, a physician at Brigham and Women’s Hospital who was a principal investigator of one of the Stribild studies, says the approval is crucial for those patients. Clinical trials, which took place over a 48-week period, indicated that Stribild was more effective than other drugs in keeping viral loads down.

“Through continued research and drug development, treatment for those infected with HIV has evolved from mul-

tipill regimens to single-pill regimens,” adds Edward Cox, MD, of the FDA’s Center for Drug Evaluation and Research.

“New combination HIV drugs like Stribild help simplify treatment regimens.” The prescription drug became available to patients in late August.

The release of Stribild sent Gilead’s stock price soaring, and JPMorgan investment analyst Geoff Meacham told the Associated Press he expects annual sales of the drug to reach $2.9 billion within three years.

However, the pill’s cost is raising eyebrows. Groups such as the Fair Pricing Coalition have protested the $28,500 annual wholesale cost, which is about $7,000 more than the price tag of Gilead’s 2006 combination drug, Atripla.

After negotiations with state AIDS service directors Gilead agreed to lower it, by a yet to be specified amount, for

AIDS Drug Assistance Programs. Groups including the AIDS Healthcare Foundation are calling on the company to also lower the price for Medicaid, Medicare, private insurers, and others.

There are a few precautions that Stribild users need to know about: It must be taken with food, may interact badly with certain other drugs, has not been tested in pregnant women, and should not be taken by those who are breast-feeding.

Like many HIV treatments, it may also cause side effects including kidney damage, fat redistribution, immune reconstitution syndrome, nausea, and headaches.

Even with these issues, Gilead officials say the pill will carry fewer complications and be more effective in treating HIV than other medications on the market. And, of course, a lot of patients are excited about a new all-inone medication. —Michelle Garcia November /december 2012 •

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STATUSstudies SYMBOLS case

Origin Theories Three new books dig to find answers on the beginnings of AIDS as researchers come to know more about how to treat HIV and AIDS, the quest to understand more about this virus continues, especially regarding its origins.

Theories on the beginnings of HIV are similar to those on the origin of other infectious diseases, including those that assume transmission, or spillover, as author David

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Quammen puts it, from the animal kingdom to humans. In his book Spillover: Animal Infections and the Next Human Pandemic, Quammen not only evaluates the origins of HIV but also compares them to origins of other diseases, such as Ebola and severe acute respiratory syndrome (SARS). The one thing many of

these diseases have in common, he writes, is the insects and animals that have been integral in transferring such viruses. Quammen’s book brings readers right into the action of stalking gorillas in the Congo and capturing bats in China in the effort to understand more about the diseases they have presumably transferred to humans.

Physician, researcher, and activist Peter Piot chronicles his career in the fascinating No Time To Lose: A Life in Pursuit of Deadly Viruses. In 1976 a young Piot was part of a medical research team that was called to study an epidemic, which the team later determined was Ebola, that was suddenly endangering thousands of lives in what is now the Democratic Republic of Congo. After Piot and his colleagues tracked the outbreak to its source, he returned to the U.S., where he continued his research on sexually transmitted diseases among vulnerable populations. His work brought him back to Africa, where he was tasked with studying the AIDS epidemic. Over the course of his research, in which he often encountered corrupt governments that wouldn’t help their citizens, he became an advocate, setting up clinics and prevention programs. That led to Piot becoming the founding director of UNAIDS. Michal Milstein and Marlin Marynick’s Undisclosed: Secrets of the AIDS Epidemic profiles some of the longestterm survivors of HIV—Gene Matarese and Michael Smithwick—as well as two doctors on the front lines of the epidemic, Mark Katz and Alan Cantwell. As Milstein writes, Matarese and Smithwick’s bodies are archives of “decades of treatments, dissections, relapses, and recoveries, and have been referred to as ‘the Rosetta Stones of AIDS.’ ” The authors not only weigh the different theories of HIV’s beginnings but also tell the story of HIV and AIDS in America, concluding that “a country’s socio-political response to a disease is the most important factor in determining the course of an epidemic.” —Michelle Garcia

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“A country’s sociopolitical response to a disease is the most important factor in determining the course of an epidemic.”

New STRIBILD is here One pill contains elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate.

Ask your healthcare provider if it is right for you, or visit STRIBILD.com to learn more.

Please see Patient Information with important warnings on the following pages.

Patient Information STRIBILDTM (STRY-bild) (elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate) Tablets

s 2EDUCE THE AMOUNT OF ()6 AND INCREASING THE #$ 4 CELLS IN YOUR BLOOD MAY help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).

Important: Ask your healthcare provider or pharmacist about medicines that should not be taken with STRIBILD. For more information, see the section “What should I tell my healthcare provider before taking STRIBILD?�

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

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

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: s FEEL VERY WEAK OR TIRED s HAVE UNUSUAL NOT NORMAL MUSCLE PAIN s HAVE TROUBLE BREATHING s HAVE STOMACH PAIN WITH - nausea - vomiting s FEEL COLD ESPECIALLY IN YOUR ARMS AND LEGS s FEEL DIZZY OR LIGHTHEADED s 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: s YOUR SKIN OR THE WHITE PART OF YOUR EYES TURNS YELLOW JAUNDICE s DARK hTEA COLOREDv URINE s LIGHT COLORED BOWEL MOVEMENTS STOOLS s LOSS OF APPETITE FOR SEVERAL DAYS OR LONGER s NAUSEA s 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. s $O NOT RUN OUT OF 342)"),$ 2ElLL YOUR PRESCRIPTION OR TALK TO YOUR HEALTHCARE provider before your STRIBILD is all gone. s $O NOT STOP TAKING 342)"),$ WITHOUT lRST TALKING TO YOUR HEALTHCARE PROVIDER s )F YOU STOP TAKING 342)"),$ 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. For more information about side effects, see the section “What are the possible side effects of STRIBILD?�

What is STRIBILD? STRIBILD is a prescription medicine that is used without other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) in adults who have never taken HIV-1 medicines before. HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

STRIBILD contains the prescription medicines elvitegravir, cobicistat, emtricitabine (EMTRIVAÂŽ) and tenofovir disoproxil fumarate (VIREADÂŽ).

It is not known if STRIBILD is safe and effective in children under 18 years of age.

When used to treat HIV-1 infection, STRIBILD may: s 2EDUCE THE AMOUNT OF ()6 IN YOUR BLOOD 4HIS IS CALLED hVIRAL LOADv s )NCREASE THE NUMBER OF #$ 4 CELLS IN YOUR BLOOD THAT HELP lGHT OFF OTHER infections.

Avoid doing things that can spread HIV-1 infection to others. s $O NOT SHARE OR RE USE NEEDLES OR OTHER INJECTION EQUIPMENT s $O NOT SHARE PERSONAL ITEMS THAT CAN HAVE BLOOD OR BODY mUIDS ON THEM LIKE TOOTHBRUSHES AND RAZOR BLADES s $O NOT HAVE ANY KIND OF SEX WITHOUT PROTECTION !LWAYS PRACTICE SAFER 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 about how to prevent passing HIV-1 to other people.

Who should not take STRIBILD? Do not take STRIBILD if you also take a medicine that contains: s ALFUZOSIN HYDROCHLORIDE 52/8!42!,ÂŽ) s CISAPRIDE 02/05,3)$ÂŽ 02/05,3)$ 15)#+3/,6ÂŽ) s ERGOT CONTAINING MEDICINES INCLUDING DIHYDROERGOTAMINE MESYLATE $ ( % ÂŽ, MIGRANALÂŽ) ERGOTAMINE TARTRATE #!&%2'/4ÂŽ -)'%2'/4ÂŽ %2'/34!4ÂŽ, MEDIHALER %2'/4!-).%ÂŽ, WIGRAINEÂŽ, WIGRETTESÂŽ) METHYLERGONOVINE MALEATE %2'/42!4%ÂŽ, METHERGINEÂŽ) s LOVASTATIN !$6)#/2ÂŽ !,4/02%6ÂŽ -%6!#/2ÂŽ) s ORAL MIDAZOLAM s PIMOZIDE /2!0ÂŽ) s RIFAMPIN 2)&!$).ÂŽ, RIFAMATEÂŽ, RIFATERÂŽ 2)-!#4!.%ÂŽ) s SILDENAlL 2%6!4)/ÂŽ), when used for treating the lung problem, pulmonary arterial hypertension (PAH) s SIMVASTATIN 3)-#/2ÂŽ 694/2).ÂŽ :/#/2ÂŽ) s TRIAZOLAM (!,#)/.ÂŽ) s 3T *OHN S WORT Hypericum perforatum OR A PRODUCT THAT CONTAINS 3T *OHN S WORT What should I tell my healthcare provider before taking STRIBILD? Before taking STRIBILD, tell your healthcare provider if you: s HAVE LIVER PROBLEMS INCLUDING HEPATITIS " INFECTION s HAVE KIDNEY PROBLEMS s HAVE BONE PROBLEMS s HAVE ANY OTHER MEDICAL CONDITIONS s ARE PREGNANT OR PLAN TO BECOME PREGNANT )T IS NOT KNOWN IF 342)"),$ CAN HARM your unborn baby. Tell your healthcare provider if you become pregnant while taking STRIBILD. Pregnancy Registry. 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. s ARE BREASTFEEDING OR PLAN TO BREASTFEED $O NOT BREASTFEED IF YOU TAKE 342)"),$ - 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.

You should not take STRIBILD if you also take: s ANY OTHER MEDICINES TO TREAT ()6 INFECTION s OTHER MEDICINES THAT CONTAIN TENOFOVIR !42)0,!ÂŽ #/-0,%2!ÂŽ, VIREADÂŽ, 4256!$!ÂŽ) s OTHER MEDICINES THAT CONTAIN EMTRICITABINE OR LAMIVUDINE #/-")6)2ÂŽ, EMTRIVAÂŽ, EPIVIRÂŽ or EPIVIR-HBVÂŽ %0:)#/-ÂŽ, TRIZIVIRÂŽ) s ADEFOVIR (%03%2!ÂŽ) Especially tell your healthcare provider if you take: s HORMONE BASED CONTRACEPTIVES BIRTH CONTROL PILLS AND PATCHES s AN ANTACID MEDICINE THAT CONTAINS ALUMINUM MAGNESIUM HYDROXIDE OR CALCIUM carbonate. Take antacids at least 2 hours before or after you take STRIBILD. s MEDICINES TO TREAT DEPRESSION s MEDICINES TO PREVENT ORGAN TRANSPLANT REJECTION

s MEDICINES TO TREAT HIGH BLOOD PRESSURE s ANY OF THE FOLLOWING MEDICINES AMIODARONE #/2$!2/.%ÂŽ 0!#%2/.%ÂŽ) ATORVASTATIN ,)0)4/2ÂŽ #!$5%4ÂŽ) BEPRIDIL HYDROCHLORIC 6!3#/2ÂŽ, BEPADINÂŽ) BOSENTAN 42!#,%%2ÂŽ) - buspirone CARBAMAZEPINE #!2"!42/,ÂŽ %0)4/,ÂŽ %15%42/ÂŽ 4%'2%4/ÂŽ) CLARITHROMYCIN ")!8).ÂŽ 02%60!#ÂŽ) CLONAZEPAM +,/./0).ÂŽ) CLORAZEPATE '%. 8%.%ÂŽ 42!.8%.%ÂŽ) COLCHICINE #/,#293ÂŽ) - medicines that contain dexamethasone DIAZEPAM 6!,)5-ÂŽ) DIGOXIN ,!./8).ÂŽ) DISOPYRAMIDE ./20!#%ÂŽ) ESTAZOLAM ETHOSUXIMIDE :!2/.4).ÂŽ) mECAINIDE 4!-"/#/2ÂŽ) mURAZEPAM mUTICASONE &,/6%.4ÂŽ &,/.!3%ÂŽ &,/6%.4ÂŽ $)3+53 &,/6%.4ÂŽ HFA, VERAMYSTÂŽ) ITRACONAZOLE 30/2!./8ÂŽ) KETOCONAZOLE .):/2!,ÂŽ) LIDOCAINE 89,/#!).%ÂŽ) - mexiletine OXCARBAZEPINE 42),%04!,ÂŽ) PERPHENAZINE PHENOBARBITAL ,5-).!,ÂŽ) - phenytoin (DILANTINÂŽ 0(%.94%+ÂŽ) PROPAFENONE 294(-/,ÂŽ) QUINIDINE .%5$%84!ÂŽ) RIFABUTIN -9#/"54).ÂŽ) - rifapentine (PRIFTINÂŽ) - risperidone (RISPERDALÂŽ 2)30%2$!, #/.34!ÂŽ) - salmeterol (SEREVENTÂŽ) or salmeterol when taken in combination with mUTICASONE !$6!)2 $)3+53ÂŽ, ADVAIR HFAÂŽ) - sildenafil (VIAGRAÂŽ TADALAlL #)!,)3ÂŽ) or vardenafil (LEVITRAÂŽ 34!89.ÂŽ), FOR THE TREATMENT OF ERECTILE DYSFUNCTION %$ )F YOU GET DIZZY OR FAINT LOW blood pressure), have vision changes or have an erection that last longer than HOURS CALL YOUR HEALTHCARE PROVIDER OR GET MEDICAL HELP RIGHT AWAY TADALAlL !$#)2#!ÂŽ), for the treatment of pulmonary arterial hypertension TELITHROMYCIN +%4%+ÂŽ) THIORIDAZINE VORICONAZOLE 6&%.$ÂŽ) WARFARIN #/5-!$).ÂŽ *!.4/6%.ÂŽ) ZOLPIDEM !-")%.ÂŽ %$,5,!2ÂŽ ).4%2-%::/ÂŽ :/,0)-)34ÂŽ) Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. Do not start any new medicines while you are taking STRIBILD without first talking with your healthcare provider or pharmacist. +NOW THE MEDICINES YOU TAKE +EEP A LIST OF YOUR MEDICINES AND SHOW IT TO YOUR healthcare provider and pharmacist when you get a new medicine.

How should I take STRIBILD? s 4AKE 342)"),$ EXACTLY AS YOUR HEALTHCARE PROVIDER TELLS YOU TO TAKE IT STRIBILD is taken by itself (not with other antiretroviral medicines) to treat HIV-1 infection. s 342)"),$ IS USUALLY TAKEN TIME EACH DAY s 4AKE 342)"),$ WITH FOOD s $O NOT CHANGE YOUR DOSE OR STOP TAKING 342)"),$ WITHOUT lRST TALKING WITH YOUR HEALTHCARE PROVIDER 3TAY UNDER A HEALTHCARE PROVIDER S CARE WHEN TAKING STRIBILD. s $O NOT MISS A DOSE OF 342)"),$ )F YOU MISS A DOSE OF 342)"),$ TAKE THE MISSED dose as soon as you remember. If it is almost time for your next dose of STRIBILD, do not take the missed dose. Take the next dose of STRIBILD at your regular time.

Do not take 2 doses at the same time to make up for a missed dose. s )F YOU TAKE TOO MUCH 342)"),$ CALL YOUR HEALTHCARE PROVIDER OR GO TO THE NEAREST hospital emergency room right away. s 7HEN YOUR 342)"),$ SUPPLY STARTS TO RUN LOW GET MORE FROM YOUR HEALTHCARE provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to STRIBILD and become harder to treat.

What are the possible side effects of STRIBILD? STRIBILD may cause the following serious side effects, including: s 3EE h7HAT IS THE MOST IMPORTANT INFORMATION ) SHOULD KNOW ABOUT 342)"),$ � s 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. s 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. s 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. s 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.

4HE MOST COMMON SIDE EFFECTS OF 342)"),$ INCLUDE s NAUSEA s 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 or pharmacist. #ALL YOUR HEALTHCARE PROVIDER FOR MEDICAL ADVICE ABOUT SIDE EFFECTS 9OU MAY REPORT side effects to FDA at 1-800-FDA-1088.

How should I store STRIBILD? s 3TORE 342)"),$ AT ROOM TEMPERATURE BETWEEN Â & TO Â & Â # TO Â # s +EEP 342)"),$ IN ITS ORIGINAL CONTAINER s +EEP THE CONTAINER TIGHTLY CLOSED s $O NOT USE 342)"),$ IF THE SEAL OVER THE BOTTLE OPENING IS BROKEN OR MISSING Keep STRIBILD and all medicines out of reach of children.

General information about STRIBILD. Medicines are sometimes prescribed for purposes other than those listed in a 0ATIENT )NFORMATION LEAmET $O NOT USE 342)"),$ FOR A CONDITION FOR WHICH IT WAS not prescribed. Do not give STRIBILD to other people, even if they have the same symptoms you have. It may harm them.

4HIS LEAmET SUMMARIZES THE MOST IMPORTANT INFORMATION ABOUT 342)"),$ )F YOU would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about STRIBILD that is written for health professionals. &OR MORE INFORMATION CALL OR GO TO WWW 342)"),$ COM What are the ingredients in STRIBILD? Active ingredients: elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate Inactive ingredients: lactose monohydrate, microcrystalline cellulose, silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, sodium lauryl sulfate, and magnesium stearate. The tablets are film-coated with a coating material CONTAINING INDIGO CARMINE &$ # BLUE ALUMINUM LAKE POLYETHYLENE GLYCOL

polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide.

4HIS 0ATIENT )NFORMATION HAS BEEN APPROVED BY THE 5 3 &OOD AND $RUG Administration.

-ANUFACTURED AND DISTRIBUTED BY Gilead Sciences, Inc. &OSTER #ITY #! )SSUED !UGUST

#/-0,%2! %-42)6! '),%!$ THE '),%!$ ,OGO '3) (%03%2!

342)"),$ THE 342)"),$ LOGO 4256!$!

AND 6)2%!$ ARE TRADEMARKS OF 'ILEAD 3CIENCES )NC OR ITS related companies. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, ,,# !LL OTHER MARKS REFERENCED HEREIN ARE THE PROPERTY OF THEIR RESPECTIVE OWNERS Š 2012 Gilead Sciences, Inc. All rights reserved. 1#

Let’s Get Real What is it about reality TV that makes it fertile ground for HIV-positive celebrities?

BROVERMAN

photos.com

By NEAL

26

hiv plus

• m ay/J U N E 2 0 1 2

N

ow hiv-positive people

are nearly impossible to find in movies or on scripted television. But there is a bright spot, and it’s on the small screen. For the past few years reality television has offered up at least half a dozen HIV-positive role models. Project Runway’s Jack Mackenroth and Mondo Guerra, Ongina from RuPaul’s Drag Race, Jamar Rogers from The Voice, David Munk on Sundance’s Girls Who Like Boys Who Like Boys, and John Gray from Bravo’s Top Design are not only accomplished in their careers, but many are also advocates for research and education, and speak out often against HIV stigma and discrimination.

At 2011’s U.S. Conference on AIDS, Mackenroth and Guerra promoted the Living Positive by Design campaign, sponsored by Merck. The two entrepreneurs talked with convention attendees about how people with HIV can maintain a positive outlook on life and how important it is to keep up with doctor’s appointments. Guerra, who won this year’s Project Runway All Stars, even participated in

NOVEMBER /DECEMBER 2012

•

RuPaul’s Drag Race star Ongina

hiv plus

27

one of the conference’s most high-profile discussions. “[Mackenroth and I] really want to convey to people living with the disease to continue to have a positive outlook on life,” Guerra tells HIV Plus. “It’s a really simple message, but a really important one that someone living with HIV may forget on a day-to-day basis.”

Mackenroth, who appeared on Project Runway’s fourth season and disclosed his status publicly after leaving the show for health reasons (not HIV-related), just launched Volttage.com, a dating and social networking site for HIV-positive men.

Since leaving that show, he’s never shied away from discussing his status and using his celebrity to battle ignorance.

“I’m not good at holding on to personal secrets, and I’m quite uncensored and outspoken,” Mackenroth says. “However, I can completely understand why others have difficulty with disclosure because of the massive stigma of living with HIV. I’ve had my share of unpleasant reactions, but it doesn’t bother me. I try to use those experiences as a chance to educate someone.”

Ongina (or Ryan Ong Palao), the bald beauty and fan favorite on the first season of RuPaul’s Drag Race, also wears her status proudly.

“It’s important that people with HIV are represented in a positive way, because being HIV-positive is not easy,” Ongina says. “People should continue to get care and attention if they are positive and stay well-protected and educated if they are negative.”

So why has reality TV produced so many HIV-positive celebrities, while actors and other high-profile people with the disease—models, athletes, fashion designers—seem so reluctant to disclose? “[Many reality TV personalities] never expected or aspired to be actors or celebrities, so our personas are not preconceived or contrived,” says Mackenroth, discussing why reality TV produces HIV-positive role models, rather than more traditional entertainment. Since some reality contestants are less concerned about their image, Mackenroth suggests, they’re less frightened about coming forward about their status.

Judging from the popularity of reality shows, people are invested in the person-

28

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• NOVEMBER /DECEMBER 2012

“People have a closer connection to reality TV stars versus scripted TV/film actors,” says Ongina.

COURTESY FX NE T WORKS

Clockwise from top left: Guerra (left) and Mackenroth at a recent AIDS Walk in New York; The Real World’s Zamora; Ongina; The Voice host Carson Daly (left) with Jamar Rogers

alities who appear on them. That attachment may make it more powerful, as opposed to celebrities who live their personal lives off-camera, when they disclose publicly.

“I think in some ways people have a closer connection to reality TV stars versus scripted TV/film actors,” Ongina says. “It’s more relatable when someone is watching reality TV and the person comes out as HIV-positive. It feels authentic.”

The most famous reality HIV activist was the genre’s first: Pedro Zamora, who starred on the third season of MTV’s The Real World in 1994. As sweet and funny as he was passionate and determined, Zamora put a face on the disease, and when he died just one day after the final episode of that season aired, it affected the nation, especially young people. Even President Bill Clinton publicly recognized Zamora’s influence.

Zamora’s boyfriend at the end of his life was Sean Sasser, who appeared frequently

on The Real World—the two men even had a wedding ceremony on the show. Sasser, now a pastry chef living in Portland, Ore., says his decision to showcase his life with Zamora on The Real World was something he didn’t spend much time thinking about.

“I was just being who I was at the time,” Sasser recalls. “Those of us afforded the opportunity to be on television see that it’s easier to just be honest with everything that we are, and HIV is just one of many different things you reveal about yourself when you’re in a reality TV situation.”

Eighteen years after appearing on The Real World, Sasser says HIV stigma is still intense, so much so that even female reality stars candid about their HIV are basically nonexistent, both he and Ongina acknowledge.

Maybe it will take reality stars leading the way for HIV-positive celebrities from film and scripted TV—and female reality stars—to follow suit. One thing is certain, seeing representations of HIVpositive people living full, healthy lives can radically alter perspectives for those living with the disease.

“If everyone came out about their status, it would diminish the stigma and draw attention to the need for a cure,” Mackenroth says. “It would also help dispel the many myths of living with HIV and take away much of the fears surrounding disclosure, treatment, and testing.” ✜

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ABOUT PREZISTA

ÂŽ

PREZISTAÂŽ is always taken with and at the same time as ritonavir (Norvir ÂŽ), in combination with other HIV medicines for the treatment of HIV infection in adults. PREZISTAÂŽ should also be taken with food. s 4HE USE OF OTHER MEDICINES ACTIVE AGAINST ()6 IN COMBINATION with PREZISTAÂŽ/ritonavir (Norvir ÂŽ MAY INCREASE YOUR ABILITY TO l GHT ()6 9OUR HEALTHCARE PROFESSIONAL WILL WORK WITH YOU TO l ND THE RIGHT combination of HIV medicines s )T IS IMPORTANT THAT YOU REMAIN UNDER THE CARE OF YOUR HEALTHCARE PROFESSIONAL DURING TREATMENT WITH 02%:)34!ÂŽ PREZISTAÂŽ 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.ÂŽ Please read Important Safety Information below, and talk to your healthcare professional to learn if PREZISTAÂŽ is right for you.

IMPORTANT SAFETY INFORMATION What is the most importa t information I should know about PREZISTAŽ? s 02%:)34!Ž can interact with other medicines and cause serious side effects. See “Who should not take PREZISTAŽ?� s 02%:)34!Ž may cause liver problems. 3OME PEOPLE TAKING PREZISTA,Ž TOGETHER WITH .ORVIR Ž (ritonavir), have developed liver PROBLEMS WHICH MAY BE LIFE THREATENING 9OUR HEALTHCARE PROFESSIONAL SHOULD DO BLOOD TESTS BEFORE AND DURING YOUR COMBINATION TREATMENT with PREZISTA.Ž 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 s 4ELL 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 s 02%:)34!Ž 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 02%:)34!ÂŽ 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 hPINK EYE v 2ASH OCCURRED MORE OFTEN IN PATIENTS TAKING PREZISTAÂŽ AND RALTEGRAVIR TOGETHER THAN WITH EITHER DRUG SEPARATELY

BUT WAS GENERALLY MILD Who should not take PREZISTAŽ? s $O NOT TAKE 02%:)34!Ž if you are taking the following medicines: alfuzosin (UroxatralŽ DIHYDROERGOTAMINE $ ( % Ž Embolex,Ž -IGRANALŽ ERGONOVINE ERGOTAMINE #AFERGOT Ž %RGOMAR Ž), METHYLERGONOVINE CISAPRIDE 0ROPULSIDŽ), pimozide (OrapŽ), oral midazolam, triazolam (HalcionŽ), the herbal supplement St. John’s wort (Hypericum perforatum), lovastatin (Mevacor,Ž Altoprev,Ž Advicor Ž), simvastatin (Zocor,Ž Simcor,Ž VytorinŽ), rifampin (Rifadin,Ž Rifater,Ž

Rifamate,Ž RimactaneŽ), sildenafil (RevatioŽ) when used to treat pulmonary arterial hypertension, indinavir (CrixivanŽ), lopinavir/ ritonavir (KaletraŽ), saquinavir (InviraseŽ), boceprevir (Victrelis™), or telaprevir (Incivek™) s "EFORE TAKING 02%:)34!,Ž tell your healthcare professional if you are TAKING SILDENAl L 6IAGRA Ž RevatioŽ), vardenafil (Levitra,Ž StaxynŽ), tadalafil (Cialis,Ž AdcircaŽ), atorvastatin (Lipitor Ž), rosuvastatin (Crestor Ž), pravastatin (PravacholŽ), or colchicine (Colcrys,Ž Col-ProbenecidŽ 4ELL YOUR HEALTHCARE PROFESSIONAL IF YOU ARE TAKING ESTROGEN BASED CONTRACEPTIVES BIRTH CONTROL 02%:)34!Ž MIGHT REDUCE THE EFFECTIVENESS OF ESTROGEN BASED CONTRACEPTIVES 9OU 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 PREZISTAŽ? s "EFORE TAKING 02%:)34!,Ž tell your healthcare professional if you have ANY MEDICAL CONDITIONS INCLUDING LIVER PROBLEMS INCLUDING HEPATITIS " OR # ALLERGY TO SULFA MEDICINES DIABETES OR HEMOPHILIA s 4ELL YOUR HEALTHCARE PROFESSIONAL IF YOU ARE PREGNANT OR PLANNING TO BECOME PREGNANT OR ARE BREASTFEEDING — The effects of PREZISTAŽ ON PREGNANT WOMEN OR THEIR UNBORN babies are not known. You and your healthcare professional will NEED TO DECIDE IF TAKING 02%:)34!Ž IS RIGHT FOR YOU — Do not breastfeed. It is not known if PREZISTAŽ 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 PREZISTAŽ? s (IGH BLOOD SUGAR DIABETES OR WORSENING OF DIABETES AND increased BLEEDING IN PEOPLE WITH HEMOPHILIA HAVE BEEN REPORTED IN PATIENTS TAKING PROTEASE INHIBITOR MEDICINES INCLUDING 02%:)34!Ž s #HANGES IN BODY FAT HAVE BEEN SEEN IN SOME PATIENTS TAKING HIV MEDICINES INCLUDING 02%:)34! Ž 4HE CAUSE AND LONG TERM HEALTH effects of these conditions are not known at this time s #HANGES IN YOUR IMMUNE SYSTEM CAN HAPPEN WHEN YOU START TAKING ()6 MEDICINES 9OUR IMMUNE SYSTEM MAY GET STRONGER AND BEGIN TO l GHT INFECTIONS THAT HAVE BEEN HIDDEN s 4HE MOST COMMON SIDE EFFECTS RELATED TO TAKING 02%:)34!Ž include DIARRHEA NAUSEA RASH HEADACHE STOMACH PAIN AND VOMITING 4HIS 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 02%:)34!Ž OR ANY OTHER MEDICINES WITHOUT l RST 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 ÂŽ) Product Information (PI and PPI) for additional information on precautionary measures.

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

28PRZDTC0288R8

PREZISTAÂŽ (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

ÂŽ

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 PREZISTAŽ (darunavir).

Once-Daily PREZISTAŽ taken with ritonavir and in combination with other HIV medications can help lower your viral load AND KEEP YOUR ()6 UNDER CONTROL OVER THE LONG TERM )N A CLINICAL STUDY OF ALMOST YEARS WEEKS OUT OF adults who had never taken HIV medications before maintained undetectable†viral loads with PREZISTAŽ plus ritonavir and Truvada.Ž Find out if the PREZISTAŽ 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 PREZISTAŽ/ritonavir 800/100 mg once daily (n=343) vs. KaletraŽ/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 Š 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 NORVIRÂŽ (ritonavir).

What is the most important information I should know about PREZISTA? t 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?� t PREZISTA may cause liver problems. Some people taking PREZISTA in combination with NORVIRŽ (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. t 5FMM ZPVS IFBMUIDBSF QSPWJEFS JG ZPV IBWF BOZ PG UIF CFMPX TJHOT BOE symptoms of liver problems. t %BSL UFB DPMPSFE VSJOF t ZFMMPXJOH PG ZPVS TLJO PS XIJUFT PG ZPVS FZFT t QBMF DPMPSFE TUPPMT CPXFM NPWFNFOUT

t OBVTFB t WPNJUJOH t QBJO PS UFOEFSOFTT PO ZPVS SJHIU TJEF CFMPX ZPVS SJCT t MPTT PG BQQFUJUF 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: t GFWFS t UJSFEOFTT t NVTDMF PS KPJOU QBJO t CMJTUFST PS TLJO MFTJPOT t NPVUI TPSFT PS VMDFST t SFE PS JOGMBNFE FZFT MJLF iQJOL FZFw DPOKVODUJWJUJT

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 QSPUFBTF JOIJCJUPS )*7 JT UIF WJSVT UIBU DBVTFT "*%4 "DRVJSFE *NNVOF %FGJDJFODZ 4ZOESPNF

When used with other HIV medicines, PREZISTA may help to reduce UIF BNPVOU PG )*7 JO ZPVS CMPPE DBMMFE iWJSBM MPBEw 13&;*45" NBZ BMTP IFMQ UP JODSFBTF UIF OVNCFS PG XIJUF CMPPE DFMMT DBMMFE $% 5 DFMM which help fight off other infections. Reducing the amount of HIV and JODSFBTJOH UIF $% 5 DFMM DPVOU NBZ JNQSPWF ZPVS JNNVOF TZTUFN This may reduce your risk of death or infections that can happen when your immune system is weak (opportunistic infections).

13&;*45" EPFT OPU DVSF )*7 JOGFDUJPO PS "*%4 BOE ZPV NBZ DPOUJOVF UP 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. t %P OPU TIBSF OFFEMFT PS PUIFS JOKFDUJPO FRVJQNFOU t %P OPU TIBSF QFSTPOBM JUFNT UIBU DBO IBWF CMPPE PS CPEZ GMVJET PO them, like toothbrushes and razor blades.

t % P OPU IBWF BOZ LJOE PG TFY XJUIPVU QSPUFDUJPO 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? %P OPU UBLF 13&;*45" with any of the following medicines: t alfuzosin (UroxatralŽ) t EJIZESPFSHPUBNJOF % ) & Ž, EmbolexŽ, MigranalŽ), ergonovine, ergotamine (CafergotŽ, ErgomarŽ) methylergonovine t cisapride t pimozide (OrapŽ) t oral midazolam, triazolam (HalcionŽ) t the herbal supplement St. John’s Wort (Hypericum perforatum) t the cholesterol lowering medicines lovastatin (MevacorŽ, AltoprevŽ, AdvicorŽ) or simvastatin (ZocorŽ, SimcorŽ, VytorinŽ) t rifampin (RifadinŽ, RifaterŽ, RifamateŽ, RimactaneŽ) t sildenafil (RevatioŽ) 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: t IBWF MJWFS QSPCMFNT JODMVEJOH IFQBUJUJT # PS IFQBUJUJT $ t BSF BMMFSHJD UP TVMGB NFEJDJOFT t IBWF IJHI CMPPE TVHBS EJBCFUFT

t IBWF IFNPQIJMJB t BSF QSFHOBOU PS QMBOOJOH UP CFDPNF QSFHOBOU *U JT OPU LOPXO JG 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. t BSF CSFBTUGFFEJOH PS QMBO UP CSFBTUGFFE %P OPU CSFBTUGFFE 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: t NFEJDJOF UP USFBU )*7 t FTUSPHFO CBTFE DPOUSBDFQUJWFT CJSUI DPOUSPM 13&;*45" NJHIU reduce the effectiveness of estrogen-based contraceptives. You must take additional precautions for birth control such as a condom. t NFEJDJOF GPS ZPVS IFBSU TVDI BT CFQSJEJM MJEPDBJOF 9ZMPDBJOF ViscousÂŽ), quinidine (NuedextaÂŽ), amiodarone (PaceroneÂŽ, CardaroneÂŽ), digoxin (Lanoxin ÂŽ), flecainide (Tambocor ÂŽ), propafenone (RythmolÂŽ) t XBSGBSJO $PVNBEJOÂŽ, JantovenÂŽ) t NFEJDJOF GPS TFJ[VSFT TVDI BT DBSCBNB[FQJOF $BSCBUSPMÂŽ, EquetroÂŽ, TegretolÂŽ, EpitolÂŽ QIFOPCBSCJUBM QIFOZUPJO %JMBOUJOÂŽ, PhenytekÂŽ) t NFEJDJOF GPS EFQSFTTJPO TVDI BT USB[BEPOF BOE EFTJQSBNJOF (NorpraminÂŽ) t DMBSJUISPNZDJO 1SFWQBDÂŽ, BiaxinÂŽ) t NFEJDJOF GPS GVOHBM JOGFDUJPOT TVDI BT LFUPDPOB[PMF /J[PSBMÂŽ), itraconazole (SporanoxÂŽ, OnmelÂŽ), voriconazole (VFendÂŽ) t DPMDIJDJOF $PMDSZTÂŽ, Col-ProbenecidÂŽ) t SJGBCVUJO .ZDPCVUJOÂŽ) t NFEJDJOF VTFE UP USFBU CMPPE QSFTTVSF B IFBSU BUUBDL IFBSU GBJMVSF or to lower pressure in the eye such as metoprolol (LopressorÂŽ, 5PQSPM 9-ÂŽ), timolol (CosoptÂŽ, BetimolÂŽ, TimopticÂŽ, IsatololÂŽ, CombiganÂŽ) t NJEB[PMBN BENJOJTUFSFE CZ JOKFDUJPO t NFEJDJOF GPS IFBSU EJTFBTF TVDI BT GFMPEJQJOF 1MFOEJMÂŽ), nifedipine (ProcardiaÂŽ, Adalat CCÂŽ, Afeditab CRÂŽ), nicardipine (CardeneÂŽ)

IMPORTANT PATIENT INFORMATION t T UFSPJET TVDI BT EFYBNFUIBTPOF GMVUJDBTPOF "EWBJS %JTLVTÂŽ, VeramystÂŽ, FloventÂŽ, FlonaseÂŽ) t CPTFOUBO 5SBDMFFSÂŽ) t N FEJDJOF UP USFBU DISPOJD IFQBUJUJT $ TVDI BT CPDFQSFWJS (VictrelisTM), telaprevir (IncivekTM) t NFEJDJOF GPS DIPMFTUFSPM TVDI BT QSBWBTUBUJO 1SBWBDIPMÂŽ), atorvastatin (LipitorÂŽ), rosuvastatin (CrestorÂŽ) t NFEJDJOF UP QSFWFOU PSHBO USBOTQMBOU GBJMVSF TVDI BT DZDMPTQPSJOF (GengrafÂŽ, SandimmuneÂŽ, NeoralÂŽ), tacrolimus (PrografÂŽ), sirolimus (RapamuneÂŽ) t TBMNFUFSPM "EWBJSÂŽ, SereventÂŽ) t NFEJDJOF GPS OBSDPUJD XJUIESBXBM TVDI BT NFUIBEPOF .FUIBEPTFÂŽ, %PMPQIJOF )ZESPDIMPSJEF CVQSFOPSQIJOF #VUSBOTÂŽ, BuprenexÂŽ, SubutexÂŽ), buprenorphine/naloxone (SuboxoneÂŽ) t NFEJDJOF UP USFBU TDIJ[PQISFOJB TVDI BT SJTQFSJEPOF 3JTQFSEBMÂŽ), thioridazine t NFEJDJOF UP USFBU FSFDUJMF EZTGVODUJPO PS QVMNPOBSZ IZQFSUFOTJPO such as sildenafil (ViagraÂŽ, RevatioÂŽ), vardenafil (LevitraÂŽ, StaxynÂŽ), tadalafil (CialisÂŽ, AdcircaÂŽ) t NFEJDJOF UP USFBU BOYJFUZ EFQSFTTJPO PS QBOJD EJTPSEFS TVDI BT sertraline (ZoloftÂŽ), paroxetine (PaxilÂŽ) 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 EPDUPS PS QIBSNBDJTU XIFO ZPV HFU B OFX NFEJDJOF %P OPU TUBSU BOZ new medicines while you are taking PREZISTA without first talking with your healthcare provider.

How should I take PREZISTA? t 5BLF 13&;*45" FWFSZ EBZ FYBDUMZ BT QSFTDSJCFE CZ ZPVS IFBMUIDBSF provider. t :PV NVTU UBLF SJUPOBWJS /037*3ÂŽ) at the same time as PREZISTA. t %P OPU DIBOHF ZPVS EPTF PG 13&;*45" PS TUPQ USFBUNFOU XJUIPVU talking to your healthcare provider first. t 5BLF 13&;*45" BOE SJUPOBWJS /037*3ÂŽ) with food. t 4XBMMPX 13&;*45" UBCMFUT XIPMF XJUI B ESJOL *G ZPV IBWF EJGGJDVMUZ 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. t 13&;*45" PSBM TVTQFOTJPO TIPVME CF HJWFO XJUI UIF TVQQMJFE PSBM dosing syringe. Shake the suspension well before each usage. t *G ZPV UBLF UPP NVDI 13&;*45" DBMM ZPVS IFBMUIDBSF QSPWJEFS PS HP 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: t *G ZPV NJTT B EPTF PG 13&;*45" CZ MFTT UIBO IPVST UBLF ZPVS missed dose of PREZISTA right away. Then take your next dose of PREZISTA at your regularly scheduled time. t *G ZPV NJTT B EPTF PG 13&;*45" CZ NPSF UIBO IPVST XBJU BOE UIFO take the next dose of PREZISTA at your regularly scheduled time.

People who take PREZISTA two times a day t *G ZPV NJTT B EPTF PG 13&;*45" CZ MFTT UIBO IPVST UBLF ZPVS missed dose of PREZISTA right away. Then take your next dose of PREZISTA at your regularly scheduled time. t *G ZPV NJTT B EPTF PG 13&;*45" CZ NPSF UIBO IPVST XBJU BOE UIFO take the next dose of PREZISTA at your regularly scheduled time. *G B EPTF PG 13&;*45" JT TLJQQFE EP OPU EPVCMF UIF OFYU EPTF %P OPU 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: t 4FF “What is the most important information I should know about PREZISTA?� t %JBCFUFT BOE IJHI CMPPE TVHBS IZQFSHMZDFNJB 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. t Changes in body fat. These changes can happen in people who take antiretroviral therapy. The changes may include an increased BNPVOU PG GBU JO UIF VQQFS CBDL BOE OFDL iCVGGBMP IVNQw CSFBTU 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.

t 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. t Increased bleeding for hemophiliacs. Some people with hemophilia have increased bleeding with protease inhibitors including PREZISTA. The most common side effects of PREZISTA include: t EJBSSIFB t IFBEBDIF t OBVTFB t BCEPNJOBM QBJO t SBTI t WPNJUJOH 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 TJEF FGGFDUT UP UIF '%" BU '%" How should I store PREZISTA? t 4UPSF 13&;*45" PSBM TVTQFOTJPO BOE UBCMFUT BU SPPN UFNQFSBUVSF < ÂĄ' ÂĄ$ > t %P OPU SFGSJHFSBUF PS GSFF[F 13&;*45" PSBM TVTQFOTJPO t ,FFQ 13&;*45" BXBZ GSPN IJHI IFBU t 13&;*45" PSBM TVTQFOTJPO TIPVME CF TUPSFE JO UIF PSJHJOBM DPOUBJOFS Keep PREZISTA and all medicines out of the reach of children.

General information about PREZISTA Medicines are sometimes prescribed for purposes other than those MJTUFE JO B 1BUJFOU *OGPSNBUJPO MFBGMFU %P OPU VTF 13&;*45" GPS B DPOEJUJPO GPS XIJDI JU XBT OPU QSFTDSJCFE %P OPU HJWF 13&;*45" UP 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.

'PS NPSF JOGPSNBUJPO DBMM 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, IZESPDIMPSJD BDJE GPS Q) BEKVTUNFOU QVSJGJFE XBUFS PREZISTA 75 mg and 150 mg Tablets: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose. The film DPBUJOH DPOUBJOT 01"%3:ÂŽ 8IJUF QPMZFUIZMFOF HMZDPM QPMZWJOZM alcohol-partially hydrolyzed, talc, titanium dioxide).

PREZISTA 400 mg and 600 mg Tablets: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose. The film DPBUJOH DPOUBJOT 01"%3:Ž 0SBOHF '% $ :FMMPX /P ø QPMZFUIZMFOF HMZDPM QPMZWJOZM BMDPIPM QBSUJBMMZ IZESPMZ[FE UBMD UJUBOJVN EJPYJEF

5IJT 1BUJFOU *OGPSNBUJPO IBT CFFO BQQSPWFE CZ UIF 6 4 'PPE BOE %SVH Administration.

Manufactured by: PREZISTA Oral Suspension Janssen Pharmaceutica, N.V. Beerse, Belgium PREZISTA Tablets +BOTTFO 0SUIP --$ (VSBCP 13 Manufactured for: +BOTTFO 5IFSBQFVUJDT %JWJTJPO PG +BOTTFO 1SPEVDUT -1 5JUVTWJMMF /+

NORVIRÂŽ is a registered trademark of its respective owner.

PREZISTAÂŽ is a registered trademark of Janssen Pharmaceuticals ÂŞ +BOTTFO 1IBSNBDFVUJDBMT *OD 3FWJTFE +VOF 1

Miranda Penn Turin/FOX

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Along Came Pauley This NCIS star is reinventing what it means to be the “girl next door” and making sure everyone gets in on the fight against HIV

By Diane Anderson-Minshall

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ith her gothy punk clothes and Bettie Page bangs, Pauley Perrette still looks a bit like the New York club scene bartender she once was— minus the white Mohawk that first attracted TV producers and modeling agents in the ’90s.

Today, as Abby Sciuto, the forensic wunderkind with a heart of gold on CBS’s number 1 drama, NCIS, Perrette is one of television’s most popular actresses. She’s also one of the most active in support of HIV causes. In August, Project Angel Food, a Los Angeles–based organization that’s prepared and delivered more than 7 million meals to people with HIV/AIDS or other life-threatening illnesses since 1989, honored Perrette, an active board member, for her philanthropic leadership. How the actress found the time (Project Angel Food is one of 30 charities she’s involved with, including groups focusing on marriage equality, global disaster assistance, and animal rights) is another story altogether. We caught up with the New Orleans–born Perrette to talk about why activism is important, the role churches should play in HIV outreach, and what it was like to portray an HIVpositive woman on the silver screen.

“For young people, the medications are working well enough to let people live their lives so well that people think HIV is over. And it’s so not over.”

Why is using your celebrity to further causes, especially HIV and AIDS awareness, important to you? I have a lot of experiences that really shaped that.

I remember once when I first moved to New York City, when I was like 21.This was before the drug cocktail, and the environment around HIV had not even evolved to where it is now. But it was Christmas Eve and I was alone in New York, and I didn’t have any money at all [laughs], I was always broke and alone. So, I went down to 14th Street and bought a little bag of Christmas tree balls and took them over to St. Vincent’s Hospital and went up to the HIV ward. I just went in and gave them each a little Christmas ball. What struck me the most was that everyone in there was alone, and that really broke my heart.

I remember when so many of my friends were dying. Fortunately, I missed the first wave of where everybody was dying. I think a lot about all of the wonderful things that are happening with HIV research. I have so many friends now who are HIV-positive and they’re living completely normal, healthy lives. But also for young people, the medications are working well enough to let people live their lives so well that people think HIV is over. And it’s so not over.

There’s a huge percentage of people who don’t know they’re positive, and many people actually get diagnosed so late in the game their HIV turns into AIDS. That happened to my friend. He just had no idea and just got sick and died.

It was fast. The part about getting the word out there and being careful is so important, and then just as a civil rights activist, it’s so important to take this stigma away, because that’s so heartbreaking to me. I want people to see me with my arms wrapped around my friends who are HIV-positive. Another thing that’s been really important is that I go to this amazing church in Hollywood that’s over 100 years old.

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Hollywood United Methodist, right?

Right, and it’s right in the center of Hollywood and our giant bell tower is there and the two big beautiful red ribbons are there and it means so much to me. A lot of bigotry [against gay and HIV-positive people] started at the church level, and we have a responsibility to combat that.

You were born in New Orleans. The South right now is one of the regions with the most HIV transmissions and the least amount of HIV education in the country. Well, those two things are a self-fulfilling prophecy. How can it be something that you can’t talk about because it’s evil or whatever baloney they say? Then how on earth are you supposed to get education out there to people to protect themselves?

You’ve actually played an HIV-positive woman, in the 2009 film To Comfort You. What was that like? There was a lot going on with that film. It was a really beautiful and heavy film. I remember when I was preparing for that and lost a lot of weight to play that role. The people that I made that movie with, we all had to volunteer with Project Angel Food. Now I’m on the board there.

Why haven’t we seen more portrayals of people with HIV? I think people are still scared and they still don’t know enough. Also, when HIV and AIDS has been portrayed, there hasn’t been much about someone getting sick and then getting better. It’s interesting that you just said that, because my fiancé, he’s now in the restaurant business, but when he was in his 20s he played the lead in one of the first movies about someone who was HIVpositive.

What was the name of it?

Heaven’s a Drag. That was 1994, and it was a big deal they made a movie about someone with AIDS.

Tell us about being honored by Project Angel Food. It was a huge, huge honor. It was the same award given to Elizabeth Taylor and Sharon Stone. It was pretty huge. All the people from Project Angel Food were there, and that was amazing because they’re just people who volunteer there, writers and directors and people that work on films. The beauty of Project Angel Food is that [its clients] not only look forward to the food and nourishment but also the company—somebody just coming by and saying hello and checking on them.

from left: ge tt y images; COURTESY Cbs; ge tt y images

Let’s talk about your career a little bit. Does your background in criminal science help on set? I can promise you this, my background in sociology has absolutely been paramount to being a civil rights activist. I love sociology, it’s my science.

And it really is understanding people and society and the way we interact with each other. It’s just created an incredible base for me as an actor and a civil rights activist.

You’ve been on NCIS since 2003. Was there a moment in your career when you felt like, OK, I really made it?

Not really. But this is true: I’m extremely frugal. I don’t wear any jewelry. All of my clothes come from Out of the Closet thrift stores. And I always say that on the red carpet, because all the money I spend on my dresses goes towards AIDS research.

[Reporters] will ask, “Who are you wearing?” And I always say, “AIDS research!”

But I’m such a private person and fame is so uncomfortable for me. Sometimes I have the feeling, What have I done to my life?

You’re ranked as one of the most likable celebrities. What’s your secret?

From left: Perrette poses before walking in L.A.’s AIDS Walk; as Abby on the hit CBS drama NCIS; at Art Project Los Angeles with AIDS Project Los Angeles executive director Craig Thompson.

I don’t know! I think a lot of that has to do with people loving Abby, my character. But I’ve always been a volunteer, I’ve always been doing these things, I’ve always been rescuing animals—I have three of them sleeping on me right now! A lot of the acts of kindness we can do are the easiest things in the world. The most powerful thing you can do is free, and that’s to be kind. ✜

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WHATâ&#x20AC;&#x2122;S UP BELOW THE

MASON DIXON? HIV runs rampant among Southern teenagers, but one organization is changing that by MICHELLE GARCIA

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tatistically, a 16-year-old girl in Mississippi has a lot going against her. Her school will probably never provide much sexual education. If it does, the lesson plan consists of antigay, abstinence-only views, even though she and her friends have probably already had sex; it’s likely that she or one of her friends is pregnant or will become pregnant before donning a cap and gown; and because one third of the kids in her group of friends didn’t use a condom the last time they had sex, one of them probably has a sexually transmitted infection such as chlamydia, gonorrhea, or HIV. On top of all that, this Mississippi girl also faces a high likelihood of illiteracy, and the quality of education she receives ranks among the lowest in the nation. Many of these statistics apply to young people in the surrounding states too. Adolescents living below the Mason-Dixon Line are subject to conservative attitudes that persist when it comes to educating children and teenagers about HIV, reproduction, and safe sex.

A trip halfway up the Appalachian Mountains to the nation’s capital shows many of the same statistics. In fact, the annual rate of AIDS diagnoses in the District of Columbia—which is technically located in the American South—is astronomically higher than the rate in almost every other city in the nation, and people ages 13-25 are hit particularly hard. But one major difference between D.C. teenagers and their peers in Mississippi or Arkansas is a significant community ally, Metro Teen AIDS. The organization, founded nearly 25 years ago, has seen many changes over the years, but the sole focus on youth has remained constant. Metro Teen AIDS executive director Adam Tenner spent the first half of his tenure at the organization turning things around. In 2001, Metro Teen AIDS was $150,000 in debt, and it had maxed out its $50,000 line of credit.

Once Tenner led the organization out of the hole, big changes came. The secret has been allowing its young clientele to guide the direction of the organization.

“Teenagers can recognize when something is coming from an adult,” Tenner says. That’s why there are upwards of 40 paid young people on staff. “We know 40

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they’re the best messengers, so we arm them with the right information.”

Tenner says Metro Teen AIDS has found success by letting its army of young people lead the efforts to reach thousands of their peers each year. One of its biggest successes, lobbying for the passage of D.C.’s in-school sexual education policy in 2007, has led to the group being the main provider of sex ed in the district’s schools. That means Metro Teen AIDS directly reaches 25,000 young people every year, a rarity in a nation where, according to the National Conference of State Legislatures, 33 states require schools to educate students on HIV, but only 18 states and the District of Columbia require public schools to offer scientific, age-appropriate sexual education, which includes information on HIV. Kevin Fenton, MD, of the Centers for Disease Control and Prevention says frank talk on sexuality and sexual health is important to any effort drive down the rate of infection and teen pregnancy. Because of programs like Metro Teen AIDS’s school outreach, the numbers in D.C. are becoming less dire. But the CDC is trying to encourage more conservative states and school districts to institute more comprehensive sexual education to reduce the transmission rate of STIs as well.

Most Southern states condemn such policies, but that’s why the CDC is now attempting to engage post–high school young adults in prevention and education efforts. Metro Teen AIDS was in the forefront of understanding what parents wanted, so it could build a parent-approved curriculum to which legislators would not object, which was key to instituting com-

prehensive sexual education in the school district.

“We polled parents in the city, and I feel like we understand what they want, and they believe that school is the best place to get the science-based, factual information about HIV and sex,” Tenner says. “So they take on the responsibility to talk about the ethical and emotional aspects of sex and HIV. We’re able to say that about 98% of D.C. parents say this is what they want,

No Data Available 0 to 40 41 to 66 67 to 102 103 to 173 174 to 385 386+

mostly because they have anxiety about the increasing numbers of young people with HIV.” After that victory came a more specialized strategy for Metro Teen AIDS, says Tenner, who credits a great deal of the organization’s success to its diverse young staff, which is broken into teams that reflect who they are, including teams for young women, LGBT youth, and street kids. Freestyle, the group’s after-school

drop-in center, sounds more like a hip lounge than a health educational center.

It is also a place to learn about HIV with programs like the Where My Girls At? group for young women on Wednesdays, a T-shirt design group, and an open mike night for budding performers. Metro Teen AIDS also embraces social media marketing with teen-led efforts like RealTalkDC, a campaign that, as its website says, reaches teens “where they are—online, on cell

2009 Rate of adults and adolescents living with an HIV diagnosis per 100,000 population according to AIDSVu.org

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Model

INDICATIONS ISENTRESS速 (raltegravir) is a prescription HIV-1 medicine used with other HIV medicines to treat adults with human immunodeficiency virus (HIV-1) infection. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

The use of other medicines active against HIV-1 in combination with ISENTRESS may increase your ability to fight HIV. ISENTRESS does not cure HIV infection or AIDS. Patients must stay on continuous HIV therapy to control infection and decrease HIV-related illnesses.

IMPORTANT RISK INFORMATION Severe, potentially life-threatening, and fatal skin reactions and allergic reactions have been reported in some patients taking ISENTRESS. If you develop a rash with any of the following symptoms, stop using ISENTRESS and contact your doctor right away: fever, generally ill feeling, extreme tiredness, muscle or joint aches, blisters or sores in mouth, blisters or peeling of skin, redness or swelling of the eyes, swelling of the mouth or face, problems breathing.

Sometimes allergic reactions can affect body organs, like the liver. Contact your doctor right away if you have any of the following signs or symptoms of liver problems: yellowing of the skin or whites of the eyes, dark or tea-colored urine, pale-colored stools/bowel movements, nausea/vomiting, loss of appetite, pain, aching or tenderness on the right side below the ribs.

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.

Tell your doctor right away if you start having new symptoms after starting your HIV medicine.

People taking ISENTRESS may still develop infections or other conditions associated with HIV infections.

The most common side effects of ISENTRESS include: headache, trouble sleeping, nausea, and tiredness. Less common side effects include: weakness, stomach pain, dizziness, depression, and suicidal thoughts and actions.

I am a catch.

I am a team player.

I am spiritual.

I am HIV positive.

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

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

In a clinical study lasting 156 weeks, patients being treated with HIV medication for the first time who took ISENTRESS® (raltegravir) plus Truvada: Had a low rate of side effects — The most common side effects of moderate to severe intensity (that interfered with or kept patients from performing daily activities) were trouble sleeping (4%), headache (4%), nausea (3%), tiredness (2%) In a clinical study lasting 156 weeks, cholesterol was measured at week 144 and patients who took ISENTRESS plus Truvada experienced less effect on LDL cholesterol (“bad” cholesterol): — Cholesterol increased an average of 7 mg/dL with ISENTRESS plus Truvada versus 22 mg/dL with Sustiva plus Truvada — When they began the study, the average LDL cholesterol of patients on ISENTRESS plus Truvada was 97 mg/dL versus 92 mg/dL for those on Sustiva plus Truvada

Ask your doctor about ISENTRESS. Not sure where to start? Visit isentress.com/questions Tell your doctor right away if you get unexplained muscle pain, tenderness, or weakness while taking ISENTRESS. This may be a sign of a rare but serious muscle problem that can lead to kidney problems.

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

Tell your doctor about all your medical conditions, including if you are pregnant or plan to become pregnant. It is not known if ISENTRESS can harm your unborn baby. Also tell your doctor if you are breastfeeding or plan to breastfeed.

You should not breastfeed if you have HIV because of the risk of passing HIV to your baby.

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

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

Please read the Patient Information on the adjacent page for more detailed information.

Need help paying for ISENTRESS? Call 1-866-350-9232

Brands mentioned are the trademarks of their respective owners.

Copyright © 2012 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved.

INFC-1052215-0000 09/12

Patient Information ISENTRESS ÂŽ (eye sen tris) (raltegravir) Film-Coated Tablets Read this Patient Information before you start taking ISENTRESS and each time you get a refill.

There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is ISENTRESS? ISENTRESS is a prescription HIV medicine used with other HIV medicines to treat adults with human immunodeficiency virus (HIV-1) infection. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

When used with other HIV medicines, ISENTRESS may reduce the amount of HIV in your blood (called â&#x20AC;&#x153;viral loadâ&#x20AC;?). ISENTRESS may also help to increase the number of CD4 (T) cells in your blood 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).

ISENTRESS does not cure HIV infection or AIDS. People taking ISENTRESS may still develop infections or other conditions associated with HIV infection. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infections.

Patients must stay on continuous HIV therapy to control infection and decrease HIV-related illnesses.

Avoid doing things that can spread HIV-1 infection to others: t Do not share needles or other injection equipment. t Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades. t Do 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 doctor if you have any questions on how to prevent passing HIV to other people.

What should I tell my doctor before taking ISENTRESS? Before taking ISENTRESS, tell your doctor if you: t IBWF MJWFS QSPCMFNT t IBWF BOZ PUIFS NFEJDBM DPOEJUJPOT t are pregnant or plan to become pregnant. It is not known if ISENTRESS can harm your unborn baby.

Pregnancy Registry: You and your doctor will need to decide if taking ISENTRESS is right for you. If you take ISENTRESS while you are pregnant, talk to your doctor about how you can be included in the Antiretroviral Pregnancy Registry. The purpose of the registry is to follow the health of you and your baby. t are breastfeeding or plan to breastfeed.

- Do not breastfeed if you are taking ISENTRESS. You should not breastfeed if you have HIV because of the risk of passing HIV to your baby.

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

Tell your doctor about all the medicines you take, including: prescription and nonprescription medicines, vitamins, and herbal supplements. Taking ISENTRESS and certain other medicines may affect each other causing serious side effects. ISENTRESS may affect the way other medicines work and other medicines may affect how ISENTRESS works.

Especially tell your doctor if you take: t SJGBNQJO 3JGBEJO 3JGBNBUF 3JGBUFS 3JNBDUBOF B NFEJDJOF DPNNPOMZ VTFE to treat tuberculosis.

Ask your doctor or pharmacist if you are not sure whether any of your medicines are included in the list above.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. Do not start any new medicines while you are taking ISENTRESS without first talking with your doctor.

How should I take ISENTRESS? t Take ISENTRESS exactly as prescribed by your doctor. t :PV TIPVME TUBZ VOEFS UIF DBSF PG ZPVS EPDUPS XIJMF UBLJOH *4&/53&44 t Do not change your dose of ISENTRESS or stop your treatment without talking with your doctor first. t 5BLF *4&/53&44 CZ NPVUI XJUI PS XJUIPVU GPPE t *4&/53&44 'JMN $PBUFE 5BCMFUT NVTU CF TXBMMPXFE XIPMF t *G ZPV NJTT B EPTF UBLF JU BT TPPO BT ZPV SFNFNCFS *G ZPV EP OPU SFNFNCFS VOUJM JU is time for your next dose, skip the missed dose and go back to your regular schedule.

Do not double your next dose or take more than your prescribed dose. t If you take too much ISENTRESS, call your doctor or go to the nearest emergency room right away. t %P OPU SVO PVU PG *4&/53&44 (FU ZPVS *4&/53&44 SFmMMFE GSPN ZPVS EPDUPS PS QIBSNBDZ before you run out.

What are the possible side effects of ISENTRESS? ISENTRESS can cause serious side effects including: t Serious skin reactions and allergic reactions. Severe, potentially life-threatening and fatal skin reactions and allergic reactions have been reported in some patients taking ISENTRESS. If you develop a rash with any of the following symptoms, stop using ISENTRESS and contact your doctor right away: ° fever ° muscle or joint aches ° redness or swelling of the eyes ° generally ill feeling ° blisters or sores in mouth ° swelling of the mouth or face ° extreme tiredness ° blisters or peeling of the skin ° problems breathing Sometimes allergic reactions can affect body organs, like the liver. Contact your doctor right away if you have any of the following signs or symptoms of liver problems: ° yellowing of the skin or whites of the eyes ° dark or tea colored urine ° pale colored stools/bowel movements ° nausea/vomiting ° loss of appetite ° pain, aching or tenderness on the right side below the ribs

t 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. Tell your doctor right away if you start having new symptoms after starting your HIV medicine.

The most common side effects of ISENTRESS include: t IFBEBDIF t OBVTFB t USPVCMF TMFFQJOH t UJSFEOFTT Less common side effects include: t XFBLOFTT t EFQSFTTJPO t TUPNBDI QBJO t TVJDJEBM UIPVHIUT BOE BDUJPOT t EJ[[JOFTT Tell your doctor right away if you get unexplained muscle pain, tenderness, or weakness while taking ISENTRESS. This may be a sign of a rare but serious muscle problem that can lead to kidney problems.

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

Tell your doctor if you have any side effect that bothers you or that does not go away.

5IFTF BSF OPU BMM UIF QPTTJCMF TJEF FGGFDUT PG *4&/53&44 'PS NPSF JOGPSNBUJPO BTL ZPVS doctor or pharmacist. $BMM ZPVS EPDUPS GPS NFEJDBM BEWJDF BCPVU TJEF FGGFDUT :PV NBZ SFQPSU TJEF FGGFDUT UP '%" BU '%" How should I store ISENTRESS? 'JMN $PBUFE 5BCMFUT t 4UPSF *4&/53&44 'JMN $PBUFE 5BCMFUT BU SPPN UFNQFSBUVSF CFUXFFO ÂĄ' UP ÂĄ' ÂĄ$ UP ÂĄ$

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

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

This leaflet gives you the most important information about ISENTRESS. If you would like to know more, talk with your doctor. You can ask your doctor or pharmacist for information about ISENTRESS that is written for health professionals.

'PS NPSF JOGPSNBUJPO HP UP XXX *4&/53&44 DPN PS DBMM

What are the ingredients in ISENTRESS? ISENTRESS Film-Coated Tablets: Active ingredient: raltegravir Inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium phosphate EJCBTJD BOIZESPVT IZQSPNFMMPTF QPMPYBNFS DPOUBJOT CVUZMBUFE hydroxytoluene as antioxidant), sodium stearyl fumarate, magnesium stearate.

The film coating contains: QPMZWJOZM BMDPIPM UJUBOJVN EJPYJEF QPMZFUIZMFOF HMZDPM UBMD red iron oxide and black iron oxide.

5IJT 1BUJFOU *OGPSNBUJPO IBT CFFO BQQSPWFE CZ UIF 6 4 'PPE BOE %SVH "ENJOJTUSBUJPO

Distributed by: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, USA 3FWJTFE "QSJM 6411* 5 3 $PQZSJHIU ÂŞ .FSDL 4IBSQ %PINF $PSQ B TVCTJEJBSZ PG Merck & Co., Inc. All rights reserved. */'$ 6 4 1BUFOU /PT 64

oNLY 18 STATES AND THE DISTRICT OF COLUMBIA REQUIRE PUBLIC SCHOOLS TO OFFER SCIENTIFIC, AGEAPPROPRIATE SEXUAL EDUCATION, WHICH INCLUDES INFORMATION ON HIV.

phones, at school, and in the streets.”

“The thing that makes me smile is giving young people the tools to be able to go out into their networks and go to parties that I’m certainly not getting invited to, and bring the information out to where the traditional messaging doesn’t work,” Tenner says.

It also helps that the Metro Teen AIDS materials are designed to catch a teenager’s eye, and the messaging is heavily guided by young people in order to maintain a decidedly unstodgy voice.

“Our materials are very youth-friendly and well-designed and colorful,” Tenner says. “We also use a texting feature so kids can get texted to find out where to get tested, where to get a condom, and where to get information.”

Tenner reminds health policy advocates that young people need to be represented when it comes to making decisions that could affect their futures.

“We can’t be afraid to be advocates,” he says. “I think our success, in no small part, is not only being a consistent provider, but we’ve been critical, even of our supporters, when talking about the needs of young people. It’s especially easy for politicians to gloss over the needs of older teenagers and young adults.”

Programs like Metro Teen AIDS not only educate teens and young adults about HIV and sexuality but also provide community-wide improvements.

“Young people’s grades increase when they can give back to their community,” Tenner says. “It’s like an investment in your community as well as their futures.

Engaging and improving their communities helps them in ways that aren’t even visible.” ✜

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you 2.0 nutrition

Coconut oil may stave off thrush.

Six Ways to Treat Candida Naturally Can one of HIV’s annoying side effects be prevented? one of the most common side effects of HIV is a candida overgrowth, otherwise known as candidiasis, yeast infection, or thrush.

Candida albicans is a natural part of the intestinal flora, but it can easily turn into an infection when a person has a weakened immune system or when antibiotics eliminate good bacteria. In these situations, the yeast that is typically eaten by probiotics (the good bacteria) goes unchecked and grows out of control, something doctors noticed in the early days of HIV. Commonly misdiagnosed or mistreated, yeast infections are typically found in the throat, vagina, or digestive tract. Symptoms include white curd-like patches in the mouth or throat; vaginal itching, burning, and discharge; and chronic abdominal bloating or painful gas. In most cases these infections are not serious, but for people with HIV, the fungal growth can become lifethreatening.

Anthony Salzarulo, a holistic health practitioner in New York City, says holistic approaches can reduce the chances of a yeast overgrowth, keeping candida in check.

“It’s more about how to balance the ecology of the body so the body is no longer a favorable host for the candida overgrowth,” says Salzarulo. “When it’s looked at in that way, then the chances of successful treatment increase exponentially.”

Natural treatment, he says, is a lifestyle change, not just a quick fix—but it beats prescription medication: “I think non-

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holistic approaches have very poor results. In my opinion, that’s why so many people come to me for this problem.”

Here are some natural remedies recommended by Salzarulo: 1. Sleep. Maintaining a healthy immune system means getting enough rest on a regular schedule.

2. Eat healthier. Avoiding refined sugars and carbohydrates will promote faster recovery from an infection, as sugars feed candida growth. Ditch alcohol and white flour altogether until the body regains its inner ecology.

Add healthy fats such as fish oil, organic raw butter, and extra virgin coconut oil, which reduce bacterial growth. Increase fiber intake with dark leafy green vegetables, which promote digestive function.

3. Get moving. Exercise

• November /december 2012

increases energy levels, mental alertness, and feelings of wellbeing, and it helps fight fatigue caused by candida. Even better: Aerobic exercise requires extensive amounts of oxygen that starve the yeast cells and kill candida growth. Running, dancing, swimming, and biking are all good forms of exercise that’ll help cleanse your body of candida overgrowth.

4. Get regular. You may want to increase your number of bowel movements. Without excretion, dead microbes remain stagnant in the body, making it impossible for antifungals and probiotics to do their job, halting treatment altogether. Consuming fiber, magnesium, and plenty of water, placing hot castor oil packs on the abdomen, and having colonics are a few things to try.

5. Add probiotics. Adding probiotics—which are in yogurt, kefir, miso, and soy products—to a candida cleanse diet will increase beneficial bacteria and fight off the infection. The good bacteria eat yeast and bring the body back to a healthy pH balance. Probiotic capsules are also available.

6. Add antifungals later. After you have incorporated these other tips into your health routine, it’s time to add natural antifungals, such as pau d’arco, oil of oregano, capric acid (which is found in coconut oil), and enteric-coated garlic.

Visit DrSalzarulo.com for holistic treatment options and forums where others offer their experiences and success stories about battling Candida.

Five New Ways to Remember Your Meds Managing your HIV? There’s an app for that.

Actually, there are quite a few.—Charles Hicks App: My Positive Agenda For: iPhone, Android, Mac, and PC Cost: Free Where: HealthyWithHIV.com Why: Perhaps the best app designed explicitly for people with HIV. Set reminders for taking your meds and learn about symptoms, therapy, and resources. Plus you can record your daily viral load into printable charts.

health

Four Tips for Dealing With Bad News Everyone deals with unwelcome medical news at some point in the aging process. But there can be better ways to cope By J. Thomas Shaw

Opposite page t: photos.com; this page: photos.com; courtesy subjec t

Get a second opinion: Emotion kicks in immediately when you get a potentially dire diagnosis, and many people don’t bother getting a second or third opinion. They consider that denial, or wishful thinking. Doctors are human; they make mistakes. Even if the diagnosis doesn’t change, another physician may suggest a different course of treatment. Try to arrange a visit with a specialist at a nationally renowned research hospital.

Empower yourself with knowledge: The Internet is filled with good information, but the trick for research is avoiding the sea of misinformation online. There are many studies from various universities to be found, and some sites, including WebMD.com, are reliable sources.

Allow for a wake-up call response: For many, knowledge of a difficult medical condition is a reminder to finally implement a healthier lifestyle. Some patients turn around their lifestyle completely with regular exercise, a balanced diet with nutri-

tion as the primary focus, and restricting or completely abstaining from alcohol and cigarettes. This can have amazing results.

Think positive and focus on what matters: At some point we all must face that we are mortal beings with limited resources.

Sometimes a good attitude is the best, if not only, weapon for facing terminal illness or a lifelong disability. Taking stock of what’s important, such as loved ones, offers a positive X factor that science has difficulty measuring, but we know has a tangible health benefit nonetheless.

J. Thomas Shaw wrote The RX Factor in consultation with Johnny Powers, a biochemical engineer with extensive experience in developing diagnostic tests. Shaw started writing novels after a career in the mortgage industry; he was the cofounder of Guaranteed Rate Inc., the largest independent mortgage bank in the country. He lives in Southern California with his wife and two children.

App: Red Ribbon HIV/AIDS Manager For: iPhone, iPod, and Android Cost: $1.99 (Android); $9.99 (iPhone, iPod) Where: Play.Google.com (Android), iTunes.

Apple.com (iPhone) Why: You can store medical information in a secure virtual safe, including meds, supplements, immunizations, lab tests, health conditions in addition to HIV, family history, allergies, advance directive, organ donor info, and emergency contact number.

App: Dosecast For: iPhone, iPad, iPod, and Android Cost: Free, or $3.99 for premium Where: Dosecast.com Why: Efficiency. It keeps track of how much medication you have left, sends refill reminders with pharmacy and prescriber info, and logs your overall drug compliance.

App: RXMindMe Prescription/ Medicine Reminder and Pill Tracker For: iPhone, iPod Cost: Free Where: RXMind.me Why: Users can photograph each med and attach it to the name of the pill on the reminder.

Bonus: FDA Drug Database is included.

App: MediRemind For: iPhone Cost: 99 cents Where: iTunes.Apple.com Why: Users can track all doctor, insurance, and referral information, get reminders, and store special instructions that accompany certain medications.

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photos.com

STATUS SYMBOLS mind+mood

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â&#x20AC;˘ november /december 2012

Gary McClain, Ph.D.

A Very Personal Question It can be awkward when someone asks how you got HIV. Here’s how to turn the experience into an opportunity

a client i’ll call sarah told me about a recent incident. “My sister asked me point-blank how I became infected.

She told me she knew it was either drugs or my ex-husband. It really took me by surprise. I wasn’t sure which was worse in her eyes, but I would learn that once I told her. What was I supposed to do?”

Another client, whom I’ll call Joe, reported the question that wasn’t asked.

“I had lunch with a friend that I had disclosed my status to a while back. He went through the names of guys who we both knew and who he suspected could be HIV-positive. I knew where he was trying to go with this, and I wasn’t going there. Was I wrong?”

That “Who gave it to you?” question can cause a lot of pain. It’s not really meant to be hurtful. Sometimes people are thoughtless, or can’t help but want to know someone else’s business. Still, it can leave you feeling like you are being judged or blamed. This question can bring up a lot of painful memories when you are focused on acceptance and moving on in your life. That question can also be disempowering if it puts you on the defensive and leaves you feeling that you somehow owe the questioner a response.

Has anyone asked you that question?

Or left it unsaid and waited for you to give them the details? Not sure how to respond? Here are some ideas.

First of all, you have a right to privacy. You don’t have any control over how other people choose to think, feel, or behave—or the questions they ask.

But you do have a right to choose how,

and if, to respond. A simple response would be “I am moving on with my life.

My focus is on the future, not the past.”

If you aren’t sure why you are being asked, then ask your own question. Start with “Why do you ask?”

This can be a good way of jolting the other person into realizing that they have asked a question that you may not be comfortable with. If they can’t come up with a reason that makes sense to you, then, again, you don’t have to answer.

Keep in mind that they may have no idea how this question makes you feel. After all, they haven’t walked in your shoes. Be honest and let them know: “It really hurts to be asked that question.”

Maybe it’s time for some “patient” education. The “How did it happen?” question can present you with an opportunity to educate someone you care about. If you feel like they can benefit from your knowledge, and want to educate them on HIV transmission, give them a mini lesson. This can also be an opportunity to ask for support: “I’m dealing with this. I have accepted my diagnosis and I’m ready to move forward in my life. I hope that I can count on you to be in my court.” Patience and compassion can benefit you and the questioner, and bring you closer together.

However, there are a couple of other things to think about. While you may not want to disclose how you were infected

to the insensitive person who has taken upon himself/herself to blurt it out, the question may be a reminder that you have never really talked with anyone about your HIV infection. Or maybe you tried and had a bad experience.

So a question for you: Does this question bring up feelings of shame or guilt? Pain that you haven’t really dealt with yet? Living with HIV brings up a lot of feelings, from the time that you receive your diagnosis and onward.

And another question: Have you sat down with someone you trust and had this conversation? Don’t keep all of those feelings inside. Dealing with your emotions is an important part of the process of integrating your HIV diagnosis into your life as well as your ongoing self-care. Maybe it’s time to sit down and have a talk with a peer educator or a mental health professional or a friend you trust to be a good, nonjudgmental listener.

Just because someone asks doesn’t mean that you have to tell.

You’re in charge of the message. But when you need to talk, reach out to someone who can listen.

Gary McClain is a counselor in New York City with a specialty in coping with chronic health conditions. His books include The Complete Idiot’s Guide to Breaking Bad Habits and Empowering Your Life With Joy.

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STATUS SYMBOLS social networks

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â&#x20AC;˘ nov ember /december 2012

Stigma’s Battlegrounds

A new group harnesses social media to get people “HIV-neutral”

T

he young founders of the Stigma Project, one of the nation’s newest HIV awareness and education organizations, owe Paris Hilton a big thank-you. In the fall, when the media got wind of nasty and uninformed comments made by the celebrity socialite, Scott McPherson and Chris Richey of the Stigma Project (TheStigmaProject.org) quickly turned the firestorm into a teachable moment. The Los Angeles–based pair created an Internet meme (see below) that quickly went viral; receiving more than 5,000 Facebook comments and shared nearly 2,000 times on the social media site. While McPherson, this magazine’s creative director, and Richey, a fund-raising account executive, formed the Stigma Project in February to break down HIV prejudices through art and education, the Paris Hilton meme raised their profile and garnered plenty of positive attention.

Supporters say the messages of the Stigma Project are especially appealing because they’re witty and humorous, never heavyhanded or preachy. While McPherson and Richey plan to place their ads on bus benches and billboards, they focus most of their energy on getting their memes on Facebook and Twitter, forums where young people pay attention and spread information to friends.

“Statistics show that around 84% of the world’s 18-to-34-yearolds can be reached through social media,” McPherson says.

“It just so happen this is the age range with the highest rate of new HIV infections. Why isn’t more being done to reach out to these people to not only educate them on HIV, but to reduce the harmful stigma associated with it? Between the popularity

of Internet memes and social media activism, Chris and I saw an opportunity here to do something new that can actually make a difference.” Part of the Stigma Project’s goal is to create an “HIV-neutral” world, which it describes in its mission statement as a “state of mind, regardless of your status, in which you are informed and aware of the constantly evolving state of HIV/AIDS.…

It is putting emphasis on the humanity of all people and not casting judgment because of their status, positive or negative.”

With the Stigma Project, McPherson and Richey want to not only lower new infection rates but make life better for those living with HIV, especially in a world where many people still think like Paris Hilton— that only gay people get HIV, that those with the disease are promiscuous, that HIV is a death sentence. As Richey puts it, “To get people ‘HIV-neutral,’ we must begin shifting toward a new way of thinking about HIV/AIDS. Moving away from thoughts full of death and sadness and toward thoughts of life and hope for the future.”

—Neal Broverman

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the last word

Milton Hershey School

Milton Hershey School Pays for Discrimination A middle-school student who was initially denied admission to a private school because he is HIV-positive wins a historic settlement

fourteen-year-old Abraham Smith, an honor roll student and competitive athlete, is determined to get into Stanford University. Accordingly, Smith (not his real name) sought to attend a quality secondary school that would help him gain admission to the renowned private university, where he plans to study engineering.

Instead, he spent eighth grade absorbed in a widely publicized antidiscrimination lawsuit against the Milton Hershey School, which rejected him last year because he has HIV. But that battle has finally come to a close. In mid September, Smith and his mother reached a settlement with the Pennsylvania school for $700,000.

The school was also ordered to pay $15,000 in civil penalties, draft nondiscrimination and equal opportunity policies, and implement training on HIV and other disabilities for staff and students by next April.

“There should no longer be any lingering

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doubt about whether people with HIV present a risk in the casual setting,” says Ronda Goldfein, executive director of the AIDS Law Project of Pennsylvania, the public-interest law firm that represented the family.

Milton Hershey School officials could not be reached for comment.

Founded in 1909 by chocolate magnate Milton Hershey and his wife, Catherine, the tuition-free private school serves more than 1,800 students, from pre-kindergarten through 12th grade, with social and financial needs like Smith, who comes from a lowincome family. Students live in homes with 10 to 12 other pupils in their age group and a pair of married houseparents.

Smith applied in April 2011, attracted by the school’s wide range of potential mentors, scholarship opportunities, and an educational environment that is still close to home, Goldfein says. Administrators, however, said Smith could not attend because the school

didn’t have the resources to meet his needs.

In November 2011, Smith and his mother filed suit, claiming the school had violated the Americans With Disabilities Act. The school followed up with a statement claiming that Smith would pose “a direct threat” to the other students, a position it publicly held for nearly a year.

But last summer, after the U.S. Department of Justice advised the school to change its position, Milton Hershey president Anthony Colistra publicly apologized to Smith, offered him admission, and announced a new equal opportunity policy and plans for mandatory HIV-related training for staff and students.

Smith has decided not to attend the school and will use the money from the settlement to fund his education elsewhere.

Usually careful about whom he shares his status with, he is relieved the suit is over, Goldfein says.

“He’s had to…accept this idea, because he has a virus, people will treat him differently and badly,” she says. “He’s had to struggle with the idea of, How is the next person I open up to going to react?”

Now with the legal ordeal behind him, Smith can focus on his ambition: an engineering degree from Stanford, with his name on it. —Lauren Jow

Hey, have you heard the news?

For eligible patients, Merck covers up to $400 on out-of-pocket costs, for each of up to 12 prescriptions.

Savings Coupon for ISENTRESS (raltegravir): eligibility restrictions, terms, and conditions apply.a To find out more visit isentress.com.

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.

a For

eligible privately insured patients. Not valid for residents of Massachusetts. Restrictions apply.

Please see full Terms and Conditions on isentress.com.

Model

Copyright Š 2012 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. INFC-1052216-0000 09/12

A MESSAGE FROM YOUR IMMUNE SYSTEM

Starting treatment early may help you live a longer, healthier life.

Treatment guidelines issued by the US Department of Health and Human Services (DHHS) recommend starting HIV medicines for all people with HIV, regardless of their CD4 count. Talk with your healthcare provider about your treatment options and all the factors you need to consider before starting HIV medicines. For more information, call toll-free 1-888-451-5723 or visit Š 2012 Gilead Sciences, Inc. All rights reserved. UN13262 06/12

TREATHIVNOW.COM.