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PrEP'ing: Are You Ready? Doctors and Advocates Are Gearing Up to Bring Truvada PrEP to People at Greatest Risk of Infection

By Enid Vázquez

July/August 2012

PrEP'ing: Are You Ready? Doctors and Advocates Are Gearing Up to Bring Truvada PrEP to People at Greatest Risk of Infection

Love it or hate it, it's coming: HIV prevention with the use of one pill, taken once a day.In May, the use of the HIV drug Truvada by HIV-negative people to prevent infection with the virus was recommended for FDA approval by the agency's Antiviral Drugs Advisory Committee (AVDAC).

"Today is an exciting day for HIV prevention," said Kenneth H. Mayer, M.D., Medical Research Director and Co-Chair of The Fenway Institute at Fenway Health in Boston, about the recommendation. "Although [Truvada] for PrEP [pre-exposure prophylaxis, or prevention] is not a panacea, this approach can prevent many new infections and could dramatically impact HIV transmission worldwide."

But for all of its promise, and all of its advocates, HIV prevention with Truvada has some concerned that it could be used incorrectly, creating a new set of potentially serious problems.

Many also worry that people on PrEP may stop using condoms or increase their risk in other ways, such as having sex with more partners. Doing so may negate the good that PrEP can do.

As well-intentioned as these people may be, they may be overlooking problems with condoms and HIV treatment, both of which if used and used correctly, are highly effective in preventing HIV transmission. Yet few come out against condoms or HIV therapy because of their potential for misuse and harm.

Even sex with condoms can be risky, and the promise of prevention for partners with HIV treatment is often unfulfilled due to lack of access -- the Centers for Disease Control and Prevention (CDC) estimates that only one in three people with HIV in the U.S. have controlled, or "undetectable," virus, and further, that one in five don't even know they're infected. People with HIV may also choose not to be on antiviral therapy for any number of reasons, and so remain more infectious to their sexual partners than if they were on treatment, especially in the absence of condoms. Never mind that those with undetectable virus in their blood may still be infectious.


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At Risk

The week that the advisory committee made its decision, a young man in Chicago struggled with the symptoms of seroconverting, including nausea, diarrhea, and nightsweats, after having three episodes of unprotected sex with a presumably HIV-negative man in another city.

Chris had chatted with this man for months over the Internet, but it wasn't until after they had sex that he told Chris, "You know, there are some people out there who say that they're HIV-negative but they're positive and they're spreading the virus. My ex-boyfriend in L.A. is one of those guys."

"He even had a word for it, 'pozzing.' I never heard of that," said Chris.

Would taking Truvada every day have helped Chris, who was now in a state of panic?

"I definitely would be somebody who would take something like that," said Chris. "It sounds almost like a miracle drug, especially after all I've been through with my friends, watching some of them get infected and some of them die. I think the drug is exciting."


When Safer Sex Isn't

Truvada is not a morning-after pill as some believe.

When Mark (not his real name) worked in HIV services in Chicago more than a decade ago, he heard from several gay men that they were infected when their sex partner took his condom off while they were having sex, usually without their knowledge. He began spreading the word about this danger in his outreach and heard back from many men who told him, "That's my story."

"I would always tell people to reach around and feel to see that the condom was still on," said Mark. "People were shocked." He remembers most distinctly a handsome young man who stood up during one of his talks and tearfully thanked him. "He was angry at his infector," said Mark, "but I remember even more his anger and hurt at friends who didn't believe that this had happened to him."

In some cases, gay men who were "tops," or insertive anal sex partners, thought they were virtually risk-free. But while they were at lower risk than the "bottom" (receptive) partner, many of them became infected nonetheless.

He's also haunted by the experience of testing two young men who were a couple. The first boyfriend tested HIV-negative, but the second one tested positive. "Right in front of me out in the lobby, he said, 'I'm negative, let's go home.' And there was nothing I could do about it. They had to send me home that day because I was going out of my mind."

Afterwards he made it a point to tell people to ask to be in the same room when their partner gets an HIV test result, and that it's a red flag if the person refuses.

Like Chris and many other gay men, Mark struggled with the deception practiced on the Internet. "I don't know how many times guys told me, 'Oh my God, you're the first person to tell me you're positive' or 'You're the first person I've met who's positive.' No, I'm just probably the first guy who was honest. Others [who were HIV-positive] either lie or they don't know they're positive. If you put your life and your care in someone else's hands based on their word, you're putting yourself at risk." Even gay men who thought they were in safe, monogamous relationships became infected by the partner they trusted, he said.

Mark says that if PrEP protects one or two people, it's worth it. "I'm on the side of using all the options we can get."


Sexual Assault

Eight years ago, Vince (not his real name) went home with a man he'd just met. They made out, but Vince, drunk, fell asleep. He woke up with the man inside him. He fought back and got the guy off him, but there was no condom, which mystified him, since "the guy didn't know me." Having always practiced protected anal sex, Vince knows that this sexual assault is how he became infected.

He had only had unprotected sex one other time -- and he thought it was protected. "I know he had on a condom, I helped him put it on. But he let it come off inside me." Vince wondered what happened to the condom when he didn't see it after sex. Thinking back on that night in a bathhouse, he says he should have asked about it. (The condom came out later when he used the bathroom.) Vince waited six months to test for HIV (the recommendation at the time) and he was negative. He says he was lucky.

But that was then and this is now. Today once-daily prevention with Truvada is an option that can be added to condom use with an off-label prescription and is already available, even without official FDA approval.

"I absolutely would have taken it, even though I always played safe. You never know when something like that is going to happen. You do everything you can to prevent it and then you make one mistake and it changes your life forever. It sucks," said Vince. He says he would take Truvada PrEP today in a heartbeat, if he was still HIV-negative and at risk, knowing what he knows now.

"Having been through that [first] experience, it would have helped when I got infected," Vince said.

Risk Perception

Realizing that you may be at risk, however, is one of the hurdles for PrEP usage. Surveys of people at high risk of becoming HIV-positive have repeatedly found that many report they were at low or no risk of infection, but after testing, many were in fact already positive.

This was raised as one of the possible reasons for the disappointing results of Truvada PrEP in women in the FEM-PrEP study. The women who became infected (an equal number in both the placebo -- fake pill -- and Truvada groups) had indicated that they were at low risk for acquiring HIV.

Did the women given Truvada not take it because of that belief? Their blood work showed little or no evidence of the drug being in their system. Largely thanks to PrEP research, "risk perception" is now an important consideration in prevention.

Yet, the large Partners PrEP study showed that Truvada did protect women against HIV. So did a CDC study in Botswana.

All of which goes to show the potential value of PrEP. Undoubtedly, sex can be complicated, and as the stories above show, often easier done than said (or discussed).


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What You Don't Know

Ironically, Chris could have used another medication intervention that's long been available, called PEP, for post-exposure prophylaxis. If certain HIV medications are taken for 28 days, beginning within 72 hours after sexual exposure, they can prevent infection from taking place. It's something he didn't think about because he wasn't aware of it.

Researchers have written about the lack of awareness among gay men of the availability of both PEP and PrEP. When there is awareness, it sometimes goes along with misunderstanding or downright misinformation. Truvada is not, for example, a morning-after pill as some believe.

If Truvada is approved for use in HIV-negative individuals, the lack of awareness around its prevention power should change drastically, with education becoming possible by its manufacturer, clinics, and community organizations.


To Be Young

"We see PrEP for youth not as a lifelong medication but as a stopgap measure," said psychologist Sybil Hosek, Ph.D., of Stroger Hospital of Cook County, the Chicago site for the Adolescent Trials Network (ATN) for HIV/AIDS Interventions.

"We know that adolescence is a risky time," said Hosek. "There's a lot of impulsivity and a lot of behavior changes -- hormonal, psychological, and emotional -- that put people in vulnerable positions when it comes to HIV. And so we feel that PrEP may be a great option during that maturation period."

The ATN points to CDC statistics showing that among adolescents and young adults (ages 13 to 25), the estimated percentage of HIV infections resulting from male-to-male contact increased from 57% in 2005 to 68% in 2008, while infections resulting from heterosexual contact or injection drug use decreased. For black youth, however, the increase was 73% in that time period.

ATN's Project PrEPare has two studies looking at PrEP effectiveness now that its initial research has shown that youth would accept and use PrEP (feasibility).These two studies are scheduled to enroll 300 youth at the network's 14 sites across the country, including Chicago. Visit www.projectpare.net.

Like other PrEP research, Project PrEPare provides condoms and counseling along with medication.

As to the argument that money should be used for treatment of actual HIV infection rather than prevention, Hosek said they're both part of the same package, with PrEP expected to increase HIV testing levels and awareness of previously unknown infection with the need for access to treatment. Moreover, she said it would help providers talk to their patients about getting HIV-positive partners into care and treatment. Like many advocates, she also points to the fact that Truvada PrEP -- especially for short-term use -- costs less than a lifetime of HIV therapy.

"I think it would help people to remember their own youth," said Hosek. "It's a time of exploration. It's a time of emotional energy and risk taking, of cognitive development. Their brains are maturing. Pleasure often takes precedence over planning. Saying 'just use a condom' is not working.

"Not that condoms aren't a great option," she continued, "but some people just aren't going to use them. So I think the more options we have for youth, the better."


Turning the Tide

In February, Boston's Fenway Institute issued a 59-page report in which it stated that, based on initial study results, "PrEP could be the 'game changer' needed to more effectively fight HIV." The institute, one of two U.S. sites involved in iPrEx, urged the FDA to approve Truvada PrEP. It continues to conduct PrEP research through HPTN 069 (NEXT PrEP), and is also involved in HPTN 061 (the BROTHERS study), a multiple-component intervention for black MSM.

HPTN (HIV Prevention Trials Network) hailed the Truvada PrEP decision as "a milestone for HIV prevention" and a webinar announcement referred to PrEP as "a bridge to the end of AIDS."

With flat funding for the AIDS Drug Assistance Program and cuts to Medicaid that are becoming more common in the states, more and more people may find themselves without access to treatment, let alone prevention. There is free access to Truvada PrEP through the iPrEx study which has expanded (iPrEx OLE) with three U.S. sites (Chicago, Boston, and San Francisco). There may also be patient assistance or co-pay assistance programs available if PrEP is FDA approved.

Earlier, in August of 2011, six organizations from around the country devoted to HIV/AIDS work and services (the AIDS Foundation of Chicago, AVAC, the Black AIDS Institute, the National Minority AIDS Council, Project Inform, and the San Francisco AIDS Foundation) urged the Department of Health & Human Services (DHHS) to establish so-called "demonstration projects" to examine PrEP effectiveness out in the real world, especially among the hardest-hit MSM of color. A year later, few demonstration projects are underway.


San Francisco Joins Miami

San Francisco and Miami, two cities that have traditionally had some of the highest rates of HIV infection in the country, have teamed up for a PrEP demonstration project funded by the National Institutes of Health (NIH).

Stephanie Cohen, M.D., M.P.H., medical director of the City Clinic for sexually transmitted infections (STIs) for the San Francisco Department of Public Health, said individuals accessing care from the clinic who are at risk of HIV infection will be offered Truvada PrEP. In addition, the Magnet gay men's health clinic in the Castro will refer men to the program.

"We are looking at uptake in PrEP -- who's interested in it, who's not, and why," said Cohen. "We plan to develop marketing and education messages from what we learn in our, and other, demonstration projects."

The goal is to enroll 300 MSM in San Francisco and 200 in Miami. A demonstration project is also in the works for New York City, she said.

"Does it work? Yes, we know it does, but how do we get it out there?" said Cohen.

The California HIV/AIDS Research Program (CHRP) of the University of California is also conducting a PrEP demonstration project, in cities throughout the state (including Oakland, San Diego, and Long Beach), focusing on high-risk MSM of color "who lack resources for testing and counseling." The program will also look at the use of TLC+ (testing and linkage to care plus treatment) in men who become infected.

"It's an historic moment in HIV prevention," said Cohen, "and there's a lot of work to be done in learning how to use this new prevention tool."

Chicago

In Chicago, Howard Brown Health Center (HBHC), which serves the LGBT (lesbian, gay, bisexual, and transgender) community, does not have a demonstration project per se. Rather, the center is making PrEP part of its primary care services. It has created a protocol for staff training so that everyone can be on the same page about who makes a good candidate for PrEP, said Kristin Keglovitz, P.A., HBHC's medical director. She said the clinic's PrEP protocol will be a multidisciplinary model involving the services of counselors in addition to prescribers. HBHC has already prescribed PrEP and even participated in the iPrEx study, she said.

Last year she prescribed PEP twice to a woman with an HIV-positive partner before telling the patient she might be better off on PrEP. It's a strategy that's backed by research showing that people taking multiple courses of PEP often go on to become infected, because they are at continuing risk for the virus.

"As an organization, and for myself as a provider, we definitely support PrEP," said Keglovitz. "It's a big milestone for prevention."

She said the strategy is "obviously not for everybody," and not a replacement for condoms. "Prevention messages will be crucial," she said.


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What Now?

The FDA advisory committee recommended that PrEP be approved for three specific risk groups -- men who have sex with men, HIV-negative partners of HIV-positive people, and others at high risk of acquiring HIV through sex. It noted that "regular HIV testing, adherence, and behavioral counseling on safer sex practices, including condom use, are essential components of healthcare delivery around PrEP."

All advocates are beating the drum for using condoms along with PrEP. Whether PrEP users out in the real world do or not remains to be seen.

But with all the unknowns surrounding PrEP, there is perhaps one true take-home message from studies and advocates alike: PrEP doesn't work if you don't take it.

Sitting on the FDA advisory committee and voting to recommend Truvada PrEP for approval, community representative Daniel Raymond of the Harm Reduction Coalition in New York City eloquently reminded everyone that, "This is the 25th anniversary of the AIDS Coalition to Unleash Power [ACT UP] and part of the legacy of that movement is empowering patients about learning and mastering the science and sharing it within our respective communities. I think that PrEP gives us the opportunity to do that all over again ... just as responsibly as we've been trying to do for the last 25 years."

Clearly, community awareness is as crucial as ever.


What You Should Know Before PrEP
  • You need to test HIV-negative before going on PrEP (pre-exposure prophylaxis or prevention).
  • This may require multiple testing (for example, testing HIV-negative three months in a row).
  • You must also be tested for hepatitis B before getting Truvada.
  • Your kidney function and serum phosphorus levels (for evidence of bone weakness) should be measured.
  • It takes about three doses (three days) for Truvada to reach adequate levels in your body for protection against HIV.
  • Adherence, or taking PrEP correctly and daily, is required.
  • PrEP must be monitored with continued testing for HIV and other sexually transmitted infections and review of any side effects that may occur.
  • Monitoring may be required every three or four months.
  • Side effect monitoring includes laboratory tests (blood draws) for potential kidney toxicity.
  • It's widely believed that PrEP should include the use of condoms and behavioral modification (finding ways to lessen the risk of infection).
  • It is possible that not using condoms along with PrEP may allow for the risk of infection, possibly negating the effects of PrEP altogether.
  • Other serious infections can occur without a condom and are epidemic in the gay community: hepatitis C, syphilis, and gonorrhea. (Remember that gonorrhea is also spread through oral sex.)
  • People who become HIV-positive while on Truvada PrEP risk the development of drug resistance. In studies, the only risk of drug resistance seen was in individuals who were already positive at the time of starting PrEP but didn't know it or people who were infected with an already drug-resistant strain of HIV.
  • Health care providers might consider supplementing vitamin D and calcium in PrEP patients. Some patients may also benefit from DEXA bone scans before and during treatment.
  • Research continues to investigate the best uses of PrEP, such as the possibility of less than daily usage and the use of other medications besides Truvada. Other biological prevention methods such as microbicides are also being studied.

Read the CDC's interim guidelines.

Special thanks to Dr. Joel Gallant of Johns Hopkins University for reviewing this article and sidebar.


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