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Act Now: Choice in HIV Prevention -- Let FDA Look at the PrEP Data

By Julie Davids

March 17, 2011

This article was provided by the HIV Prevention Justice Alliance.

Do you believe that we need new tools in our HIV prevention toolbox? At the HIV Prevention Justice Alliance, we support broad and strategic research to explore new methods and interventions for HIV prevention.

Like many of you, we were intrigued by the results of the iPrex trial of pre-exposure prophylaxis (PrEP) that came out late last year. The U.S. Food and Drug Administration (FDA) should review those results and determine if PrEP is safe and effective enough to be approved for widespread use.

Unfortunately, a key HIV health care provider is asking the FDA to deny this choice to gay men and transgender people across the United States. Sign this letter as individuals and/or organizations to support immediate FDA review of PrEP.

The iPrEx trial showed that daily use of the treatment pill TDF/FTC (brand name Truvada) as part of a comprehensive prevention package reduced the risk of HIV infection by 44 percent across the whole group of gay men, other men who have sex with men (MSM) and transgender women who have sex with men (TSM) who volunteered in the study. Half of that group received Truvada and half did not in order to compare whether its use made a difference.

44% may not seem like a home run, but it can have a powerful impact for the people who need it. It's well within the accepted range for many widely used prevention interventions and medical treatments -- and could be the first step towards a true advance in HIV prevention. And it's much better than 0% protection for folks who are unable to use condoms, for whatever reason.

But check this out: for the men and transgender women in the trial who were able to take the drug as prescribed, there were very high levels of protection against HIV. The people who were given Truvada but who did not have detectable levels of drug in their blood (meaning for whatever reason -- and we need to learn more about these reasons -- they weren't taking the pills) were not protected as well. In addition, trial participants used more condoms, and reduced their number of sex partners -- and there was no sign of PrEP treatment increasing drug resistance in this study.

At the HIV PJA, we are disturbed and disheartened to see that a key HIV care provider is misrepresenting these findings and spreading misinformation about PrEP in their quest to get the FDA to ignore the iPrex data. You may have received an invitation from AIDS Healthcare Foundation (AHF) to sign a petition to block FDA consideration of PrEP, which they are mocking as a "magic pill." FDA is one of the world's foremost regulatory bodies that makes decisions on how drugs, like Truvada, can be used.

As part of a growing alliance of national organizations, we are asking you to NOT to sign the AHF letter. Instead, please sign this letter asking for the FDA to do their job and objectively review the data.

The fight against HIV/AIDS is complicated -- and this is no exception. We need vigorous and open dialogue and debate about how to learn more about the best uses of PrEP, to bring down the costs of all prevention and treatment, and include all affected communities are included in deciding if and how to use this intervention. One thing we learned from iPrEx is that adherence to pill-taking matters. In this study, PrEP reduced HIV risk among individuals who took the drug regularly and reported high levels of adherence. Many people weren't able to adhere and, in these people, PrEP didn't have a benefit.

But what we don't need is misinformation, intimidation, or suppression of the data. We can't afford to have the discussion and debate silenced.

For that reason, we're asking you to take a stand on advancing the discussion on PrEP. And part of that involves the Food and Drug Administration (FDA) looking at the data to see if it's time to approve it as preventive therapy for MSM and TSM, or if we need more data first.

FDA approval -- if it is warranted -- could lead towards greater insurance coverage, well-designed pilot-programs, increased public debate and discussion of PrEP, and consideration of approval in countries around the world. To endorse the letter to FDA, click here.

Clearly, we need further studies and pilot programs to help at-risk individuals figure out if and how they will be able to take the drug regularly, and ensure that they use other methods of protection as much as possible but not use PrEP if they are not able to take it consistently and correctly. We need to demand lower drug prices for HIV treatment and preventive therapies. And we need all insurance companies and public programs to remove all barriers to key tools against the epidemic, like HIV testing, medication access, and prevention tools like condoms and sterile syringes.

But in the meantime, we think it is wrong to try to block the FDA from looking at the iPrex data, and to put a roadblock up against something that could make a dent in new infections.

As Jeff Berry wrote in response to the AHF ad,

Of course there is no magic pill. There has never been, and never will be, a one-size-fits-all method to prevent the spread of HIV. And for those populations who may be at higher risk, or who may not have the luxury of having all of the tools at their disposal (for example men or women whose partners are unwilling or unable to use a condom or other form of protection), if they could use a microbicide gel or even a pill to lessen their risk, why would we not want that?

We stand against misrepresentation of the iPrex data, and to any suppression of debate on this possible intervention. We ask you as individuals, as well as representatives as organizations and coalitions, to click here to stand up for the data review and accurate information in our communities. Stand up for truth, and for honest, open debate.

Julie, on behalf of the HIV PJA

P.S. Whether PrEP is something we'd personally use or not, we all should support clear and accurate information on what is and isn't known, and respectful public debate and dialogue. There are people currently considering PrEP use -- including some HIV negative gay men in relationships with HIV+ partners -- who deserve accurate information to aid their decision-making. We'd like to share this story from a PrEP user who posted to a gay blog just this week:

I've been using Truvada for PrEP for about three months now, and I'm thankful that it's available. I'm in an open, serodiscordant relationship; my partner converted after we'd been together for two years. My partner is on medication, and has an undetectable viral load. Even with condoms, however, our sex life plummeted, because he was SO frightened of the possibility of infecting me. This added layer of protection is a huge boon for those like me, who actually DO take their pill every day on a consistent basis. If you take it properly, the success rate is 94% -- not the minimized 44% that this so-called "AIDS Healthcare Foundation" is misrepresenting as the whole story.

My insurance does happen to cover the cost of Truvada, other than the copay I have for any name-brand medication, and they haven't so much as batted an eye. My physician, an expert on HIV care and prevention, monitors me carefully according to the CDC's interim guidelines to ensure that I'm not suffering side effects or toxicity problems.

Again, this is a GREAT TOOL for those who are actually RESPONSIBLE in using it. "AIDS Healthcare Foundation" seems to think that we should toss it aside because SOME won't take it every day, or because it's not 100% effective. The truth is, condoms aren't 100% effective either, but we still promote them. The truth is HIV+ individuals don't always take their meds properly, but we don't dismiss the meds for that reason. I'm personally offended and disturbed at "AIDS Healthcare Foundation's" extreme and irresponsible activism on this.

Please join us in the call for open discussion of PrEP data, and stay tuned for more information as we move forward. And, as always, contact us if you have a story or perspective you'd like to share.

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