Leading HIV/AIDS Groups Call on FDA and Gilead to Approve PrEP

Thirteen prominent U.S. HIV/AIDS organizations have written an open letter to the Food and Drug Administration and Gilead Sciences calling for "prompt regulatory review" of  pre-exposure prophylaxis (PrEP) for gay/bisexual men and transgender women.

PrEP is the daily use of an  antiretroviral drug therapy that has dramatically reduced new infections in HIV-negative gay and bisexual men. Daily use of the cocktail—a combination of Truvada and/or Viread—has shown up to 73 percent efficacy in preventing HIV transmission.

The letter urges regulators and the drug manufacturer  "not to delay review "because of distinct questions about the safety and efficacy of PrEP in heterosexual cohorts.

The letter reads in part:

Data from multiple clinical trials in different populations showing that antiretroviral drugs for HIV treatment can also prevent HIV infection have accumulated to the point where FDA approval decisions could be made for this intervention. The approval issues for the different populations are not identical. For the reasons outlined below, we urge the FDA and Gilead Sciences to reconsider plans to combine the approval for a prevention indication for both men who have sex with men, including transgender populations (MSM) and heterosexuals into a single filing.

The combination could unnecessarily delay approval for MSM, the group at greatest risk of HIV infection in the United States.

There have been some questions about resilience and the impact of powerful antiretrovirals on a healthy immune system. But the major question: Who will pay for the drug? In the United States, Truvada can cost $36 a day or up to $14,000 a year.

"We desperately need new strategies and tools to reduce the rapidly increasing rates of HIV infection in black gay and bisexual men," says Phill Wilson, executive director of the Black AIDS Institute.  "We've had evidence of PrEP's effectiveness in MSM for almost a year now. It's time to use every tool at our disposal to reduce the 50,000 new HIV infections that occur each year in this country. "

The groups include AIDS Foundation of Chicago, AIDS United, AVAC, Black AIDS Institute, Fenway Health, GMHC, Harlem United, and the National Minority AIDS Council.

The news comes after the release of disturbing HIV seroconversion data. New HIV cases among Black gay and bisexual men aged 13-29 rose an estimated 48 percent between 2006-2009, according to the Centers for Disease Control and Prevention. New infections rates are much higher in some cities—such as Milwaukee, where an estimated 42 percent of Black gay/bi men could be infected.

See our recent series "Reversing the Alarming HIV Increase Among Black Gay Men Part 1" and "Part 2", as well as "What Pre-Exposure Prophylaxis Could Mean for Black Gay and Bi Men" and "Clinical Trials Show PrEP Reduces Heterosexual HIV Transmission" that were syndicated by the Black AIDS Institute across Black print and web properties.

Comments

[Derrick from Philly]

Well, I certainly hope it works in reducing transmission. But, My God, it is expensive.

[Striving4MoreRU]

The gay community has gone backwards with endorsing, showcasing and promoting bareback sex; these drugs I feel are not going to slow down transmission just accelerate them...by giving a false sense of security!

[Former COGIC]

Striving: Are you one of those hateful bible thumping conservatives? Because that's how you sound. You sound just like some stupid bigot who says teaching teens about sex or giving them condoms will encourage sex.

Guess what? PEOPLE ALREADY HAVE SEX and unfortunately everyone is NOT using condoms. That is a reality, from sub-Saharan Africa which has the world's highest HIV rates (and no large gay community "promoting bareback sex") to sky high teen pregnancies, STD and HIV among straight Black folks in USA.

PrEP would be used IN ADDITION to condoms. It's just another option. We have to do something, your thinking isn't helping the problem.

[Ramon]

Co-signing COGIC.
Striving, are you one of the gay bashers? I can't tell.

[john]

"daily use of an antiretroviral drug therapy". What? So now we need a drug just to exist? F*ck that. I'll stick to safer sex.

[Striving4MoreRU]

Thank you John safer sex is the BEST method PERIOD...so many people have made a fetish out of bareback sex (both negative and positive men)...it is out of control...

[Greg G]

John and StrivingMore: You're right that safe sex is the best method ... but many people across the world, in the black community, and in the black and latino communities are not doing it. That's like saying, "Abstinence is the best policy" So how do you address that?

Striving: Your repeated comments about "fetish bareback sex" do sound like comments by ignorant bigots. The simple fact is that the vast majority of HIV infections are in HETEROSEXUAL people ... who of course have "fetished" bareback sex for centuries. And still do in videos, porn, etc so you can't blame it on gays. And repeatedly saying this doesn't add anything to the discussion.

Safe sex and condoms are the best way to go, but I can think of dozens of reasons why people can't, won't or don't use them. They have a long term partner and think both are "safe". They're drunk or high. They're being raped. Their partner forces them not to. They're trading sex for food, housing or money, which many people are forced to do.

PrEP is not a "magic pill" or magic bullet. In a best case scenario, it would work WITH condoms. And if the person slips up, they have back-up. It's like having car insurance, but wearing your seat belt and stopping at a red light.

The bottom line: HIV rates are sky high in black and brown communities, many people straight and gay are not using condoms, black gay men have the highest infection rates, black people and black gay men have the highest mortality rates from AIDS, and health outcomes are diminishing. Simply using a condom would stop HIV .... but just saying "use a condom" DOES NOT address the start public health reality.