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 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.