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FDA Panel Recommends Approval Of Truvada As HIV Prevention Tool

“In a move that could lead to a new milestone for treatment in the evolution of the worldwide AIDS epidemic,” a Food and Drug Administration (FDA) panel on Thursday recommended Gilead Sciences’ antiretroviral drug Truvada be approved for pre-exposure prophylaxis (PrEP) to prevent HIV among healthy people at risk of contracting the virus, Reuters reports, noting the drug is already approved to treat HIV infection (Morgan, 5/10). “The panel voted 19-3 to approve the drug for use in gay men and 19-2, with one member abstaining, for heterosexual couples in which one person is HIV-negative,” according to the Wall Street Journal (Dooren, 5/10). “The recommendation is the first time that government advisers have advocated giving antiviral medicine to healthy people who might be exposed through sexual activity to the virus that causes AIDS,” the New York Times writes (Grady, 5/10). Though the FDA is not required to follow the panel’s advice, it usually does, and “[a] final decision is expected by June 15,” the Associated Press/Fox News reports (5/11).

Some panel members and advocates who testified during the public comment period raised concern over the lack of safety and efficacy data among some populations; how well people could adhere to the daily drug regimen, which, if not taken consistently, could lead to drug-resistant HIV strains; and whether users of the drug would develop a “false sense of security” and not use other prevention methods, such as condoms, according to BBC News (5/10). Others welcomed the panel’s decision, according to the Washington Post. Jennifer Kates, vice president of global health and HIV policy at the Kaiser Family Foundation, said the panel’s votes are an “important moment” in the fight against HIV/AIDS, but she added “there’s no single thing that’s going to change the trajectory of the epidemic,” the newspaper notes, adding that there are 50,000 new HIV infections annually in the U.S., and 2.7 million new infections each year worldwide, according to UNAIDS (Vastag, 5/10).