FDA panel recommends approval of Truvada as preventive treatment for HIV

May 11 2012

"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' Truvada as a treatment for preventing HIV infection among healthy people at risk of contracting the virus, Reuters reports, noting, "It already has FDA approval to treat people infected with the human immunodeficiency virus" (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).

"The voting was not unanimous, and some members of the 22-member panel voted no or abstained because they thought there was not enough data to prove the drug safe and effective in women or black people," according to the New York Times, which notes that adherence to the daily drug regimen is also a concern for some (5/10). "Opposition to the prospect of approving the drug is based on concerns that users could gain a false sense of security, and fears of a drug-resistant strain of HIV. There is also concern that the high cost of Truvada could divert limited funding from more cost-effective options," BBC News writes (5/10). 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," according to the Washington Post. There are 50,000 new HIV infections annually in the U.S., and 2.7 million new infections each year worldwide, according to UNAIDS, the newspaper notes (Vastag, 5/10).