FDA Advisers Endorse Truvada for HIV Prevention
BY Trudy Ring
May 11 2012 3:29 PM ET
A Food and Drug Administration advisory committee has recommended that the drug Truvada be approved for use in HIV prevention, which would make it the first medication approved for such an application.
Truvada is already used to treat HIV, but studies have indicated that it can help prevent people from contracting the virus. The committee Thursday voted 19-3 that it be approved for the latter use, known as pre-exposure prophylaxis (PrEP), among HIV-negative, sexually active gay and bisexual men, CNN reports. The panel also endorsed its use by HIV-negative people who have a positive partner.
The FDA usually follows committee recommendations but not always. Sources said it could make a decision on Truvada by June 15, but FDA officials would not confirm this date.
AIDS activists were not universally enthused about this use for Truvada, voicing worries about side effects — including kidney problems, especially in African-Americans — and a possible decrease in condom use. “A recommendation for the use of Truvada as PrEP is akin to issuing an engraved invitation for lawsuits,” said activist Miki Jackson. “To knowingly recommend a drug as powerful as Truvada with such serious side effects and given to people who are perfectly healthy is frightening.”
Registered nurse Robert Elliott said, “There is no question that, if efforts on using PrEP is widespread, condom use and other means of preventing HIV infection will decrease.” Michael Weinstein, president and founder of the Los Angeles–based AIDS Healthcare Foundation, said that “approving PrEP would be a reckless act.”
Those on the other side included Richard Elion, director of clinical research at the Whitman-Walker Clinic in Washington, D.C., who said, “What we need currently is additional tools for our powerful tool box.” Chris Collins, vice president and director of public policy for amfAR, the Foundation for AIDS Research, said that “PrEP is certainly not for everyone, but it may have a role in bringing HIV infection rates down. It’s time to learn how PrEP may be useful in the real world. ”
Truvada, manufactured by Gilead Sciences, is a combination of the drugs Emtriva (emtricitabine) and Viread (tenofovir). In people with HIV, it suppresses replication of the virus.