FDA Panel EndorsesTruvada to Prevent HIV Infection in Healthy People
A panel of federal health advisers has endorsed the first drug shown to prevent HIV infection in healthy people, clearing the way for a potentially landmark approval in the 30-year-old effort against the virus that causes AIDS.
In a series of votes, the Food and Drug Administration advisory panel recommended approval of the daily pill Truvada for healthy people who are at high risk of contracting HIV, including gay and bisexual men and heterosexual couples with one HIV-infected person. The FDA is not required to follow the panel’s advice, though it usually does. A final decision is expected by June 15.
Drugmaker Gilead Sciences Inc., of Foster City, already markets Truvada as a treatment for people who are infected with HIV.
Last July, I interviewed Dr. Paul Volberding, co-director of the Center for AIDS Research at the University of California, San Francisco, about the research into Truvada up to that time. He said results showed “the kind of effect we might expect from a very good vaccine.” We also discussed what populations might consider using Truvada as a prophylactic and whether giving healthy people a preventative drug might induce them to engage in riskier sexual activity.