HIV prevention pill receives FDA panel support

On Thursday, a panel of outside experts that advises the US Food and Drug Administration (FDA) voted to support approval of the daily pill Truvada to prevent HIV in healthy people. The FDA is not obliged to follow the advice of its Antiviral Drugs Advisory Committee, but should it do so, then Gilead Sciences Inc's Truvada will be the first drug indicated for reducing the risk of uninfected individuals acquiring the AIDS virus. Truvada (emtricitabine and tenofovir disoproxil fumarate) has been used to treat people already infected with HIV-1 in the United States since 2004. According to Gilead, it is currently the most-prescribed antiretroviral treatment in the US. The 22-member panel voted 19 to 3 in favor of approving the pill as a pre-exposure prophylaxis or PrEP in non-HIV-infected men who have sex with men (the highest risk group). It also voted 19 to 2 (with 1 abstaining) in favor of use in uninfected partners of HIV-infected individuals, and 12 to 8 (with 2 abstaining) in those at risk of HIV infection through sexual activity. The voting took place after 11 hours of deliberations and public consultation in Silver Spring, Maryland. The panel reviewed efficacy and safety data from several clinical studies of Truvada for PrEP. These included two large placebo-controlled Phase 3 trials, and several other clinical studies on the use of Truvada for HIV risk reduction. The Phase 3 trials were supported by the US National Institutes of Health and the University of Washington. According to a report from Reuters, one of the panel members who voted against using the drug to prevent HIV infection, said she did so because the clinical studies did not measure the risk of kidney problems in black people, considered to be the group most at risk of developing kidney side effects when taking AIDS drugs. Dr Lauren Wood of the National Cancer Institute said: "I don't think that is adequate when you're talking about the population that is most at risk." Those who welcome the panel's decision see it as another tool for preventing HIV infection, alongside safer sex, condom use and regular HIV testing. Others are against the drug because of concerns that it could give users a false sense of security, and that it could also lead to a drug-resistant strain of HIV. The FDA is expected to reach a decision by 15 June.