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FDA Approves Truvada for Reducing Risk of Acquiring HIV

The FDA had previously approved Truvada for use in combination with other antiretroviral agents for the treatment of HIV-infected adults and children 12 years old or older.

As part of PrEP, non–HIV-infected individuals who are at high risk of infection will take Truvada daily to lower their chances of becoming infected with HIV should they be exposed to the virus. A PrEP indication means Truvada is approved for use as part of a comprehensive HIV prevention strategy that includes other prevention methods, such as safe sex practices, risk- reduction counseling, and regular HIV testing.

Truvada for PrEP was approved with a risk evaluation and mitigation strategy (REMS) to minimize the risk to uninfected individuals of acquiring HIV infection and to reduce the risk of developing resistant HIV-1 variants. The safety and efficacy of Truvada were demonstrated in two large, randomized, double-blind, placebo-controlled clinical trials––the iPrEx and Partners PrEP studies.

The iPrEx trial evaluated Truvada in 2,499 HIV-negative men or transgender women who have sex with men and with evidence of high risk behavior for HIV infection. Truvada was effective in reducing the risk of HIV infection by 42% compared with placebo in this population. The drug’s efficacy was strongly correlated with drug adherence.

The Partners PrEP trial was conducted in 4,758 heterosexual couples where one partner was HIV-infected and the other was not (serodiscordant couples). The trial evaluated the efficacy and safety of Truvada and tenofovir versus placebo in preventing HIV infection in the uninfected male or female partner. In this study, Truvada reduced the risk of becoming infected by 75% compared with placebo.

In the two trials, the most common side effects associated with Truvada included diarrhea, nausea, abdominal pain, headache, and weight loss. Serious adverse events were uncommon.

Read the news release from the FDA Web site.

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