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On July 16, 2012, the FDA announced that it has approved tenofovir/FTC (Truvada) for use as pre-exposure prophylaxis (PrEP) in HIV-negative individuals who engage in sexual activity with HIV-positive partners. The drug, which is the first to be approved for this indication, is to be taken once daily and used in conjunction with safer sex practices. HIV seronegativity should be confirmed before receipt of PrEP and at least every 3 months during use.
The approval is based on two clinical trials of daily tenofovir/FTC for PrEP: the iPrEx study, which demonstrated 42% efficacy among men who have sex with men, and the Partners PrEP study, which demonstrated 84% efficacy among heterosexual men and 66% efficacy among heterosexual women (JW AIDS Cli…