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The agency has approved Gilead Sciences’ Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) for reducing the risk of HIV-1 infection.
FDA announced it has approved Gilead Sciences’ Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) for adults and adolescents weighing at least 35 kg (77 lbs) for HIV-1 pre-exposure prophylaxis (PrEP), an HIV prevention method that doesn’t involve taking medicine on a daily basis, to reduce the risk of HIV-1 infection from sex, excluding those who have receptive vaginal sex because of lack of FDA evaluation, according to an Oct. 3, 2019 press release.
Originally approved in 2016 in combination with other antiretoviral drugs for the treatment of HIV-1 infection in adults and pediatric patients, the drug was evaluated in a randomized, double-blind trial in over 5000 HIV-negative men and transgender women who have sex with men and were at risk of HIV-1 infection, according to the release. The trial ended positively with the drug showing a reduced risk of acquiring the HIV-1 infection.
“PrEP drugs are highly effective when taken as indicated in the drug labeling and can prevent HIV infection,” said Jeffrey Murray, MD, deputy director of the Division of Antiviral Products in FDA’s Center for Drug Evaluation and Research, in the press release. “This approval provides more prevention options for certain patients at-risk for acquiring HIV and helps further efforts by [FDA] and the US Department of Health and Human Services to facilitate the development of HIV treatment and prevention options to reduce new HIV infections.”
Risks outlined in the release include the worsening of hepatitis B virus symptoms in those who take the drug and also have the hep B virus.