Second PrEP preventative HIV treatment approved by FDA
The FDA has announced its approval of Descovy, a PrEP method therapy, to reduce the risk of HIV-1 infection from sex.
The US Food and Drug Administration (FDA) has approved Descovy (emtricitabine 200mg and tenofovir alafenamide 25mg) for adults at-risk of HIV. The drug will reduce the risk of HIV-1 infection from sex.
The drug, produced by Gilead Sciences, is designed as a pre-exposure prophylaxis (PrEP) prevention method. This is a medicine taken daily by an HIV-negative patient to prevent contraction of the virus. However, it is not intended for those who have receptive vaginal sex as the effectiveness of this population has not been evaluated.
The safety and efficacy of Descovy for PrEP were evaluated in a randomised, double-blind multinational trial. The study compared Descovy to Truvada, a daily dose combination of two drugs approved to prevent the acquisition of HIV. The trial demonstrated that Descovy was similar to Truvada in reducing the risk of acquiring HIV-1 infection.
“This approval provides more prevention options for certain patients at-risk for acquiring HIV and helps further efforts by the 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,” said Jeffrey Murray, MD, deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research.