The drug hasn’t been approved for PrEP with those at risk through vaginal sex
WASHINGTON — The Food and Drug Administration (FDA) approved Descovy for use in pre-exposure prophylaxis (PrEP) on Thursday.
The FDA said that it was not indicated to be useful for people at risk of HIV through vaginal sex because that had yet to be evaluated.
“PrEP drugs are highly effective when taken as indicated in the drug labeling and can prevent HIV infection,” said Jeffrey Murray, M.D., M.P.H., deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “This approval provides more prevention options for certain patients at-risk for acquiring HIV and helps further efforts by the FDA and the U.S. Department of Health and Human Services to facilitate the development of HIV treatment and prevention options to reduce new HIV infections.” ‘
The agency said that Descovy was found to be as effective as Truvada, the current drug used for PrEP. Like, PrEP with Truvada, it should be used with people who test HIV-negative immediately before starting and every three months afterwards.
It was approved for HIV treatment back in 2016. The most common side effect of Descovy was diarrhea.
Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) is produced by Gilead Sciences.