FDA approves Gilead’s Descovy as PrEP

Prescribers have a new option for pre-exposure prophylaxis, or PrEP, against HIV. The Food and Drug Administration has approved Gilead’s Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) as HIV PrEP in at-risk adults and adolescents weighing at least 35kg, excluding those who have receptive vaginal sex. 

Descovy is not indicated in individuals at risk of HIV infection from receptive vaginal sex because the effectiveness in this population has not been evaluated, the FDA said. 

"PrEP drugs are highly effective when taken as indicated in the drug labeling and can prevent HIV infection," said Jeffrey Murray, deputy director of the division of antiviral products in the FDA's Center for Drug Evaluation and Research. "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."

PrEP is an HIV prevention method in which people who do not have HIV take medicine on a daily basis to reduce their risk of getting HIV if they are exposed to the virus. Descovy for PrEP should be used as part of a comprehensive strategy, including adherence to daily administration and safer sex practices, including condoms, to reduce the risk of sexually acquired infections.

Descovy was FDA approved in 2016 in combination with other antiretoviral drugs to treat HIV-1 infection in adults and pediatric patients.