Today, the U.S. Food and Drug Administration approved Gilead’s drug Descovy to be used as PrEP, an HIV prevention strategy that when taken properly makes it virtually impossible to contract the virus from someone who’s living with HIV.

This makes Descovy the second drug approved by the FDA to be used as PrEP, following the approval of Truvada (also manufactured by Gilead) in 2012.

“PrEP drugs are highly effective when taken as indicated in the drug labeling and can prevent HIV infection,” 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 statement on the FDA’s website.

The approval is part of long-term efforts to end the HIV epidemic by 2030. As part of the government’s initiative “Ending the HIV Epidemic: A Plan for America,” the aim is to reduce new diagnoses by 75 percent in the next five years and by 90 percent in the next 10 years.

Descovy was already approved to be used as HIV treatment (in combination with other antiretroviral drugs) in 2016. The drug is a fixed-dose combination containing 200mg of emtricitabine and 25 mg of tenofovir alafenamide.

The FDA panel voted 16-2 in favor of approving Descovy as PrEP in men who have sex with men (MSM) and transgender women, but later split 10-8 when it came to deciding whether it should be approved for cisgender women because “the effectiveness in this population has not been evaluated,” according to the FDA.

Therefore, while it is approved to be used by MSM and transgender women who have sex with men, it has yet to be approved for transgender men or cisgender women.

https://www.hivplusmag.com/prevention/2019/10/03/fda-approves-second-drug-be-used-prep-descovy