FDA Approves New Option for HIV PrEP

The US Food and Drug Administration (FDA) has approved descovy (emtricitabine, 200 mg, and tenofovir alafenamide, 25 mg) for at-risk adults and adolescents weighing at least 35 kg for HIV-1 pre-exposure prophylaxis (PrEP) to reduce HIV-1 infection risk from sex, excluding in those who have receptive vaginal sex.

The safety and efficacy of descovy for PrEP was evaluated in a randomized, double-blind, multinational trial involving 5387 HIV-negative men and transgender women who have sex with men who were at risk of HIV-1 infection. The participants were randomly assigned to receive either once-daily descovy or truvada (emtricitabine, tenofovir disoproxil fumarate, 200 mg/300 mg). Overall, descovy was similar to truvada in its reduction of HIV-1 infection risk. The most commonly reported adverse effect was diarrhea.

Descovy features a boxed warning indicating risk of exacerbations for individuals with hepatitis B virus infection who discontinue descovy. The drug is contraindicated in individuals with unknown or positive HIV-1 status.

Descovy was first approved in 2016 to be used in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults and pediatric patients.

—Michael Potts

Reference:

FDA approves second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic [press release]. Silver Spring, MD; US Food and Drug Administration: October 3, 2019. https://www.fda.gov/news-events/press-announcements/fda-approves-second-drug-prevent-hiv-infection-part-ongoing-efforts-end-hiv-epidemic. Accessed October 4, 2019.