FRIDAY, Oct. 4, 2019 (HealthDay News) -- The U.S. Food and Drug Administration granted approval to Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) for HIV-1 preexposure prophylaxis (PrEP), the agency announced yesterday.
Descovy is indicated for at-risk adults and adolescents weighing at least 35 kg and is intended to reduce the risk for HIV-1 infection from sex excluding receptive vaginal sex. In 2016, the drug was approved in combination with other antiretroviral drugs to treat HIV-1 infection. The FDA notes that Descovy for PrEP should be used in combination with safer sex practices to reduce the risk for sexually acquired infections.
The approval of Descovy for PrEP was based on data from a randomized, double-blind multinational trial of 5,387 at-risk HIV-negative men and transgender women who have sex with men. Researchers compared once-daily Descovy to Truvada (emtricitabine, tenofovir disoproxil fumarate, 200 mg/300 mg) in this population and followed patients for 48 to 96 weeks. Descovy performed similarly to Truvada in reducing the risk for HIV-1 infection.
The most commonly reported adverse reaction in HIV-negative individuals taking Descovy was diarrhea. A Boxed Warning on the prescribing information for Descovy indicates that patients with hepatitis B virus (HBV) are at risk for exacerbations of HBV if they discontinue products containing emtricitabine or tenofovir disoproxil fumarate, such as Descovy. Descovy is contraindicated in individuals with unknown or positive HIV-1 status. The drug should only be administered to those who are confirmed HIV-negative before initiating treatment and at least every three months during use.
Approval was granted to Gilead Sciences.