The US Food and Drug Administration (FDA) said on Thursday that it has granted approval to Gilead Sciences Inc (NASDAQ:GILD) for Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) for HIV-1 pre-exposure prophylaxis (PrEP).

The approval covers at-risk adults and adolescents weighing at least 35kg for PrEP to reduce the risk of HIV-1 infection from sex, excluding those who have receptive vaginal sex. Descovy is not indicated in individuals at risk of HIV-1 infection from receptive vaginal sex because the effectiveness in this population has not been evaluated.

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.

On 5 February 2019, President Trump announced an initiative, Ending the HIV Epidemic: A Plan for America, in his State of the Union to eliminate new HIV infections in the nation as well as provide hardest-hit communities with additional expertise, technology and resources required to address the HIV epidemic. The aim is to reduce new infections by 75% in the next five years and by 90% in the next ten years.

The safety and efficacy of Descovy for PrEP were evaluated in Gilead's randomised, double-blind multinational trial in 5,387 HIV-negative men and transgender women who have sex with men and were at risk of HIV-1 infection. The trial compared once daily Descovy to Truvada (emtricitabine, tenofovir disoproxil fumarate, 200 mg/300 mg). The primary endpoint was the rate of HIV-1 infection in each group. The trial showed that Descovy was similar to Truvada in reducing the risk of acquiring HIV-1 infection.