Gilead Sciences has secured approval from the US Food and Drug Administration (FDA) for HIV pre-exposure prophylaxis (PrEP) indication of Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF).
Descovy for PrEP has been approved to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing minimum 35kg who are HIV-negative and at-risk for sexually acquired HIV, excluding individuals at-risk from receptive vaginal sex.
Under a priority review designation, the FDA has approved the supplemental new drug application (sNDA) for Descovy.
The approval of a PrEP indication for Descovy was based on data from the DISCOVER multi-year global phase 3 registrational clinical study.
The trial assessed the safety and efficacy of Descovy for PrEP compared against Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets; F/TDF) for PrEP in reducing the risk of acquiring HIV-1 infection.
Gilead recruited more than 5,300 adult cisgender men who have sex with men or transgender women (TGW) who have sex with men in the trial.
The incidence of documented HIV infection per 100 person-years after all participants had a follow-up of at least 48 weeks and at least half had 96 weeks of follow-up was the primary efficacy endpoint of the study.
DISCOVER trial showed that Descovy achieved non-inferiority to Truvada in study participants who were at risk of HIV acquisition, said the company.
The statistically significant advantages were also reported with respect to all six pre-specified secondary endpoints for both renal and bone laboratory parameters in patients receiving Descovy compared to Truvada.
According to the company, Descovy does not prevent other sexually transmitted infections or cure HIV infection or AIDS.
Gilead Sciences chairman and CEO Daniel O’Day said: “Descovy for PrEP provides a new HIV prevention option that matches Truvada’s high efficacy with statistically significant improvements in renal and bone safety, which can be an important consideration as people at risk increasingly use PrEP for longer periods of time.
“This is a reflection of Gilead’s continued commitment to addressing the evolving needs of people living with or at risk for HIV and to driving innovation across the HIV care continuum.”