While Gilead Sciences snagged approval for its new HIV-1 prevention drug, it is only indicated for use in men and transgender women.
FDA cleared the pre-exposure prophylaxis (PrEP) indication for Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF). Descovy for PrEP is indicated to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg. who are HIV-negative and at-risk for sexually acquired HIV—excluding women.
“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,” said FDA in a statement.
“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,” said Daniel O’Day, chairman and CEO of Gilead, in a statement from the pharma maker.
FDA approved the supplemental New Drug Application (sNDA) for Descovy under a priority review designation. Descovy has a Boxed Warning in its U.S. product label regarding the risk of post treatment acute exacerbation of hepatitis B. The Descovy label also includes a Boxed Warning regarding the risk of drug resistance with PrEP use in undiagnosed early HIV-1 infection.
The approval of a PrEP indication for Descovy, taken once daily with or without food in patients weighing at least 35 kg, is based on data from the DISCOVER trial, a multi-year global phase 3 registrational clinical trial that evaluated the safety and efficacy of Descovy for PrEP compared with that of emtricitabine 200 mg. and tenofovir disoproxil fumarate 300 mg tablets; F/TDF) for PrEP (Truvada, Gilead) in reducing the risk of acquiring HIV-1 infection.
Enrollment included more than 5,300 adult cisgender men who have sex with men or transgender women (TGW) who have sex with men.
In the DISCOVER trial, Descovy achieved non-inferiority to Truvada in participants who were at risk of HIV acquisition. Efficacy was strongly correlated to adherence to daily dosing.
In addition, statistically significant advantages were observed with respect to all six pre-specified secondary endpoints for both renal and bone laboratory parameters in patients receiving Descovy compared to Truvada, Gilead said.
FDA approved Descovy in 2016 in combination with other antiretoviral drugs to treat HIV-1 infection in adults and pediatric patients.
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