Provides equal performance with improvements in renal and bone lab tests.
Descovy® (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets) from Gilead Sciences is currently approved by the U.S. Food and Drug Administration (FDA) in combination with other antiretroviral agents for the treatment of HIV infection in patients weighing ≥ 25 kg.
According to John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development at Gilead Sciences, when used in combination with other agents for HIV treatment, Descovy offers higher efficacy and improved renal and bone safety compared with Truvada® (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets), which is also from Gilead.
Truvada is currently the only medication approved in the United States for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection among individuals who are HIV-negative and at risk for HIV. Based on the results of its phase III DISCOVER trial evaluating the safety and efficacy of Descovy compared to Truvada in men and transgender women who have sex with men at high risk for sexually acquired HIV infection, Gilead submitted a supplemental New Drug Application (sNDA) to the FDA for Descovy for PrEP, along with a Priority Review voucher.
In the clinical trial, Descovy was shown to work as well as Truvada in study participants who were at substantial and sustained risk of HIV acquisition while also providing statistically significant improvements in renal and bone laboratory parameters.