FDA Approves Gilead’s Descovy for HIV Pre-Exposure Prophylaxis

[et_pb_section admin_label=”section”] [et_pb_row admin_label=”row”] [et_pb_column type=”4_4″][et_pb_text admin_label=”Text”]Gilead announced the U.S. FDA has approved an additional indication for Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF) to include pre-exposure prophylaxis (PrEP). 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 individuals at-risk from receptive vaginal sex. The FDA approved this indication under Priority Review. The FDA approval was based on the phase 3 DISCOVER trial, a multi-year trial that evaluated the safety and efficacy of Descovy for PrEP compared with that of Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets; F/TDF) for PrEP in reducing the risk of acquiring HIV-1 infection. Enrollment included 5,387 adult cisgender men who have sex with men or transgender women (TGW) who have sex with men.  The primary efficacy endpoint of DISCOVER was the incidence of documented HIV infection per 100 person-years after all participants had follow-up of at least 48 weeks and at least half had 96 weeks of follow-up. Among the 2,694 subjects (4,370 person-years (PY)) who were at risk of HIV-1 infection and received once-daily Descovy, seven HIV-1 infections (HIV-1 incidence 0.16/100 PY) were reported. Among the 2,693 subjects (4,386 PY) who were at risk of HIV-1 infection and received Truvada, 15 HIV infections (0.34/100 PY) were reported. These results thus demonstrated that Descovy achieved non-inferiority to Truvada. Efficacy was strongly correlated to adherence to daily dosing. 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.  The Descovy label comes with a Boxed Warning 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. About PrEP  PrEP is an HIV prevention strategy in which medicine is taken daily before an HIV-negative person may be exposed to the virus through sex to help reduce the risk of infection. According to the Centers for Disease Control and Prevention (CDC), PrEP is highly effective at reducing the risk of HIV infection in at-risk populations.  About Descovy Descovy is a two-drug combination of emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV nucleoside analog reverse transcriptase inhibitors.[/et_pb_text][/et_pb_column] [/et_pb_row] [/et_pb_section]