Gilead Sciences, Inc. today announced results from the DISCOVER trial, a two-year Phase 3 randomized, controlled, double-blind study evaluating the safety and efficacy of the investigational use of once-daily Descovy (emtricitabine 200 mg and tenofovir alafenamide 25mg) for HIV pre-exposure prophylaxis (PrEP), compared with Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg), in men who have sex with men and transgender women at risk for sexually acquired HIV infection.
In a late-breaker oral abstract presented today at the Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle, 5,387 study participants were randomized in a 1:1 ratio and received either Descovy or Truvada. Among the 2,694 participants (4,370 patient-years) who were at risk of HIV-1 infection and received once-daily Descovy, seven HIV infections (HIV incidence 0.16/100 person-years (PY)) were reported. Among the 2,693 participants (4,386 patient-years) who were at risk of HIV-1 infection and received Truvada, 15 HIV infections (0.34/100 PY) were reported. Descovy met the pre-established criteria for non-inferiority to Truvada using a stringent rate ratio statistical comparison, as demonstrated by the upper bound of the 95 percent confidence interval for HIV-1 infection rate ratio being less than the predefined non-inferiority margin of 1.62/100 PY. Additionally, statistically significant advantages with respect to bone and renal laboratory parameters were observed for participants receiving Descovy as compared with those receiving Truvada, which were pre-specified secondary endpoints.
As the largest HIV prevention trial conducted to date, the DISCOVER trial results clearly demonstrate Descovy for PrEP„¢ achieved a clinical profile similar to the high efficacy of Truvada and a more favorable bone and renal safety profile, said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development, Gilead Sciences. We look forward to filing regulatory applications for Descovy for the PrEP indication as a potential important new option to prevent individuals from becoming infected and contribute to the achievement of national and global HIV prevention goals.
In the U.S., Descovy is approved in combination with other antiretroviral agents for the treatment of HIV infection in patients weighing ‰¥ 35 kg and is not indicated for PrEP. Truvada is indicated in combination with safer sex practices for HIV PrEP to reduce the risk of sexually acquired HIV in at-risk adults and adolescents weighing ‰¥ 35 kg. Descovy and Truvada each have a Boxed Warning in their respective product labels regarding the risk of post-treatment acute exacerbation of hepatitis B; the Truvada label also carries a Boxed Warning for the risk of drug resistance with PrEP in undiagnosed early HIV infection. See below for Important Safety Information and complete Indications.