Gilead Sciences 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 for HIV pre-exposure prophylaxis, compared with Truvada, 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 in Seattle, 5,387 study participants were randomized in a 1:1 ratio and received either Descovy or Truvada. Among the 2,694 participants who were at risk of HIV-1 infection and received once-daily Descovy, seven HIV infections were reported. Among the 2,693 participants who were at risk of HIV-1 infection and received Truvada, 15 HIV infections 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.”
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