Data demonstrate non-inferiority of once-daily Descovy vs. once-daily Truvada for prevention of HIV infection

Gilead Sciences, Inc. announced results from the DISCOVER trial, a two-year Phase III 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 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.

Comment:The results mean Descovy met the study's primary endpoint. It also significantly outperformed Truvada on secondary endpoints of bone and renal safety. Gilead said the data support a supplemental regulatory filing for Descovy for PrEP (HIV pre-exposure prophylaxis).