Gilead reports Phase III data for HIV combo in treatment-naïve patients

Gilead Sciences Inc. (NASDAQ:GILD) reported data from the Phase III GS-US-380-1489 and GS-US-380-1490 trials in treatment-naïve patients with HIV-1 infection showing that once-daily 50/200/25 mg bictegravir/emtricitabine/tenofovir alafenamide met the primary endpoint in both trials of non-inferiority to a dolutegravir-containing regimen in the proportion of patients who achieved HIV-1 RNA levels of <50 copies/mL at week 48. Gilead plans to submit an NDA to FDA this month and an MAA to EMA in 3Q17 for the combination.

In GS-US-380-1489, bictegravir/emtricitabine/tenofovir alafenamide was non-inferior to Triumeq dolutegravir/abacavir/lamivudine on the primary endpoint. In GS-US-380-1490, bictegravir/emtricitabine/tenofovir alafenamide was non-inferior to Tivicay dolutegravir plus Gilead's Descovy emtricitabine/tenofovir alafenamide on the primary endpoint. The double-blind, international trials each enrolled 600 patients...