Gilead reports Phase III data for HIV combo in virologically suppressed patients

Gilead Sciences Inc. (NASDAQ:GILD) reported data from the Phase III GS-US-380-1844 and GS-US-380-1878 trials in virologically suppressed 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 in the proportion of patients with virologic failure defined as 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 the double-blind, international GS-US-380-1844 trial, patients were randomized to switch to bictegravir/emtricitabine/tenofovir alafenamide or stay on their existing regimen of either Tivicay dolutegravir plus abacavir/lamivudine or Triumeq dolutegravir/abacavir/lamivudine. In the open-label, international GS-US-380-1878 trial, patients were randomized to switch to bictegravir/emtricitabine/tenofovir alafenamide or stay on a suppressive regimen that included 2 nucleoside/nucleotide reverse transcriptase inhibitors and a boosted protease inhibitor. Regimens included Prezista darunavir from Johnson & Johnson (NYSE:JNJ) or Reyataz atazanavir from Bristol-Myers Squibb (NYSE:BMY), plus abacavir/lamivudine or Truvada emtricitabine/tenofovir disoproxil fumarate. Each trial enrolled 520 patients...