Gilead's switching to Biktarvy non-inferior in Phase III to treat HIV-1 in women

Gilead Sciences Inc. (NASDAQ:GILD) reported data from the open-label, international Phase III GS-US-380-1961 trial in 470 virologically suppressed adult women with HIV-1 infection showing that switching from either a boosted protease inhibitor or boosted Vitekta elvitegravir-containing regimen to once-daily 50/200/25 mg Biktarvy bictegravir/emtricitabine/tenofovir alafenamide was non-inferior to remaining on a boosted protease inhibitor or boosted Vitekta elvitegravir-containing regimen. The company said 1.7% of patients in both arms had virologic failure defined as HIV-1 RNA levels of ≥50 copies/mL at week 48, the primary endpoint.

Additionally, 95.7% of patients who switched to Biktarvy achieved HIV-1 RNA levels of <50 copies/mL at week 48, a secondary endpoint, vs. 95.3% of patients who remained on a boosted protease inhibitor or boosted Vitekta elvitegravir-containing regimen. Data were presented at the Conference on Retroviruses and Opportunistic Infections in Boston...