Gilead announces 96-week results from Phase 3 study of Biktarvy
Gilead Sciences announced 96-week results from a Phase 3, randomized, double-blinded study evaluating the safety and efficacy of Biktarvy for the treatment of HIV-1 infection in treatment-naive adults. In the ongoing study, Biktarvy was found to be statistically non-inferior to a regimen of dolutegravir and emtricitabine/tenofovir alafenamide (50 mg) through 96 weeks of therapy. The data were presented during a late-breaking abstract session at the 2018 HIV Glasgow conference in Glasgow, Scotland, UK. "This study demonstrated the high efficacy, high barrier to resistance and long-term tolerability profile of Biktarvy through 96 weeks, reaffirming its role as a first-line treatment option for appropriate adult HIV patients who are starting therapy," said Hans-Jurgen Stellbrink, MD, PhD, Professor of Internal Medicine, Infectious Diseases, at the University of Hamburg, Germany and lead study author. "Biktarvy was also shown to have few discontinuations due to adverse events through 96 weeks, which may be an important consideration for health care providers making clinical care decisions."