Gilead Sciences, Inc. today 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-naïve 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.
“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-Jürgen 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.”
In Study, treatment-naïve adults were randomized 1:1 in a blinded fashion to receive Biktarvy or DTG+FTC/TAF. At Week 96, non-inferiority was maintained from the primary endpoint measurement at Week 48, with 84.1 percent of patients taking Biktarvy and 86.5 percent (n=281/325) of patients taking DTG+FTC/TAF achieving RNA levels less than 50 copies/mL. In the resistance analysis population, none of the study participants randomized to Biktarvy developed treatment-emergent resistance.
Biktarvy was well-tolerated with low discontinuations due to adverse events in both treatment arms. The most commonly reported adverse events were diarrhea (18 percent for Biktarvy vs. 16 percent for DTG+FTC/TAF) and headache (16 percent vs. 15 percent).
Study is ongoing and will remain randomized and blinded through 144 weeks.
Biktarvy is approved in Australia, Canada, the European Union, Hong Kong and the United States.