Gilead announces data from OLE of two Phase 3 studies of Biktarvy

Gilead Sciences announced new, long-term data from open-label extensions of two Phase 3 studies of Biktarvy, demonstrating the sustained efficacy and safety profile and no treatment-emergent resistance with Biktarvy for the treatment of HIV-1 in treatment-naive adults. The data were presented at the 28th Conference on Retroviruses and Opportunistic Infections. In both studies, greater than 98% of participants who initiated treatment with Biktarvy and remained in the study achieved and maintained an undetectable viral load through four years of follow-up. The high efficacy and durable viral suppression were also observed in participants who switched to Biktarvy from a dolutegravir-containing triple therapy for the 48-week OLE periods. No treatment-emergent resistance to any components of Biktarvy occurred in participants treated with Biktarvy. Gilead presented additional Biktarvy data at virtual CROI 2021, including findings from a 144-week analysis of the same Phase 3 studies, which demonstrated that people living with HIV who received initial therapy with Biktarvy reached and maintained an undetectable viral load with no treatment-emergent resistance through 144 weeks. In a subgroup analysis of participants with transmitted-drug resistance based on retrospective sequencing of baseline samples, Biktarvy achieved comparably high levels of durable viral suppression through 144 weeks among participants with and without TDR.