Biktarvy shows high efficacy and durable viral suppression in treatment-naïve adults with HIV-1 in four-year data presented at CROI – Gilead Sciences

Gilead Sciences, Inc. announced new, long-term data from open-label extensions (OLE) of two Phase III studies (Study 1489 and Study 1490) of Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF), demonstrating the sustained efficacy and safety profile and no treatment-emergent resistance with Biktarvy for the treatment of HIV-1 in treatment-naïve adults.

The data were presented at the 28th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2021).

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 (HIV-1 RNA <50 copies/mL) through four years of follow-up (n=235/237 for study 1489, n=241/243 for study 1490). 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 (n=212 for study 1489, n=225 for study 1490). 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 III studies (Study 1489 and Study 1490), 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 (n=634). In a subgroup analysis of participants with transmitted-drug resistance (TDR, n=248) 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 (98% vs. 97%; as treated analysis).