Biktarvy demonstrates high efficacy and durable viral suppression at five years in treatment-naïve adults with HIV.

The data were presented at the 29th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2022). In both studies, greater than 98% of participants who initiated treatment with Biktarvy and remained in the study for all 240 weeks achieved and maintained an undetectable viral load (HIV-1 RNA greater than 50 copies/mL) through five years of follow-up (Week 240, 1489 n=208/213, 1490: n=218/219, missing equals excluded analysis). Through five years of analysis, zero cases of treatment failure due to emergent resistance were detected among the final resistance analysis population of both studies, further demonstrating the efficacy and tolerability profile of Biktarvy for the treatment of HIV-1 in treatment-naïve adults.

Data support long-term use of Biktarvy, with no significant changes to metabolic, bone and renal markers. Among study participants, median change in weight from baseline through Week 240 was 6.1 kg, consistent with previously presented data. Study 1489 also demonstrated small impacts on bone mineral density (BMD) outcomes through five years. Mean percentage changes in hip and spine BMD through Week 240 in Biktarvy participants were -0.29% and -0.23%, respectively. In both studies, five participants (n=5/634) experienced a study-drug related adverse event (AE) that led to drug discontinuation. Furthermore, through 240 weeks, numerically small median changes in eGFR and stable TC:HDL ratios were observed in both studies.