Long-term persistence, effectiveness, safety, and metabolic impact of bictegravir/emtricitabine/tenofovir alafenamide fixed-dose combination in people living with HIV in the BICTARG cohort

INTRODUCTION: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a preferred antiretroviral regimen in international guidelines, but long-term real-world data in Latin American people living with HIV (PLWH) are scarce. This study describes 48-month persistence, virological effectiveness, safety and metabolic changes in the Argentine BICTARG cohort. MATERIAL AND METHODS: We conducted an observational, retrospective, open cohort study including treatment-naïve (TN) and treatment-experienced (TE) adults with HIV who initiated B/F/TAF between October 2019 and December 2022 at a large HIV centre. Persistence on B/F/TAF, virological suppression (VS, <50 copies/mL), B/F/TAF-related adverse events (AEs), and metabolic parameters (fasting glucose, cholesterol, and triglycerides) were assessed at 24, 36 and 48 months. RESULTS: Overall, 3,057 PLWH were included: 425 TN (14%) and 2,632 TE (86%). In TN, persistence at 24, 36 and 48 months was 99%, 97% and 95%, and VS rates were 95%, 93% and 90%, respectively, with no AEs reported. In TE, persistence was 98%, 96%, and 88%, and VS rates were 96%, 98%, and 98%; AE rates were ≤0.4%, with no virological failure. Fasting glucose remained unchanged; TN participants showed increases in total, LDL, and HDL cholesterol, whereas in TE participants, lipid levels were stable and triglycerides decreased over time (p<0.001). CONCLUSIONS: In this large Argentine cohort, B/F/TAF demonstrated high persistence, sustained VS, low AE rates and an overall favourable metabolic profile over 48 months in both TN and TE PLWH, providing the first long-term real-world evidence from Latin America.