Long-term treatment durability and safety after switching to bictegravir/emtricitabine/tenofovir alafenamide in real-world practice: a 144-week update from the BICTEL cohort.

OBJECTIVE

Real-world evidence on bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) beyond 96 weeks remains limited. We assessed treatment durability, tolerability and laboratory safety after switching to BIC/FTC/TAF through 144 weeks in routine HIV care.

METHODS

As of 30 March 2026, 180 participants enrolled in the open BICTEL cohort reached the week-144 time point and were included in this retrospective observational update. Primary outcome was HIV-RNA <50 copies/mL at week 144. Secondary outcomes included longitudinal immunological, metabolic, renal and hepatic changes, assessed overall and by age group (<55 versus ≥55 years). Mixed-effects models were used for selected repeated outcomes.

RESULTS

At week 144, 90.6% of participants had HIV-RNA <50 copies/mL and 1.7% had HIV-RNA ≥200 copies/mL. Among 173 participants with paired virological data, suppression was maintained from baseline to week 144 (P = 0.593). No permanent discontinuations, regimen switches or tolerability-related interruptions occurred through week 144. CD4+ T-cell count and CD4+/CD8+ ratio increased significantly. Total cholesterol, low-density lipoprotein cholesterol, triglycerides and total cholesterol/high-density lipoprotein ratio decreased, while body mass index remained stable. Liver enzymes were unchanged. Estimated glomerular filtration rate declined modestly. No statistically significant age-by-time interactions were detected.

CONCLUSIONS

These findings provide long-term real-world evidence of sustained virological effectiveness, no tolerability-related discontinuations, sustained immunological improvement and an overall stable metabolic and hepatic laboratory profile after switching to BIC/FTC/TAF through 144 weeks in a cohort including older and clinically complex people with HIV.