Real-World Outcomes Among People Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide: A Comparison between Those with and without Advanced HIV-1 Disease

Background We aimed to evaluate outcomes of people with HIV-1 (PWH) initiating bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) according to the presence or absence of advanced HIV-1 disease (AHD). Methods We conducted a multicenter retrospective cohort study of newly diagnosed PWH initiating BIC/FTC/TAF during 2019–2024. The primary outcome was ever achieving viral load (VL) measurement <50 copies/mL within 48±12 weeks, regardless of subsequent viral rebound. Associations between clinical and laboratory variables and outcomes were analysed using logistic regression and Fine-Gray subdistribution hazard models. Results Of 577 PWH (median CD4 counts, 225 cells/µL), 248 (43.0%) presented with AHD. Baseline VL >100,000 copies/mL (adjusted odds ratio [aOR] 0.34; 95% confidence interval [CI] 0.18–0.66) and AHD (aOR 0.48; 95% CI 0.27–0.83) were associated with lower odds of achieving the primary outcome independently. Stratified by baseline VL of 100,000 copies/mL, the proportion achieving the primary outcome was significantly lower among PWH with AHD than among those without (76.1% vs 88.4%, P =0.006) in the high VL subgroup. Conversely, proportions were similar by AHD status in the low VL subgroup (93.1% vs 94.0%, P =0.78). Conclusion Virologic outcomes with BIC/FTC/TAF were not statistically different between PWH with and without AHD among those with baseline VL ≤100,000 copies/mL.