Virologic Outcomes of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Advanced HIV-1 Disease: A Propensity-Weighted Multicenter Cohort Study.

Background

Rapid and effective viral suppression (VS) is fundamental to immune reconstitution and reducing clinical morbidity in people with HIV-1. This study aimed to evaluate the effectiveness of co-formulated bictegravir, emtricitabine, and tenofovir alafenamide (BIC/FTC/TAF) to achieve VS among people with advanced HIV-1 disease (AHD).

Methods

We conducted a multicenter retrospective cohort study of newly diagnosed people with AHD between 2018 and 2024. Clinical outcomes were compared between those initiating BIC/FTC/TAF and those initiating other regimens. The primary outcome was ever achieving plasma HIV-1 RNA viral load (VL) <200 copies/mL within 48 weeks. Inverse probability of treatment weighting (IPTW) was applied to adjust for baseline confounding; weighted logistic regression and the Fine-Gray hazard models were used to evaluate associations between initial regimens and clinical outcomes.

Results

Of 467 people with AHD included, the median baseline CD4 count was 61 cells/mm3; 248 (53.1%) initiated BIC/FTC/TAF, while 219 (46.9%) initiated others. In unadjusted analysis, the BIC/FTC/TAF group had similar rates of ever achieving VL <200 copies/mL (93.2% vs 91.3%) and CD4 recovery >200 cells/mm3 (66.5% vs 68.5%) within 48 weeks, but it demonstrated a significantly higher rate of ≥10,000-fold decline in VL within 4 weeks (37.8% vs 27.0%). In IPTW-adjusted analysis, initiation of BIC/FTC/TAF was independently associated with achieving the primary outcome (weighted OR 2.44; 95% CI 1.01-5.93), with consistent findings in sensitivity analyses. Regimen changes were less frequent in the BIC/FTC/TAF group (2.8% vs 10.5%).

Conclusion

BIC/FTC/TAF is highly effective in facilitating VS among people with AHD.