Adjunctive albuvirtide is associated with improved immune recovery in treatment-naive patients with advanced HIV disease receiving bictegravir/emtricitabine/tenofovir alafenamide: a retrospective propensity score-matched cohort study

Background Treatment-naive patients with advanced HIV infection may have incomplete immune reconstitution despite effective antiretroviral therapy (ART). We evaluated whether adjunctive albuvirtide (ABT) added to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) was associated with improved 24-week immune recovery and short-term safety. Methods This single-center retrospective cohort included adults with baseline CD4+ T-cell counts <200 cells/μL who initiated ABT+B/F/TAF or B/F/TAF alone. Variable-ratio propensity score matching (up to 1:2) yielded 86 patients (33 receiving ABT+B/F/TAF and 53 receiving B/F/TAF). The primary endpoint was a composite of a CD4+ T-cell increase >150 cells/μL and HIV RNA <50 copies/mL at week 24. Secondary outcomes included virological suppression, changes in CD4+ T-cell count and CD4/CD8 ratio, and documented adverse events. A multivariable sensitivity analysis was performed in the complete unmatched cohort (N = 124). Results The composite endpoint was achieved more frequently with ABT+B/F/TAF than with B/F/TAF alone (45.5% vs. 22.6%, P = 0.027). The median CD4+ T-cell increase was also greater (165 vs. 106 cells/μL, P = 0.005). HIV RNA <20 copies/mL occurred in 75.8% versus 54.7% of patients, but the difference did not meet the prespecified significance threshold (P = 0.050). In the complete cohort, ABT+B/F/TAF remained associated with immune recovery after multivariable adjustment (adjusted OR = 6.355, 95% CI: 1.539–26.244; P = 0.011). Documented adverse events were similar between groups (54.5% vs. 50.9%, P = 0.732). No Grade ≥3 adverse events, treatment-related adverse events, or adverse-event-related treatment modifications were documented. Conclusion Adjunctive ABT was associated with greater short-term immune recovery without an apparent increase in documented adverse events. The retrospective design, limited matched sample, residual confounding, and 24-week follow-up preclude causal inference. These findings require confirmation in prospective randomized trials.