24-Month Outcomes of Bictegravir/Emtricitabine/Tenofovir Alafenamide in People with HIV from the Italian BICSTaR Cohort.

Abstract

Introduction: The Italian BICSTaR cohort is part of a multinational cohort study assessing real-world effectiveness, safety, persistence, and patient-reported outcomes (PROs) of B/F/TAF in treatment-naïve (TN) and treatment-experienced (TE) people with HIV (PWH) in routine clinical care.

Methods: Final month 24 (M24) outcomes included virological effectiveness (HIV-1 RNA <50 copies/mL; missing/discontinuation/loss-to-follow-up=excluded (M=E) and discontinuation=failure (D=F) analyses), immunological changes, drug-related adverse events (DRAEs), treatment persistence, body weight, and PROs (HIV Symptom Index (HIV-SI) and HIV Treatment Satisfaction (HIVTSQ, only M12)).

Results: 205 PWH (29 TN, 176 TE) were eligible for M24 analysis (82% male, 96% white, 44% >50 years). Median CD4 cell count was 225/μL in TN, 724/μL in TE; 94% of TE had <50 HIV-1 copies/mL pre-switch; 92% switched to B/F/TAF to optimize therapy. In M=E analysis, 96% (24/25) of TN and 97% (144/148) of TE had <50 HIV-1 RNA copies/mL at M24. In the D=F analysis, rates were 92% (24/26) in TN and 92% (144/156) in TE. Median CD4 cell count increased in TN and remained stable in TE. DRAEs were reported for 6%, leading to discontinuation in 2%. HIV-SI decreased in TN (median (interquartile range, IQR): -3 (-5, 0)), and remained stable in TE. Median HIVTSQ change score (IQR) was +28 (21, 30) in TE.

Discussion: Outcomes were consistent with international real-world B/F/TAF data, with safety findings aligning with the established profile.

Conclusions: B/F/TAF was well tolerated, with high levels of viral suppression and treatment persistence over 24 months. HIV symptom burden remained stable or improved, while treatment satisfaction increased.