Effectiveness and Safety Profile of BIC/TAF/FTC in People living with HIV Switched from Other Antiretroviral Regimens: A Real-Life Retrospective Cohort Analysis.

Background Switching antiretroviral therapy (ART) is a common strategy in people living with HIV (PLWH) to improve tolerability, to manage comorbidities, and to optimize long-term safety. Bictegravir/tenofovir alafenamide/emtricitabine (BIC/TAF/FTC) is a single-tablet regimen with proven effectiveness in clinical trials. Real-world data continue to confirm its effectiveness across diverse clinical settings.

Methods We conducted a retrospective observational cohort study including PLWH who switched to BIC/TAF/FTC from other ART regimens in routine clinical practice. At both baseline and during follow-up, we collected demographic characteristics, comorbidities, virological and immunological markers, and laboratory safety parameters.

Results The study included 177 PLWH, with a median age of 55 years (IQR 44.4-60.3). 70.6% were male and 68.9% were aged ≥50 years. The median follow-up was 38.7 months (IQR 26.9-52.2). At baseline, 93.2% (165/177) of participants had suppressed HIV-RNA (<50 copies/mL). After switching to BIC/TAF/FTC, virological suppression (HIV-RNA <50 copies/mL) improved to 98.3% (174/177) at follow-up (p=0.007). Three participants had HIV-RNA ≥50 copies/mL at follow-up; none showed confirmed virological failure and no new resistance mutations were identified. Median CD4+ T-cell count showed a non-statistically significant trend toward increase from 562 (IQR 373-774) to 596 cells/μL (IQR 396-753) (p=0.057), while the CD4/CD8 ratio increased from 0.90 (IQR 0.60-1.30) to 0.94 (IQR 0.65-1.51) (p<0.001). A statistically significant decrease in total cholesterol (189 vs 180 mg/dL, p=0.013) was also observed. No clinically significant changes were observed in renal, hepatic, or hematological parameters.

Conclusions In this real-life cohort, switching to BIC/TAF/FTC was associated with an improvement in virological suppression, an increase in CD4/CD8 ratio, and a favorable safety and metabolic profile, supporting its use as an effective and well-tolerated switch option in routine clinical practice.