Bictegravir/Tenofovir Alafenamide/Emtricitabine in Real-Life: A Multi-Year Experience.

Introduction: Long-term real-world data on bictegravir/emtricitabine/tenofovir alafenamide (BIC-STR), particularly in key subgroups, remain limited. The primary endpoints of the study were changes in CD4+ cell count and viral load after BIC-STR introduction. The secondary endpoints were the impact of the therapy on metabolic profile and body mass index. Methods: Retrospective observational cohort study including people living with HIV (PLWH) receiving BIC-STR with more than 6 months of follow-up at a tertiary Infectious Diseases clinic (Perugia, Italy). Immunovirological outcomes (HIV-RNA, CD4 count, CD4/CD8 ratio) and metabolic parameters were assessed up to 48 months, with subgroup analyses (treatment-naïve/experienced, >60 years, women, and foreign nationals). Results: 425 patients were included (median follow-up 37.7 months, IQR, 22.1-55.8 months). Most were treatment-experienced (367/425, 86.4%) and viral suppression improved after switching, reaching 90.7% with HIV-RNA < 50 cp/mL; HIV-RNA declined mainly within the first 6 months and then remained stable. CD4 count and CD4/CD8 ratio increased significantly over time, with similar immunovirological trends in older patients (>60 years; 138/425, 32.3%), women (94/425, 22.1%), and foreign nationals (143/425, 33.7%). In treatment-experienced patients not on statins, HDL and LDL did not change significantly, while triglycerides decreased (median from 110 mg/dL, IQR 78.0-164.0, to 103 mg/dL, IQR 70.3-147.8; p = 0.007). In ART-naïve patients (58/425, 13.6%), HDL (median from 41, IQR, 33.0-47.0 to 47, IQR 39.0-54.7, p = 0.0003) and BMI (median from 23.2, IQR 21.7-26.3 to 25.7, IQR 23.4-29.0, p < 0.0001) increased, whereas other lipid changes were not significant. BMI increased only in underweight and normal-weight naïve patients, not in overweight/obese individuals. Conclusions: BIC-STR showed sustained effectiveness, immunological benefit, and favourable metabolic outcomes in routine practice, including, PLWH > 60 years, women, and foreign nationals subgroups.