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Background Beyond achieving rapid virologic suppression, modern antiretroviral therapy (ART) aims to reverse systemic damage and organ-specific stress. While the efficacy of BIC/FTC/TAF is well-documented, real-world evidence regarding its capacity to improve liver fibrosis markers (FIB-4) and immune homeostasis (CD4/CD8 ratio) in treatment-naïve cohorts remains a critical clinical endpoint for long-term health optimization.Methods We conducted a multicenter observational study of ART-naïve PWH from the SHINE and SHIC cohorts initiating BIC/FTC/TAF with 96-week follow-up. Durability was assessed via Kaplan–Meier estimates. Effectiveness was primarily evaluated through longitudinal changes in hepatic parameters (FIB-4 and liver enzymes) and secondarily through immunological (CD4/CD8 ratio) and metabolic trends. Safety was monitored via adverse event (AE) discontinuations.Results A total of 144 PWH were included (median age 43.1 years; 52.1% MSM). Baseline median CD4+ count was 304 cells/mm 3 and median HIV-RNA was 168,000 copies/mL (table 1).Regarding hepatic health, a significant and progressive improvement in liver enzymes (p<0.0027) and the FIB-4 index was observed over 96 weeks (p<0.0001), suggesting a marked reduction in hepatic stress and potential reversal of early fibrosis risk following ART initiation. This hepatic amelioration was accompanied by profound immunological normalization: the median CD4+ count rose from 306 to 696.5 cells/mm3 (p<0.0001), and the CD4/CD8 ratio significantly increased from 0.35 to 0.75 (p<0.0001), while reaching increasing virological success overtime (figures 1 and 2).The regimen demonstrated excellent durability; the cumulative probability of discontinuation was 11.4% at 6 months and 20.9% at 24 months. Notably, the primary driver for discontinuation was treatment simplification (e.g., switch to long-acting CAB/RPV, 8.3%), while no discontinuations due to virological failure were observed. Discontinuations due to AEs were rare (4.3% at 24 months).Metabolically, the lipid profile remained stable with a favorable increase in HDL cholesterol, while a minor, non-clinically significant increase in creatinine was observed, consistent with the known pharmacodynamics of bictegravir on tubular secretion.Conclusions In this 96-week real-world analysis, BIC/FTC/TAF proved to be a powerful driver of systemic health restoration. The significant reduction in FIB-4 scores and liver enzymes highlights a specific benefit for hepatic preservation in naïve patients. Combined with absolute virologic success and robust CD4/CD8 ratio optimization, BIC/FTC/TAF confirms its role as a premier first-line strategy for comprehensive clinical recovery beyond simple viral suppression.Abstract P97 Table 1PHW epidemiological and clinical characteristicsAbstract P97 Figure 1–2