{
  "abstract": "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",
  "authors": [
    {
      "affiliations": [
        "Unit of Infectious Diseases, ARNAS Garibaldi Nesima Hospital, Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy",
        "Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy",
        "Unit of Infectious Diseases, G. Martino University Hospital, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy"
      ],
      "name": "S Spampinato"
    },
    {
      "affiliations": [
        "Unit of Infectious Diseases, Department of Medicine, Surgery and Pharmacy, University of Sassari, Sassari, Italy"
      ],
      "name": "A De Vito"
    },
    {
      "affiliations": [
        "Unit of Infectious Diseases, ARNAS Garibaldi Nesima Hospital, Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy"
      ],
      "name": "D Bivona"
    },
    {
      "affiliations": [
        "Unit of Infectious Diseases, ARNAS Garibaldi Nesima Hospital, Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy"
      ],
      "name": "F Velardita"
    },
    {
      "affiliations": [
        "Unit of Infectious Diseases, ARNAS Garibaldi Nesima Hospital, Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy"
      ],
      "name": "A Marino"
    },
    {
      "affiliations": [
        "Unit of Infectious Diseases, ARNAS Garibaldi Nesima Hospital, Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy"
      ],
      "name": "B Cacopardo"
    },
    {
      "affiliations": [
        "Unit of Infectious Diseases, ARNAS Garibaldi Nesima Hospital, Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy"
      ],
      "name": "B M Celesia"
    },
    {
      "affiliations": [
        "Unit of Infectious Diseases, ARNAS Garibaldi Nesima Hospital, Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy"
      ],
      "name": "G Nunnari"
    },
    {
      "affiliations": [
        "Unit of Infectious Diseases, Department of Medicine, Surgery and Pharmacy, University of Sassari, Sassari, Italy"
      ],
      "name": "G Madeddu"
    }
  ],
  "title": "P97 Hepatic health restoration and immune optimization in ART-naïve PWH starting BIC/FTC/TAF: a 96-week multicenter analysis of FIB-4 dynamics and CD4/CD8 ratio abstract",
  "uid": "ca0357d4-11cc-5560-ae3b-abae744213f8"
}