{
  "abstract": "Background Data on the effectiveness and durability of B/F/TAF in people with HIV (PWH) switching from DTG-based two-drug oral regimens (2DR) are limited. We aimed to characterize treatment-experienced PWH switching from DTG-based 2DR to B/F/TAF and to evaluate virological, immunological, and metabolic outcomes.Methods OPTIMIZE-BIC (GS-IT-380-7670) is a retrospective analysis including PWH from the ICONA cohort who switched from DTG+3TC or DTG+RPV (single- or multi-tablet regimens) to B/F/TAF, between Jul-2019 and Apr-2025, regardless of HIV-RNA at switch. We included only PWH with ≥1 HIV-RNA measurement post-switch. Participants were stratified by HIV-RNA at switch: <50 copies/ml (uVL) or ≥50 copies/ml (dVL). The primary endpoint was virological suppression (HIV-RNA <50 copies/ml) at the last follow-up. Secondary endpoints included time to: -virological failure (VF, 2 consecutive HIV-RNA >50 or single >1000 copies/ml followed by ART-change) among uVL; -virological suppression (VS) among dVL; -treatment discontinuation (TD) for any reason and for toxicity. Changes in CD4 count, CD4/CD8 ratio, liver enzymes, and lipid profile were assessed. Kaplan–Meier methods and mixed linear regression models were used.Results Eighty-three PWH were included; median age 48 years (IQR 38–58), 69.9% male, and median ART exposure of 7.7 years (IQR 3.6–11.4). At switch, 47 (56.6%) were in the uVL group and 36 (43.4%) in the dVL group ( table 1). After a median follow-up of 1.4 years (IQR 0.6–2.6), overall 74/83 PWH (89.2%, 95%CI 80.4–94.9) had HIV-RNA <50 copies/mL at last observation.In the dVL group, 83.3% (95%CI 67.2–93.6) had HIV-RNA <50 cps/ml at last assessment. Median time to suppression was 3.5 months (95%CI 2.8–5.3), with 81.8% (95%CI 67.2–92.6) of PWH reaching VS by 1-year (figure 1A).In the uVL group, HIV-RNA was <50 cps/ml at last measurement in 93.6% (95%CI 82.5–98.7). Only 1 VF occurred with a probability of 3.1% at 1 year (95%CI 0.45–20.2, figure 1B).17 PWH discontinued B/F/TAF during follow-up. The cumulative probability of TD for any reason was 10.1% (95% CI 5.0–20.2, figure 1C) at 1 year, with no significant differences between dVL and uVL (p=0.498). Discontinuations were mainly driven by treatment simplification (n=7, 6.4%), lack of virological control (n=3, 3.6%) and toxicity (n=3, 3.6%). At 1 year the probability of TD for toxicity was 3.2% (95%CI 0.8-11.6, figure 1D).The CD4/CD8 ratio significantly increased in both groups. Among dVL, CD4 counts increased significantly at 12 months (figure 2). Liver enzymes and lipid parameters remained stable, with a modest increase in HDL cholesterol (figure 3).Conclusions In this real-world cohort, switching from DTG-based 2DR to B/F/TAF resulted in high rates of virological suppression, rapid viral control in viremic PWH, low virological failure, and good treatment durability, with favorable immunological trends and a neutral metabolic profile.Abstract OC68 Figure 1–3Abstract OC68 Table 1",
  "authors": [
    {
      "affiliations": [
        "Unit of Infectious Diseases, Department of Medicine, Surgery and Pharmacy, University of Sassari, Sassari, Italy"
      ],
      "name": "A De Vito"
    },
    {
      "affiliations": [
        "Fondazione ICONA, Milan, Italy",
        "National PhD Programme in One Health Approaches to Infectious Diseases and Life Science Research, Department of Public Health, Experimental and Forensic Medicine, University of Pavia, Pavia, Italy"
      ],
      "name": "A Tavelli"
    },
    {
      "affiliations": [
        "Department of Infectious Diseases, Luigi Sacco University Hospital, ASST Fatebenefratelli Sacco, Milan, Italy",
        "Department of Biomedical and Clinical Sciences, University of Milan, Milan, Italy"
      ],
      "name": "A Giacomelli"
    },
    {
      "affiliations": [
        "U.O.C. Immunodeficienze Virali e IST, INMI L. Spallanzani IRCCS – Roma, Italy"
      ],
      "name": "V Mazzotta"
    },
    {
      "affiliations": [
        "Unit of Infectious Diseases, Divisione A, ASL Città di Torino, Torino, Italy"
      ],
      "name": "G Orofino"
    },
    {
      "affiliations": [
        "Dipartimento di Sicurezza e Bioetica - Sezione di Malattie Infettive, Università Cattolica del Sacro Cuore, Rome, Italy"
      ],
      "name": "R Serraino"
    },
    {
      "affiliations": [
        "Infectious Diseases Unit, SM Goretti Hospital, Latina, Italy"
      ],
      "name": "R Marocco"
    },
    {
      "affiliations": [
        "S.C. Malattie Infettive – ASST Grande Ospedale Metropolitano Niguarda – Milano, Italy"
      ],
      "name": "R Rossotti"
    },
    {
      "affiliations": [
        "Clinica Malattie Infettive - Ospedale San Raffaele, Università Vita-Salute – Milano, Italy"
      ],
      "name": "S Nozza"
    },
    {
      "affiliations": [
        "Gilead Sciences Srl, Italy"
      ],
      "name": "L Albini"
    },
    {
      "affiliations": [
        "Gilead Sciences Srl, Italy"
      ],
      "name": "G Forcina"
    },
    {
      "affiliations": [
        "Infectious Diseases Unit, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy"
      ],
      "name": "A Vergori"
    },
    {
      "affiliations": [
        "Department of Health Sciences, University of Genoa, Genoa, Italy",
        "Infectious Disease Unit, IRCCS Ospedale Policlinico San Martino, Genoa, Italy"
      ],
      "name": "A Di Biagio"
    },
    {
      "affiliations": [
        "Fondazione ICONA, Milan, Italy"
      ],
      "name": "A d’Arminio Monforte"
    },
    {
      "affiliations": [
        "Unit of Infectious Diseases, Department of Medicine, Surgery and Pharmacy, University of Sassari, Sassari, Italy"
      ],
      "name": "G Madeddu"
    }
  ],
  "title": "OC68 Clinical outcomes in PWH switching from oral combinations with dolutegravir (DTG) + lamivudine (3TC) or rilpivirine (RPV) to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF): data from the Italian ICONA foundation cohort (OPTIMIZE-BIC analysis)",
  "uid": "692940ef-6978-509b-9b8a-7f29601557b3"
}