{
  "abstract": "Background Switching antiretroviral therapy (ART) in virologically suppressed (VS) people with HIV (PWH) may optimize genetic barrier, reduce pill-burden and drug-drug interactions, and improve safety. The ESSENTIAL Study assessed the real-world effectiveness and safety of switching to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), including switches from rilpivirine-based regimens.Material and Methods ESSENTIAL Study (GS-IT-380-7059) is a single-site retrospective study including VS (HIV-RNA <50 copies/mL for ≥3 months) PWH aged ≥ 18 years who switched to BIC/FTC/TAF at ASST Fatebenefratelli Sacco from July 2019 to April 2024. Demographic, clinical and immuno-virological data were collected at baseline (time of the switch), 6 and 12 months thereafter. The primary objective was the effectiveness of BIC/FTC/TAF at 6 and 12 months after the switch (observational analysis). A 95% Confidence Interval (CI) was calculated around the observed response rates with Wald asymptotic method. A subgroup analysis evaluated individuals switching from RPV/FTC/TAF.Results A total of 799 PWH were included; median age 53 years, 83% had ≥1 comorbidity, and 34% taking at least 3 concomitant medications ( table 1). The main reason for switching to BIC/FTC/TAF was to increase genetic barrier (figure 1). Virological suppression at 6 and 12 months was 97.4% (95% CI 96.3 %-98.5 %) (observed 746/766) and 98% (95% CI 97%-99%) (observed 728/743), respectively. Treatment discontinuation occurred in 4.1% (95% CI 2.8%-5.5%) (observed 33/799) at 6 months and in 3% (95% CI 1.8-4.2%) (observed 23/766) between 6-12 months. Reasons for discontinuation are reported in figure 2, with adverse events- or toxicity-related discontinuations accounting for a minority of all treatment interruptions. Among 103 PWH switching from RPV/FTC/TAF (baseline characteristics summarized in table 2), virological suppression rates at 6 and 12 months were 93.9% (95% CI 89.2%- 98.6%) (observed 93/99) and 98% (95% CI 95.2%- 100%) (observed 96/98), respectively.Conclusions In a large real-world cohort with substantial comorbidity and polypharmacy, switching to BIC/FTC/TAF showed high virological effectiveness at 6 and 12 months, with few treatment-related discontinuations. High effectiveness was also showed in individuals switching from RPV/FTC/TAF, indicating BIC/FTC/TAF is an appropriate option for optimizing regimens in treatment experienced PWH.This study is sponsored by Gilead Sciences.Abstract SC34 Figure 1–2Abstract SC34 Table 1–2",
  "authors": [
    {
      "affiliations": [
        "Department of Infectious Diseases - ASST Fatebenefratelli Sacco, Milan, Italy"
      ],
      "name": "MV Cossu"
    },
    {
      "affiliations": [
        "Department of Infectious Diseases - ASST Fatebenefratelli Sacco, Milan, Italy"
      ],
      "name": "D Moschese"
    },
    {
      "affiliations": [
        "Department of Infectious Diseases - ASST Fatebenefratelli Sacco, Milan, Italy"
      ],
      "name": "M Matone"
    },
    {
      "affiliations": [
        "Department of Infectious Diseases - ASST Fatebenefratelli Sacco, Milan, Italy"
      ],
      "name": "G Carrozzo"
    },
    {
      "affiliations": [
        "Department of Infectious Diseases - ASST Fatebenefratelli Sacco, Milan, Italy"
      ],
      "name": "G Pozza"
    },
    {
      "affiliations": [
        "Department of Infectious Diseases - ASST Fatebenefratelli Sacco, Milan, Italy"
      ],
      "name": "A Poloni"
    },
    {
      "affiliations": [
        "Gilead Sciences S.r.l – Italy"
      ],
      "name": "L Albini"
    },
    {
      "affiliations": [
        "Gilead Sciences S.r.l – Italy"
      ],
      "name": "G Forcina"
    },
    {
      "affiliations": [
        "Department of Infectious Diseases - ASST Fatebenefratelli Sacco, Milan, Italy",
        "DIBIC Luigi Sacco, University of Milan, Italy"
      ],
      "name": "A Riva"
    },
    {
      "affiliations": [
        "Department of Infectious Diseases - ASST Fatebenefratelli Sacco, Milan, Italy",
        "DIBIC Luigi Sacco, University of Milan, Italy"
      ],
      "name": "A Giacomelli"
    },
    {
      "affiliations": [
        "Department of Infectious Diseases - ASST Fatebenefratelli Sacco, Milan, Italy",
        "DIBIC Luigi Sacco, University of Milan, Italy",
        "Centre for Multidisciplinary Research in Health Science (MACH), University of Milan, Milan, Italy"
      ],
      "name": "A Gori"
    }
  ],
  "title": "SC34 12 months effectiveness and safety of switching to BIC/FTC/TAF in virologically suppressed people with HIV on any ARV-regimens including NNRTIs: a retrospective analysis (ESSENTIAL study)",
  "uid": "3401a5e7-30e1-5bed-8ea5-b7e590ab5794"
}