{
  "abstract": "Background The widespread adoption of cabotegravir (CAB)/rilpivirine (RPV) long-acting (LA) in clinical practice may be limited not only by organizational challenges but also by clinical uncertainties due to limited real-world evidence in selected key-subgroups of people with HIV (PWH).Methods PWH enrolled in the ICONA Cohort who started CAB/RPV with HIV-RNA <50 cp/ml and with ≥1 follow-up (FU) were included. Aim: to estimate the risk of treatment failure (TF, defined as CAB/RPV discontinuation for any cause, TD, or virological failure, VF50, 2 HIV-RNA >50 cp/ml or a single >1000 cp/ml followed by ART change), according to selected exposures of interest: PWH aged ≥60 years (vs <60), females (vs males), migrants (vs Italy-born), PWH without availability of genotype resistance test (GRT) before CAB/RPV start, PWH with previous HBV infection (HBcAb pos vs HBcAb neg), body mass index (BMI) ≥30kg/m 2 (vs <30kg/m2).TF was compared across exposure groups using standard survival analysis (Kaplan-Meier (KM) curves) and multivariable Cox regression models stratified by center. Covariate adjustment for each exposure was guided by a directed acyclic graph. Secondary analysis of TD and VF50 were also performed, VF was also evaluated as 2 HIV-RNA >200 cp/ml or one >1000 cp/ml followed by ART change (VF200).Results Overall, 920 PWH started CAB/RPV LA ( table 1): 11.6% females, 10.8% ≥60 years, 7.4% with BMI ≥30 kg/m2, 11.7% non-Italians, 17.9% anti-HBc pos and 8.7% without previous GRT available (% excludes missing data).In a median FU of 21 months (interquartile range, IQR, 10-30) 104 TF occurred (12 VF50 and 92 TD); the estimated cumulative probability of TF was 9.2% (95% CI 7.4-11.4%) at 1-yr and 12.4% (10.2%-15.0%) at 2-yrs.KM curves showed comparable cumulative probabilities of TF across the selected exposures (figure 1). In the adjusted Cox regression model, no evidence for a difference between the groups in TF was observed (females vs males, adjusted hazard rate, aHR, 1.02, 95% CI 0.52-1.99; migrants vs Italian-born, 0.90, 0.47-1.69; obese vs BMI<30 kg/m2, 1.33, 0.65-2.74; previous GRT available vs not, 0.49, 0.21-1.16; age ≥60 ys vs <60, 0.82; 0.41-1.64; AntiHBc pos vs AntiHBc neg, 1.14, 0.66-1.97) (table 2).Estimated cumulative probability of TD, mainly driven by toxicity/adverse events (69.3%), was 9.2% (7.4-11.4%) at 1-yr and 12.2% (10.0-14.8%) at 2-yrs. Similarly, no evidence for a difference in aHR of TD was detected.Estimated cumulative probability of VF50 was 1.5% (0.8-2.6%) at 1-yr and 11/12 VF occurred <1yr from CAB/RPV start. The estimated 1-yr probability of VF200 was 0.7% (0.3-1.6%).Conclusions In this real-world Italian study, rate of TF of CAB/RPV was 12.4% at 2 years, with no evidence of differences across the key groups evaluated, supporting a broader use of this strategy across heterogeneous groups, while acknowledging the low prevalence of key exposures; residual confounding and potential selection bias cannot be excluded.Abstract OC74 Figure 1 and Table 1–2Estimated probability of treatment failure by key exposure groups",
  "authors": [
    {
      "affiliations": [
        "National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy"
      ],
      "name": "R Gagliardini"
    },
    {
      "affiliations": [
        "ICONA Foundation, 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 Biomedical and Clinical Sciences, Università degli Studi di Milano, Milan, Italy",
        "Department of Infectious Diseases, ASST Fatebenefratelli Sacco, L. Sacco University Hospital, Milan, Italy"
      ],
      "name": "A Giacomelli"
    },
    {
      "affiliations": [
        "Infectious Diseases, Vita-Salute San Raffaele University, Milano, Italy",
        "Infectious Diseases Unit, IRCCS San Raffaele Scientific Institute, Milano, Italy"
      ],
      "name": "AR Raccagni"
    },
    {
      "affiliations": [
        "National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy"
      ],
      "name": "V Mazzotta"
    },
    {
      "affiliations": [
        "Infectious and Tropical Diseases Unit, Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties G. D’Alessandro University of Palermo, Palermo, Italy"
      ],
      "name": "L Pipitò"
    },
    {
      "affiliations": [
        "Department of Biomedical Sciences & Public Health, Polytechnic University of Marche, Ancona, Italy"
      ],
      "name": "L Brescini"
    },
    {
      "affiliations": [
        "ICONA Foundation, Milan, Italy"
      ],
      "name": "S De Benedittis"
    },
    {
      "affiliations": [
        "Infectious Diseases, Vita-Salute San Raffaele University, Milano, Italy",
        "Infectious Diseases Unit, IRCCS San Raffaele Scientific Institute, Milano, Italy"
      ],
      "name": "C Muccini"
    },
    {
      "affiliations": [
        "UOC Malattie Infettive, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Dipartimento di Sicurezza e Bioetica, Università Cattolica del Sacro Cuore, Rome, Italy"
      ],
      "name": "A Cingolani"
    },
    {
      "affiliations": [
        "Clinic of Infectious Diseases, ASST Santi Paolo e Carlo, Department of Health Sciences, University of Milan, Milan, Italy"
      ],
      "name": "G Marchetti"
    },
    {
      "affiliations": [
        "National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy"
      ],
      "name": "A Antinori"
    },
    {
      "affiliations": [
        "ICONA Foundation, Milan, Italy"
      ],
      "name": "A d’Arminio Monforte"
    },
    {
      "affiliations": [
        "National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy",
        "ICONA Foundation, 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",
        "Department of Biomedical and Clinical Sciences, Università degli Studi di Milano, Milan, Italy",
        "Department of Infectious Diseases, ASST Fatebenefratelli Sacco, L. Sacco University Hospital, Milan, Italy",
        "Infectious Diseases, Vita-Salute San Raffaele University, Milano, Italy",
        "Infectious Diseases Unit, IRCCS San Raffaele Scientific Institute, Milano, Italy",
        "Infectious and Tropical Diseases Unit, Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties G. D’Alessandro University of Palermo, Palermo, Italy",
        "Department of Biomedical Sciences & Public Health, Polytechnic University of Marche, Ancona, Italy",
        "UOC Malattie Infettive, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Dipartimento di Sicurezza e Bioetica, Università Cattolica del Sacro Cuore, Rome, Italy",
        "Clinic of Infectious Diseases, ASST Santi Paolo e Carlo, Department of Health Sciences, University of Milan, Milan, Italy"
      ],
      "name": "on behalf of the ICONA Foundation Cohort"
    }
  ],
  "title": "OC74 Outcomes of cabotegravir-rilpivirine in key groups of people with HIV (PWH): data from the ICONA cohort",
  "uid": "f1c08478-13e3-5386-b002-434e8e9b7243"
}