{
  "abstract": "Background The onset of adverse events (AEs) is the main cause of discontinuation of long-acting (LA) cabotegravir+rilpivirine (CAB+RPV) in observational and randomized studies. Nevertheless, data are scarce on the choice of the following oral regimen, on the potential additional AEs that develop during the pharmacokinetic tail of CAB and RPV, and on the virologic outcomes in people who discontinue LA treatment for reasons other than virologic failure (VF).Materials and Methods This is a multicenter, prospective, observational study conducted within the SCOLTA (Surveillance Cohort Long-Term Toxicity Antiretrovirals) project; it includes people with HIV (PWH) who discontinued LA CAB/RPV therapy after at least one follow-up visit. Descriptive statistics were used to summarize data.Results The study included 700 PWH on LA CAB+RPV, with an observed all-cause therapy interruption rate of 13.3% (93/700) and a median follow-up of 23 months (IQR 14-30). The main reasons for treatment discontinuation were AEs and the subject’s decision, accounting for 47.3% (44/93) and 16.1% (11/93) of all interruptions, respectively ( table 1). Injection site reactions (ISRs) were the most frequent AE, accounting for 45.5% of cases, followed by arthromyalgias and infectious complications, each accounting for 11.4% of cases (table 2). Excluding people who were lost to follow-up and the deceased, we evaluated the oral regimen selected after LA discontinuation in the remaining study participants. Among the subgroup that discontinued injectables for reasons other than VF, and excluding one subject who returned to the same PI-based therapy that was in place before initiating LA, 100% maintained a NNRTI- and/or INSTI-based regimen without the need to introduce new ARV classes or a PI-based therapy. Considering those who discontinued injectables due to VF, 4 out of 10 people switched to a PI-based regimen (table 3).The resumption of the same drug co-formulation utilized before the LA regimen occurred in 20.0% (2/10), 76.9% (15/65), and 84.1% (37/44) of PWH who interrupted LA due to VF, due to any cause other than VF, and due to AEs, respectively. Overall, 92.1% of regimens after LA interruption were NNRTI (16%), INSTI (57.3%), or NNRTI+INSTI (18.7%)-based. No new AEs were recorded after switching back to oral therapy throughout the whole cohort. Six months after resuming oral therapy, HIV-RNA loads <30 copies/mL and <200 copies/mL were recorded in 96.0% (72/75) and 98.7% (74/75) of individuals, respectively.Conclusions Among individuals who interrupted injectables for reasons other than VF, the majority returned to the same pre-LA oral co-formulation. The superimposition of CAB+RPV pharmacokinetic tail with an oral NNRTI and/or INSTI-based regimen did not lead to the development of AEs, even in people with a previous AE to CAB or RPV. Six months after the reintroduction of oral therapy, the virologic suppression rate was high throughout the cohort.Abstract SC22 Table 1–3",
  "authors": [
    {
      "affiliations": [
        "Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy"
      ],
      "name": "M Giurco"
    },
    {
      "affiliations": [
        "Infectious Disease Clinic, IRCCS Azienda Ospedaliera Metropolitana, Genova, Italy"
      ],
      "name": "L Taramasso"
    },
    {
      "affiliations": [
        "Fondazione ASIA, Milan, Italy"
      ],
      "name": "E Ricci"
    },
    {
      "affiliations": [
        "Infectious Disease Unit, Fondazione IRCCS San Gerardo dei Tintori, Monza - University of Milano-Bicocca, Monza, Italy"
      ],
      "name": "N Squillace"
    },
    {
      "affiliations": [
        "Unit of Infectious Diseases, Department of Clinical and Experimental Medicine, University of Foggia, Foggia, Italy"
      ],
      "name": "S Ferrara"
    },
    {
      "affiliations": [
        "Department of Infectious Diseases, Galliera Hospital, Genoa, Italy"
      ],
      "name": "A Parisini"
    },
    {
      "affiliations": [
        "Unit of Infectious Diseases, Divisione A, Amedeo di Savoia Hospital, Torino, Italy"
      ],
      "name": "G Orofino"
    },
    {
      "affiliations": [
        "Unit of Infectious Diseases, ASST della Valle Olona – Busto Arsizio (VA), Italy"
      ],
      "name": "B Menzaghi"
    },
    {
      "affiliations": [
        "AOU Infectious and Tropical Diseases, Careggi Hospital, Florence, Italy"
      ],
      "name": "F Lagi"
    },
    {
      "affiliations": [
        "Infectious Diseases Unit, SS. Antonio e Biagio e Cesare Arrigo Hospital, Alessandria, Italy"
      ],
      "name": "E Sarchi"
    },
    {
      "affiliations": [
        "Infectious Diseases Unit, Ospedale S. Anna, Como, Italy"
      ],
      "name": "L Pusterla"
    },
    {
      "affiliations": [
        "Unit of Infectious Diseases, Department of Medicine, Surgery and Pharmacy, University of Sassari, Italy"
      ],
      "name": "G Madeddu"
    },
    {
      "affiliations": [
        "Infectious disease Unit, IRCCS Policlinico Sant’ Orsola, University of Bologna, Italy"
      ],
      "name": "L Calza"
    },
    {
      "affiliations": [
        "Infectious Diseases and Gender Medicine Unit, Cotugno Hospital, AO dei Colli, Naples, Italy"
      ],
      "name": "MA Carleo"
    },
    {
      "affiliations": [
        "Infectious Diseases Department, Sanremo Hospital, Sanremo, Italy"
      ],
      "name": "G Cenderello"
    },
    {
      "affiliations": [
        "Infectious Diseases Unit, SS. Trinità Hospital, Cagliari, Italy"
      ],
      "name": "G Angioni"
    },
    {
      "affiliations": [
        "Clinic of Infectious Diseases, Department of Medicine and Science of Aging, G. d’Annunzio University, Chieti-Pescara, Chieti, Italy"
      ],
      "name": "K Falasca"
    },
    {
      "affiliations": [
        "SOC 1 USL Centro Firenze, Unit of Infectious Diseases, Santa Maria Annunziata Hospital, Florence, Italy"
      ],
      "name": "E Salomoni"
    },
    {
      "affiliations": [
        "Infectious Diseases Unit, ASST Ovest Milanese, Legnano and DIBIC, University of Milan, Italy"
      ],
      "name": "S Rusconi"
    },
    {
      "affiliations": [
        "Unit of Infectious Diseases, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy"
      ],
      "name": "GF Pellicanò"
    },
    {
      "affiliations": [
        "Unit of Infectious Diseases, San Paolo Hospital, Milano, Italy"
      ],
      "name": "T Bini"
    },
    {
      "affiliations": [
        "Infectious Diseases Clinic, Department of Medicine and Surgery, University of Perugia, Italy"
      ],
      "name": "G De Socio"
    },
    {
      "affiliations": [
        "Infectious Disease Unit, Fondazione IRCCS San Gerardo dei Tintori, Monza - University of Milano-Bicocca, Monza, Italy"
      ],
      "name": "P Bonfanti"
    },
    {
      "affiliations": [
        "Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy",
        "Infectious Disease Clinic, IRCCS Azienda Ospedaliera Metropolitana, Genova, Italy"
      ],
      "name": "A Di Biagio"
    },
    {
      "affiliations": [
        "Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy",
        "Infectious Disease Clinic, IRCCS Azienda Ospedaliera Metropolitana, Genova, Italy",
        "Fondazione ASIA, Milan, Italy",
        "Infectious Disease Unit, Fondazione IRCCS San Gerardo dei Tintori, Monza - University of Milano-Bicocca, Monza, Italy",
        "Unit of Infectious Diseases, Department of Clinical and Experimental Medicine, University of Foggia, Foggia, Italy",
        "Department of Infectious Diseases, Galliera Hospital, Genoa, Italy",
        "Unit of Infectious Diseases, Divisione A, Amedeo di Savoia Hospital, Torino, Italy",
        "Unit of Infectious Diseases, ASST della Valle Olona – Busto Arsizio (VA), Italy",
        "AOU Infectious and Tropical Diseases, Careggi Hospital, Florence, Italy",
        "Infectious Diseases Unit, SS. Antonio e Biagio e Cesare Arrigo Hospital, Alessandria, Italy",
        "Infectious Diseases Unit, Ospedale S. Anna, Como, Italy",
        "Unit of Infectious Diseases, Department of Medicine, Surgery and Pharmacy, University of Sassari, Italy",
        "Infectious disease Unit, IRCCS Policlinico Sant’ Orsola, University of Bologna, Italy",
        "Infectious Diseases and Gender Medicine Unit, Cotugno Hospital, AO dei Colli, Naples, Italy",
        "Infectious Diseases Department, Sanremo Hospital, Sanremo, Italy",
        "Infectious Diseases Unit, SS. Trinità Hospital, Cagliari, Italy",
        "Clinic of Infectious Diseases, Department of Medicine and Science of Aging, G. d’Annunzio University, Chieti-Pescara, Chieti, Italy",
        "SOC 1 USL Centro Firenze, Unit of Infectious Diseases, Santa Maria Annunziata Hospital, Florence, Italy",
        "Infectious Diseases Unit, ASST Ovest Milanese, Legnano and DIBIC, University of Milan, Italy",
        "Unit of Infectious Diseases, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy",
        "Unit of Infectious Diseases, San Paolo Hospital, Milano, Italy",
        "Infectious Diseases Clinic, Department of Medicine and Surgery, University of Perugia, Italy"
      ],
      "name": "for the CISAI study Group"
    }
  ],
  "title": "SC22 Life after long-acting therapy: what happens when CAB/RPV is discontinued?",
  "uid": "52081c70-dee4-5226-b911-669e4204bdee"
}