{
  "abstract": "Background The triple regimen of RPV/FTC/TAF was recommended in the past both as initial and switch strategies in people living with HIV (PWH) and largely adopted in clinical practice due to its safety, tolerability, efficacy and convenience. We report on the durability of this single tablet regimen and the reasons for treatment discontinuation (TD) in the INSTI era.Methods Retrospective and observational study in PWH consecutively enrolled on RPV/FTC/TAF in 6 large HIV clinics, in Northern Italy. The primary composite endpoint was TD defined as any reason of discontinuation (including virological failure (VF), as confirmed HIV RNA >50 copies/mL or any values followed by a switch). Survival analysis with Kaplan-Meier estimator was used to assess the probability of treatment discontinuation over time.Results A total of 2658 PWH were included in the study, 75% were males, 45% heterosexual, 36% MSM, and 80% were born in Italy. Median nadir (IQR) CD4 count was 308 (183-453) cells/ml and 20% had AIDS. At study entry, median age (IQR) was 48 (40-45) years, median CD4 count (IQR) was 660 (481-870) cells/ml and 68% had received 3 or less treatment lines. Overall, 82% of PWH had switched from other effective regimens (NNRTI-, PI- and INSTI-based triple options in 86%, 3% and 2.4%, respectively). A total of 1497 (56.3%) of subjects discontinued this regimen. The major reasons for stopping were simplification to 2-drug regimens (51.5%), drug interactions (16%), toxicity (5.6 %), lost to follow-up (4.6%), side effects (3.2%) and pregnancy (2.6%), while VF occurred in 4.4% of individuals. A total of 2.3% of individuals died during the follow-up. Among those who discontinued, 57.4% were switched to 2-drug INSTI-based regimens (i.e. DTG/3TC, DTG/RPV and CABO/RPV LA for 49.7%, 33% and 9.1%, respectively), while the remaining subjects mostly switched to 3-drug INSTI-based regimens (27%). For those continuing on RPV/FTC/TAF, median (IQR) follow-up since this regimen initiation was 6 (5-7) years.Conclusions RPV/FTC/TAF demonstrated a high virological efficacy and durability as switch strategy in real life. TD was largely driven by simplification to 2-drug regimens or shift to a regimen with a higher barrier to resistance, while virological failure was infrequent.",
  "authors": [
    {
      "affiliations": [
        "Infectious Diseases Unit, ASST Papa Giovanni XXIII, Bergamo, Italy"
      ],
      "name": "D Ripamonti"
    },
    {
      "affiliations": [
        "Infectious Diseases Unit, ASST Papa Giovanni XXIII, Bergamo, Italy"
      ],
      "name": "L Comi"
    },
    {
      "affiliations": [
        "FROM-Fondazione per la Ricerca Ospedale di Bergamo-ETS, Bergamo, Italy"
      ],
      "name": "D Valenti"
    },
    {
      "affiliations": [
        "School of Medicine and Surgery, University of Milan, Milan, Italy"
      ],
      "name": "A Cargnelutti"
    },
    {
      "affiliations": [
        "Department of Infectious Diseases, ASST Fatebenefratelli Sacco, Milano, Italy"
      ],
      "name": "MV Cossu"
    },
    {
      "affiliations": [
        "Department of Infectious Diseases, ASST Fatebenefratelli Sacco, Milano, Italy"
      ],
      "name": "A Poloni"
    },
    {
      "affiliations": [
        "Department of Infectious Diseases, ASST Fatebenefratelli Sacco, Milano, Italy",
        "Department of Biomedical and Clinical Sciences, Università degli Studi di Milano, Milan, Italy"
      ],
      "name": "A Giacomelli"
    },
    {
      "affiliations": [
        "IRCCS Fondazione San Gerardo dei Tintori, University of Milano Bicocca, Monza, Italy"
      ],
      "name": "G Lapadula"
    },
    {
      "affiliations": [
        "IRCCS Fondazione San Gerardo dei Tintori, University of Milano Bicocca, Monza, Italy"
      ],
      "name": "L Mezzadri"
    },
    {
      "affiliations": [
        "IRCCS Fondazione San Gerardo dei Tintori, University of Milano Bicocca, Monza, Italy"
      ],
      "name": "P Bonfanti"
    },
    {
      "affiliations": [
        "Infectious and Tropical Diseases Unit, Department of Molecular Medicine, Padua University Hospital, Padova, Italy"
      ],
      "name": "M Mazzitelli"
    },
    {
      "affiliations": [
        "Infectious and Tropical Diseases Unit, Department of Molecular Medicine, Padua University Hospital, Padova, Italy"
      ],
      "name": "A Cattelan"
    },
    {
      "affiliations": [
        "Department of Medical Science and Infectious Diseases, Fondazione IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy"
      ],
      "name": "R Gulminetti"
    },
    {
      "affiliations": [
        "Department of Medical Science and Infectious Diseases, Fondazione IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy"
      ],
      "name": "L Pagnucco"
    },
    {
      "affiliations": [
        "Department of Medical Science and Infectious Diseases, Fondazione IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy"
      ],
      "name": "A Celsi"
    },
    {
      "affiliations": [
        "Department of Infectious and Tropical Diseases, University of Brescia, Brescia, Italy"
      ],
      "name": "S Rapino"
    },
    {
      "affiliations": [
        "Department of Infectious and Tropical Diseases, University of Brescia, Brescia, Italy"
      ],
      "name": "B Fioretti"
    },
    {
      "affiliations": [
        "FROM-Fondazione per la Ricerca Ospedale di Bergamo-ETS, Bergamo, Italy"
      ],
      "name": "A Francavilla"
    },
    {
      "affiliations": [
        "Department of Infectious and Tropical Diseases, University of Brescia, Brescia, Italy"
      ],
      "name": "E Focà"
    }
  ],
  "title": "OC67 Reasons for discontinuation of single-tablet regimen rilpivirine/emtricitabine/tenofovir alafenamide (RPV/FTC/TAF) in the era of 2nd-generation INSTIs",
  "uid": "16dcacfd-7e32-54b2-ae71-574be80f8a0b"
}