PLoS Medicine (Nov 2020)

Efficacy and safety of dolutegravir plus emtricitabine versus standard ART for the maintenance of HIV-1 suppression: 48-week results of the factorial, randomized, non-inferiority SIMPL'HIV trial.

  • Delphine Sculier,
  • Gilles Wandeler,
  • Sabine Yerly,
  • Annalisa Marinosci,
  • Marcel Stoeckle,
  • Enos Bernasconi,
  • Dominique L Braun,
  • Pietro Vernazza,
  • Matthias Cavassini,
  • Marta Buzzi,
  • Karin J Metzner,
  • Laurent A Decosterd,
  • Huldrych F Günthard,
  • Patrick Schmid,
  • Andreas Limacher,
  • Matthias Egger,
  • Alexandra Calmy,
  • Swiss HIV Cohort Study (SHCS)

DOI
https://doi.org/10.1371/journal.pmed.1003421
Journal volume & issue
Vol. 17, no. 11
p. e1003421

Abstract

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BackgroundDolutegravir (DTG)-based dual therapy is becoming a new paradigm for both the initiation and maintenance of HIV treatment. The SIMPL'HIV study investigated the outcomes of virologically suppressed patients on standard combination antiretroviral therapy (cART) switching to DTG + emtricitabine (FTC). We present the 48-week efficacy and safety data on DTG + FTC versus cART.Methods and findingsSIMPL'HIV was a multicenter, open-label, non-inferiority randomized trial with a factorial design among treatment-experienced people with HIV in Switzerland. Participants were enrolled between 12 May 2017 and 30 May 2018. Patients virologically suppressed for at least 24 weeks on standard cART were randomized 1:1 to switching to DTG + FTC or to continuing cART, and 1:1 to simplified patient-centered monitoring versus standard monitoring. The primary endpoint was the proportion of patients virologically suppressed with ConclusionsIn this study, DTG + FTC as maintenance therapy was non-inferior to cART in terms of efficacy, with a similar safety profile and a greater improvement in quality of life, thus expanding the offer of 2-drug simplification options among virologically suppressed individuals.Trial registrationClinicalTrials.gov NCT03160105.