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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

Author

Listed:
  • 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
  • and the Swiss HIV Cohort Study (SHCS)

Abstract

Background: Dolutegravir (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 findings: SIMPL’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

Suggested Citation

  • Delphine Sculier & Gilles Wandeler & Sabine Yerly & Annalisa Marinosci & Marcel Stoeckle & Enos Bernasconi & Dominique L Braun & Pietro Vernazza & Matthias Cavassini & Marta Buzzi & Karin J Metzner & , 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," PLOS Medicine, Public Library of Science, vol. 17(11), pages 1-17, November.
    • Handle: RePEc:plo:pmed00:1003421
    DOI: 10.1371/journal.pmed.1003421
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