학술논문
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.
Document Type
article
Author
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)
Source
PLoS Medicine, Vol 17, Iss 11, p e1003421 (2020)
Subject
Language
English
ISSN
1549-1277
1549-1676
1549-1676
Abstract
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.