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Clinical Trial
. 2024 Oct 16;11(11):ofae618.
doi: 10.1093/ofid/ofae618. eCollection 2024 Nov.

Efficacy and Safety of Dolutegravir Plus Emtricitabine vs Combined Antiretroviral Therapy for the Maintenance of HIV Suppression: Results Through Week 144 of the SIMPL'HIV Trial

Annalisa Marinosci  1 , Delphine Sculier  1   2 , Gilles Wandeler  3   4 , Sabine Yerly  5 , Marcel Stoeckle  6 , Enos Bernasconi  7   8 , Dominique L Braun  9   10 , Pietro Vernazza  11 , Matthias Cavassini  12 , Laurent Decosterd  13 , Huldrych F Günthard  9   10 , Patrick Schmid  11 , Andreas Limacher  14 , Mattia Branca  14 , Alexandra Calmy  1 ; Swiss HIV Cohort Study
Collaborators, Affiliations
Clinical Trial

Efficacy and Safety of Dolutegravir Plus Emtricitabine vs Combined Antiretroviral Therapy for the Maintenance of HIV Suppression: Results Through Week 144 of the SIMPL'HIV Trial

Annalisa Marinosci et al. Open Forum Infect Dis. .

Abstract

The SIMPL'HIV study investigated whether switching to dolutegravir (DTG) + emtricitabine (FTC) was noninferior to continuing combined antiretroviral therapy for maintaining HIV-1 suppression at 144 weeks. The study demonstrated that viral suppression, CD4 gains, adverse events, quality of life, and patient satisfaction were comparable between groups, confirming DTG + FTC's safety and efficacy for long-term management of HIV-1 infection.

Keywords: HIV-1 dual therapy; dolutegravir + emtricitabine; maintenance treatment; patient satisfaction; quality of life.

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Conflict of interest statement

Potential conflicts of interest. A.M.: none. D.S.: ViiV honoraria for interview writing “Experts Lounge Vocabria/Rekambys,” published in Medical Tribune, ViiV honoraria for the webinar presentation “Regarder au-delà des frontières,” Gilead support for attending an EACS conference. G.W.: grants or contracts from Gilead Sciences and Roche Diagnostics (all paid to my institution), advisory boards for Gilead Sciences, ViiV, and MSD (all paid to my institution). S.Y.: none. M.S.: support for attending meetings and/or travel from Gilead (paid to my institution), advisory boards for Gilead Sciences, ViiV, and MSD (all paid to my institution). E.B.: grants and contracts from Merck Sharp and Dohme, consulting fees from Moderna (all paid to my institution), payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Pfizer, support for attending meetings and/or travel from Gilead Sciences, Merck Sharp and Dohme, ViiV Healthcare, and Pfizer, honoraria for participation in a data safety monitoring board or advisory board from Gilead Sciences, Merck Sharp and Dohme, ViiV Healthcare, Pfizer, Moderna, Astra-Zeneca, AbbVie, and Ely Lilly (all paid to my institution). D.L.B.: consulting fees from Gilead, MSD, ViiV, and Pfizer, payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Pfizer, ViiV, and MSD, support for attending meetings and/or travel from MSD and ViiV. P.V.: none. M.C.: research grants from Gilead, MSD, and ViiV, payment for expert opinion from Gilead, MSD, and ViiV, support for attending meetings and/or travel from Gilead (all paid to my institution). L.D.: support for drug analyses by mass spectrometry from AC (SNSF funding), funding from SNSF for “Novel Long Acting Injectable Antiretrovirals: Real-Life Monitoring in the Swiss HIV Cohort Study,” honoraria for presentation at the occasion of the advisory board “Therapeutic Drug Monitoring of oritavancin” from Menarini Switzerland. H.F.G.: grants or contracts from the Swiss National Science Foundation, Swiss HIV Cohort Study, and National Institutes of Health, unrestricted research grants from Gilead Sciences and Yvonne Jacob Foundation, a travel grant from Gilead Sciences, honoraria for participation in a DSMB or advisory board from Merck, Gilead Sciences, ViiV Healthcare, Johnson & Johnson, Janssen, Novartis, and GSK. P.S.: support for attending meetings and/or travel and honoraria for participation in a DSMB or advisory board from ViiV Healthcare and Gilead Sciences. A.L.: none. M.B.: none. A.C.: unrestricted education grants from ViiV, Gilead, and MSD.

Figures

Figure 1.
Figure 1.
CONSORT flowchart of recruited patients. aParticipants discontinued the study between baseline and week 48. Abbreviations: cART, combined antiretroviral therapy; CONSORT, Consolidated Standards of Reporting Trials; DTG, dolutegravir; FTC, emtricitabine; ITT, intention-to-treat; PP, per-protocol.
See this image and copyright information in PMC

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