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HIV-1 reservoir size and dynamics are promising parameters to ensure the safe prescription of simplified maintenance antiretroviral therapy in chronically HIV-1 infected patients. In the SIMPL’HIV trial, HIV-1 DNA was quantified in peripheral blood mononuclear cells obtained at baseline and week 48 to investigate changes over time and evidence of a predictive relationship to maintain HIV-1 RNA

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, Delphine Sculier and co-workers study switching to dual antiretroviral therapy including dolutegravir in virologically-suppressed patients with HIV infection., Author summary Why was the study done? Treatment simplification among people with HIV has been tested worldwide and includes reducing the number and/or dosage of antiretroviral drugs, and simplifying monitoring, but without compromising adherence and quality of life. We evaluated the combination of dolutegravir (DTG) + emtricitabine (FTC) as an alternative to standard therapy combinations in an HIV population highly representative of routine clinical conditions. Simplified patient-centered monitoring was also evaluated, to allow patients to receive care outside the hospital as is usual in Switzerland. What did the researchers do and find? We conducted the SIMPL’HIV study, a randomized trial with a factorial design, to permit patients with a suppressed viral load to receive a simplified treatment of DTG + FTC and/or simplified patient-centered monitoring. Efficacy of the DTG + FTC regimen was defined as keeping the patient’s HIV viral load below 100 copies/ml through 48 weeks of study duration. The combination of DTG with FTC had a similar efficacy in maintaining viral suppression through 48 weeks of treatment as standard combined antiretroviral therapy, without jeopardizing safety, and it improved patient quality of life. What do these findings mean? These results provide further evidence on the efficacy of 2-drug DTG-based regimens as a simplified switch option for patients whose viral load is well controlled on standard treatment, including those with a low CD4 nadir, and expands the currently existing options for dual maintenance therapy. Our efficacy definition allowed us to observe the occurrence of HIV viral load blips, irrespective of the treatment arm, without any consequences for HIV management. The quality of life of the participants was already very satisfactory at the start of the study and further increased over time with the simplified DTG + FTC treatment.