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oai:repisalud.isciii.es:20.500.12105/185092025-04-29T09:49:16Zcom_20.500.12105_15322com_20.500.12105_2051col_20.500.12105_16927col_20.500.12105_16969col_20.500.12105_16988
Repisalud author Podzamczer, D author Micán, Rafael author Tiraboschi, J author Portilla, J author Domingo, P author Llibre, J M author Ribera, E author Vivancos, M J author Morano, L author Masiá, M author Gómez, C author Fanjul, F author Payeras, A author Inciarte, A author Estrada, V author Rivero, A author Castro, Á author Bernal, E author Vinuesa, D author Knobel, H author Troya, J author Macías, J author Montero, M author Sanz, J author Navarro-Alcaraz, A author Caicedo, A author Fernández, G author Martínez, E author Moreno, S 2024-02-19T15:32:10Z 2024-02-19T15:32:10Z 2021-11-25 10.1093/ofid/ofab595 2328-8957 Open forum infectious diseases http://hdl.handle.net/10668/19822 35237700 http://hdl.handle.net/20.500.12105/18509 Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) is the reference for combination therapy based on protease inhibitors due to its efficacy, tolerability, and convenience. Head-to-head randomized comparisons between D/C/F/TAF and combination therapy based on integrase inhibitors in antiretroviral-naive patients are lacking. Adult (>18 years old) human immunodeficiency virus-infected antiretroviral-naive patients (HLA-B∗5701 negative and hepatitis B virus negative), with viral load (VL) ≥500 c/mL, were centrally randomized to initiate D/C/F/TAF or dolutegravir/abacavir/lamivudine (DTG/3TC/ABC) after stratifying by VL and CD4 count. Clinical and analytical assessments were performed at weeks 0, 4, 12, 24, and 48. The primary endpoint was VL 18 years old) human immunodeficiency virus-infected antiretroviral-naive patients (HLA-B∗5701 negative and hepatitis B virus negative), with viral load (VL) ≥500 c/mL, were centrally randomized to initiate D/C/F/TAF or dolutegravir/abacavir/lamivudine (DTG/3TC/ABC) after stratifying by VL and CD4 count. Clinical and analytical assessments were performed at weeks 0, 4, 12, 24, and 48. The primary endpoint was VL Between September 2018 and 2019, 316 patients were randomized and 306 patients were included in the ITT-exposed analysis (151 D/C/F/TAF and 155 DTG/3TC/ABC). Almost all (94%) participants were male and their median age was 35 years. Forty percent had a baseline VL >100 000 copies/mL, and 13% had 100 000 copies/mL, and 13% had We could not demonstrate the noninferiority of D/C/F/TAF relative to DTG/ABC/3TC as initial antiretroviral therapy, although both regimens were similarly well tolerated. eng darunavir/cobicistat dolutegravir naive patients tenofovir alafenamide virologic efficacy Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir/Abacavir/Lamivudine in Antiretroviral-Naive Adults (SYMTRI): A Multicenter Randomized Open-Label Study (PReEC/RIS-57). research article