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https://hdl.handle.net/2445/184316
Title: | Darunavir/cobicistat/emtricitabine/tenofovir alafenamide versus dolutegravir /abacavir/lamivudine in antiretroviral-naïve adults (SYMTRI): a multicenter randomized open-label study (PReEC/RIS-57) |
Author: | Podzamczer Palter, Daniel Micán, Rafael Tiraboschi, Juan Manuel Portilla, Joaquín Domingo, Pere (Domingo Pedrol) Llibre, Josep María Ribera, Esteban Vivancos Gallego, M. J. Morano, Luís Masiá, Maria Del Mar Gómez, C. Fanjul, Francisco Payeras, A. Inciarte Portillo, Alexy Estrada, Vicente Rivero, Antonio Castro, Á. Bernal, E. Vinuesa, D. Knobel Freud, Hernando Javier Troya, Jesús Macías, J. Montero, M. Sanz, J. Navarro Alcaraz, A. Caicedo, A. Fernández, G. Martínez Chamorro, Esteban José Moreno, S. Symtri Study Investigators |
Keywords: | Antiretrovirals Utilització de medicaments Antiretroviral agents Drug utilization |
Issue Date: | 25-Nov-2021 |
Publisher: | Oxford University Press (OUP) |
Abstract: | D/C/F/TAF is the reference for combination therapy based on protease inhibitors but has not been compared with regimens containing integrase inhibitors as initial ART. We could not demonstrate D/C/F/TAF noninferiority relative to DTG/ABC/3TC, although both regimens were similarly well tolerated. Background 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. Methods 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 <50 c/mL at week 48 in the intention-to-treat (ITT)-exposed population (US Food and Drug Administration snapshot analysis, 10% noninferiority margin). Results 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 <200 CD4 cells/mu L. Median weight was 73 kg and median body mass index was 24 kg/m(2). At 48 weeks, 79% (D/C/F/TAF) versus 82% (DTG/3TC/ABC) had VL <50 c/mL (difference, -2.4%; 95% confidence interval [CI], -11.3 to 6.6). Eight percent versus four percent experienced virologic failure but no resistance-associated mutations emerged. Four percent versus six percent had drug discontinuation due to adverse events. In the per-protocol analysis, 94% versus 96% of patients had VL <50 c/mL (difference, -2%; 95% CI, -8.1 to 3.5). There were no differences in CD4 cell count or weight changes. Conclusions 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. |
Note: | Reproducció del document publicat a: https://doi.org/10.1093/ofid/ofab595 |
It is part of: | Open Forum Infectious Diseases, 2021, vol 9, num 3 |
URI: | https://hdl.handle.net/2445/184316 |
Related resource: | https://doi.org/10.1093/ofid/ofab595 |
ISSN: | 2328-8957 |
Appears in Collections: | Articles publicats en revistes (Medicina) Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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