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http://hdl.handle.net/2445/184316
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DC Field | Value | Language |
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dc.contributor.author | Podzamczer Palter, Daniel | - |
dc.contributor.author | Micán, Rafael | - |
dc.contributor.author | Tiraboschi, Juan Manuel | - |
dc.contributor.author | Portilla, Joaquín | - |
dc.contributor.author | Domingo, Pere (Domingo Pedrol) | - |
dc.contributor.author | Llibre, Josep María | - |
dc.contributor.author | Ribera, Esteban | - |
dc.contributor.author | Vivancos Gallego, M. J. | - |
dc.contributor.author | Morano, Luís | - |
dc.contributor.author | Masiá, Maria Del Mar | - |
dc.contributor.author | Gómez, C. | - |
dc.contributor.author | Fanjul, Francisco | - |
dc.contributor.author | Payeras, A. | - |
dc.contributor.author | Inciarte Portillo, Alexy | - |
dc.contributor.author | Estrada, Vicente | - |
dc.contributor.author | Rivero, Antonio | - |
dc.contributor.author | Castro, Á. | - |
dc.contributor.author | Bernal, E. | - |
dc.contributor.author | Vinuesa, D. | - |
dc.contributor.author | Knobel Freud, Hernando Javier | - |
dc.contributor.author | Troya, Jesús | - |
dc.contributor.author | Macías, J. | - |
dc.contributor.author | Montero, M. | - |
dc.contributor.author | Sanz, J. | - |
dc.contributor.author | Navarro Alcaraz, A. | - |
dc.contributor.author | Caicedo, A. | - |
dc.contributor.author | Fernández, G. | - |
dc.contributor.author | Martínez Chamorro, Esteban José | - |
dc.contributor.author | Moreno, S. | - |
dc.contributor.author | Symtri Study Investigators | - |
dc.date.accessioned | 2022-03-22T10:36:04Z | - |
dc.date.available | 2022-03-22T10:36:04Z | - |
dc.date.issued | 2021-11-25 | - |
dc.identifier.issn | 2328-8957 | - |
dc.identifier.uri | http://hdl.handle.net/2445/184316 | - |
dc.description.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. | - |
dc.format.extent | 9 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Oxford University Press (OUP) | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1093/ofid/ofab595 | - |
dc.relation.ispartof | Open Forum Infectious Diseases, 2021, vol 9, num 3 | - |
dc.relation.uri | https://doi.org/10.1093/ofid/ofab595 | - |
dc.rights | cc by-nc-nd (c) Podzamczer Palter, Daniel et al, 2021 | - |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/3.0/es/ | * |
dc.source | Articles publicats en revistes (Medicina) | - |
dc.subject.classification | Antiretrovirals | - |
dc.subject.classification | Utilització de medicaments | - |
dc.subject.other | Antiretroviral agents | - |
dc.subject.other | Drug utilization | - |
dc.title | Darunavir/cobicistat/emtricitabine/tenofovir alafenamide versus dolutegravir /abacavir/lamivudine in antiretroviral-naïve adults (SYMTRI): a multicenter randomized open-label study (PReEC/RIS-57) | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.identifier.idgrec | 723331 | - |
dc.date.updated | 2022-03-22T08:43:22Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 35237700 | - |
Appears in Collections: | Articles publicats en revistes (Medicina) Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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ofab595.pdf | 654.98 kB | Adobe PDF | View/Open |
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