dc.creator | Podzamczer, D. | es |
dc.creator | Micán, R. | es |
dc.creator | Tiraboschi, J. | es |
dc.creator | Portilla, J. | es |
dc.creator | Domingo, P. | es |
dc.creator | Llibre, J. M. | es |
dc.creator | Macías Sánchez, Juan | es |
dc.creator | Moreno, S. | es |
dc.date.accessioned | 2022-10-14T18:27:09Z | |
dc.date.available | 2022-10-14T18:27:09Z | |
dc.date.issued | 2022 | |
dc.identifier.citation | Podzamczer, D., Micán, R., Tiraboschi, J., Portilla, J., Domingo, P., Llibre, J.M.,...,Moreno, S. (2022). Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir/Abacavir/Lamivudine in Antiretroviral-Naive Adults (SYMTRI): A Multicenter Randomized Open-Label Study (PReEC/RIS-57). OPEN FORUM INFECTIOUS DISEASES, 9 (3), ofab595. https://doi.org/10.1093/ofid/ofab595. | |
dc.identifier.issn | 2328-8957 | es |
dc.identifier.uri | https://hdl.handle.net/11441/137936 | |
dc.description.abstract | 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/μL. Median weight was 73 kg and median body
mass index was 24 kg/m2
. 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. | es |
dc.format | application/pdf | es |
dc.format.extent | 9 p. | es |
dc.language.iso | eng | es |
dc.publisher | OXFORD UNIV PRESS | es |
dc.relation.ispartof | OPEN FORUM INFECTIOUS DISEASES, 9 (3), ofab595. | |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ | * |
dc.subject | Darunavir/cobicistat | es |
dc.subject | Dolutegravir | es |
dc.subject | Naive patients | es |
dc.subject | Tenofovir alafenamide | es |
dc.subject | Virologic efficacy | es |
dc.title | Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir/Abacavir/Lamivudine in Antiretroviral-Naive Adults (SYMTRI): A Multicenter Randomized Open-Label Study (PReEC/RIS-57) | es |
dc.type | info:eu-repo/semantics/article | es |
dcterms.identifier | https://ror.org/03yxnpp24 | |
dc.type.version | info:eu-repo/semantics/publishedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Medicina | es |
dc.relation.publisherversion | https://academic.oup.com/ofid/article/9/3/ofab595/6439785 | es |
dc.identifier.doi | 10.1093/ofid/ofab595 | es |
dc.journaltitle | OPEN FORUM INFECTIOUS DISEASES | es |
dc.publication.volumen | 9 | es |
dc.publication.issue | 3 | es |
dc.publication.initialPage | ofab595 | es |