دورية أكاديمية
Dolutegravir plus lamivudine for maintenance of HIV viral suppression in adults with and without historical resistance to lamivudine: 48-week results of a non-randomized, pilot clinical trial (ART-PRO).
| العنوان: | Dolutegravir plus lamivudine for maintenance of HIV viral suppression in adults with and without historical resistance to lamivudine: 48-week results of a non-randomized, pilot clinical trial (ART-PRO). |
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| المؤلفون: | De Miguel, Rosa, Rial-Crestelo, David, Dominguez-Dominguez, Lourdes, Montejano, Rocío, Esteban-Cantos, Andrés, Aranguren-Rivas, Paula, Stella-Ascariz, Natalia, Bisbal, Otilia, Bermejo-Plaza, Laura, Garcia-Alvarez, Mónica, Hernando, Asunción, Santacreu-Guerrero, Mireia, Cadiñanos, Julen, Mayoral, Mario, Castro, Juan Miguel, Moreno, Victoria, Martin-Carbonero, Luz, Delgado, Rafael, Rubio, Rafael, Pulido, Federico, Arribas, José Ramón, Alejos, Belén |
| المساهمون: | Instituto de Salud Carlos III |
| بيانات النشر: | Elsevier |
| سنة النشر: | 2020 |
| المجموعة: | REPISALUD (REPositorio Institucional en SALUD del Instituto de Salud Carlos III - ISCIII) |
| الوصف: | Corrigendum to "Dolutegravir plus lamivudine for maintenance of HIV viral suppression in adults with and without historical resistance to lamivudine: 48-week results of a non-randomized, pilot clinical trial (ART-PRO)". EBioMedicine. 2023 Mar;89:104486. doi:10.1016/j.ebiom.2023.104486. PMID: 36806001 ; Background: We investigated the efficacy of a switch to dolutegravir plus lamivudine in aviremic individuals without evidence of persistent lamivudine resistance-associated mutations in baseline proviral DNA population sequencing. Methods: Open-label, single-arm, 48-week pilot trial. HIV-1 infected adults, naïve to integrase inhibitors, with CD4+ above 350 cell/μL and fewer than 50 HIV-1 RNA copies per mL the year prior to study entry switched to dolutegravir plus lamivudine. Participants were excluded if baseline proviral DNA population genotyping detected lamivudine resistance-associated mutations. To detect resistance minority variants, proviral DNA next-generation sequencing was retrospectively performed from baseline samples. Primary efficacy endpoint was proportion of participants with fewer than 50 HIV-1 RNA copies per mL at week 48. Safety and tolerability outcomes were incidence of adverse events and treatment discontinuations. ART-PRO is registered with ClinicalTrials.gov, NCT03539224. Findings: 41 participants switched to dolutegravir plus lamivudine, 21 with lamivudine resistance mutations in historical plasma genotypes. Baseline next-generation sequencing detected lamivudine resistance mutations (M184V/I and/or K65R/E/N) over a 5% threshold in 15/21 (71·4%) and 3/20 (15%) of participants with and without history of lamivudine resistance, respectively. At week 48, 92·7% of participants (38/41) had fewer than 50 HIV-1 RNA copies per mL. There were no cases of virologic failure. Three participants with historical lamivudine resistance were prematurely discontinued from the study (2 protocol violations, one adverse event). Ten participants (4 in the group with historical lamivudine resistance) had a ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 2352-3964 |
| العلاقة: | https://doi.org/10.1016/j.ebiom.2020.102779Test; info:eu_repo/grantAgreement/ES/PI16/00837; info:eu_repo/grantAgreement/ES/PI16/00678; EBioMedicine . 2020 May;55:102779.; http://hdl.handle.net/20.500.12105/10862Test; EBioMedicine |
| DOI: | 10.1016/j.ebiom.2020.102779 |
| الإتاحة: | https://doi.org/20.500.12105/10862Test https://doi.org/10.1016/j.ebiom.2020.102779Test https://hdl.handle.net/20.500.12105/10862Test |
| حقوق: | http://creativecommons.org/licenses/by-nc-nd/4.0Test/ ; Attribution-NonCommercial-NoDerivatives 4.0 Internacional ; open access |
| رقم الانضمام: | edsbas.B36058FB |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 23523964 |
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| DOI: | 10.1016/j.ebiom.2020.102779 |