48-Week effectiveness and tolerability of dolutegravir (DTG) + lamivudine (3TC) in antiretroviral-naïve adults living with HIV: A multicenter real-life cohort

Background The main international guidelines indicate DTG/3TC therapy as one of the preferred regimens for people living with HIV (PLWH), due to its observed efficacy in randomized clinical trials. However, information in real-life cohorts is relatively scarce for first-line use. Methods A retrospec...

Descripción completa

Detalles Bibliográficos
Autores: Cabello Úbeda, Alfonso, Quirós, J. C.L.B. de, Martín Carbonero, Luz, Sanz Sanz, Jesús, Vergas, Jorge, Mena, Álvaro, Torralba, Miguel, Segurado, Marta Hernández, Pinto, Adriana, Tejerina, Francisco, Palmier, Esmeralda, Gutiérrez, Ángela, Vázquez, Pilar, Pulido, Federico, Górgolas Hernández-Mora, Miguel
Tipo de recurso: artículo
Fecha de publicación:2022
País:España
Institución:Universidad Autónoma de Madrid
Repositorio:Biblos-e Archivo. Repositorio Institucional de la UAM
Idioma:inglés
OAI Identifier:oai:repositorio.uam.es:10486/716125
Acceso en línea:http://hdl.handle.net/10486/716125
https://dx.doi.org/10.1371/journal.pone.0277606
Access Level:acceso abierto
Palabra clave:Medicina
id ES_bf5f37dbe614f79fc61126418a375eea
oai_identifier_str oai:repositorio.uam.es:10486/716125
network_acronym_str ES
network_name_str España
repository_id_str
spelling 48-Week effectiveness and tolerability of dolutegravir (DTG) + lamivudine (3TC) in antiretroviral-naïve adults living with HIV: A multicenter real-life cohortCabello Úbeda, AlfonsoQuirós, J. C.L.B. deMartín Carbonero, LuzSanz Sanz, JesúsVergas, JorgeMena, ÁlvaroTorralba, MiguelSegurado, Marta HernándezPinto, AdrianaTejerina, FranciscoPalmier, EsmeraldaGutiérrez, ÁngelaVázquez, PilarPulido, FedericoGórgolas Hernández-Mora, MiguelMedicinaBackground The main international guidelines indicate DTG/3TC therapy as one of the preferred regimens for people living with HIV (PLWH), due to its observed efficacy in randomized clinical trials. However, information in real-life cohorts is relatively scarce for first-line use. Methods A retrospective multicenter study of adult PLWH starting DTG+3TC as a first-line regimen before January 31st, 2020. Virological failure (VF) was defined as 2 consecutive HIV RNA viral load (VL) >50 copies/mL. Results 135 participants were included. Treatment was started without knowing baseline drug resistance testing (bDRT) results in 71.9% of cases, with baseline resistance mutations being later confirmed in 17 patients (12.6%), two of them with presence of M184V mutation. Effectiveness at week 48 was 85.2% (CI95%: 78.1-90.7%) (ITT missing = failure [M = F]) and 96.6% (CI 95%: 91.6-99.1%) (per-protocol analysis). Six patients (4.4%) discontinued treatment. One developed not confirmed VF after discontinuing treatment due to poor adherence; no resistance-associated mutations emerged. Three discontinued treatments due to central nervous system side effects (2.2%), and two due to a medical decision after determining the M184V mutation in bDRT. Finally, 14 (10.4%) were lost to follow-up, most of them due to the COVID-19 pandemic. Conclusions In a real-life multicenter cohort of ART-naïve PLWH, treatment initiation with DTG + 3TC showed high effectiveness and favorable safety results, comparable to those of randomized clinical trials, without treatment-emergent resistance being observed through week 48. Starting treatment before receiving the results of baseline drug resistance testing did not have an impact on the regimen's effectivenessThis research has been funded by a ViiV Healthcare S.L. grant in 2020. The author who received the gran has been ACU. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscriptPublic Library of ScienceDepartamento de MedicinaFacultad de Medicina20222022-11-01research articlehttp://purl.org/coar/resource_type/c_2df8fbb1VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10486/716125https://dx.doi.org/10.1371/journal.pone.0277606reponame:Biblos-e Archivo. Repositorio Institucional de la UAMinstname:Universidad Autónoma de MadridInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Attribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:repositorio.uam.es:10486/7161252026-06-23T12:46:27Z
dc.title.none.fl_str_mv 48-Week effectiveness and tolerability of dolutegravir (DTG) + lamivudine (3TC) in antiretroviral-naïve adults living with HIV: A multicenter real-life cohort
title 48-Week effectiveness and tolerability of dolutegravir (DTG) + lamivudine (3TC) in antiretroviral-naïve adults living with HIV: A multicenter real-life cohort
spellingShingle 48-Week effectiveness and tolerability of dolutegravir (DTG) + lamivudine (3TC) in antiretroviral-naïve adults living with HIV: A multicenter real-life cohort
Cabello Úbeda, Alfonso
Medicina
title_short 48-Week effectiveness and tolerability of dolutegravir (DTG) + lamivudine (3TC) in antiretroviral-naïve adults living with HIV: A multicenter real-life cohort
title_full 48-Week effectiveness and tolerability of dolutegravir (DTG) + lamivudine (3TC) in antiretroviral-naïve adults living with HIV: A multicenter real-life cohort
title_fullStr 48-Week effectiveness and tolerability of dolutegravir (DTG) + lamivudine (3TC) in antiretroviral-naïve adults living with HIV: A multicenter real-life cohort
title_full_unstemmed 48-Week effectiveness and tolerability of dolutegravir (DTG) + lamivudine (3TC) in antiretroviral-naïve adults living with HIV: A multicenter real-life cohort
title_sort 48-Week effectiveness and tolerability of dolutegravir (DTG) + lamivudine (3TC) in antiretroviral-naïve adults living with HIV: A multicenter real-life cohort
dc.creator.none.fl_str_mv Cabello Úbeda, Alfonso
Quirós, J. C.L.B. de
Martín Carbonero, Luz
Sanz Sanz, Jesús
Vergas, Jorge
Mena, Álvaro
Torralba, Miguel
Segurado, Marta Hernández
Pinto, Adriana
Tejerina, Francisco
Palmier, Esmeralda
Gutiérrez, Ángela
Vázquez, Pilar
Pulido, Federico
Górgolas Hernández-Mora, Miguel
author Cabello Úbeda, Alfonso
author_facet Cabello Úbeda, Alfonso
Quirós, J. C.L.B. de
Martín Carbonero, Luz
Sanz Sanz, Jesús
Vergas, Jorge
Mena, Álvaro
Torralba, Miguel
Segurado, Marta Hernández
Pinto, Adriana
Tejerina, Francisco
Palmier, Esmeralda
Gutiérrez, Ángela
Vázquez, Pilar
Pulido, Federico
Górgolas Hernández-Mora, Miguel
author_role author
author2 Quirós, J. C.L.B. de
Martín Carbonero, Luz
Sanz Sanz, Jesús
Vergas, Jorge
Mena, Álvaro
Torralba, Miguel
Segurado, Marta Hernández
Pinto, Adriana
Tejerina, Francisco
Palmier, Esmeralda
Gutiérrez, Ángela
Vázquez, Pilar
Pulido, Federico
Górgolas Hernández-Mora, Miguel
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Departamento de Medicina
Facultad de Medicina
dc.subject.none.fl_str_mv Medicina
topic Medicina
description Background The main international guidelines indicate DTG/3TC therapy as one of the preferred regimens for people living with HIV (PLWH), due to its observed efficacy in randomized clinical trials. However, information in real-life cohorts is relatively scarce for first-line use. Methods A retrospective multicenter study of adult PLWH starting DTG+3TC as a first-line regimen before January 31st, 2020. Virological failure (VF) was defined as 2 consecutive HIV RNA viral load (VL) >50 copies/mL. Results 135 participants were included. Treatment was started without knowing baseline drug resistance testing (bDRT) results in 71.9% of cases, with baseline resistance mutations being later confirmed in 17 patients (12.6%), two of them with presence of M184V mutation. Effectiveness at week 48 was 85.2% (CI95%: 78.1-90.7%) (ITT missing = failure [M = F]) and 96.6% (CI 95%: 91.6-99.1%) (per-protocol analysis). Six patients (4.4%) discontinued treatment. One developed not confirmed VF after discontinuing treatment due to poor adherence; no resistance-associated mutations emerged. Three discontinued treatments due to central nervous system side effects (2.2%), and two due to a medical decision after determining the M184V mutation in bDRT. Finally, 14 (10.4%) were lost to follow-up, most of them due to the COVID-19 pandemic. Conclusions In a real-life multicenter cohort of ART-naïve PLWH, treatment initiation with DTG + 3TC showed high effectiveness and favorable safety results, comparable to those of randomized clinical trials, without treatment-emergent resistance being observed through week 48. Starting treatment before receiving the results of baseline drug resistance testing did not have an impact on the regimen's effectiveness
publishDate 2022
dc.date.none.fl_str_mv 2022
2022-11-01
dc.type.none.fl_str_mv research article
http://purl.org/coar/resource_type/c_2df8fbb1
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv http://hdl.handle.net/10486/716125
https://dx.doi.org/10.1371/journal.pone.0277606
url http://hdl.handle.net/10486/716125
https://dx.doi.org/10.1371/journal.pone.0277606
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Public Library of Science
publisher.none.fl_str_mv Public Library of Science
dc.source.none.fl_str_mv reponame:Biblos-e Archivo. Repositorio Institucional de la UAM
instname:Universidad Autónoma de Madrid
instname_str Universidad Autónoma de Madrid
reponame_str Biblos-e Archivo. Repositorio Institucional de la UAM
collection Biblos-e Archivo. Repositorio Institucional de la UAM
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869418364133179392
score 15.812455

Similares en LA Referencia