Decay kinetics of HIV-1-RNA in seminal plasma with dolutegravir/lamivudine versus dolutegravir plus emtricitabine/tenofovir alafenamide in treatment-naive people living with HIV

© The Author(s) 2023. Published by Oxford University Press on behalf of British Society for Antimicrobial Chemotherapy. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted re...

Descripción completa

Detalles Bibliográficos
Autores: Saborido-Alconchel, Abraham, Serna, Ana, López-Cortés, Luis Eduardo, Trujillo-Rodríguez, María, Praena-Fernández, Juan Manuel, Domínguez-Macías, Montserrat, Lozano, Carmen, Muñoz-Muela, Esperanza, Espinosa, Nuria, Roca-Oporto, Cristina, Sotomayor, César, Herrero, Marta, Gutiérrez Valencia, Alicia, López-Cortés, Luis F.
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2023
País:España
Institución:Consejo Superior de Investigaciones Científicas (CSIC)
Repositorio:DIGITAL.CSIC. Repositorio Institucional del CSIC
OAI Identifier:oai:digital.csic.es:10261/350033
Acceso en línea:http://hdl.handle.net/10261/350033
Access Level:acceso abierto
id ES_eaae78c9f05f2ffadda9c0dab3a84cc3
oai_identifier_str oai:digital.csic.es:10261/350033
network_acronym_str ES
network_name_str España
repository_id_str
dc.title.none.fl_str_mv Decay kinetics of HIV-1-RNA in seminal plasma with dolutegravir/lamivudine versus dolutegravir plus emtricitabine/tenofovir alafenamide in treatment-naive people living with HIV
title Decay kinetics of HIV-1-RNA in seminal plasma with dolutegravir/lamivudine versus dolutegravir plus emtricitabine/tenofovir alafenamide in treatment-naive people living with HIV
spellingShingle Decay kinetics of HIV-1-RNA in seminal plasma with dolutegravir/lamivudine versus dolutegravir plus emtricitabine/tenofovir alafenamide in treatment-naive people living with HIV
Saborido-Alconchel, Abraham
title_short Decay kinetics of HIV-1-RNA in seminal plasma with dolutegravir/lamivudine versus dolutegravir plus emtricitabine/tenofovir alafenamide in treatment-naive people living with HIV
title_full Decay kinetics of HIV-1-RNA in seminal plasma with dolutegravir/lamivudine versus dolutegravir plus emtricitabine/tenofovir alafenamide in treatment-naive people living with HIV
title_fullStr Decay kinetics of HIV-1-RNA in seminal plasma with dolutegravir/lamivudine versus dolutegravir plus emtricitabine/tenofovir alafenamide in treatment-naive people living with HIV
title_full_unstemmed Decay kinetics of HIV-1-RNA in seminal plasma with dolutegravir/lamivudine versus dolutegravir plus emtricitabine/tenofovir alafenamide in treatment-naive people living with HIV
title_sort Decay kinetics of HIV-1-RNA in seminal plasma with dolutegravir/lamivudine versus dolutegravir plus emtricitabine/tenofovir alafenamide in treatment-naive people living with HIV
dc.creator.none.fl_str_mv Saborido-Alconchel, Abraham
Serna, Ana
López-Cortés, Luis Eduardo
Trujillo-Rodríguez, María
Praena-Fernández, Juan Manuel
Domínguez-Macías, Montserrat
Lozano, Carmen
Muñoz-Muela, Esperanza
Espinosa, Nuria
Roca-Oporto, Cristina
Sotomayor, César
Herrero, Marta
Gutiérrez Valencia, Alicia
López-Cortés, Luis F.
author Saborido-Alconchel, Abraham
author_facet Saborido-Alconchel, Abraham
Serna, Ana
López-Cortés, Luis Eduardo
Trujillo-Rodríguez, María
Praena-Fernández, Juan Manuel
Domínguez-Macías, Montserrat
Lozano, Carmen
Muñoz-Muela, Esperanza
Espinosa, Nuria
Roca-Oporto, Cristina
Sotomayor, César
Herrero, Marta
Gutiérrez Valencia, Alicia
López-Cortés, Luis F.
author_role author
author2 Serna, Ana
López-Cortés, Luis Eduardo
Trujillo-Rodríguez, María
Praena-Fernández, Juan Manuel
Domínguez-Macías, Montserrat
Lozano, Carmen
Muñoz-Muela, Esperanza
Espinosa, Nuria
Roca-Oporto, Cristina
Sotomayor, César
Herrero, Marta
Gutiérrez Valencia, Alicia
López-Cortés, Luis F.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla
ViiV Healthcare
Instituto de Salud Carlos III
Ministerio de Ciencia e Innovación (España)
European Commission
Consejo Superior de Investigaciones Científicas [https://ror.org/02gfc7t72]
description © The Author(s) 2023. Published by Oxford University Press on behalf of British Society for Antimicrobial Chemotherapy. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
publishDate 2023
dc.date.none.fl_str_mv 2023
2024
2024
dc.type.none.fl_str_mv info:eu-repo/semantics/article
http://purl.org/coar/resource_type/c_6501
Publisher's version
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/10261/350033
url http://hdl.handle.net/10261/350033
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv The underlying dataset has been published as supplementary material of the article in the publisher platform at https://doi.org/10.1093/jac/dkad245
https://doi.org/10.1093/jac/dkad245

dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Oxford University Press
publisher.none.fl_str_mv Oxford University Press
dc.source.none.fl_str_mv reponame:DIGITAL.CSIC. Repositorio Institucional del CSIC
instname:Consejo Superior de Investigaciones Científicas (CSIC)
instname_str Consejo Superior de Investigaciones Científicas (CSIC)
reponame_str DIGITAL.CSIC. Repositorio Institucional del CSIC
collection DIGITAL.CSIC. Repositorio Institucional del CSIC
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869423160831508480
spelling Decay kinetics of HIV-1-RNA in seminal plasma with dolutegravir/lamivudine versus dolutegravir plus emtricitabine/tenofovir alafenamide in treatment-naive people living with HIVSaborido-Alconchel, AbrahamSerna, AnaLópez-Cortés, Luis EduardoTrujillo-Rodríguez, MaríaPraena-Fernández, Juan ManuelDomínguez-Macías, MontserratLozano, CarmenMuñoz-Muela, EsperanzaEspinosa, NuriaRoca-Oporto, CristinaSotomayor, CésarHerrero, MartaGutiérrez Valencia, AliciaLópez-Cortés, Luis F.© The Author(s) 2023. Published by Oxford University Press on behalf of British Society for Antimicrobial Chemotherapy. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.[Background] This was a substudy of a Phase IV, randomized clinical trial (ClinicalTrials.gov identifier: NCT04295460) aiming to compare the activity of dolutegravir/lamivudine versus dolutegravir plus tenofovir alafenamide/emtricitabine (DTG + TAF/FTC) in the male genital tract.[Methods] Participants were asymptomatic adults without sexually transmitted diseases, treatment-naive people living with HIV (PLWH), with CD4+ T cell counts >200 cells/mm3 and plasma HIV-1-RNA levels >5000 and <500 000 copies/mL, randomized (1:1) to DTG + TAF/FTC or dolutegravir/lamivudine. Blood plasma (BP) and seminal plasma (SP) were collected at baseline and Weeks 4, 8, 12 and 24. HIV-1-RNA was measured in BP and SP using the Cobas 6800 system (Roche Diagnostics) with a lower detection limit of 20 copies/mL. The primary efficacy endpoint was the proportion of subjects with undetectable SP HIV-1-RNA at Week 12 by intention-to-treat analysis.[Results] Fifteen participants in the DTG + TAF/FTC and 16 in the dolutegravir/lamivudine arms were analysed, with basal SP viral load of 4.81 (4.30–5.43) and 4.76 (4.09–5.23), P = 0.469, respectively. At Week 12, only one participant in each treatment arm had a detectable SP HIV-1-RNA (DTG + TAF/FTC, 141 copies/mL; dolutegravir/lamivudine, 61 copies/mL). Based on the estimated means, there was no significant difference in the decay of HIV-1-RNA in both BP and SP over time between the two arms of treatment (F = 0.452, P = 0.662, and F = 1.147, P = 0.185, respectively).[Conclusions] After 12 weeks of treatment, there were no differences in the percentage of undetectable SP HIV-1-RNA in naive PLWH who started dolutegravir/lamivudine compared with DTG + TAF/FTC.This work was supported by a collaboration agreement between Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (FISEVI) and ViiV Healthcare UK Ltd. The funders had no role in study design, data collection, analysis, conclusions, publication decision or manuscript preparation. There was no financial compensation to researchers. Instituto de Salud Carlos III through the Subprogram Miguel Servet (CP19/00159) to A.G.V., PFIS contracts (FI19/00304) to E.M.M. and (FI21/00165) to A.S.A., from the Ministerio de Ciencia e Innovación, Spain. All of them co-financed by the European Regional Development Fund ‘a way to make Europe’.Peer reviewedOxford University PressFundación Pública Andaluza para la Gestión de la Investigación en Salud de SevillaViiV HealthcareInstituto de Salud Carlos IIIMinisterio de Ciencia e Innovación (España)European CommissionConsejo Superior de Investigaciones Científicas [https://ror.org/02gfc7t72]202420242023info:eu-repo/semantics/articlehttp://purl.org/coar/resource_type/c_6501Publisher's versioninfo:eu-repo/semantics/publishedVersionapplication/pdfhttp://hdl.handle.net/10261/350033reponame:DIGITAL.CSIC. Repositorio Institucional del CSICinstname:Consejo Superior de Investigaciones Científicas (CSIC)InglésThe underlying dataset has been published as supplementary material of the article in the publisher platform at https://doi.org/10.1093/jac/dkad245https://doi.org/10.1093/jac/dkad245Síinfo:eu-repo/semantics/openAccessoai:digital.csic.es:10261/3500332026-05-22T06:33:51Z
score 15,812455