Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world study.

INTRODUCTION: Second-generation integrase strand transfer inhibitors (INSTIs) are preferred treatment options worldwide, and dolutegravir (DTG) is the treatment of choice in resource-limited settings. Nevertheless, in some resource-limited settings, these drugs are not always available. An analysis...

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Autores: Santos JR, Casadellà M, Noguera-Julian M, Micán-Rivera R, Domingo P, Antela A, Portilla J, Sanz J, Montero-Alonso M, Navarro J, Masiá M, Valcarce-Pardeiro N, Ocampo A, Pérez-Martínez L, García-Vallecillos C, Vivancos MJ, Imaz A, Iribarren JA, Hernández-Quero J, Villar-García J, Barrufet P, Paredes R
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2023
País:España
Institución:Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL)
Repositorio:r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
OAI Identifier:oai:isabial.fundanetsuite.com:p9836
Acceso en línea:https://isabial.portalinvestigacion.com/publicaciones9836
https://www.frontiersin.org/articles/10.3389/fcimb.2023.1187999/full
Access Level:acceso abierto
Palabra clave:HIV
dolutegravir
elvitegravir
integrase strand transfer inhibitors (INSTI)
raltegravir
real-world study
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repository_id_str
spelling Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world study.Santos JRCasadellà MNoguera-Julian MMicán-Rivera RDomingo PAntela APortilla JSanz JMontero-Alonso MNavarro JMasiá MValcarce-Pardeiro NOcampo APérez-Martínez LGarcía-Vallecillos CVivancos MJImaz AIribarren JAHernández-Quero JVillar-García JBarrufet PParedes RHIVdolutegravirelvitegravirintegrase strand transfer inhibitors (INSTI)raltegravirreal-world studyINTRODUCTION: Second-generation integrase strand transfer inhibitors (INSTIs) are preferred treatment options worldwide, and dolutegravir (DTG) is the treatment of choice in resource-limited settings. Nevertheless, in some resource-limited settings, these drugs are not always available. An analysis of the experience with the use of INSTIs in unselected adults living with HIV may be of help to make therapeutic decisions when second-generation INSTIs are not available. This study aimed to evaluate the real-life effectiveness and safety of dolutegravir (DTG), elvitegravir/cobicistat (EVG/c), and raltegravir (RAL) in a large Spanish cohort of HIV-1-infected patients. METHODS: Real-world study of adults living with HIV who initiated integrase INSTIs DTG, EVG/c, and RAL-based regimens in three settings (ART-naïve patients, ART-switching, and ART-salvage patients). The primary endpoint was the median time to treatment discontinuation after INSTI-based regimen initiation. Proportion of patients experiencing virological failure (VF) (defined as two consecutive viral loads (VL) =200 copies/mL at 24 weeks or as a single determination of VL =1,000 copies/mL while receiving DTG, EVG/c or RAL, and at least 3 months after INSTI initiation) and time to VF were also evaluated. RESULTS: Virological effectiveness of EVG/c- and RAL-based regimens was similar to that of DTG when given as first-line and salvage therapy. Treatment switching for reasons other than virological failure was more frequent in subjects receiving EVG/c and, in particular, RAL. Naïve patients with CD4+ nadir <100 cells/µL were more likely to develop VF, particularly if they initiated RAL or EVG/c. In the ART switching population, initiation of RAL and EVG/c was associated with both VF and INSTI discontinuation. There were no differences in the time to VF and INSTI discontinuation between DTG, EVG/c and RAL. Immunological parameters improved in the three groups and for the three drugs assessed. Safety and tolerability were consistent with expected safety profiles. DISCUSSION: Whereas second-generation INSTIs are preferred treatment options worldwide, and DTG is one of the treatment of choices in resource-limited settings, first-generation INSTIs may still provide high virological and immunological effectiveness when DTG is not available.FRONTIERS MEDIA SA2023info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://isabial.portalinvestigacion.com/publicaciones9836https://www.frontiersin.org/articles/10.3389/fcimb.2023.1187999/fullFrontiers in Cellular and Infection MicrobiologyISSN: 22352988reponame:r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicanteinstname:Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL)Inglésinfo:eu-repo/semantics/openAccessoai:isabial.fundanetsuite.com:p98362026-06-12T10:20:37Z
dc.title.none.fl_str_mv Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world study.
title Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world study.
spellingShingle Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world study.
Santos JR
HIV
dolutegravir
elvitegravir
integrase strand transfer inhibitors (INSTI)
raltegravir
real-world study
title_short Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world study.
title_full Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world study.
title_fullStr Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world study.
title_full_unstemmed Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world study.
title_sort Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world study.
dc.creator.none.fl_str_mv Santos JR
Casadellà M
Noguera-Julian M
Micán-Rivera R
Domingo P
Antela A
Portilla J
Sanz J
Montero-Alonso M
Navarro J
Masiá M
Valcarce-Pardeiro N
Ocampo A
Pérez-Martínez L
García-Vallecillos C
Vivancos MJ
Imaz A
Iribarren JA
Hernández-Quero J
Villar-García J
Barrufet P
Paredes R
author Santos JR
author_facet Santos JR
Casadellà M
Noguera-Julian M
Micán-Rivera R
Domingo P
Antela A
Portilla J
Sanz J
Montero-Alonso M
Navarro J
Masiá M
Valcarce-Pardeiro N
Ocampo A
Pérez-Martínez L
García-Vallecillos C
Vivancos MJ
Imaz A
Iribarren JA
Hernández-Quero J
Villar-García J
Barrufet P
Paredes R
author_role author
author2 Casadellà M
Noguera-Julian M
Micán-Rivera R
Domingo P
Antela A
Portilla J
Sanz J
Montero-Alonso M
Navarro J
Masiá M
Valcarce-Pardeiro N
Ocampo A
Pérez-Martínez L
García-Vallecillos C
Vivancos MJ
Imaz A
Iribarren JA
Hernández-Quero J
Villar-García J
Barrufet P
Paredes R
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv HIV
dolutegravir
elvitegravir
integrase strand transfer inhibitors (INSTI)
raltegravir
real-world study
topic HIV
dolutegravir
elvitegravir
integrase strand transfer inhibitors (INSTI)
raltegravir
real-world study
description INTRODUCTION: Second-generation integrase strand transfer inhibitors (INSTIs) are preferred treatment options worldwide, and dolutegravir (DTG) is the treatment of choice in resource-limited settings. Nevertheless, in some resource-limited settings, these drugs are not always available. An analysis of the experience with the use of INSTIs in unselected adults living with HIV may be of help to make therapeutic decisions when second-generation INSTIs are not available. This study aimed to evaluate the real-life effectiveness and safety of dolutegravir (DTG), elvitegravir/cobicistat (EVG/c), and raltegravir (RAL) in a large Spanish cohort of HIV-1-infected patients. METHODS: Real-world study of adults living with HIV who initiated integrase INSTIs DTG, EVG/c, and RAL-based regimens in three settings (ART-naïve patients, ART-switching, and ART-salvage patients). The primary endpoint was the median time to treatment discontinuation after INSTI-based regimen initiation. Proportion of patients experiencing virological failure (VF) (defined as two consecutive viral loads (VL) =200 copies/mL at 24 weeks or as a single determination of VL =1,000 copies/mL while receiving DTG, EVG/c or RAL, and at least 3 months after INSTI initiation) and time to VF were also evaluated. RESULTS: Virological effectiveness of EVG/c- and RAL-based regimens was similar to that of DTG when given as first-line and salvage therapy. Treatment switching for reasons other than virological failure was more frequent in subjects receiving EVG/c and, in particular, RAL. Naïve patients with CD4+ nadir <100 cells/µL were more likely to develop VF, particularly if they initiated RAL or EVG/c. In the ART switching population, initiation of RAL and EVG/c was associated with both VF and INSTI discontinuation. There were no differences in the time to VF and INSTI discontinuation between DTG, EVG/c and RAL. Immunological parameters improved in the three groups and for the three drugs assessed. Safety and tolerability were consistent with expected safety profiles. DISCUSSION: Whereas second-generation INSTIs are preferred treatment options worldwide, and DTG is one of the treatment of choices in resource-limited settings, first-generation INSTIs may still provide high virological and immunological effectiveness when DTG is not available.
publishDate 2023
dc.date.none.fl_str_mv 2023
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://isabial.portalinvestigacion.com/publicaciones9836
https://www.frontiersin.org/articles/10.3389/fcimb.2023.1187999/full
url https://isabial.portalinvestigacion.com/publicaciones9836
https://www.frontiersin.org/articles/10.3389/fcimb.2023.1187999/full
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv FRONTIERS MEDIA SA
publisher.none.fl_str_mv FRONTIERS MEDIA SA
dc.source.none.fl_str_mv Frontiers in Cellular and Infection Microbiology
ISSN: 22352988
reponame:r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
instname:Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL)
instname_str Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL)
reponame_str r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
collection r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
repository.name.fl_str_mv
repository.mail.fl_str_mv
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