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

IntroductionSecond-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...

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Autores: Santos J.R., 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 M.J., Imaz A., Iribarren J.A., Hernández-Quero J., Villar-García J., Barrufet P., Paredes R.
Tipo de documento: artigo
Estado:Versão publicada
Data de publicação:2023
País:España
Recursos:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
Repositório:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
OAI Identifier:oai:iibsantpau.fundanetsuite.com:p16377
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https://www.scopus.com/inward/record.uri?eid=2-s2.0-85164418847&doi=10.3389%2ffcimb.2023.1187999&partnerID=40&md5=5c8202b38b381220e5b0a64c3d9415b6
Access Level:Acceso aberto
Palavra-chave:HIV
integrase strand transfer inhibitors (INSTI)
real-world study
raltegravir
elvitegravir
dolutegravir
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spelling Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world studySantos J.R.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 M.J.Imaz A.Iribarren J.A.Hernández-Quero J.Villar-García J.Barrufet P.Paredes R.HIVintegrase strand transfer inhibitors (INSTI)real-world studyraltegravirelvitegravirdolutegravirIntroductionSecond-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. MethodsReal-world study of adults living with HIV who initiated integrase INSTIs DTG, EVG/c, and RAL-based regimens in three settings (ART-naive 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) & GE;200 copies/mL at 24 weeks or as a single determination of VL & GE;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. ResultsVirological 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. Naive patients with CD4+ nadir <100 cells/& mu;L 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. DiscussionWhereas 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 S.A.2023info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=16377https://www.scopus.com/inward/record.uri?eid=2-s2.0-85164418847&doi=10.3389%2ffcimb.2023.1187999&partnerID=40&md5=5c8202b38b381220e5b0a64c3d9415b6Frontiers in Cellular and Infection MicrobiologyISSN: 22352988reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pauinstname:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)Inglésinfo:eu-repo/semantics/openAccessoai:iibsantpau.fundanetsuite.com:p163772026-06-14T12:41:47Z
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 J.R.
HIV
integrase strand transfer inhibitors (INSTI)
real-world study
raltegravir
elvitegravir
dolutegravir
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 J.R.
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 M.J.
Imaz A.
Iribarren J.A.
Hernández-Quero J.
Villar-García J.
Barrufet P.
Paredes R.
author Santos J.R.
author_facet Santos J.R.
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 M.J.
Imaz A.
Iribarren J.A.
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 M.J.
Imaz A.
Iribarren J.A.
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
integrase strand transfer inhibitors (INSTI)
real-world study
raltegravir
elvitegravir
dolutegravir
topic HIV
integrase strand transfer inhibitors (INSTI)
real-world study
raltegravir
elvitegravir
dolutegravir
description IntroductionSecond-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. MethodsReal-world study of adults living with HIV who initiated integrase INSTIs DTG, EVG/c, and RAL-based regimens in three settings (ART-naive 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) & GE;200 copies/mL at 24 weeks or as a single determination of VL & GE;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. ResultsVirological 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. Naive patients with CD4+ nadir <100 cells/& mu;L 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. DiscussionWhereas 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
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dc.identifier.none.fl_str_mv https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=16377
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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 S.A.
publisher.none.fl_str_mv Frontiers Media S.A.
dc.source.none.fl_str_mv Frontiers in Cellular and Infection Microbiology
ISSN: 22352988
reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
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