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, José Ramón, Casadellà, Maria, Noguera Julian, Marc, Micán Rivera, Rafael, Domingo, Pere, Antela, Antonio, Portilla, Joaquín, Sanz, Jesús, Montero Alonso, Marta, Navarro, Jordi, Masiá, Maria Del Mar, Valcarce Pardeiro, Nieves, Ocampo, Antonio, Pérez Martínez, Laura, García Vallecillos, Coral, Vivancos, María Jesús, Imaz, Arkaitz, Iribarren, José Antonio, Hernández Quero, José, Villar García, Judit, Barrufet, Pilar, Paredes, Roger, Instinct Study Group
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2023
País:España
Recursos:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:2445/201088
Acesso em linha:https://hdl.handle.net/2445/201088
Access Level:acceso abierto
Palavra-chave:Persones seropositives
Inhibidors de la integrasa
HIV-positive persons
Integrase inhibitors
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spelling Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world studySantos, José RamónCasadellà, MariaNoguera Julian, MarcMicán Rivera, RafaelDomingo, PereAntela, AntonioPortilla, JoaquínSanz, JesúsMontero Alonso, MartaNavarro, JordiMasiá, Maria Del MarValcarce Pardeiro, NievesOcampo, AntonioPérez Martínez, LauraGarcía Vallecillos, CoralVivancos, María JesúsImaz, ArkaitzIribarren, José AntonioHernández Quero, JoséVillar García, JuditBarrufet, PilarParedes, RogerInstinct Study GroupPersones seropositivesInhibidors de la integrasaHIV-positive personsIntegrase inhibitorsIntroductionSecond-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 SA2023202320232023info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion15 p.application/pdfhttps://hdl.handle.net/2445/201088Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésReproducció del document publicat a: https://doi.org/10.3389/fcimb.2023.1187999Frontiers in Cellular and Infection Microbiology, 2023, vol. 13https://doi.org/10.3389/fcimb.2023.1187999cc by (c) Santos, José Ramón et al, 2023http://creativecommons.org/licenses/by/3.0/es/info:eu-repo/semantics/openAccessoai:recercat.cat:2445/2010882026-05-29T05:05:01Z
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, José Ramón
Persones seropositives
Inhibidors de la integrasa
HIV-positive persons
Integrase inhibitors
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, José Ramón
Casadellà, Maria
Noguera Julian, Marc
Micán Rivera, Rafael
Domingo, Pere
Antela, Antonio
Portilla, Joaquín
Sanz, Jesús
Montero Alonso, Marta
Navarro, Jordi
Masiá, Maria Del Mar
Valcarce Pardeiro, Nieves
Ocampo, Antonio
Pérez Martínez, Laura
García Vallecillos, Coral
Vivancos, María Jesús
Imaz, Arkaitz
Iribarren, José Antonio
Hernández Quero, José
Villar García, Judit
Barrufet, Pilar
Paredes, Roger
Instinct Study Group
author Santos, José Ramón
author_facet Santos, José Ramón
Casadellà, Maria
Noguera Julian, Marc
Micán Rivera, Rafael
Domingo, Pere
Antela, Antonio
Portilla, Joaquín
Sanz, Jesús
Montero Alonso, Marta
Navarro, Jordi
Masiá, Maria Del Mar
Valcarce Pardeiro, Nieves
Ocampo, Antonio
Pérez Martínez, Laura
García Vallecillos, Coral
Vivancos, María Jesús
Imaz, Arkaitz
Iribarren, José Antonio
Hernández Quero, José
Villar García, Judit
Barrufet, Pilar
Paredes, Roger
Instinct Study Group
author_role author
author2 Casadellà, Maria
Noguera Julian, Marc
Micán Rivera, Rafael
Domingo, Pere
Antela, Antonio
Portilla, Joaquín
Sanz, Jesús
Montero Alonso, Marta
Navarro, Jordi
Masiá, Maria Del Mar
Valcarce Pardeiro, Nieves
Ocampo, Antonio
Pérez Martínez, Laura
García Vallecillos, Coral
Vivancos, María Jesús
Imaz, Arkaitz
Iribarren, José Antonio
Hernández Quero, José
Villar García, Judit
Barrufet, Pilar
Paredes, Roger
Instinct Study Group
author2_role author
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 Persones seropositives
Inhibidors de la integrasa
HIV-positive persons
Integrase inhibitors
topic Persones seropositives
Inhibidors de la integrasa
HIV-positive persons
Integrase inhibitors
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
2023
2023
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://hdl.handle.net/2445/201088
url https://hdl.handle.net/2445/201088
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: https://doi.org/10.3389/fcimb.2023.1187999
Frontiers in Cellular and Infection Microbiology, 2023, vol. 13
https://doi.org/10.3389/fcimb.2023.1187999
dc.rights.none.fl_str_mv cc by (c) Santos, José Ramón et al, 2023
http://creativecommons.org/licenses/by/3.0/es/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc by (c) Santos, José Ramón et al, 2023
http://creativecommons.org/licenses/by/3.0/es/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 15 p.
application/pdf
dc.publisher.none.fl_str_mv Frontiers Media SA
publisher.none.fl_str_mv Frontiers Media SA
dc.source.none.fl_str_mv Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))
reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,812455

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