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...
| Autores: | , , , , , , , , , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Fecha de publicación: | 2023 |
| País: | España |
| Institución: | Universitat Politècnica de Catalunya (UPC) |
| Repositorio: | UPCommons. Portal del coneixement obert de la UPC |
| Idioma: | inglés |
| OAI Identifier: | oai:upcommons.upc.edu:2117/400635 |
| Acceso en línea: | https://hdl.handle.net/2117/400635 https://dx.doi.org/10.3389/fcimb.2023.1187999 |
| Access Level: | acceso abierto |
| Palabra clave: | Biomathematics Biomatemàtica Classificació AMS::92 Biology and other natural sciences::92B Mathematical biology in general Àrees temàtiques de la UPC::Matemàtiques i estadística::Matemàtica aplicada a les ciències |
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Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world studyRamon Santos, JoseCasadellà, MariaNoguera Julian, MarcMicán Rivera, RafaelDomingo Pedrol, PereAntela, AntonioPortilla, JoaquinSanz Sanz, JesúsMontero Alonso, MartaNavarro Mercade, JordiMasiá, MarValcarce Pardeiro, NievesPérez Álvarez, Nuria|||0000-0001-6582-1553BiomathematicsBiomatemàticaClassificació AMS::92 Biology and other natural sciences::92B Mathematical biology in generalÀrees temàtiques de la UPC::Matemàtiques i estadística::Matemàtica aplicada a les ciènciesIntroduction: 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.Peer Reviewed20232023-06-2620242024-01-31journal articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/2117/400635https://dx.doi.org/10.3389/fcimb.2023.1187999reponame:UPCommons. Portal del coneixement obert de la UPCinstname:Universitat Politècnica de Catalunya (UPC)Inglésengopen accesshttp://purl.org/coar/access_right/c_abf2Attribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:upcommons.upc.edu:2117/4006352026-05-27T15:37:01Z |
| 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 Ramon Santos, Jose Biomathematics Biomatemàtica Classificació AMS::92 Biology and other natural sciences::92B Mathematical biology in general Àrees temàtiques de la UPC::Matemàtiques i estadística::Matemàtica aplicada a les ciències |
| 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 |
Ramon Santos, Jose Casadellà, Maria Noguera Julian, Marc Micán Rivera, Rafael Domingo Pedrol, Pere Antela, Antonio Portilla, Joaquin Sanz Sanz, Jesús Montero Alonso, Marta Navarro Mercade, Jordi Masiá, Mar Valcarce Pardeiro, Nieves Pérez Álvarez, Nuria|||0000-0001-6582-1553 |
| author |
Ramon Santos, Jose |
| author_facet |
Ramon Santos, Jose Casadellà, Maria Noguera Julian, Marc Micán Rivera, Rafael Domingo Pedrol, Pere Antela, Antonio Portilla, Joaquin Sanz Sanz, Jesús Montero Alonso, Marta Navarro Mercade, Jordi Masiá, Mar Valcarce Pardeiro, Nieves Pérez Álvarez, Nuria|||0000-0001-6582-1553 |
| author_role |
author |
| author2 |
Casadellà, Maria Noguera Julian, Marc Micán Rivera, Rafael Domingo Pedrol, Pere Antela, Antonio Portilla, Joaquin Sanz Sanz, Jesús Montero Alonso, Marta Navarro Mercade, Jordi Masiá, Mar Valcarce Pardeiro, Nieves Pérez Álvarez, Nuria|||0000-0001-6582-1553 |
| author2_role |
author author author author author author author author author author author author |
| dc.subject.none.fl_str_mv |
Biomathematics Biomatemàtica Classificació AMS::92 Biology and other natural sciences::92B Mathematical biology in general Àrees temàtiques de la UPC::Matemàtiques i estadística::Matemàtica aplicada a les ciències |
| topic |
Biomathematics Biomatemàtica Classificació AMS::92 Biology and other natural sciences::92B Mathematical biology in general Àrees temàtiques de la UPC::Matemàtiques i estadística::Matemàtica aplicada a les ciències |
| 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 2023-06-26 2024 2024-01-31 |
| dc.type.none.fl_str_mv |
journal article http://purl.org/coar/resource_type/c_6501 VoR http://purl.org/coar/version/c_970fb48d4fbd8a85 |
| dc.type.openaire.fl_str_mv |
info:eu-repo/semantics/article |
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article |
| dc.identifier.none.fl_str_mv |
https://hdl.handle.net/2117/400635 https://dx.doi.org/10.3389/fcimb.2023.1187999 |
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https://hdl.handle.net/2117/400635 https://dx.doi.org/10.3389/fcimb.2023.1187999 |
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Inglés eng |
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Inglés |
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eng |
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open access http://purl.org/coar/access_right/c_abf2 Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ |
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info:eu-repo/semantics/openAccess |
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open access http://purl.org/coar/access_right/c_abf2 Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ |
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