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

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• dc.contributor.author Santos, José Ramón
• dc.contributor.author Villar García, Judit
• dc.contributor.author INSTINCT study group
• dc.date.accessioned 2024-05-10T05:51:32Z
• dc.date.available 2024-05-10T05:51:32Z
• dc.date.issued 2023
• dc.description.abstract 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.
• dc.format.mimetype application/pdf
• dc.identifier.citation Santos JR, Casadellà M, Noguera-Julian M, Micán-Rivera R, Domingo P, Antela A, et al. Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world study. Front Cell Infect Microbiol. 2023 Jun 26;13:1187999. DOI: 10.3389/fcimb.2023.1187999
• dc.identifier.doi http://dx.doi.org/10.3389/fcimb.2023.1187999
• dc.identifier.issn 2235-2988
• dc.identifier.uri http://hdl.handle.net/10230/60093
• dc.language.iso eng
• dc.publisher Frontiers
• dc.relation.ispartof Front Cell Infect Microbiol. 2023 Jun 26;13:1187999
• dc.rights © 2023 Santos, Casadellà, Noguera-Julian, Micán-Rivera, Domingo, Antela, Portilla, Sanz, Montero-Alonso, Navarro, Masiá, Valcarce-Pardeiro, Ocampo, Pérez-Martínez, García-Vallecillos, Vivancos, Imaz, Iribarren, Hernández-Quero, Villar-García, Barrufet, Paredes and INSTINCT study group. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. http://creativecommons.org/licenses/by/4.0/
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.rights.uri http://creativecommons.org/licenses/by/4.0/
• dc.subject.keyword HIV
• dc.subject.keyword Dolutegravir
• dc.subject.keyword Elvitegravir
• dc.subject.keyword Integrase strand transfer inhibitors (INSTI)
• dc.subject.keyword Raltegravir
• dc.subject.keyword Real-world study
• dc.title Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world study
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/publishedVersion