Comparison of the design and methodology of Phase 3 clinical trials of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) and dolutegravir-based dual therapy (DTG) in HIV: a systematic review of the literature

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• dc.contributor.author Grau Cerrato, Santiago
• dc.contributor.author Miró, José María
• dc.contributor.author Olalla, Julian
• dc.contributor.author Alcalá, Juan C.
• dc.contributor.author Castro, Antonio
• dc.contributor.author Rubio-Rodríguez, Darío
• dc.contributor.author Rubio-Terrés, Carlos
• dc.date.accessioned 2023-03-30T06:00:20Z
• dc.date.available 2023-03-30T06:00:20Z
• dc.date.issued 2023
• dc.description.abstract Introduction: Current recommended antiretroviral regimens include a combination of two (dual; DT) or three (triple; TT) antiretroviral drugs. This study aims to determine whether the quality of evidence from clinical trials of dolutegravir (dolutegravir/lamivudine [DTG/3TC] or dolutegravir/rilpivirine [DTG/RPV]) is methodologically comparable to that of clinical trials conducted with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). Areas covered: A systematic review of the medical literature was carried out in PubMed without date or language restrictions, following the PRISMA guidelines. All aspects of the methodological design of phase 3 randomized clinical trials (RCTs) of DT and TT, evaluated by the European Medicines Agency (registration trials), were reviewed. The quality of clinical trials was assessed using the Jadad scale. Expert opinion: The search identified 5, 3 and 2 phase 3 RCTs with BIC/FTC/TAF, DTG/3TC and DTG/RPV, respectively, that met the inclusion criteria. The designs would not be comparable due to differences in pre-randomization losses, blinding, patient recruitment, as well as differences in methodological quality, with the average score of the RCTs conducted with BIC/FTC/TAF, DTG/3TC and DTG/RPV being 4.2 (high quality), 3.0 (medium quality) and 3.0 (medium quality), respectively. Due to methodological differences between the BIC/FTC/TAF, DTG/3TC and DTG/RPV RCTs, the results of these are not comparable.
• dc.format.mimetype application/pdf
• dc.identifier.citation Grau S, Miró JM, Olalla J, Alcalá JC, Castro A, Rubio-Rodríguez D, Rubio-Terrés C. Comparison of the design and methodology of Phase 3 clinical trials of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) and dolutegravir-based dual therapy (DTG) in HIV: a systematic review of the literature. Expert Rev Anti Infect Ther. 2023 Jan;21(1):65-76. DOI: 10.1080/14787210.2023.2149490
• dc.identifier.doi http://dx.doi.org/10.1080/14787210.2023.2149490
• dc.identifier.issn 1478-7210
• dc.identifier.uri http://hdl.handle.net/10230/56378
• dc.language.iso eng
• dc.publisher Taylor & Francis
• dc.relation.ispartof Expert Rev Anti Infect Ther. 2023 Jan;21(1):65-76
• dc.rights © 2022 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in any way.
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.rights.uri http://creativecommons.org/licenses/by-nc-nd/4.0/
• dc.subject.keyword HIV
• dc.subject.keyword Bictegravir
• dc.subject.keyword Clinical trial
• dc.subject.keyword Dolutegravir
• dc.subject.keyword Emtricitabine
• dc.subject.keyword Lamivudine drug combination
• dc.subject.keyword Review
• dc.subject.keyword Rilpivirine drug combination
• dc.subject.keyword Tenofovir alafenamide drug combination
• dc.title Comparison of the design and methodology of Phase 3 clinical trials of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) and dolutegravir-based dual therapy (DTG) in HIV: a systematic review of the literature
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/publishedVersion