| 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 |
| Authors: |
Grau Cerrato, Santiago; Miró, José María; Olalla, Julian; Alcalá, Juan C.; Castro, Antonio; Rubio-Rodríguez, Darío; Rubio-Terrés, Carlos |
| Publisher Information: |
Taylor & Francis |
| Publication Year: |
2023 |
| Collection: |
UPF Digital Repository (Universitat Pompeu Fabra, Barcelona) |
| Subject Terms: |
HIV; Bictegravir; Clinical trial; Dolutegravir; Emtricitabine; Lamivudine drug combination; Review; Rilpivirine drug combination; Tenofovir alafenamide drug combination |
| Description: |
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. |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
English |
| Relation: |
Expert Rev Anti Infect Ther. 2023 Jan;21(1):65-76; http://hdl.handle.net/10230/56378; http://dx.doi.org/10.1080/14787210.2023.2149490 |
| DOI: |
10.1080/14787210.2023.2149490 |
| Availability: |
http://hdl.handle.net/10230/56378; https://doi.org/10.1080/14787210.2023.2149490 |
| 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. ; http://creativecommons.org/licenses/by-nc-nd/4.0/ ; info:eu-repo/semantics/openAccess |
| Accession Number: |
edsbas.1F686FA9 |
| Database: |
BASE |