RT Journal Article
T1 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.
A1 Grau, Santiago
A1 Miró, Jose Maria
A1 Olalla, Julian
A1 Alcalá, Juan C
A1 Castro, Antonio
A1 Rubio-Rodríguez, Dario
A1 Rubio-Terrés, Carlos
K1 HIV
K1 bictegravir
K1 clinical trial
K1 dolutegravir
K1 emtricitabine
K1 lamivudine drug combination
K1 review
K1 rilpivirine drug combination
K1 tenofovir alafenamide drug combination
AB 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). 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. 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.
YR 2022
FD 2022-11-27
LK http://hdl.handle.net/10668/19684
UL http://hdl.handle.net/10668/19684
LA en
DS RISalud
RD Apr 6, 2025