PMID- 33977505
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220110
IS  - 2193-8229 (Print)
IS  - 2193-6382 (Electronic)
IS  - 2193-6382 (Linking)
VI  - 10
IP  - 3
DP  - 2021 Sep
TI  - Meta-Analysis of Efficacy and Safety of Coformulated Bictegravir, Emtricitabine, 
      and Tenofovir Alafenamide Among People Living with HIV.
PG  - 1331-1346
LID - 10.1007/s40121-021-00449-z [doi]
AB  - INTRODUCTION: Integrase strand transfer inhibitor (InSTI)-based antiretroviral 
      regimens have become the recommended antiretroviral therapy for people living 
      with HIV (PLWH) who are antiretroviral-naive or stably antiretroviral-treated. 
      This meta-analysis aimed to systematically review the efficacy and safety of 
      coformulated bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) among 
      PLWH. METHODS: Randomized controlled trials (RCTs) were included to compare the 
      efficacy and safety between BIC/FTC/TAF and other antiretroviral regimens 
      containing a non-nucleoside reverse transcriptase inhibitor, protease inhibitor, 
      or integrase strand transfer inhibitor plus two nucleos(t)ide reverse 
      transcriptase inhibitors. A Mantel-Haenszel model was used to investigate the 
      combination or interaction of a group of independent studies. I(2) was used to 
      determine whether a fixed-effect model or random-effect model was to be used. 
      RESULTS: A total of seven published randomized clinical trials including 3547 
      participants were analyzed; three studies were conducted in antiretroviral-naive 
      PLWH and four in stably antiretroviral-treated PLWH. At week 48, the efficacy 
      with BIC/FTC/TAF was not statistically significantly different from that with 
      control regimens [odds ratio (OR) 1.01 (95% CI 0.79, 1.30)]. BIC/FTC/TAF had 
      comparable safety profiles to control regimens: OR for all adverse effects (AEs) 
      was 0.92 (95% CI 0.78, 1.09); OR for any grade 3 or grade 4 AEs was 0.96 (95% CI 
      0.66, 1.39); and OR for treatment-related AEs was 1.31 (95% CI 0.68, 2.53). 
      CONCLUSIONS: This meta-analysis of published randomized clinical trials of 
      antiretroviral-naive and stably antiretroviral-treated PLWH suggests that 
      BIC/FTC/TAF is as safe and efficacious as are its comparators at week 48. The 
      interstudy differences in selected populations and control regimens may lead to 
      the high heterogeneity of the meta-analysis.
CI  - (c) 2021. The Author(s).
FAU - Chen, I-Wen
AU  - Chen IW
AD  - Graduate Institute of Clinical Medicine, National Taiwan University College of 
      Medicine, Taipei, Taiwan.
AD  - Department of Pharmaceutical Chemistry, University of Toronto, Toronto, Canada.
FAU - Sun, Hsin-Yun
AU  - Sun HY
AD  - Department of Internal Medicine, National Taiwan University Hospital and National 
      Taiwan University College of Medicine, 7 Chung-Shan South Road, Taipei, Taiwan.
FAU - Hung, Chien-Ching
AU  - Hung CC
AUID- ORCID: 0000-0001-7345-0836
AD  - Department of Internal Medicine, National Taiwan University Hospital and National 
      Taiwan University College of Medicine, 7 Chung-Shan South Road, Taipei, Taiwan. 
      hcc0401@ntu.edu.tw.
AD  - Department of Tropical Medicine and Parasitology, National Taiwan University 
      College of Medicine, Taipei, Taiwan. hcc0401@ntu.edu.tw.
AD  - Department of Medical Research, China Medical University Hospital, Taichung, 
      Taiwan. hcc0401@ntu.edu.tw.
AD  - China Medical University, Taichung, Taiwan. hcc0401@ntu.edu.tw.
LA  - eng
PT  - Journal Article
DEP - 20210511
PL  - New Zealand
TA  - Infect Dis Ther
JT  - Infectious diseases and therapy
JID - 101634499
PMC - PMC8322367
OTO - NOTNLM
OT  - Adverse effects
OT  - Bictegravir/emtricitabine/tenofovir alafenamide
OT  - HIV integrase inhibitor
OT  - Highly active antiretroviral therapy
OT  - Randomized controlled trial
OT  - Sustained virologic response
EDAT- 2021/05/13 06:00
MHDA- 2021/05/13 06:01
PMCR- 2021/05/11
CRDT- 2021/05/12 07:15
PHST- 2021/03/01 00:00 [received]
PHST- 2021/04/19 00:00 [accepted]
PHST- 2021/05/13 06:00 [pubmed]
PHST- 2021/05/13 06:01 [medline]
PHST- 2021/05/12 07:15 [entrez]
PHST- 2021/05/11 00:00 [pmc-release]
AID - 10.1007/s40121-021-00449-z [pii]
AID - 449 [pii]
AID - 10.1007/s40121-021-00449-z [doi]
PST - ppublish
SO  - Infect Dis Ther. 2021 Sep;10(3):1331-1346. doi: 10.1007/s40121-021-00449-z. Epub 
      2021 May 11.