PMID- 38349226
OWN - NLM
STAT- Publisher
LR  - 20240221
IS  - 1473-5571 (Electronic)
IS  - 0269-9370 (Linking)
DP  - 2024 Feb 12
TI  - Switch to bictegravir/emtricitabine/tenofovir alafenamide from dolutegravir-based 
      therapy: 96-week pooled analysis.
LID - 10.1097/QAD.0000000000003865 [doi]
AB  - OBJECTIVE: To evaluate the efficacy and safety of 96 weeks of 
      bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) treatment in 
      participants switching from dolutegravir (DTG)-based therapy. DESIGN: Studies 
      1489 (NCT02607930) and 1490 (NCT02607956) were phase 3 randomized, double-blind, 
      active-controlled, first-line therapy trials in people with HIV-1. After 
      144 weeks of DTG-based or B/F/TAF treatment, participants could enter a 96-week 
      open-label extension (OLE) of B/F/TAF. METHODS: A pooled analysis evaluated viral 
      suppression (HIV-1 RNA <50 copies/mL) and changes in CD4+ cell count at OLE Weeks 
      48 and 96, treatment-emergent resistance, safety and tolerability after switch 
      from a DTG-based regimen to B/F/TAF. Outcomes by prior treatment were summarized 
      using descriptive statistics and compared by two-sided Wilcoxon rank sum test. 
      RESULTS: At OLE Week 96, participants who switched to B/F/TAF (N=519) maintained 
      high levels of virologic suppression (99.5% and 99.1% in those switching from 
      DTG/abacavir/lamivudine and DTG+F/TAF, respectively) and CD4+ cell count, with no 
      treatment-emergent resistance to B/F/TAF. Twenty-one participants experienced 
      drug-related adverse events (AEs) after switching, with diarrhea, weight gain and 
      headache occurring most commonly. There were no cases of proximal renal 
      tubulopathy, drug-related Grade 4 AEs or serious AEs. Two participants 
      discontinued B/F/TAF due to treatment-related AEs. Participants who switched from 
      DTG/abacavir/lamivudine experienced statistically significant greater weight gain 
      than those who switched from DTG+F/TAF; however, median weight change from the 
      blinded phase baseline to OLE Week 96 was numerically similar across treatment 
      groups. CONCLUSIONS: This medium-term analysis demonstrates the safety and 
      efficacy of switching to B/F/TAF from a DTG-containing regimen in people with 
      HIV-1.
CI  - Copyright (c) 2024 The Author(s). Published by Wolters Kluwer Health, Inc.
FAU - Orkin, Chloe
AU  - Orkin C
AD  - Queen Mary University of London, London, UK.
FAU - Antinori, Andrea
AU  - Antinori A
AD  - National Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, Rome, 
      Italy.
FAU - Rockstroh, Jurgen K
AU  - Rockstroh JK
AD  - University Hospital Bonn, Bonn, Germany.
FAU - Moreno-Guillen, Santiago
AU  - Moreno-Guillen S
AD  - Hospital Ramon y Cajal, Madrid, Spain.
FAU - Martorell, Claudia T
AU  - Martorell CT
AD  - The Research Institute, Springfield, MA, USA.
FAU - Molina, Jean-Michel
AU  - Molina JM
AD  - University of Paris Cite, Department of Infectious Diseases, Hopital Saint-Louis 
      and Lariboisiere, Paris, France.
FAU - Lazzarin, Adriano
AU  - Lazzarin A
AD  - San Raffaele Hospital Milan, Milan, Italy.
FAU - Maggiolo, Franco
AU  - Maggiolo F
AD  - Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.
FAU - Yazdanpanah, Yazdan
AU  - Yazdanpanah Y
AD  - AP-HP Hopital Bichat, Paris, France.
FAU - Andreatta, Kristen
AU  - Andreatta K
AD  - Gilead Sciences, Inc., Foster City, CA, USA.
FAU - Huang, Hailin
AU  - Huang H
AD  - Gilead Sciences, Inc., Foster City, CA, USA.
FAU - Hindman, Jason T
AU  - Hindman JT
AD  - Gilead Sciences, Inc., Foster City, CA, USA.
FAU - Martin, Hal
AU  - Martin H
AD  - Gilead Sciences, Inc., Foster City, CA, USA.
FAU - Pozniak, Anton
AU  - Pozniak A
AD  - Chelsea and Westminster Hospital, London, UK.
LA  - eng
PT  - Journal Article
DEP - 20240212
PL  - England
TA  - AIDS
JT  - AIDS (London, England)
JID - 8710219
SB  - IM
EDAT- 2024/02/13 12:45
MHDA- 2024/02/13 12:45
CRDT- 2024/02/13 09:43
PHST- 2024/02/13 12:45 [pubmed]
PHST- 2024/02/13 12:45 [medline]
PHST- 2024/02/13 09:43 [entrez]
AID - 00002030-990000000-00450 [pii]
AID - 10.1097/QAD.0000000000003865 [doi]
PST - aheadofprint
SO  - AIDS. 2024 Feb 12. doi: 10.1097/QAD.0000000000003865.