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Lookup NU author(s): Professor Quentin AnsteeORCiD, Professor Pierre Bedossa
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© 2023 AGA InstituteBackground And Aims: Cenicriviroc (CVC) is a novel, orally administered, chemokine receptor type 2 and 5 antagonist that showed antifibrotic potential in preclinical and phase IIb studies of nonalcoholic steatohepatitis (NASH). Herein, we report efficacy and safety results from the phase III study. Methods: The AURORA (A Study for the Efficacy and Safety of CVC for the Treatment of Liver Fibrosis in Adults With NASH) study was a phase III, randomized, double-blind, placebo-controlled, 2-part study of patients with NASH and stage 2/3 liver fibrosis. Adults, 18–75 years of age, were randomized to CVC 150 mg or placebo once daily for 12 months (part 1) or 60 months (part 2). Liver biopsies were performed at screening, month 12, and early study discontinuation or termination. The primary efficacy endpoint was the proportion of patients with fibrosis improvement ≥1 stage without worsening of steatohepatitis at month 12 relative to screening. Adverse events were assessed throughout the study. Results: A total of 1778 patients were randomized and discontinued (part 1: n = 1293; part 2: n = 485). In part 1, at month 12, a similar proportion of patients receiving CVC or placebo achieved the primary endpoint (22.3% vs 25.5%; odds ratio, 0.84; 95% confidence interval, 0.63–1.10; P =.21) and complete resolution of steatohepatitis without worsening of fibrosis (23.0% vs 27.2%; P =.21). The safety profile was generally comparable across treatment groups. Conclusions: This study did not demonstrate the efficacy of CVC for treating liver fibrosis assessed by histology in adults with NASH; however, CVC was safe and well tolerated in patients with NASH and liver fibrosis. (ClinicalTrials.gov, Number: NCT03028740).
Author(s): Anstee QM, Neuschwander-Tetri BA, Wai-Sun Wong V, Abdelmalek MF, Rodriguez-Araujo G, Landgren H, Park GS, Bedossa P, Alkhouri N, Tacke F, Sanyal AJ
Publication type: Article
Publication status: Published
Journal: Clinical Gastroenterology and Hepatology
Year: 2024
Volume: 22
Issue: 1
Pages: 124-134.e1
Print publication date: 01/01/2024
Online publication date: 13/04/2023
Acceptance date: 02/04/2023
Date deposited: 08/06/2023
ISSN (print): 1542-3565
ISSN (electronic): 1542-7714
Publisher: Elsevier
URL: https://doi.org/10.1016/j.cgh.2023.04.003
DOI: 10.1016/j.cgh.2023.04.003
PubMed id: 37061109
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