A Randomized, Placebo-Controlled Trial of Cenicriviroc for Treatment of Nonalcoholic Steatohepatitis with Fibrosis

Antonio Craxi, Rohit Loomba, Stephen A. Harrison, Scott L. Friedman, Zachary Goodman, Geoffrey Farrell, Laurent Fischer, Jeffrey Vest, Star Seyedkazemi, Liza Melchor-Khan, Pamela Vig, Vincent Wai-Sun Wong, Kris V. Kowdley, Sven Francque, Frank Tacke, Manal F. Abdelmalek, Guruprasad P. Aithal, Brian L. Wiens, Vlad Ratziu, Juan CaballeriaEric Lefebvre, Arun Sanyal, Krzysztof Simon

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289 Citazioni (Scopus)

Abstract

The aim of this study was to evaluate cenicriviroc (CVC), a dual antagonist of C-C chemokine receptor types 2 and 5, for treatment of nonalcoholic steatohepatitis (NASH) with liver fibrosis. A randomized, double-blind, multinational phase 2b study enrolled subjects with NASH, a nonalcoholic fatty liver disease activity score [NAS] ≥4, and liver fibrosis (stages 1-3, NASH Clinical Research Network) at 81 clinical sites. Subjects (N = 289) were randomly assigned CVC 150 mg or placebo. Primary outcome was ≥2-point improvement in NAS and no worsening of fibrosis at year 1. Key secondary outcomes were: resolution of steatohepatitis and no worsening of fibrosis; improvement in fibrosis by ≥1 stage and no worsening of steatohepatitis. Biomarkers of inflammation and adverse events were assessed. Full study recruitment was achieved. The primary end point of NAS improvement in the intent-to-treat population and resolution of steatohepatitis was achieved in a similar proportion of subjects on CVC (N = 145) and placebo (N = 144) (16% vs 19%, P = 0.52 and 8% vs 6%, P = 0.49, respectively). However, the fibrosis end point was met in significantly more subjects on CVC than placebo (20% vs 10%; P = 0.02). Treatment benefits were greater in those with higher disease activity and fibrosis stage at baseline. Biomarkers of systemic inflammation were reduced with CVC. Safety and tolerability of CVC were comparable to placebo.
Lingua originaleEnglish
Numero di pagine0
RivistaHEPATOLOGY
Stato di pubblicazionePublished - 2017

All Science Journal Classification (ASJC) codes

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