Obeticholic acid demonstrates sustained improvements at month 24 in transaminases and non-invasive markers of fibrosis: Results of a post hoc analysis from the interim analysis of the REGENERATE study

R Loomba,V Ratziu,Q.M Anstee,S Harrison,A.J Sanyal,M Rinella,Z.Y Younossi,Z Goodman,P Bedossa,R Shringarpure,H Zhou,M Noureddin,E Bugianesi

doi:10.1016/j.dld.2020.12.067

Obeticholic acid demonstrates sustained improvements at month 24 in transaminases and non-invasive markers of fibrosis: Results of a post hoc analysis from the interim analysis of the REGENERATE study

R Loomba, V Ratziu + Show 11 more

https://doi.org/10.1016/j.dld.2020.12.067

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Journal: Digestive and Liver Disease

Publication Date: Feb 23, 2021

Affiliation: Northwestern University, Inova Health System, Newcastle University, Pinnacle Clinical Research, University of Turin, University of California, San Diego, Intercept Pharmaceuticals (United States), Cedars-Sinai Medical Center, Sorbonne Université

#Non-invasive Markers Of Fibrosis #Non-invasive Markers + Show 8 more

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Abstract

Introduction: In the REGENERATE (NCT02548351) interim analysis, 18 months’ treatment with obeticholic acid (OCA) improved histologic liver fibrosis in patients with nonalcoholic steatohepatitis (NASH) and advanced fibrosis. The ongoing REGENERATE study will continue through clinical outcomes for verification and description of clinical benefit. To assess durability of response and the relationship between changes in non-invasive markers and histologic fibrosis improvement, transaminases and non-invasive markers were analyzed in patients with 24-month data at the planned 18-month interim analysis.

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