Interesting re-analysis of REGENERATE using three independent pathologists to confirm biopsy-based efficacy findings with Ocaliva in pre-cirrhotic MASH patients.
Given how subjective histological assessment is, per se, it makes sense that panel assessment involving several independent pathologists would improve reliability in all prospective phase IIb/III trials.
Is obeticholic acid an effective and safe treatment for individuals with pre-cirrhotic fibrosis and NASH?
Obeticholic acid (OCA) is in development for pre-cirrhotic liver fibrosis treatment in non-alcoholic steatohepatitis (NASH). This study published in the Journal of Hepatology validated OCA's efficacy and safety in the phase III REGENERATE trial through the evaluation of liver tissue slides from 1,000 participants receiving OCA for over four years, with the independent assessment by three pathologists. Results confirmed OCA's superiority to a placebo in reducing fibrosis, serum ALT levels, and liver stiffness. OCA exhibited good tolerability and a favorable safety profile, confirming the initial assessment by a single pathologist.
By Arun J. Sanyal et al.
#OpenAccess here: https://lnkd.in/eiW2u_79
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