Rinella M, Dufour JF, Anstee QM, et al. - Obeticholic acid (OCA) therapy for nonalcoholic steatohepatitis (NASH) conferred rapid and sustained improvements in various noninvasive tests (NITs) in the REGENERATE Month 18 interim analysis. Dynamic alterations in selected NITs distinguished histologic responders from non-responders. Overall, NITs could be beneficial in evaluating histologic response to OCA therapy.

• In the phase 3 REGENERATE study, experts focused on alterations in various NITs in patients with NASH and fibrosis stage F2 or F3 (N = 931) treated with OCA or placebo.

• OCA-treated patients showed rapid, sustained decreases from baseline in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase levels, as well as in FIB-4 (fibrosis-4), FibroTest, FibroMeter, and FibroScan-AST scores, compared with the placebo group.

• The OCA 25 mg group showed reduction in liver stiffness by vibration-controlled transient elastography vs placebo group at Month 18.

• NIT changes were related to shifts in histologic fibrosis stage.

• In cases with ≥1-stage fibrosis improvement, greatest improvements occurred; however, ALT, AST, FIB-4, and FibroTest were also improved in OCA-treated patients whose histologic fibrosis remained stable.