Abstract
REGENERATE showed that treatment with OCA improved histological liver fibrosis in NASH patients.1 However, liver biopsy is an impractical tool to monitor patients’ response to therapy. Here, we evaluate the potential utility of non-invasive tests in monitoring NASH patients with fibrosis during treatment. Patients with fibrosis stages 2 and 3 were randomized (1:1:1) to placebo, OCA 10mg or OCA 25mg QD. Change in non-invasive biomarker scores of fibrosis (FIB-4 index, AST to platelet ratio index [APRI]), FibroSure® and NASH (CK-18), and liver stiffness via transient elastography (TE, subset of patients), were assessed.
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