VIDEO: OCA improves various surrogate markers of liver fibrosis

BOSTON — In this exclusive video at The Liver Meeting, Gideon Hirschfield, MA, MB, PhD, of the Institute of Biomedical Research at the University of Birmingham, UK, discusses long-term safety extension data from a phase 3 clinical trial investigating obeticholic acid in primary biliary cholangitis, and how it has had positive effects on two surrogate markers for liver fibrosis.

“What’s exciting about obeticholic acid is its clear effects on liver biochemistry and the vast majority of patients [have experienced] falling alkaline phosphatase,” Hirschfield said. “We really, truly believe this is good for patients and this is a surrogate of reduction in disease activity. It will take time before we can move towards evidence of patients [with PBC] living longer, but what we can do is demonstrate improvements in other surrogate markers of liver fibrosis.”

Hirschfield and colleagues looked at the use of obeticholic acid’s (OCA) effect on APRI — a marker of AST to platelet ratio — and liver elastography — a marker of liver stiffness and fibrosis.

“What’s exciting in the data is in patients given OCA, we do see the trends in the right direction to improvements in APRI and elastography,” Hirschfield said.

Hirschfield noted that the numbers are small and the statistics have limitations, but it is encouraging for the first new treatment for PBC in a long time.

“We are starting to get the first evidence that this new therapy for PBC — first new therapy in 20 years — is likely to have an impact on liver fibrosis and therefore we believe will be prolonging the lives of our patients with PBC.”

Disclosure: Hirschfield reports consulting for BioTie, Intercept, Janssen, Lumena and Medigene.