OCA improves non-invasive markers of NASH, advanced fibrosis

Early and sustained improvements in non-invasive markers of nonalcoholic steatohepatitis and advanced fibrosis were observed in patients treated with obeticholic acid, according to research presented at The Digital International Liver Congress.

“Improvements over time were generally consistent in patients with stage 2 or 3 fibrosis at baseline,” Jerome Boursier, MD, PhD, from Angers University Hospital in France, said during his presentation. “OCA treatment was associated with favorable shifts in [Fibroscan-AST] score.”

Boursier and colleagues randomly assigned patients with NASH with fibrosis stage 2 and stage 3 to either placebo (n= 311), OCA 10 mg (n = 312) or OCA 25 mg (n =308) once daily. Investigators analyzed changes in FibroMeter (FM, n = 604), FM vibration-controlled transient elastography (VCTE, n = 604), and Fibroscan-AST (FAST, n = 391) in a subset of patients with a mixed-effect repeated measures model.

Results showed scores across groups were not significantly different at baseline. At baseline, patients with stage 3 fibrosis compared with those with stage 2 fibrosis had higher scores. Patients treated with OCA experienced improvements in FM, FM VCTE and FAST at 6 months and was sustained through 18 months. In both OCA dose groups, Boursier and colleagues observed a therapeutic response; however, no improvements were observed in the placebo group.

“The [Randomized Global Phase 3 Study to Evaluate the Impact on NASH with Fibrosis of Obeticholic Acid Treatment] study remains ongoing and will continue through clinical outcomes for verification and description of clinical benefit,” he said.