Bezafibrate as Second-Line Treatment of Primary Biliary Cholangitis

The majority of patients with primary biliary cholangitis (PBC) have complete biochemical response to ursodeoxycholic acid (UDCA) therapy. For those who do not, second-line therapies are sought, such as the recently FDA-approved obeticholic acid. Fibrates, agonists of peroxisome proliferation-activated receptors, also show promise in this setting.

In the current industry-funded, phase III trial, researchers randomized 100 patients with PBC and inadequate biochemical response to UDCA to receive once-daily bezafibrate 400 mg or placebo in addition to UDCA for 24 months. Inadequate biochemical response was defined as alkaline phosphatase (APT) or aspartate aminotransferase (AST) >1.5 times the upper limit of the normal range or an abnormal tota…