Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
Three-drug regimen shows promise for refractory primary biliary cholangitis
Key clinical point: A three-drug regimen was effective and safe in patients with primary biliary cholangitis refractory to two drugs.
Major finding: Triple therapy normalized alkaline phosphatase levels in 5 of 10 patients who had been persistently abnormal on two drugs.
Study details: Single-center, observational study of 10 patients with primary biliary cholangitis.
Disclosures: Ms. Smets had no disclosures.
Citation:
Smets L et al. J Hepatol. 2019 April;70[1]:e130.
Clinicians in Europe already use this triple therapy in appropriate patients. Bezafibrate is cheap, it has been used since the 1970s to lower triglyceride levels, and it is generally safe. Following the report of results from the BEZURSO trial in 2018, guidelines changed to accept the option of adding a fibrate to ursodeoxycholic acid and obeticholic acid.
In my own practice I follow the steps used by the KU Leuven group, going from monotherapy with ursodeoxycholic acid to combination treatment with obeticholic acid, and then we routinely add bezafibrate when patients don’t have a full response to the dual regimen, or if they have ongoing complaints of pruritis. I will sometimes start a fibrate even in patients with a complete biochemical response to dual therapy if pruritis remains a problem. Not all patients have relief of their itching when a fibrate is added, but many do.
Thomas Berg, MD, is professor and head of hepatology at University Hospital in Leipzig, Germany. He has received personal fees and research support from several companies including Intercept, the company that markets obeticholic acid (Ocaliva). He made these comments in an interview.