OPERA is a new trial evaluating a novel treatment strategy in newly diagnosed patients with primary biliary cholangitis (PBC). 

Despite recent progress in the treatment of PBC, a number of patients still go on to develop cirrhosis and need liver transplants. The current treatment approach is to start with gentle treatment with a drug called ursodeoxycholic acid (UDCA or “urso”) and only move on to more powerful treatments in people who don’t respond to urso. Response to urso is at present only assessed after it has been used for a year. At present it is not known if this delay in adding additional therapy to urso is a contributor to the ongoing risk seen in PBC.

OPERA will explore whether using one of the existing additional PBC drugs (Obeticholic Acid, brand name OCALIVA) at the beginning of the disease, in patients who are most at risk of not responding to urso, makes a difference to treatment success in PBC.

The study is funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanims Evaluation (EME Programme and led by Professor David Jones from the Newcastle University and Newcastle upon Tyne NHS Foundation Trust.