AASLD-AGA Guideline on Primary Biliary Cholangitis Recommends UDCA First Line, Suggests PPAR Agonists and Linerixibat

The American Association for the Study of Liver Diseases (AASLD) and the American Gastroenterological Association (AGA) have issued a joint clinical practice guideline on the management of primary biliary cholangitis (PBC) in adults, published in Hepatology.

A multidisciplinary panel performed systematic reviews for 6 prioritized clinical questions and used the Grading of Recommendations Assessment, Development and Evaluation framework to develop 6 recommendations. The certainty of evidence ranged from moderate to very low. AGA provided all financial support, and no industry funding was accepted.

The only strong recommendation favors ursodeoxycholic acid (UDCA) over no treatment in treatment-naive PBC, based on moderate-certainty evidence. The guideline describes UDCA at 13 to 15mg/kg/d as first-line therapy and states it should be continued even with persistent serum alkaline phosphatase elevation. For people with inadequate response to or intolerance of UDCA, the societies suggest the peroxisome proliferator–activated receptor (PPAR) agonists elafibranor or seladelpar, as add-on therapy or alternative monotherapy, respectively (low certainty). The guideline notes that elafibranor (80mg/d) and seladelpar (10mg/d) have received accelerated FDA approval as second-line therapy.

The societies also issued conditional recommendations suggesting testing for sp100 and gp210 antibodies in suspected PBC with negative antimitochondrial antibodies, measuring liver stiffness to improve prognostication, and using UDCA prophylaxis after liver transplantation for PBC to prevent recurrence and graft failure. For moderate to severe cholestatic pruritus, they suggest linerixibat as an option (low certainty). In pooled placebo-controlled trial data, linerixibat 40mg twice daily produced a small reduction of 0.78 points on the Worst Itch Numeric Rating Scale. The guideline notes that people who place a higher value on avoiding gastrointestinal side effects or costs may reasonably choose not to use it.

According to the guideline, the recommendations are intended to guide shared management decisions rather than represent a specific standard. The panel identified fatigue, metabolic bone disease, and PBC-autoimmune hepatitis overlap as areas still needing guidance.

Source: Levy C, Mayo MJ, Carey EJ, et al. AASLD AGA clinical practice guideline on management of primary biliary cholangitis. Hepatology. Published online October 22, 2026. doi:10.1097/HEP.0000000000001875