Two updates in the Guidelines for PBC

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PRACTICE GUIDANCE

Primary biliary cholangitis: 2021 practice guidance update from the American Association for the Study of Liver Diseases

Lindor, Keith D.*,1; Bowlus, Christopher L.2; Boyer, James3; Levy, Cynthia4; Mayo, Marlyn5

Author Information

Hepatology 75(4) 1012-1013, April 2022. | DOI: 10.1002/hep.32117

CHANGES FROM THE PRIOR AMERICAN ASSOCIATION FOR THE STUDY OF LIVER DISEASES PRACTICE GUIDANCE ON PRIMARY BILIARY CHOLANGITIS

Guidance Statements 9 and 10 that were published in the 2018 Practice Guidance on primary biliary cholangitis (PBC) have been revised.[1]

PURPOSE AND SCOPE OF THIS PRACTICE GUIDANCE

This American Association for the Study of Liver Diseases 2021 practice guidance on PBC is a focused update of the PBC guidance published in 2018. The major changes from the last guidance to this guidance include information about obeticholic acid (OCA).

OCA

In May 2021, the Food and Drug Administration issued a new warning restricting the use of OCA in patients with advanced cirrhosis.[2] This is defined as cirrhosis with current or prior evidence of liver decompensation (e.g., encephalopathy, coagulopathy) or portal hypertension (e.g., ascites, gastroesophageal varices, or persistent thrombocytopenia).

REVISED GUIDANCE STATEMENTS

Two guidance statements that were published in the 2018 practice guidance on PBC have been revised as follows:

9. Fibrates can be considered as off‐label alternatives for patients with PBC and inadequate response to ursodeoxycholic acid, although fibrates are discouraged in patients with decompensated liver disease.

10. OCA is contraindicated in patients with advanced cirrhosis. This is defined as cirrhosis with current or prior evidence of liver decompensation (e.g., encephalopathy, coagulopathy) or portal hypertension (e.g., ascites, gastroesophageal varices, or persistent thrombocytopenia). Furthermore, we would recommend careful monitoring of any patient with cirrhosis, even if not advanced, receiving OCA.