Title: Primary biliary cholangitis: 2021 practice guidance update from the American Association for the Study of Liver Diseases
Abstract: HepatologyEarly View PRACTICE GUIDANCEFree Access Primary biliary cholangitis: 2021 practice guidance update from the American Association for the Study of Liver Diseases Keith D. Lindor, Corresponding Author Keith D. Lindor [email protected] Mayo Clinic Arizona, Scottsdale, Arizona, USA Correspondence Keith D. Lindor, Mayo Clinic Arizona, Scottsdale, AZ, USA. Email: [email protected] for more papers by this authorChristopher L. Bowlus, Christopher L. Bowlus University of California Davis, Sacramento, California, USASearch for more papers by this authorJames Boyer, James Boyer orcid.org/0000-0002-8959-6036 Yale School of Medicine, New Haven, Connecticut, USASearch for more papers by this authorCynthia Levy, Cynthia Levy University of Miami, Miami, Florida, USASearch for more papers by this authorMarlyn Mayo, Marlyn Mayo University of Texas Southwestern Medical Center, Dallas, Texas, USASearch for more papers by this author Keith D. Lindor, Corresponding Author Keith D. Lindor [email protected] Mayo Clinic Arizona, Scottsdale, Arizona, USA Correspondence Keith D. Lindor, Mayo Clinic Arizona, Scottsdale, AZ, USA. Email: [email protected] for more papers by this authorChristopher L. Bowlus, Christopher L. Bowlus University of California Davis, Sacramento, California, USASearch for more papers by this authorJames Boyer, James Boyer orcid.org/0000-0002-8959-6036 Yale School of Medicine, New Haven, Connecticut, USASearch for more papers by this authorCynthia Levy, Cynthia Levy University of Miami, Miami, Florida, USASearch for more papers by this authorMarlyn Mayo, Marlyn Mayo University of Texas Southwestern Medical Center, Dallas, Texas, USASearch for more papers by this author First published: 24 August 2021 https://doi.org/10.1002/hep.32117 Funding information: The funding for the development of this practice guidance was provided by the American Association for the Study of Liver Diseases. This updated practice guidance was approved by the American Association for the Study of Liver Diseases on July 30, 2021. AboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat 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. ACKNOWLEDGMENT The authors are grateful for the valuable contributions of the American Association for the Study of Liver Diseases Practice Guideline Committee. Members of the committee include George Ioannou (chair); Rabab Ali, Scott W. Biggins, Roniel Cabrera, Henry Chang, Michael F. Chang, Albert Do, David S. Goldberg, R. W. Ray Kim (board liaison), Lindsay Y. King, Cynthia Levy, Jeff McIntyre, Jessica L. Mellinger, Anthony J. Michaels, Mindie H. Nguyen, Nadia Ovchinsky, Anjana A. Pillai, Daniel S. Pratt, Hugo R. Rosen, Christopher J. Sonnenday, Matthew J. Stotts, Lisa B. VanWagner, and Elizabeth C. Verna. CONFLICT OF INTEREST Dr. Mayo consults for and received grants from Cymabay. She received grants from Intercept. Dr. Levy consults for, advises, and received grants from Intercept, Cymabay, Genfit, GSK, Pliant, Mirum, and Cara Therapeutics. She consults for and advises Escient, Teva, and Calliditas. She received grants from Gilead, Novartis, High Tide, Zydus, and Target PharmaSolutions. She receives royalities from Up-to-date. REFERENCES 1Lindor KD, Bowlus CL, Boyer J, Levy C, Mayo M. Primary biliary cholangitis: 2018 practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2019; 69: 394– 419. https://doi.org/10.1002/hep.30145Wiley Online LibraryPubMedWeb of Science®Google Scholar 2 US Food and Drug Administration. Due to risk of serious liver injury, FDA restricts use of Ocaliva (obeticholic acid) in primary biliary cholangitis (PBC) patients with advanced cirrhosis. https://www.fda.gov/drugs/drug-safety-and-availability/due-risk-serious-liver-injury-fda-restricts-use-ocaliva-obeticholic-acid-primary-biliary-cholangitis. Accessed May 2021. Google Scholar Early ViewOnline Version of Record before inclusion in an issue ReferencesRelatedInformation
Publication Year: 2021
Publication Date: 2021-12-20
Language: en
Type: article
Indexed In: ['crossref', 'pubmed']
Access and Citation
Cited By Count: 48
AI Researcher Chatbot
Get quick answers to your questions about the article from our AI researcher chatbot