Bethesda, MD, and Alexandria, VA (Oct. 16, 2026) — For the first time, a joint guideline from the American Gastroenterological Association (AGA) and American Association for the Study of Liver Diseases (AASLD) evaluates newer medications for primary biliary cholangitis (PBC), the most common cholestatic disease in adults. Published in Gastroenterology and HEPATOLOGY , the guideline provides evidence-based recommendations for diagnosis and treatment.
The guideline addresses recent changes in the PBC treatment landscape and key challenges clinicians face, including diagnosing patients with less common antibody profiles, determining when to move beyond first-line therapy, and managing PBC-related itching. Because most people living with PBC are cared for by general gastroenterologists rather than hepatology specialists, the guideline is designed to ensure the broader GI community has access to the latest evidence and standards of care.
“The PBC treatment landscape has changed significantly in the past five years, with new options for second-line therapy and the removal of a treatment that had been used for the past decade,” said guideline author David N. Assis, MD. “This guideline provides clinicians and patients with practical, evidence-based guidance on navigating challenging diagnoses and selecting appropriate second-line therapies as today’s treatment options continue to evolve.”
This guideline complements AASLD's broader 2018 and 2021 PBC guidance, which addressed PBC care more comprehensively, with special emphasis on second-line treatment options. This is very timely given the withdrawal of obeticholic acid from the U.S. market late in 2025.
Taken together, the recommendations support a personalized approach to PBC care that considers each patient's risk of disease progression, disease characteristics, symptoms, and preferences. The goal is to intervene early and tailor treatment over time to help slow disease progression and preserve quality of life.
Key updates:
AGA and AASLD offer six recommendations for the diagnosis and management of PBC:
The certainty of evidence supporting the recommendations ranges from moderate to very low, highlighting both advances in PBC care and areas that need more research.
“This guideline is not intended to be a comprehensive guide to managing every aspect of PBC,” said guideline author Marlyn Mayo, MD. “Instead, it answers specific clinical questions, such as when to use a particular drug or diagnostic test and how to use it appropriately. There are still many areas where we do not have enough evidence to make firm recommendations, underscoring the need for continued research.”
Knowledge gaps and future directions
Despite recent advances, significant questions remain about how best to manage PBC.
More research is needed to understand how peroxisome proliferator-activated receptor agonists affect long-term outcomes, including mortality, transplant-free survival, and cirrhosis decompensation. Well-designed comparative studies examining these outcomes could help inform future recommendations.
Additional research is also needed to determine how frequently elastography should be repeated to monitor patients and how clinicians should manage patients who do not respond to second-line therapy. Currently, evidence is insufficient to provide clear recommendations in these areas. Addressing these gaps will be important as diagnostic tools and treatment options continue to evolve.
Understanding PBC
Primary biliary cholangitis (PBC) is a long-term autoimmune liver disease. In PBC, the body's immune system mistakenly attacks small bile ducts inside the liver. Over time, this damage can make it harder for bile to flow normally. This can lead to scarring of the liver, called fibrosis, and in some people, may eventually cause cirrhosis , liver failure, or the need for a liver transplant.
PBC is not caused by alcohol use, and it is not contagious. Most people with PBC can live for many years with proper treatment and monitoring.
Early diagnosis and treatment with ursodeoxycholic acid can help slow disease progression, protect liver function, and improve long-term outcomes. Newer therapies may help people whose disease does not respond adequately to first-line treatment or who experience severe itching.
Learn more at the AGA GI Patient Center .
Explore the new PBC Guideline at The Liver Meeting® (TLM) 2026
Attendees can take a deeper dive into the new PBC guideline at TLM 2026 in Denver, CO, during " From Evidence to Practice: New Guidelines on Hepatitis Delta, Pediatric Liver Transplantation, Primary Biliary Cholangitis, and Pruritus " on Friday, Nov. 6, and " Inside the Journals: AASLD AGA Guideline on Management of PBC " on Saturday, Nov. 7. Hear expert faculty highlight key updates and practical considerations for applying the new recommendations to PBC diagnosis, risk stratification, and management in clinical practice.
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Media Contacts:
AGA: Annie Mehl, communications and media relations manager, media@gastro.org , 301-327-0013
AASLD: Elise Bender at media@aasld.org, 703-360-6939
About the AGA Institute
The American Gastroenterological Association is the trusted voice of the GI community. Founded in 1897, AGA represents members from around the globe who are involved in all aspects of the science, practice, and advancement of gastroenterology. The AGA Institute administers the practice, research, and educational programs of the organization. www.gastro.org
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About Gastroenterology
Gastroenterology is the most prominent journal in the field of gastrointestinal disease. As the official journal of the AGA Institute, Gastroenterology delivers up-to-date and authoritative coverage of both basic and clinical gastroenterology. Regular features include articles by leading authorities and reports on the latest treatments for diseases. Original research is organized by clinical and basic-translational content, as well as by alimentary tract, liver, pancreas, and biliary content. www.gastrojournal.org/
About AASLD
The American Association for the Study of Liver Diseases (AASLD) is the leading organization of scientists and health care professionals committed to preventing and curing liver disease. AASLD fosters research that leads to improved treatment options for millions of liver disease patients and advances the science and practice of hepatology through educational conferences, training programs, professional publications, and partnerships with government agencies and sister societies.
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About HEPATOLOGY
The premier publication in the field of liver disease, HEPATOLOGY publishes original, peer-reviewed articles concerning all aspects of liver structure, function, and disease. Each month, the distinguished Editorial Board monitors and selects only the best articles on subjects such as immunology, chronic hepatitis, viral hepatitis, cirrhosis, genetic and metabolic liver diseases and their complications, liver cancer, and drug metabolism. Follow the journal on X at @HEP_Journal .
Gastroenterology
AGA/AASLD Clinical Practice Guideline on Management of Primary Biliary Cholangitis
22-Oct-2026