This marks the first joint guideline from the American Gastroenterological Association (AGA) and American Association for the Study of Liver Diseases (AASLD) reviewing newer treatments for primary biliary cholangitis (PBC), the most common cholestatic disease in adults. Published in Gastroenterology and HEPATOLOGY, the guideline offers evidence-based guidance for diagnosis and treatment. The document addresses recent shifts in PBC therapy approaches and key challenges clinicians encounter, such as identifying patients with atypical antibody patterns, deciding when to advance beyond initial therapy, and managing PBC-related itching.
Shifting Treatment Options
Over the past five years, the environment surrounding PBC treatment has undergone significant changes, including the introduction of new second-line therapy options and the discontinuation of a treatment that was previously used for over a decade, according to David N. Assis, M.D., a guideline author.
The new guideline serves as a companion to the broader PBC guidance issued by AASLD in 2018 and 2021, which provided a more wide-ranging approach to PBC care with a focus on second-line treatment options, and its release is timely given the recent withdrawal of obeticholic acid from the US market in late 2025.
Practical Recommendations
The recommendations provided in the guideline support a tailored approach to PBC care, taking into account the individual patient’s risk of disease progression, characteristics of the disease, symptoms, and personal preferences, with the aim of intervening early and adjusting treatment over time to slow disease progression and preserve the patient’s quality of life.
Marlyn Mayo, M.D., a guideline author, emphasizes that the document is not intended to serve as a full guide for managing all aspects of PBC, but rather to address specific clinical questions, such as the appropriate use of particular drugs or diagnostic tests, and to provide guidance on how to use them effectively.
“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, showing the need for continued research.”
Diagnosis and Management
The AGA and AASLD have issued six recommendations for the diagnosis and management of PBC, including the use of SP100 and GP210 antibodies to aid in the diagnosis of suspected PBC in patients who test negative for antimitochondrial antibodies, which may help some patients avoid the need for a liver biopsy.
Post-Transplant Care
Ursodeoxycholic acid prophylaxis after a liver transplant is recommended to reduce the risk of PBC recurrence and graft failure. 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.