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Second line PBC Therapy

CE / CME

Choosing Optimal Second-line Therapy for PBC  

Pharmacists: 0.75 contact hour (0.075 CEUs)

Physicians: maximum of 0.75 AMA PRA Category 1 Credit

Nurse Practitioners/Nurses: 0.75 Nursing contact hour

Released: March 31, 2026

Expiration: March 30, 2027

Activity

Progress
1 2 3
Course Completed

References

  1. Cançado GGL, Lleo A, Levy C, et al. Primary biliary cholangitis and the narrowing gap towards optimal disease control. Lancet Gastroenterol Hepatol. 2025;10:855-870. 
  2. Lindor KD, Bowlus CL, Boyer J, et al. Primary biliary cholangitis: 2018 practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2019;69:394-419. 
  3. Corpechot C, Lemoinne S, Soret PA, et al. Adequate versus deep response to ursodeoxycholic acid in primary biliary cholangitis: to what extent and under what conditions is normal alkaline phosphatase level associated with complication-free survival gain? Hepatology. 2024;79:39-48. 
  4. Gulamhusein AF, Hirschfield GM. Primary biliary cholangitis: pathogenesis and therapeutic opportunities. Nat Rev Gastroenterol Hepatol. 2020;17:93-110.
  5. Levy C, Manns M, Hirschfield G. New treatment paradigms in primary biliary cholangitis. Clin Gastroenterol Hepatol. 2023;21:2076-2087.
  6. Hirschfield GM, Dyson JK, Alexander GJM, et al. The British Society of Gastroenterology/UK-PBC primary biliary cholangitis treatment and management guidelines. Gut. 2018;67:1568-1594. 
  7. Ding D, Guo G, Cui L, et al. Prognostic significance of liver stiffness in patients with primary biliary cholangitis: validation of Baveno VII criteria. Hepatol Int. 2024;18:206-215. 
  8. Lammers WJ, van Buuren HR, Hirschfield GM, et al. Levels of alkaline phosphatase and bilirubin are surrogate end points of outcomes of patients with primary biliary cirrhosis: an international follow-up study. Gastroenterology. 2014;147:1338-1349. 
  9. Kumagi T, Guindi M, Fischer SE, et al. Baseline ductopenia and treatment response predict long-term histological progression in primary biliary cirrhosis. Am J Gastroenterol. 2010;105:2186-2194.
  10. Carbone M, Mells GF, Pells G, et al. Sex and age are determinants of the clinical phenotype of primary biliary cirrhosis and response to ursodeoxycholic acid. Gastroenterology. 2013;144:560-569.
  11. Murillo Perez CF, Ioannou S, Hassanally I, et al. Optimizing therapy in primary biliary cholangitis: Alkaline phosphatase at six months identifies one-year non-responders and predicts survival. Liver Int. 2023;43:1497-1506. 
  12. Lindor KD, Bowlus CL, Boyer J, et al. Primary biliary cholangitis: 2021 practice guidance update from the American Association for the Study of Liver Diseases. Hepatology. 2022;75:1012-1013.
  13. Murillo Perez CF, Harms MH, Lindor KD, et al. Goals of treatment for improved survival in primary biliary cholangitis: treatment target should be bilirubin within the normal range and normalization of alkaline phosphatase. Am J Gastroenterol. 2020;115:1066-1074.
  14. Murillo Perez CF, Hirschfield GM, Corpechot C, et al. Fibrosis stage is an independent predictor of outcome in primary biliary cholangitis despite biochemical treatment response. Aliment Pharmacol Ther. 2019;50:1127-1136.
  15. Fenofibrate [prescribing information]. North Chicago, IL: AbbVie; 2025.
  16. Obeticholic acid [prescribing information]. New York, NY: Intercept; 2022.
  17. Elafibranor [prescribing information]. Cambridge, MA: Ipsen; 2024.
  18. Seladelpar [prescribing information]. Foster City, CA: Gilead; 2026.
  19. Kowdley KV, Bowlus CL, Levy C, et al. Efficacy and safety of elafibranor in primary biliary cholangitis. N Engl J Med. 2024;390:795-805. 
  20. Hirschfield GM, Bowlus CL, Mayo MJ, et al. A phase 3 trial of seladelpar in primary biliary cholangitis. N Engl J Med. 2024;390:783-794.
  21. Levy C, Akarca U, Alvares-da-Silva MR, et al. Long-term treatment with elafibranor leads to biochemical and symptomatic improvements for at least 3 years in patients with primary biliary cholangitis. Presented at: American Association for the Study of Liver Diseases; November 7-11, 2025. Abstract 5016.
  22. Pratt D, Lawitz EJ, Bowlus CL, et al. Seladelpar is associated with a sustained reduction in cholestatic markers and a consistent safety profile in patients with PBC treated up to 48 months in the ongoing, open-label ASSURE study. Presented at: American Association for the Study of Liver Diseases; November 7-11, 2025. Abstract 0213.
  23. Bowlus C, Hirschfield G, Villamil A, et al. Disease control as evidenced by longitudinal transient elastography measurements in the ASSURE Study: 36 months of treatment with seladelpar is associated with stable or improved liver stiffness in patients with primary biliary cholangitis. Presented at: American Association for the Study of Liver Diseases; November 7-11, 2025. Abstract 5031.
  24. Jamal F, Elshaer A, Alatout MH, et al. Second-line therapies in primary biliary cholangitis: a comparative review of obeticholic acid, fibrates, seladelpar, and elafibranor. Biomedicines. 202524;13:2335. 
  25. European Association for the Study of the Liver. Management of liver diseases in pregnancy. guidelinecentral.com/guideline/4544243/#section-4937055. Accessed March 26, 2026.

 

AI Disclosure Statement
Artificial intelligence (AI) was used to assist with editorial refinement of transcript-derived educational content for this module. The platform used was ChatGPT GPT-5.4 Thinking on March 13, 2026. AI assistance was limited to language editing and manuscript organization. All content was reviewed, verified, and finalized by human editors to ensure accuracy and compliance with ACCME Standards for Integrity and Independence in Accredited Continuing Education.