Now Playing:
Up Next:
Take CE/CME Test
Liver Disorders, Rare Autoimmune Diseases CE/CME accredited

A relaxed discussion between two faculty focussed on real world clinical issues. Useful tips below will show how to navigate the activity. Join the conversation. Close

Achieving best practice management of primary biliary cholangitis, now and in the future

  • Downloads including slides are available for this activity in the Toolkit
Learning Objectives

After watching this activity, participants should be better able to:

  • Describe the recommendations for diagnosis and management of patients with primary biliary cholangitis
  • Evaluate emerging treatment options for patients with primary biliary cholangitis
  • Review and implement individualized management for patients with primary biliary cholangitis

Professor Gideon Hirschfield and Dr Palak Trivedi engage in conversation about current best practice in the treatment and management of primary biliary cholangitis, and the potential for emerging therapies and personalization of patient care to improve patient outcomes in the future.

This activity is jointly provided by USF Health and touchIME. read more

Target Audience

This activity has been designed to meet the educational needs of gastroenterologists and hepatologists involved in the management of patients with primary biliary cholangitis.


USF Health adheres to the Standards for Integrity and Independence in Accredited Continuing Education. All individuals in a position to influence content have disclosed to USF Health any financial relationship with an ineligible organization. USF Health has reviewed and mitigated all relevant financial relationships related to the content of the activity. The relevant relationships are listed below. All individuals not listed have no relevant financial relationships.


Professor Gideon Hirschfield discloses: Consultancy fees from CymaBay Therapeutics, Escient Pharmaceuticals, Gilead Sciences, GSK, HighTide Therapeutics, Intercept Pharmaceuticals, Inc., Ipsen, Mirum and Pliant Therapeutics.

Dr Palak Trivedi discloses: Advisory board fees from CymaBay Therapeutics, Dr. Falk Pharma and Ipsen. Grants/research support from ADVANZ PHARMA and GSK. Speaker’s bureau fees from ADVANZ PHARMA and Dr. Falk Pharma.

Content reviewer

Nyingi M. Kemmer, MD, MPH, MSc has no relevant financial relationships to disclose.

Touch Medical Directors

Anne Nunn and Kathy Day have no financial interests/relationships or affiliations in relation to this activity.

USF Health Office of Continuing Professional Development and touchIME staff have no financial interests/relationships or affiliations in relation to this activity.

Requirements for Successful Completion

In order to receive credit for this activity, participants must review the content and complete the post-test and evaluation form. Statements of credit are awarded upon successful completion of the post-test and evaluation form.

If you have questions regarding credit please contact 



This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through a joint providership of USF Health and touchIME. USF Health is accredited by the ACCME to provide continuing medical education for physicians.

USF Health designates this enduring material for a maximum of 0.75 AMA PRA Category 1 CreditTM.  Physicians should claim only the credit commensurate with the extent of their participation in the activity.

The European Union of Medical Specialists (UEMS) – European Accreditation Council for Continuing Medical Education (EACCME) has an agreement of mutual recognition of continuing medical education (CME) credit with the American Medical Association (AMA). European physicians interested in converting AMA PRA Category 1 CreditTM into European CME credit (ECMEC) should contact the UEMS (

Advanced Practice Providers

Physician Assistants may claim a maximum of 0.75 Category 1 credits for completing this activity. NCCPA accepts AMA PRA Category 1 CreditTM from organizations accredited by ACCME or a recognized state medical society.

The AANPCP accepts certificates of participation for educational activities approved for AMA PRA Category 1 CreditTM by ACCME-accredited providers. APRNs who participate will receive a certificate of completion commensurate with the extent of their participation.

Date of original release: 15 December 2022. Dates credits expire: 15 December 2024.

If you have any questions regarding credit please contact


This activity is CE/CME accredited

To obtain the CE/CME credit(s) from this activity, please complete this post-activity test.

Claim Credit

Topics covered in this activity

Liver Disorders / Rare Autoimmune Diseases
  • 1000+ topical and insightful peer-reviewed journal articles
  • 100+ hours of bite-sized congress highlights
  • 8 major therapy areas packed with the latest scientific advances
  • 150+ specialties offering learn-on-the-go medical education
  • + Concise email updates and newsletters so you never miss out
Register For Free Now
Claim Credit
Achieving best practice management of primary biliary cholangitis, now and in the future
0.75 CE/CME credit

Question 1/5
What are the key markers for diagnosing PBC?

ALP, alkaline phosphatase; AMA, anti-mitochondrial antibody; gGT, gamma-glutamyl transferase; Ig, immunoglobulin; PBC, primary biliary cholangitis.

In adult patients with cholestasis and no likelihood of systemic disease, a diagnosis of PBC can be made based on elevated ALP and the presence of AMA.1–5 High IgM concentrations do not form part of standard diagnostic paradigms but can be useful in making a clinical diagnosis in patients with other atypical features.2 Elevation of serum IgG can be a feature of the presence of additional autoimmune hepatitis-like features in PBC; it is also more commonly reported in AMA-negative series. Elevated IgG can also be a reflection of advanced fibrosis/cirrhosis generally.2  gGT determination is not used to reach a diagnosis or guide therapy, although there is a strong correlation between gGT and ALP.2 Elevation in bilirubin is characteristic of advanced disease; it is also an important prognostic marker.2


ALP, alkaline phosphatase; AMA, anti-mitochondrial antibody; gGT, gamma-glutamyl transferase; Ig, immunoglobulin; PBC, primary biliary cholangitis.


  1. Hirschfield GM, et al. Expert Rev Gastroenterol Hepatol. 2021;15:929–39.
  2. Hirschfield GM, et al. Gut. 2018;67:1568–94.
  3. European Association for the Study of the Liver. J Heptatol. 2017;67:145–72.
  4. You H, et al. Hepatol Int. 2022;16:1–23.
  5. Lindor KD, et al. Hepatology. 2019;69:394–419.
Question 2/5
Following 12 months’ treatment with UDCA (15 mg/kg/day), your patient had an insufficient response and you add OCA to her treatment regimen, titrating up from 5 to 10 mg/day. Her response is still insufficient. What should you do?

OCA, obeticholic acid; UDCA, ursodeoxycholic acid.

Fibrates are currently used off-label for treating PBC.1 They can be used in combination with either UCDA or OCA, or with both as a triplet therapy (UDCA+OCA+fibrate).2 Available data for triplet therapy demonstrate how it may normalize biochemical liver tests and improve pruritus in patients with difficult-to-treat PBC.3 Data suggest the optimal dose for UDCA is 13–15 mg/kg/day with no benefit observed from increasing the dose to 23–25 mg/kg/day.4 The maximum recommended dose for OCA is 10 mg/day.5,6


OCA, obeticholic acid; PBC, primary biliary cholangitis; UDCA, ursodeoxycholic acid.


  1. Alvaro D, et al. Liver Int. 2020;40:2590–601.
  2. Floreani A, et al. Biomedicines. 2022;10:2033.
  3. Soret P-A, et al. Aliment Pharmacol Ther. 2021;53:1138–46.
  4. Hirschfield GM, et al. Gut. 2018;67:1568–94.
  5. FDA. Obeticholic acid PI. Available at: (accessed 24 November 2022).
  6. EMA. Obeticholic acid SmPC. Available at: (accessed 24 November 2022).
Question 3/5
When assessing treatment benefit from emerging therapeutic agents, what outcomes are you likely to be targeting?

ALP, alkaline phosphatase; AST, aspartate aminotransferase.

Based on a patient cohort from the GLOBAL PBC Study Group (time zero, n=2,281; time 1 year, n=2,555), who were UDCA-treated and untreated, the 10-year survival in patients with ALP ≤1 × ULN or ALP 1.0–1.67 × ULN was 93.2% and 86.1%, respectively. The 10-year survival rates of patients with bilirubin ≤0.6 × ULN and >0.6 × ULN were 91.3% and 79.2%, respectively. Targeting normal ALP or bilirubin levels ≤0.6 × ULN is thus likely to optimize outcomes in patients with PBC.


ALP, alkaline phosphatase; PBC, primary biliary cholangitis; UDCA, ursodeoxycholic acid; ULN, upper limit of normal.


Murillo Perez CF, et al. Am J Gastroenterol. 2020;115:1066–74.

Question 4/5
In the context of PBC, what are the key features of a personalized approach to disease management?

PBC, primary biliary cholangitis.

Although clinical management is important for the disease course and physical symptoms, research suggests individualized support, driven by a formal assessment of patients’ needs rather than by assumptions regarding prognosis should be offered.1 Health literacy and resultant patient empowerment is particularly important in PBC where clinicians may be less familiar treating it.2 Healthcare professionals should encourage patients to seek support in different patient associations or organisations for access to additional support outside the healthcare setting.1 Patients should be offered the opportunity to participate in clinical trials if they fall into targeted groups.3


PBC, primary biliary cholangitis.


  1. Grønkjær LL, Lauridsen MM. JHEP Reports. 2021;3:100370.
  2. Leighton J, et al. Frontline Gastroenterol. 2021;12:370–3.
Question 5/5
You have a male patient who had an insufficient response to UDCA and is now on UDCA + OCA. He is suffering from severe fatigue and itch. You have added fibrates to his regimen to manage the itch and excluded potential contributors to the fatigue (e.g. sleep apnoea, hypothyroidism). What should you do now to minimize the impact of the fatigue on his quality of life?

OCA, obeticholic acid; UDCA, ursodeoxycholic acid.

Patients with PBC tend to lead sedentary lives due to fear of exacerbating their fatigue, but muscle fatigability is increased when physical activity is reduced.1 There is no evidence to suggest that exercise is harmful in PBC-related fatigue, and there are pilot data to suggest that structured exercise initiated at tolerable levels may be beneficial;2 markers of muscle fatigue were improved with repeated single exercise episodes.1,3 Trials with modafinil in PBC suggest it has no impact on fatigue versus placebo.4


PBC, primary biliary cholangitis.


  1. Lynch EN, et al. World J Hepatol. 2022;14:1111–19.
  2. Hirschfield GM, et al. Gut. 2018;67:1568–94.
  3. Hollingsworth KE, et al. J Hepatol. 2010;53:155–61.
  4. Silveira MG,et al. Am J Ther. 2017; 24:e167–76.
Back to Activity
Copied to clipboard!
accredited arrow-down-editablearrow-downarrow_leftarrow-right-bluearrow-right-dark-bluearrow-right-greenarrow-right-greyarrow-right-orangearrow-right-whitearrow-right-bluearrow-up-orangeavatarcalendarchevron-down consultant-pathologist-nurseconsultant-pathologistcrosscrossdownloademailexclaimationfeedbackfiltergraph-arrowinterviewslinkmdt_iconmenumore_dots nurse-consultantpadlock patient-advocate-pathologistpatient-consultantpatientperson pharmacist-nurseplay_buttonplay-colour-tmcplay-colourAsset 1podcastprinter scenerysearch share single-doctor social_facebooksocial_googleplussocial_instagramsocial_linkedin_altsocial_linkedin_altsocial_pinterestlogo-twitter-glyph-32social_youtubeshape-star (1)tick-bluetick-orangetick-red tick-whiteticktimetranscriptup-arrowwebinar Sponsored Department Location NEW TMM Corporate Services Icons-07NEW TMM Corporate Services Icons-08NEW TMM Corporate Services Icons-09NEW TMM Corporate Services Icons-10NEW TMM Corporate Services Icons-11NEW TMM Corporate Services Icons-12Salary £ TMM-Corp-Site-Icons-01TMM-Corp-Site-Icons-02TMM-Corp-Site-Icons-03TMM-Corp-Site-Icons-04TMM-Corp-Site-Icons-05TMM-Corp-Site-Icons-06TMM-Corp-Site-Icons-07TMM-Corp-Site-Icons-08TMM-Corp-Site-Icons-09TMM-Corp-Site-Icons-10TMM-Corp-Site-Icons-11TMM-Corp-Site-Icons-12TMM-Corp-Site-Icons-13TMM-Corp-Site-Icons-14TMM-Corp-Site-Icons-15TMM-Corp-Site-Icons-16TMM-Corp-Site-Icons-17TMM-Corp-Site-Icons-18TMM-Corp-Site-Icons-19TMM-Corp-Site-Icons-20TMM-Corp-Site-Icons-21TMM-Corp-Site-Icons-22TMM-Corp-Site-Icons-23TMM-Corp-Site-Icons-24TMM-Corp-Site-Icons-25TMM-Corp-Site-Icons-26TMM-Corp-Site-Icons-27TMM-Corp-Site-Icons-28TMM-Corp-Site-Icons-29TMM-Corp-Site-Icons-30TMM-Corp-Site-Icons-31TMM-Corp-Site-Icons-32TMM-Corp-Site-Icons-33TMM-Corp-Site-Icons-34TMM-Corp-Site-Icons-35TMM-Corp-Site-Icons-36TMM-Corp-Site-Icons-37TMM-Corp-Site-Icons-38TMM-Corp-Site-Icons-39TMM-Corp-Site-Icons-40TMM-Corp-Site-Icons-41TMM-Corp-Site-Icons-42TMM-Corp-Site-Icons-43TMM-Corp-Site-Icons-44TMM-Corp-Site-Icons-45TMM-Corp-Site-Icons-46TMM-Corp-Site-Icons-47TMM-Corp-Site-Icons-48TMM-Corp-Site-Icons-49TMM-Corp-Site-Icons-50TMM-Corp-Site-Icons-51TMM-Corp-Site-Icons-52TMM-Corp-Site-Icons-53TMM-Corp-Site-Icons-54TMM-Corp-Site-Icons-55TMM-Corp-Site-Icons-56TMM-Corp-Site-Icons-57TMM-Corp-Site-Icons-58TMM-Corp-Site-Icons-59TMM-Corp-Site-Icons-60TMM-Corp-Site-Icons-61TMM-Corp-Site-Icons-62TMM-Corp-Site-Icons-63TMM-Corp-Site-Icons-64TMM-Corp-Site-Icons-65TMM-Corp-Site-Icons-66TMM-Corp-Site-Icons-67TMM-Corp-Site-Icons-68TMM-Corp-Site-Icons-69TMM-Corp-Site-Icons-70TMM-Corp-Site-Icons-71TMM-Corp-Site-Icons-72