Primary Biliary Cholangitis (PBC) | GileadPro

This website is developed and funded by Gilead Sciences Ltd and intended for healthcare professionals in the United Kingdom. Adverse Events Reporting

Pbc banner

PBC
(Primary Biliary Cholangitis)

Progression of PBC may result in end-stage liver failure and its associated complications1

PBC is a rare, progressive, autoimmune disease2

It is characterised by the destruction of the bile ducts, subsequent cholestasis and progressive fibrosis which lead to cirrhosis.3 If left untreated, PBC may ultimately lead to end-stage liver disease and its related complications.4

Pruritus is one of the most burdensome symptoms of PBC5,6

Up to 70–80% of patients with PBC experience pruritus2,7

UDCA is suboptimal for many patients with PBC, with up to 40% not responding to treatment and a further 3–5% intolerant to treatment8,9

Almost 90% of patients with PBC in the UK receive UDCA as first-line treatment, but nearly one third receive a suboptimal dose (<13 mg/kg/day).10

Impact of PBC on QoL

Pruritus can have a wide-reaching impact on patients' lives and can affect multiple activities11,12

Baseline EQ-5D-5 level responses from 146 adult patients with PBC and mild, moderate or severe pruritus (GLIMMER)*12

Pbc piechart

*GLIMMER was a multicentre, randomised, double-blind, placebo-controlled, parallel-group, phase IIb, dose-finding study in 146 adult patients with PBC and pruritus (n=35, 76, 37; mild, moderate, severe pruritus respectively).12

‡On day 1, patients entered an initial, 4-week, single-blind, placebo run-in to establish baseline symptoms. Adults with proven PBC and moderate-to-severe cholestatic pruritus were considered for enrolment. Evaluation of health status was undertaken using the EQ-5D-5L health domains and utility index assessed on day 1 (entry to placebo run-in), baseline and week 16. Limitations of the study: HRQoL and pruritus data were collected as prespecified endpoints, but the study was not designed to specifically assess the link between them. Analyses were performed in a clinical trial setting, not the real world. In some subgroups, patient numbers are small, which may limit the strength of the conclusions.12

†Percentage is the combined total number of patients with mild, moderate or severe pruritus reporting slight, moderate, severe, or extreme/unable to complete activity problems. However, across all domains, patients with severe pruritus at baseline were more impacted, compared with patients who had mild or moderate pruritus.

‡EQ-5D-5L data missing for 1 patient in the severe subgroup (n=36).12

PBC affects ~25,000 people in the UK10,13

PBC is most often diagnosed in women over the age of 5014

The prevalence of PBC is considerably higher in women than men (9:1),2,15 but appears to have stabilised in women following several years of increase.2

Despite being a rare disease, PBC accounts for ~10% of liver transplants in the UK2,10

The disease may recur in up to a third of patients (35%) after a liver transplant, requiring further treatment and management.2,16

Additionally, complications associated with PBC increase healthcare costs.*17

There is currently no cure for PBC, with treatments aiming to manage symptoms, improve QoL, and slow disease progression2,18

  • Approximately 50% of patients in the UK with an inadequate response to UDCA currently receive second-line treatment for PBC10
  • Over a third of patients with PBC in the UK are not regularly assessed for fatigue (43%) or pruritus (38%)10
  • Only 55% of patients with PBC in the UK have been assessed in the past 5 years for risk of fractures10

*Data assessing the cost of liver transplants in patients with PBC are lacking. However, the average cost per patient with hepatitis C who has undergone liver transplantations, from assessment to 2 years post-transplant, exceeds £110,000.19

Pbc treatment management banner
PBC

Treatment Management

Treatment goals for PBC are expanding20

Aim for Alp

Aim for ALP normalisation21,22

ALP normalisation is increasingly recognised as a new treatment goal in PBC.20 Normalisation of ALP and total bilirubin levels in PBC may improve complication‑free survival and QoL for patients at high risk of disease progression.22
Assess treatment

Assess treatment efficacy early23,24

Biochemical responses to UDCA therapy at 6 months have the same predictive value as those after 1 year of treatment.23,24
Treatment full disease

Target full disease control20,22

Treatment targets for PBC are evolving to now consider normalising liver biochemistry and low symptom burden.20,22

ALP levels are strong predictors of UDCA response and long-term outcomes22

ALP levels >1.67 × ULN are associated with adverse liver-related outcomes, such as:24-26

Cholestatis

Cholestasis

Destruction

Bile duct destruction

Diseases progression

Disease progression

In patients with adequate response to UDCA, persistent ALP elevation above 1.0 × ULN is associated with poorer outcomes.21

10-year transplant-free survival rates from a GLOBAL PBC Study Group analysis (N=2555) were:26

93% in patients with ALP ≤1 × ULN
86% in patients with ALP 1.0–1.67 × ULN

*Limitations of the GLOBAL PBC Study should be noted: whereas total serum bilirubin levels in healthy patients are primarily composed of unconjugated bilirubin, it is predominantly conjugated in patients with PBC. The real-world nature of the cohort only allowed evaluation of total bilirubin, since independent measurements of the conjugated and unconjugated forms are not part of routine standard of care.26

Abbreviations:

EQ-5D-5L = European Quality of Life 5 Dimensions 5 Levels; HRQoL = Health-Related Quality of Life; QoL = quality of life; PBC = primary biliary cholangitis. ALP = alkaline phosphatase; UDCA = ursodeoxycholic acid; ULN = upper limit of normal.

References
  1. European Association for the Study of the Liver. J Hepatol. 2017;67:145–172.
  2. Hirschfield GM, et al. Gut. 2018;67(9):1568–1594.
  3. Li H, et al. Biomed Pharmacother. 2021;140:111754.
  4. Tababi R, et al. Future Sci OA. 2024;10(1):FSO975.
  5. Hegade VS, et al. Clin Gastroenterol Hepatol. 2019;17(7):1379–1387.
  6. Trivella J, et al. Hepatol Commun. 2023;7(6):e0179.
  7. Lindor KD, et al. Hepatology. 2019;69(1):394–419.
  8. Hirschfield GM, et al. Gastroenterology. 2015;148(4):751–761.
  9. Invernizzi P, et al. Dig Liver Dis. 2017;49(8):841–846.
  10. Abbas N, et al. JHEP Reports. 2024;6(1):100931.
  11. Mitchell-Thain R, et al. Gut. 2023;72(3 suppl):A37.
  12. Smith HT, et al. Hepatol Commun. 2025;9:e0635.
  13. UK-PBC. Epidemiology of PBC. https://www.ukpbc.com/about/aboutpbc/epidemiology-of-pbc/. Accessed February 2026.
  14. Burke L, et al. Cureus. 2022;14(6):e25609.
  15. Tanaka A, et al. Lancet. 2024;404(10457):1053–1066.
  16. Manousou P, et al. Liver Transpl. 2010;16(1):64–73.
  17. Rice S, et al. Clin Gastroenterol Hepatol. 2021;19(4):768–776.
  18. NHS. Treatment (primary biliary cholangitis). https://www.nhs.uk/conditions/primary-biliary-cholangitis-pbc/treatment/. Accessed February 2026.
  19. Singh J and Longworth L. Value Health. 2014;17(7):A368.
  20. Levy C, et al. Clin Gastroenterol Hepatol. 2023;21(8):2076–2087.
  21. Corpechot C, et al. Hepatology. 2024;79:39–48.
  22. Martins A and Levy C. Curr Opin Gastroenterol. 2025;41(2):74–80.
  23. Zhang L-N, et al. Hepatology. 2013;58(1):264–272.
  24. Kowdley KV, et al. Am J Gastroenterol. 2023;118(2):232–242.
  25. Lammers WJ. Gastroenterol. 2014;147(6):1338–1349.
  26. Murillo Perez CF, et al. Am J Gastroenterol. 2020;115(7):1066–1074.

UKI-LIV-0146 | February 2026