Individualizing the PBC Care Pathway: From Baseline and Beyond

Chair, Gideon M. Hirschfield, MA, MB, BChir, FRCP, PhD, prepared useful Practice Aids pertaining to primary biliary cholangitis for this CME/AAPA activity titled “Individualizing the PBC Care Pathway: From Baseline and Beyond.” For the full presentation, downloadable Practice Aids, and complete CME/AAPA information, and to apply for credit, please visit us at https://bit.ly/3ZnNPSA. CME/AAPA credit will be available until March 3, 2026.

1. PBC Diagnostic Process
1,2

Full abbreviations, accreditation, and disclosure information available at PeerView.com/QZC40 1. Lindor KD et al. Hepatology . 2019;69:394-419. 2. Selmi C et al. Lancet . 2011;377:1600 -1609.
Consider
liver
biopsy
ALP ↑
Exclude
nonliver
source
Exclude
biliary
obstruction
AMA,
disease-
specific
ANA
PBC diagnosis requires at least two of these three criteria:
1. Elevated ALP
2. AMA positive or ANA positive (sp100 or gp210)
3. Liver biopsy consistent with PBC

2. PBC Treatment Goals
1

Full abbreviations, accreditation, and disclosure information available at PeerView.com/QZC40 1. Cançado GGL et al. Lancet Gastro Hep . 2025 [Epub ahead of print].
Short-term targets Intermediate targets Long-term targets
Adjust and
individualize
Establish
diagnosis
Risk
stratify
Start
therapy
Treat to
target
Monitor
add-on
Disease
activity
Improve symptoms
and liver biochemistry
Normalize ALP
and bilirubin
Reduce fibrosis, increase
transplant free survival, and
normalize quality of life
Stratify disease
risk, start UDCA
treatment, and
set goals
Reassess patient
bloodwork and
quality of life;
consider early 2L
therapy for
high-risk patients
Consider 2L therapies
for patients with
incomplete response
to UDCA
Reassess
patient-reported
outcomes and liver
fibrosis through
elastography;
consider add-on
combination
therapies if targets
not reached

3. Second-Line Treatments for PBC
1-4

Full abbreviations, accreditation, and disclosure information available at PeerView.com/QZC40 1. Nevens F et al. N Engl J Med . 2016;375:631-643. 2. Hirschfield GM et al. N Engl J Med . 2024;390:783-794. 3. Kowdley KV et al. N Engl J Med . 2024;390:795-805. 4. Giannini EG et al. Liver Int . 2024;45:e16222.
Note: Bezafibrate data not included because it is not approved or available as monotherapy in the United States.
Characteristic
Baseline ALP, units/L
(treatment group)
Response rate, %
Therapeutic response, %
ALP normalization, %
ALP reduction, %
Risk of new-onset
pruritus, RR (95% CI)
4
Obeticholic acid
1
(5-10 mg, N = 70;
10 mg, N = 73)
326 ± 116 (5-10 mg)
316 ± 104 (10 mg)
46 (5-10 mg)
47 (10 mg)
36 (5-10 mg)
37 (10 mg)
Not reported
33 (5-10 mg)
39 (10 mg)
1.43 (1.09-1.88) (5-10 mg)
1.79 (1.37-2.33) (10 mg)
Seladelpar
2
(N = 128)
41.7
61.7
314.6 ± 123
25
42.4
Elafibranor
3
(N = 108)
321.3 ± 121.9
51
47
15
40.6 ± 5.3
0.77 (0.43-1.38)0.30 (0.12-0.80)