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• The Child-Pugh score is an FDA-recommended
classification for assessing
hepatic impairment1
• Drugs that are predominantly metabolized by the liver
must be studied in a
controlled trial with patients who have varying degrees of liver
impairment1
• Dosage modifications due to hepatic impairment may be
based on the
Child-Pugh score1
Child-Pugh Score Uses Five Clinical Measures of Hepatic
Impairment—Each Is Scored on a Scale of 1 to 3 (3 = highest
severity) 2,3
Encephalopathy is classified as Grade 0 to 44:
Grade
0 —No abnormality detected
1 —Shortened attention span, impaired addition and subtraction
skills,
mild euphoria or anxiety
2 —Lethargy, apathy, disoriented to time, personality
change,
inappropriate behavior
3 —Somnolence, semi-stupor, responsive to stimuli, confused
when
awake, gross disorientation
4 —Coma, little or no response to stimuli, mental state not
testable
PARAMETER
POINTS ASSIGNED
1 2 3
Ascites Absent Slight Moderate
Bilirubin, total (mg/dL) 1.0-2.0 2.0‐3.0 >3.0
Albumin (g/dL) >3.5 2.8‐3.5 6.0
–International normalized ratio (INR) 2.3
Encephalopathy None Grade 1‐2 Grade 3‐4
ASSESSING HEPATIC IMPAIRMENT
USING CHILD-PUGH SCORE
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© 2011 Eisai Inc. All rights reserved. Printed in USA/ July 2011
ERI 205
The Grade of Hepatic Impairment Is Equal to the Child‐Pugh
Score/Classification of A, B, or C
Sample Patient Assessment Using Child-Pugh
Score/Classification
Total score of 8 points corresponds to a Child‐Pugh
score/classification of B(moderate hepatic impairment)
• Once each measure is scored, points are totaled to
classify the degree of
hepatic impairment2
• Degree of hepatic impairment is classified by one of
three Grades—A, B, or
C—with Grade A being mild and Grade C being severe2
• Dosage modifications due to hepatic impairment may be
based on the
Child-Pugh score1
A PATIENT WITH THESE LAB VALUES WOULD BE SCORED AS FOLLOWS
Ascites: absent 1 point
Bilirubin 2.2 mg/dL 2 points
Albumin 3.7 g/dL 1 point
INR of 2.0 2 points
Grade 1 encephalopathy 2 points
Total score 8 points
References: 1. US Department of Health and Human Services
Food and Drug Administration. Guidance for industry:
pharmacokinetics in
patients with impaired hepatic function: study design, data
analysis, and impact on dosing and labeling.
http://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/ucm072123.pdf.
Updated May 30, 2003. Accessed March 21, 2011. 2. Pugh RNH,
Murray-
Lyon IM, Dawson JL, Pietroni MC, Williams R. Transection of the
oesophagus for bleeding oesophageal varices. Br J Surg .
1973;60(8):646-649.
3. Lucey MR, Brown KA, Everson GT, et al. Minimal criteria
for placement of adults on the liver transplant waiting list: a
report of a national
conference organized by the American Society of Transplant
Physicians and the American Association for the Study of Liver
Diseases. Liver
Transpl Surg . 1997;3(6):628‐637. 4. Munoz SJ. Hepatic
encephalopathy. Med Clin North Am . 2008;92(4):795-812.
GRADE2 DESCRIPTION POINTS
A Mild; well‐compensated disease 5‐6
B Moderate; significant functional compromise 7‐9
C Severe; decompensated disease 10‐15
