2021. Validation of a Clinical Index for Predicting Risk of Advanced Liver Disease in Chronic Hepatitis C
TF Imperiale, Roudebush VA Medical Center, Indianapolis, LJ Born, Northside Gastroenterology, Indianapolis, DC Pound, Indianapolis Gastroenterology and Hepatology, Indianapolis, AR Baluyut, Indiana University Medical Center, Indianapolis, PY Kwo, Indiana University Medical Center, Indianapolis

Objectives: From a previous cohort of adults with hepatitis C, we derived a clinical index from physical exam and laboratory data that stratified risk for cirrhosis. Since validation of the index might preclude the need for liver biopsy (LBx) for some patients, we sought to validate the index on an independent cohort.

Methods: Using 4 hospitals in Indianapolis (two of which are university-based), we abstracted demographic and clinical data from the medical records of consecutive patients age > 18 years who underwent LBx for hepatitis C between 1996 and 2000. Excluded were patients with hepatic comorbidity, prior interferon (IFN) treatment (Rx), and incomplete records. Values closest to LBx were abstracted.  A point was given for each of 8 variables: spider nevi, gynecomastia, encephalopathy, ascites, albumin < 3.5 mg/dl, platelets < 150,000, prothrombin time > 2 s prolonged, and total bilirubin > 1.5 mg/dl.  Advanced liver disease (ALD) was defined as cirrhosis or bridging fibrosis.  Receiver operating characteristic (ROC) curve areas evaluated discrimination of the index for cirrhosis and ALD.

Results:  Of 307 patients, 31 were excluded because of hepatitis B infection (7), prior IFN Rx (8), labs obtained while on IFN (8), and incomplete data (8). Among 276 patients, mean age was 44.2 yrs, 70% were men, 13% had cirrhosis, and 29% had ALD.  In the low risk group (score of 0), which comprised 66% of the cohort, risks for cirrhosis and ALD were 4.4% and 13%, respectively.  In the high risk group (score of >=3), which comprised 4% of the cohort, risks for cirrhosis and ALD were 50% and 92%, respectively. ROC curve area was 0.77 for cirrhosis and 0.76 for ALD. Exclusion of gynecomastia, ascites and encephalopathy from the model resulted in similar risk gradients and ROC areas.

Conclusions: This index demonstrated good discrimination and external validity for estimating risk of cirrhosis and ALD. A score of 0 indicates a low risk of cirrhosis while a score of > 3 indicates a high risk of ALD. 

Impact: Use of this index would preclude the need for LBx in a substantial proportion of patients with chronic hepatitis C.