We sought to develop a clinically useful index comprising standard and physiologically relevant variables to predict the probability of significant hepatic fibrosis in subjects with chronic hepatitis C virus (HCV) infection. Fibrosis was graded as mild (stages F0 or F1) or significant (stages F2-F4). Thirty-five clinical and laboratory parameters were analyzed initially in 176 patients with detectable HCV RNA to derive a fibrosis probability index (FPI) to predict significant fibrosis. This index then was validated in a second group of 126 subjects. Among 18 variables associated with severe fibrosis on univariate analysis, multiple logistic regression analysis identified age, aspartate aminotransferase (AST), total cholesterol level, insulin resistance (by homeostasis model), and past alcohol intake as independent predictors of significant fibrosis. The area under the receiver operating characteristic (ROC) curves was 0.84 for the initial cohort and 0.77 for the validation cohort. In the initial cohort, the sensitivity of the FPI based on these five predictors was 96%, and the negative predictive value was 93% at a score of >0.2. At scores >0.8, the FPI was 94% specific and had a positive predictive value of 87%. In conclusion, an FPI using routinely assessed markers and incorporating a measure of insulin resistance can reliably predict the probability of significant hepatic fibrosis in most patients with chronic HCV infection. Such an index should prove useful to guide decision making regarding the need for liver biopsy, and potentially for avoiding or deferring biopsy in a large proportion of patients with mild liver disease.
(HEPATOLOGY 2004;39:1239 -1247.) C hronic infection with the hepatitis C virus (HCV) runs a protracted course, and symptoms that impair quality of life are not related to the severity of the hepatic fibrosis. Although the outcome of chronic hepatitis C infection is variable, between 4% and 22% of patients progress to cirrhosis over 20 years. 1 The extent of hepatic fibrosis is the major determinant of adverse clinical outcomes in chronic HCV infection; liver failure, hepatocellular carcinoma, and portal hypertension are almost exclusively confined to those with stage 3 or stage 4 fibrosis. [2][3][4] Conversely, although impressive advances have been achieved in the efficacy of antiviral therapy, this is based on interferon-based therapies that have a high rate of unpleasant or dangerous adverse effects and involve considerable cost and inconvenience. Hence, the decision to treat or not to treat an individual patient requires a careful consideration of the risk of cirrhosis versus the likelihood of response.
The National Institutes of Health, French and Asia-Pacific consensus guidelines currently recommend antiviral therapy for those with moderate to severe stages of