Background/Aims: To determine whether gender, age, hepatitis B virus genotype, core promoter and precore mutations, HBeAg/anti-HBe status, HBV DNA, ALT levels and cirrhosis on presentation were independent risk factors and derive a novel risk score for the development of HCC. Methods: CHB patients (820) were followed up (mean duration 76.8 months) for the occurrence of HCC. Results: The 5- and 10-year prevalence of HCC were 4.4% and 6.3%, respectively. Cox regression analysis showed that male gender (p = 0.025, RR 2.98), increasing age (p < 0.001, RR 1.07), higher HBV DNA levels (p = 0.02, RR 1.28), core promoter mutations (p = 0.007, RR 3.66), and presence of cirrhosis (p < 0.001, RR 7.31) were independent risks for the development of HCC. A risk score was derived and validated with sensitivity > 84% and specificity > 76% to predict the 5- and 10-year risks for the development of HCC. The AUC for the 5- and 10-year prediction were 0.88 and 0.89, respectively. Conclusions:The risk score, based on age, gender, HBV DNA levels, core promoter mutations and cirrhosis, can estimate the chance of development of HCC in 5 and 10 years after presentation. It can be used to identify high-risk CHB patients for treatment and screening of HCC. (C) 2008 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
