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Quantitative Serum Levels of Hepatitis B Virus DNA and Surface Antigen are Independent Risk Predictors of Hepatocellular Carcinoma
Prof. Chien-Jen Chen, Taiwan
Background and Aim: Serum level of hepatitis B virus (HBV) DNA is an important predictor of hepatocellular carcinoma (HCC) risk in patients with chronic HBV infection. In addition, serum level of HBV surface antigen (HBsAg) has been found to be an important predictor of HBsAg seroclearance in chronic hepatitis B patients treated with α-interferon and anti-virals. The specific aims of this study were to examine the independent and interactive effects of serum HBV DNA and HBsAg levels on the development of HCC.
Methods: A total of 3,411 HBsAg-seropositive and anti-HCV-seronegative participants in the REVEAL-HBV study cohort had adequate serum samples collected at study entry for the quantification of HBsAg using the Roche Elecsys II Assay. Cox proportional hazard regression models were used to estimate the multivariate-adjusted hazard ratio of developing HCC for each risk predictor.
Results: There was a moderate correlation between serum levels of HBV DNA and HBsAg (r=0.59). Serum levels of HBV DNA and HBsAg at study entry were significantly associated with HCC risk in a dose-response manner. Incidence rates of HCC per 100,000 person-years were 105.1, 297.4 and 546.6 for serum HBsAg levels of <100, 100-999, and ≧1000 IU/mL, respectively, as well as 129.1, 394.2 and 1132.7 for serum HBV DNA levels of <10000, 10000-<1000000 and ≧1000000 copies/mL, respectively. Quantitative serum levels of HBV DNA and HBsAg were both independent HCC risk predictors in the Cox proportional hazards models. In a separate combination analysis of serum HBV DNA and HBsAg levels, the multivariate-adjusted hazard ratios (95% confidence interval) of developing HCC were 1.00 (reference), 2.96 (1.97-7.38), 5.53 (2.44-12.54), 2.94 (1.05-8.22), 7.15 (3.29-15.54), and 9.22 (4.34-19.58) for serum levels of HBV DNA (copies/mL)/HBsAg (IU/mL) of <10000/<100, <10000/100-999, <10000/≧1000, ≧10000/<100, ≧10000/100-999, and ≧10000/≧1000, respectively, after adjustment for age, gender, serum alanine aminotransferase level, HBeAg serostatus, cirrhosis status, and family history of HCC. The significant biological gradient of HCC risk associated with increasing serum HBV DNA and HBsAg levels remained, even in HBeAg-seronegative participants without cirrhosis at study entry.
Conclusion: Serum levels of both HBV DNA and HBsAg should be monitored for the appropriate clinical management of chronic hepatitis B patients.
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