Clinical evaluation of hepatitis B core-related antigen in chronic hepatitis B and hepatocellular carcinoma patients.

Abstract Background Hepatitis B core-related antigen (HBcrAg) has been revealed as an important marker of Hepatitis B virus (HBV) infection recently. We aimed to evaluate the HBcrAg assay for indication of HBV loads in chronic hepatitis B (CHB) and hepatocellular carcinoma (HCC) patients and assess the association between HBcrAg/cccDNA and HCC recurrence. Methods HBcrAg was measured by chemiluminescence enzyme immunoassay. Intrahepatic covalently closed circular DNA (cccDNA) was measured by real-time PCR with TaqMan fluorescent probes based on liver specimens from 89 HCC patients. Results HBcrAg correlated positively with HBV DNA irrespective of HBeAg status. Both HBcrAg and HBV DNA were associated with cccDNA in patients with elevated serum HBV DNA (>4 log IU/mL). In patients with non-elevated HBV DNA (≤4 log IU/mL), no relationship between HBV DNA and cccDNA was observed, but we still documented a modest correlation between HBcrAg and cccDNA. Finally, the recurrence-free survival rates were significantly lower in HCC patients with high intrahepatic cccDNA and serum HBcrAg levels than those with low cccDNA/HBcrAg levels (p = 0.035, p = 0.003 respectively). Conclusions HBcrAg not only can serve as a biomarker to assess HBV loads in patients as well as provide a good method for monitoring cccDNA in HCC, but also can be used as a good prognostic predictor for HCC patients.