Clin Mol Hepatol > Accepted Articles
Hepatitis B core-related antigen: a novel and promising surrogate biomarker to guide anti-HBV therapy
Takako Inoue1, Takehisa Watanabe2, Yasuhito Tanaka2,3
1Department of Clinical Laboratory Medicine, Nagoya City University Hospital, Nagoya, Japan
2Department of Gastroenterology and Hepatology, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan
3Department of Virology & Liver unit, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
Correspondence :  Yasuhito Tanaka ,
Tel: +81-96-373-5146, Fax: +81-96-371-0582, Email:
Received: December 2, 2022  Revised: February 19, 2023   Accepted: March 7, 2023
The current requirement for biomarkers to detect hepatitis B virus (HBV) infection is polarized. One is a fully-automated and highly sensitive measurement system; the other is a simple system for point-of-care testing (POCT) in resource-limited areas. Hepatitis B core-related antigen (HBcrAg) reflects intrahepatic covalently closed circular DNA and serum HBV DNA. Even in patients with undetectable serum HBV DNA or HBsAg loss, HBcrAg may remain detectable. Decreased HBcrAg levels are associated with reduction of the occurrence of hepatocellular carcinoma (HCC) in chronic hepatitis B (CHB). Recently, a fully-automated, novel high-sensitivity HBcrAg assay (iTACT-HBcrAg, cut-off value: 2.1 log U/mL) has been developed. This attractive assay has been released in Japan very recently. iTACT-HBcrAg can be useful for monitoring HBV reactivation and prediction of HCC occurrence, as an alternative to HBV DNA. Moreover, monitoring HBcrAg may be suitable for determining the therapeutic effectiveness of approved drugs and novel drugs under development. Presently, international guidelines recommend anti-HBV prophylaxis for pregnant women with high viral loads to prevent mother-to-child transmission of HBV. However, >95% of HBV-infected individuals live in countries where HBV DNA quantification is not available. Worldwide elimination of HBV needs the scaling-up of examination and medication services in resource-limited areas. Based on this situation, a rapid and easy HBcrAg assay as a POCT is valuable. This review provides the latest information regarding the clinical use of a new surrogate marker, HBcrAg, in HBV management, based on iTACT-HBcrAg or POCT, and introduces novel agents targeting HBV RNA/protein.
KeyWords: hepatitis B core-related antigen (HBcrAg), covalently closed circular DNA (cccDNA), HBV reactivation, point-of-care testing (POCT), RNA destabilizer
METRICS Graph View
  • 1 Crossref
  •  0 Scopus
  • 584 View
  • 107 Download
Related articles

Editorial Office
The Korean Association for the Study of the Liver
Room A1210, 53 Mapo-daero(MapoTrapalace, Dowha-dong), Mapo-gu, Seoul, 04158, Korea
TEL: +82-2-703-0051   FAX: +82-2-703-0071    E-mail:
Copyright © The Korean Association for the Study of the Liver.         
TODAY : 1195
TOTAL : 1298407
Close layer