Clinical usefulness of a novel high-sensitivity hepatitis B core-related antigen assay to determine the initiation of treatment for HBV reactivation.

Abstract

BACKGROUNDS:

A fully automated, novel, high-sensitivity hepatitis B core-related antigen assay (iTACT-HBcrAg) has been developing. The purpose of this study is to evaluate the efficacy of measuring HBcrAg, using that assay, to diagnose HBV reactivation in a multi-center setting, compared with ultra-high-sensitivity HBsAg (iTACT-HBsAg) and HBV DNA assays.

METHODS:

Forty-four patients with HBV reactivation from 2008 to 2020 were enrolled in four hospitals. Serial serum specimens from the patients were assessed retrospectively for their HBcrAg levels by iTACT-HBcrAg (lower limit of detection; 2.0 log U/mL) and HBsAg levels by iTACT-HBsAg (lower limit of detection; 0.0005 IU/mL); these were compared to the HBV DNA levels. HBV reactivation was defined as detection of serum HBV DNA, including unquantifiable detection.

RESULTS:

At HBV reactivation and/or thereafter, HBV DNA levels were quantified (≥ 1.3 log IU/mL) in the sera of 27 patients, and were below the level of quantification (< 1.3 log IU/mL) in the sera of 17 patients. Of the 27 patients with HBV reactivation and whose serum HBV DNA was quantified, the sera of 26 and 24 patients (96.3% and 88.9%) were positive by iTACT-HBcrAg and iTACT-HBsAg, respectively. HBcrAg was detectable by iTACT-HBcrAg before HBV DNA was quantifiable in 15 of the 27 patients. Of the 11 patients with HBV reactivation and undetectable HBcrAg by iTACT-HBcrAg at HBV reactivation and/or thereafter, 10 had unquantifiable HBV DNA and none developed HBV reactivation-related hepatitis.

CONCLUSIONS:

The iTACT-HBcrAg assay is useful for monitoring HBV reactivation to determine the initiation of treatment with nucleos(t)ide analogues.

• Authors: Takanori Suzuki, Takako Inoue, Kentaro Matsuura, Shigeru Kusumoto, Shinya Hagiwara, Shintaro Ogawa, Shintaro Yagi, Atsushi Kaneko, Kei Fujiwara, Takehisa Watanabe, Katsumi Aoyagi, Yukitomo Urata, Akihiro Tamori, Hiromi Kataoka, Yasuhito Tanaka
• Journal: Journal of gastroenterology (J Gastroenterol) Vol. 57 Issue 7 Pg. 486-494 (07 2022) ISSN: 1435-5922 [Electronic] Japan
• PMID: 35478052 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2022. Japanese Society of Gastroenterology.

Chemical References

• Biomarkers
• DNA, Viral
• Hepatitis B Core Antigens
• Hepatitis B Surface Antigens

Topics

• Biomarkers
• DNA, Viral
• Hepatitis B Core Antigens
• Hepatitis B Surface Antigens
• Hepatitis B virus (genetics)
• Hepatitis B, Chronic (drug therapy)
• Humans
• Retrospective Studies