Baseline quantitative hepatitis B core antibody titre alone strongly predicts HBeAg seroconversion across chronic hepatitis B patients treated with peginterferon or nucleos(t)ide analogues.

Abstract

OBJECTIVE:

The investigation regarding the clinical significance of quantitative hepatitis B core antibody (anti-HBc) during chronic hepatitis B (CHB) treatment is limited. The aim of this study was to determine the performance of anti-HBc as a predictor for hepatitis B e antigen (HBeAg) seroconversion in HBeAg-positive CHB patients treated with peginterferon (Peg-IFN) or nucleos(t)ide analogues (NUCs), respectively.

DESIGN:

This was a retrospective cohort study consisting of 231 and 560 patients enrolled in two phase IV, multicentre, randomised, controlled trials treated with Peg-IFN or NUC-based therapy for up to 2 years, respectively. Quantitative anti-HBc evaluation was conducted for all the available samples in the two trials by using a newly developed double-sandwich anti-HBc immunoassay.

RESULTS:

At the end of trials, 99 (42.9%) and 137 (24.5%) patients achieved HBeAg seroconversion in the Peg-IFN and NUC cohorts, respectively. We defined 4.4 log10 IU/mL, with a maximum sum of sensitivity and specificity, as the optimal cut-off value of baseline anti-HBc level to predict HBeAg seroconversion for both Peg-IFN and NUC. Patients with baseline anti-HBc ≥4.4 log10 IU/mL and baseline HBV DNA <9 log10 copies/mL had 65.8% (50/76) and 37.1% (52/140) rates of HBeAg seroconversion in the Peg-IFN and NUC cohorts, respectively. In pooled analysis, other than treatment strategy, the baseline anti-HBc level was the best independent predictor for HBeAg seroconversion (OR 2.178; 95% CI 1.577 to 3.009; p<0.001).

CONCLUSIONS:

Baseline anti-HBc titre is a useful predictor of Peg-IFN and NUC therapy efficacy in HBeAg-positive CHB patients, which could be used for optimising the antiviral therapy of CHB.

• Authors: Rong Fan, Jian Sun, Quan Yuan, Qing Xie, Xuefan Bai, Qin Ning, Jun Cheng, Yanyan Yu, Junqi Niu, Guangfeng Shi, Hao Wang, Deming Tan, Mobin Wan, Shijun Chen, Min Xu, Xinyue Chen, Hong Tang, Jifang Sheng, Fengmin Lu, Jidong Jia, Hui Zhuang, Ningshao Xia, Jinlin Hou, Chronic Hepatitis B Study Consortium
• Journal: Gut (Gut) Vol. 65 Issue 2 Pg. 313-20 (Feb 2016) ISSN: 1468-3288 [Electronic] England
• PMID: 25586058 (Publication Type: Clinical Trial, Phase IV, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Chemical References

• Hepatitis B Antibodies
• Hepatitis B e Antigens
• Interferon-alpha
• Nucleosides
• Recombinant Proteins
• Polyethylene Glycols
• peginterferon alfa-2a

Topics

• Adult
• Cohort Studies
• Female
• Hepatitis B Antibodies (analysis)
• Hepatitis B e Antigens (immunology)
• Hepatitis B, Chronic (immunology, therapy)
• Humans
• Interferon-alpha (therapeutic use)
• Male
• Nucleosides (therapeutic use)
• Polyethylene Glycols (therapeutic use)
• Recombinant Proteins (therapeutic use)
• Retrospective Studies
• Sensitivity and Specificity
• Seroconversion