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Original article

Hepatitis B core-related antigen levels predict pegylated interferon-α therapy response in HBeAg-positive chronic hepatitis B

Boris JB Beudeker, Zwier MA Groothuismink, Robert A de Man, Harry LA Janssen, Annemiek A van der Eijk, Andre Boonstra, Milan J Sonneveld

Corresponding author name: Milan J Sonneveld
Corresponding author e-mail: m.j.sonneveld@erasmusmc.nl

doi: 10.3851/IMP3367

Abstract

Background: Serum hepatitis B core-related antigen (HBcrAg) levels reflect intrahepatic hepatitis B virus (HBV) replication activity. We aimed to study whether HBcrAg levels predict response to peginterferon (PEG-IFN) treatment in HBeAg positive chronic hepatitis B (CHB) patients.

Methods: We studied HBcrAg levels in 222 HBeAg-positive patients treated with PEG-IFN with or without lamivudine for 52 weeks in a global randomized trial and compared kinetics across treatment arms and types of response. Optimal HBcrAg cut-offs for stopping therapy were compared to and combined with the currently recommended HBsAg-based stopping-rules.

Results: Baseline HBcrAg levels could not discriminate between responders and non-responders (p=0.91). HBcrAg levels of patients responding to PEG-IFN therapy showed a more pronounced on-treatment decline (mean declines 3.4 vs 1.0 log U/mL; p<0.0001), which was sustained until the end of follow-up (mean declines week 3.8 vs. 1.0 log U/mL; p<0.0001). In the PEG-IFN monotherapy group, HBcrAg levels of >8.35 log U/mL at week 24 identified 19 patients (19%) of whom 1 (NPV=95%) achieved a response. The performance of this HBcrAg-based stopping rule alone was not superior to the one based on HBsAg >20,000 IU/mL. Among patients with an HBsAg <20,000 (n=56), 9 (16%) had an HBcrAg >8.35, of whom 8 achieved no response (NPV 89%).

Conclusions: HBeAg-positive CHB patients with a response to PEG-IFN therapy achieve a more pronounced HBcrAg decline. HBcrAg levels at week 24 of therapy could be used to identify non-responders in combination with the established HBsAg based stopping-rules.

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