High end-of-treatment hepatitis B core-related antigen levels predict hepatitis flare after stopping nucleot(s)ide analogue therapy.

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  • Additional Information
    • Source:
      Publisher: Wiley-Blackwell Country of Publication: United States NLM ID: 101160857 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1478-3231 (Electronic) Linking ISSN: 14783223 NLM ISO Abbreviation: Liver Int Subsets: MEDLINE
    • Publication Information:
      Publication: Malden, MA : Wiley-Blackwell
      Original Publication: Oxford, UK : Blackwell Munksgaard, c2003-
    • Subject Terms:
      Hepatitis B Core Antigens*/blood ; Antiviral Agents*/therapeutic use ; Hepatitis B, Chronic*/drug therapy ; Hepatitis B, Chronic*/blood ; Biomarkers*/blood ; DNA, Viral*/blood ; Hepatitis B virus*/genetics; Humans ; Male ; Female ; Middle Aged ; Prospective Studies ; Adult ; Hepatitis B Surface Antigens/blood ; RNA, Viral/blood ; Withholding Treatment ; Symptom Flare Up ; Aged
    • Abstract:
      Background and Aims: Accurate biomarkers to predict outcomes following discontinuation of nucleos(t)ide analogue (NA) therapy are needed. We evaluated serum hepatitis B core-related antigen (HBcrAg) level as a biomarker for predicting outcomes after NA discontinuation.
      Methods: Patients with HBeAg-negative chronic hepatitis B (CHB) without cirrhosis were enrolled in a prospective trial evaluating clinical outcomes until 96 weeks after NA discontinuation. End of treatment (EOT) and off-treatment levels of serum HBcrAg, HBsAg, HBV RNA and HBV DNA were used to predict key clinical outcomes including hepatitis flare (ALT ≥5 × ULN and HBV DNA > 2000 IU/mL). The SCALE-B score was calculated for the purposes of model validation.
      Results: HBcrAg was tested amongst 65 participants. The median age was 54 years, 54% were male and 83% were Asian. HBcrAg was detectable in 86% patients. HBcrAg level ≥4 log U/mL at EOT was predictive of hepatitis flare [8/10 (80%) vs. 17/55 (31%), p = .001]. The presence of either HBcrAg ≥4 log U/mL or detectable HBV RNA at EOT predicted for both biochemical relapse and hepatitis flare. The SCALE-B model at EOT predicted for virological relapse, biochemical relapse, hepatitis flare and HBsAg loss in this cohort. An increase in the serum HBcrAg level off-treatment was also associated with hepatitis flare. No participant with EOT HBcrAg level ≥4 log U/mL achieved HBsAg loss.
      Conclusions: High levels of serum HBcrAg predict for hepatitis flare after stopping NA therapy and low likelihood of HBsAg loss at week 96. People with high levels of serum HBcrAg are not suitable candidates for NA discontinuation.
      (© 2024 The Author(s). Liver International published by John Wiley & Sons Ltd.)
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    • Contributed Indexing:
      Keywords: biomarker; hepatitis B; hepatitis B core‐related antigen; hepatitis flare; nucleot(s)ide analogue; nucleot(s)ide analogue discontinuation
    • Accession Number:
      0 (Hepatitis B Core Antigens)
      0 (Antiviral Agents)
      0 (Biomarkers)
      0 (DNA, Viral)
      0 (Hepatitis B Surface Antigens)
      0 (RNA, Viral)
    • Publication Date:
      Date Created: 20240715 Date Completed: 20241009 Latest Revision: 20241009
    • Publication Date:
      20241009
    • Accession Number:
      10.1111/liv.16029
    • Accession Number:
      39007640