Clin Mol Hepatol.  2023 Apr;29(2):482-495. 10.3350/cmh.2022.0322.

Long-term prognosis and the need for histologic assessment of chronic hepatitis B in the serological immune-tolerant phase

Affiliations
  • 1Division of Gastroenterology and Hepatology, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Korea
  • 2Department of Internal Medicine, Kyungpook National University Hospital, Kyungpook National University School of Medicine, Daegu, Korea
  • 3Department of Biostatistics, Clinical Trial Center, Soonchunhyang University Bucheon Hospital, Bucheon, Korea
  • 4Department of Internal Medicine, College of Medicine, Ewha Womans University, Seoul, Korea
  • 5College of Medicine, Soonchunhyang University, Cheonan, Korea
  • 6Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea

Abstract

Background/Aims
The histologic status of the immune-tolerant (IT) phase of chronic hepatitis B relative to long-term outcomes is unclear. This study aimed to discover how the serological criteria currently in use correspond to histologic criteria in determining the IT phase and indication for liver biopsy.
Methods
Patients in the serological IT phase determined by positive hepatitis B e antigen, hepatitis B virus (HBV) DNA ≥106 IU/mL, and normal or minimally elevated alanine aminotransferase (ALT) ≤60 IU/L, who underwent liver biopsy at three different hospitals were included. The distribution of the histologic IT phase, defined as fibrosis of stage 1 or less and inflammation of grade 1 or less, was compared with that of the serological IT phase. The risk factors for the incidence of liver-related events, such as hepatocellular carcinoma, liver cirrhosis, liver transplantation, and death, were also analyzed.
Results
Eighty-two (31.7%) out of 259 clinically suspected IT phase patients belonged to the histologic IT phase. Age over 35, high AST, and low albumin were useful for ruling out the histologic IT phase. Risk factors predicting liver-related events were age and significant fibrosis stage. There was no significant difference in the proportion of histologic IT phase and clinical prognosis between normal ALT and mildly elevated ALT groups. However, even in patients with normal ALT, age was an important factor in predicting the presence of the histologic IT phase.
Conclusions
A significant number of patients who belonged to the serological IT phase were not in the histologic IT phase. Patients over 35 years and those with high AST, low albumin, and low HBV DNA levels were more likely to experience poor long-term clinical outcomes. Therefore, additional histologic assessment should be considered.

Keyword

Fibrosis; Biopsy; Hepatitis B virus
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