Prevalence, Clinical Presentation and Outcome of Hepatitis B Patients With Indeterminate Phase: A Systematic Review

Jie Li1,2, Xiaoming Xu3, Jiacheng Liu1

  • 1Department of Infectious Diseases, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China.

Journal of Viral Hepatitis
|February 28, 2026
PubMed

Insights

Nearly 40% of chronic hepatitis B (CHB) patients fall into an indeterminate phase, lacking defined immune classifications. These patients face risks for hepatocellular carcinoma and liver-related adverse outcomes, necessitating further research for tailored treatments.

Area of Science:

  • Hepatology
  • Virology
  • Clinical Medicine

Background:

  • Current chronic hepatitis B (CHB) guidelines define distinct immune phases.
  • A significant proportion of CHB patients do not fit these classifications, existing in an 'indeterminate phase'.

Purpose of the Study:

  • To systematically evaluate the prevalence, clinical presentation, and outcomes of CHB patients in the indeterminate phase.
  • To analyze indeterminate CHB patients based on the American Association for the Study of Liver Diseases (AASLD) 2018 and European Association for the Study of the Liver (EASL) 2017 guidelines.

Main Methods:

  • A meta-analysis was conducted, searching four databases from inception to August 21, 2024.
  • Fifty studies reporting on indeterminate CHB patients according to AASLD 2018 or EASL 2017 guidelines were included in the analysis.

Main Results:

  • The prevalence of indeterminate CHB patients was approximately 38.9% by AASLD 2018 guidelines and 38.8% by EASL 2017 guidelines.
  • The pooled incidence rate for hepatocellular carcinoma in indeterminate CHB patients was around 5.3 per 1000 person-years, and for liver-related events, it was approximately 7.3-9.8 per 1000 person-years, depending on the guideline used.

Conclusions:

  • The indeterminate phase affects nearly 40% of CHB patients.
  • These patients are at risk for hepatocellular carcinoma and adverse liver-related outcomes.
  • Further research is crucial to develop specific treatment strategies for indeterminate CHB patients.

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