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Updated: Jun 26, 2025

Author Spotlight: Advancements and Challenges in Hepatitis B Virus Detection
Published on: December 15, 2023
[New progress on diagnosis and treatment for indeterminate-phase chronic hepatitis B virus-infected patients]
1Department of Infectious Diseases, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing 210008, China.
Insights
Patients with indeterminate phase chronic hepatitis B virus (HBV) infection, a common clinical challenge, face higher risks. Antiviral therapy is recommended to reduce liver disease progression and hepatocellular carcinoma (HCC) risk.
Area of Science:
- Hepatology
- Virology
- Internal Medicine
Background:
- Chronic hepatitis B virus (HBV) infection is typically classified into four stages by authoritative guidelines.
- A significant proportion (30%-50%) of patients fall into an
- indeterminate phase
- lacking clear classification.
- These patients often exhibit substantial liver damage, including cirrhosis, and are at elevated risk for hepatocellular carcinoma (HCC) and mortality without antiviral treatment.
Purpose of the Study:
- To review current research on the prevalence, clinical characteristics, disease progression, and treatment benefits in indeterminate phase chronic HBV patients.
- To explore strategies for improved management of this patient group.
- To address the lack of unified classification standards and rapid diagnostic methods for at-risk indeterminate phase patients.
Main Methods:
- Literature review of studies on indeterminate phase chronic HBV infection.
- Analysis of clinical characteristics, disease progression, and treatment outcomes.
- Examination of existing guidelines and expert opinions, including the 2022 "Expert Opinions on Expanding Antiviral Treatment for Chronic Hepatitis B".
Main Results:
- Preliminary research indicates that antiviral treatment in indeterminate phase patients yields good virological response and significantly reduces HCC risk.
- Aggressive treatment is recommended for indeterminate phase patients with over one year of follow-up, according to 2022 expert opinions.
- Despite treatment benefits, challenges remain in refining classification and developing non-invasive diagnostic tools for risk stratification.
Conclusions:
- The indeterminate phase of chronic HBV infection represents a critical clinical challenge with significant risks of liver disease progression and HCC.
- Antiviral therapy shows promise for improving outcomes in this population.
- Further research is needed to establish standardized classification criteria and develop effective non-invasive diagnostic methods for better patient management.
Abstract:
Authoritative guidelines at home and abroad typically classify chronic hepatitis B virus (HBV) infection into four stages. However, in clinical practice, a considerable number of patients do not meet the guidelines for staging and are called "indeterminate phase" chronic HBV- infected patients. Studies have shown that patients in the indeterminate phase account for about 30%-50% of chronic HBV infection, have significant liver histological changes or even cirrhosis in a large proportion, and are at a higher risk of HCC and death if they do not receive antiviral therapy. Preliminary research shows that patients in the indeterminate phase who receive antiviral treatment have a good virological response and a remarkable reduced HCC risk. To this end, the 2022 publication "Expert Opinions on Expanding Antiviral Treatment for Chronic Hepatitis B" recommends aggressive treatment for patients with an indeterminate phase who have undergone more than a year of follow-up. However, there is still a lack of unified standards to refine the classification, as well as a lack of effective and rapid non-invasive diagnostic methods to identify patients in the indeterminate phase who are at risk for disease progression. This article aims to review the researches on the proportion, clinical characteristics, disease progression, and treatment benefits to further explore how to better manage indeterminate-phase chronic HBV-infected patients.
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