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Development of a Hepatitis B Virus Reporter System to Monitor the Early Stages of the Replication Cycle
Published on: February 1, 2017
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Getting to HBV cure-Will new biomarkers help?
Jordan J Feld1, Adam J Gehring1,2, Fabien Zoulim3
1Division of Gastroenterology & Hepatology, Department of Medicine, Toronto Centre for Liver Disease, University Health Network, Toronto, Ontario, Canada.
Hepatology (Baltimore, Md.)
|April 1, 2025
Summary
Novel biomarkers for chronic hepatitis B (CHB) are crucial for developing new treatments. These markers help assess treatment effectiveness and guide strategies toward a cure for CHB infection.
Area of Science:
- Hepatology and Virology
- Biomarker Discovery and Validation
Background:
- Chronic hepatitis B (CHB) infection management traditionally relies on serological, virological, biochemical, and histological markers.
- Emerging biomarkers, including HBV RNA, hepatitis B core-related antigen (HBcrAg), hepatitis B core antigen (HBcAg), and quantitative hepatitis B surface antigen (qHBsAg), offer new insights.
- Novel immunological biomarkers are also under investigation for their role in CHB.
Purpose of the Study:
- To review existing and novel serological, virological, and immunological biomarkers for CHB.
- To highlight the utility of these biomarkers in guiding the development of novel antiviral strategies aimed at achieving a cure for CHB.
- To propose new terminology for clinical endpoints, including Sustained Control, Resolved Chronic Infection, and Cure.
Main Methods:
- Review of current literature on CHB biomarkers.
- Analysis of the role of novel biomarkers (HBV RNA, HBcrAg, HBcAg, qHBsAg) in clinical settings.
- Discussion on the application of biomarkers in assessing novel antiviral agents and defining clinical endpoints.
Main Results:
- Novel biomarkers provide deeper insights into HBV biology and can significantly aid in designing and evaluating new CHB therapies.
- Biomarkers are essential for confirming drug mechanisms, target engagement, patient selection for clinical trials, and defining treatment response.
- Proposed new terminology aims to more accurately define CHB stages and treatment outcomes, distinguishing between Sustained Control, Resolved Chronic Infection, and Cure.
Conclusions:
- Novel biomarkers are pivotal for advancing CHB treatment strategies towards a cure.
- Accurate assessment using validated biomarkers is key for patient management and drug development.
- Standardized terminology for clinical endpoints will improve clarity and consistency in CHB research and clinical practice.
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