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Author Spotlight: Advancements and Challenges in Hepatitis B Virus Detection
Published on: December 15, 2023
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Hepatitis B cure: From discovery to regulatory approval
Anna S Lok1, Fabien Zoulim2, Geoffrey Dusheiko3
1Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, MI.
Hepatology (Baltimore, Md.)
|August 2, 2017
Summary
A functional cure for chronic hepatitis B, defined by sustained loss of hepatitis B surface antigen, is a feasible goal. New therapies and standardized assays are needed to achieve this for improved patient outcomes.
Area of Science:
- Hepatology and Virology
- Immunology and Infectious Diseases
Background:
- Chronic hepatitis B (CHB) currently requires lifelong treatment for most patients.
- Novel therapies targeting hepatitis B virus (HBV) entry, replication, assembly, secretion, and immune modulation are under development.
- Standardized efficacy and safety assessments are crucial for new CHB treatments.
Framework:
- A 2016 workshop convened stakeholders to establish consensus on treatment endpoints for CHB cure.
- The consensus defined a 'functional cure'—sustained loss of hepatitis B surface antigen (HBsAg)—as a feasible and improved treatment goal over complete eradication.
- This functional cure is associated with better clinical outcomes than current therapies.
Implementation:
- Standardized assays for novel biomarkers should be developed concurrently with new antiviral and immune therapies.
- Clinical trial designs must incorporate these new endpoints and assays for regulatory approval.
- Initial monotherapy studies are recommended to assess safety and antiviral activity before combination therapies.
Implications:
- Achieving functional hepatitis B virus cure will likely require combination antiviral and immune modulatory therapies.
- The safety of new curative therapies must be prioritized, considering the established safety of current nucleos(t)ide analogues.
- Parallel development of therapies and diagnostic assays will expedite the pathway to regulatory approval and clinical implementation.
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