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Chronic Hepatitis B Finite Treatment: Similar and Different Concerns With New Drug Classes
Marion G Peters1, Man-Fung Yuen2, Norah Terrault3
1Department of Medicine, Northwestern University, Chicago, Illinois, USA.
Summary
Experts reached consensus on stopping finite curative therapies for chronic hepatitis B (HBV) infection. This guidance addresses trial design, patient selection, and criteria for stopping and restarting HBV treatment.
Area of Science:
- Hepatology
- Virology
- Clinical Trial Design
Background:
- Chronic hepatitis B (HBV) affects over 250 million globally, causing liver disease and cancer.
- Current treatments only suppress HBV, lacking a definitive cure.
- Novel finite curative therapies combining multiple agents are under development.
Purpose of the Study:
- To establish consensus on criteria for stopping finite HBV therapies in clinical studies.
- To guide the demonstration of sustained off-treatment efficacy and safety.
Main Methods:
- Convened a multistakeholder HBV Forum webinar and working group discussions.
- Included experts from academia, clinical practice, industry, patient advocacy, and regulatory agencies.
- Synthesized viewpoints on key aspects of finite therapy cessation.
Main Results:
- Outlined areas of consensus on trial design for finite HBV therapy studies.
- Defined patient selection, outcomes, and biomarker considerations.
- Established criteria for stopping therapy, retreatment, and follow-up duration.
Conclusions:
- Multistakeholder consensus provides a framework for evaluating finite curative HBV therapies.
- Addresses critical aspects for future clinical trial design and regulatory considerations.
- Highlights unmet needs and future research directions in HBV curative therapy development.
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