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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.

Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America
|August 26, 2023
PubMed

Insights

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.
Keywords:
HBV biomarkerschronic hepatitis Bfunctional curenew combination therapystopping finite therapy

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