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Clinical Trial Design for Immune-Based Therapy of Hepatitis B Virus

Upkar S Gill1,2, Antonio Bertoletti2,3,4

  • 1Department of Hepatology, Centre for Immunobiology, Blizard Institute, Barts and The London School of Medicine and Dentistry, QMUL, London, United Kingdom.

Seminars in Liver Disease
|June 1, 2017
PubMed

Insights

Novel immune therapies are needed for chronic hepatitis B virus (HBV) treatment. This review discusses new agents and strategies to achieve a functional cure for HBV, moving beyond current lifelong antiviral therapies.

Area of Science:

  • Hepatology
  • Immunology
  • Virology

Background:

  • Current direct antiviral therapies for chronic hepatitis B virus (HBV) control replication but necessitate lifelong treatment and often lead to viral rebound upon cessation.
  • Interferon-based immune modulation offers a functional cure for only a subset of patients with chronic HBV.
  • There is an urgent need for novel therapeutic strategies to achieve a sustained functional cure for chronic HBV.

Purpose of the Study:

  • To review emerging novel immune therapies for chronic hepatitis B virus (HBV) infection.
  • To discuss the optimal utilization of these new agents for achieving a functional cure.
  • To identify potential treatment endpoints for chronic HBV therapy.

Main Methods:

  • Review of current literature on novel HBV therapeutics in development.
  • Analysis of immune-modulating agents and their mechanisms of action.
  • Discussion of clinical trial data and future therapeutic strategies.

Main Results:

  • A multitude of novel immune agents are in clinical trials for HBV.
  • These agents aim to restore host immune control against HBV.
  • Strategies include combination therapies and targeted immune stimulation.

Conclusions:

  • Novel immune therapies represent a promising frontier for achieving a functional cure in chronic HBV.
  • Personalized treatment approaches will be crucial for optimizing outcomes.
  • Defining clear endpoints for treatment cessation is essential for future clinical practice.

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