Related Experiment Video

Updated: Jan 4, 2026

A Competent Hepatocyte Model Examining Hepatitis B Virus Entry through Sodium Taurocholate Cotransporting Polypeptide as a Therapeutic Target
11:34

A Competent Hepatocyte Model Examining Hepatitis B Virus Entry through Sodium Taurocholate Cotransporting Polypeptide as a Therapeutic Target

Published on: May 10, 2022

2.6K

Guidance for design and endpoints of clinical trials in chronic hepatitis B - Report from the 2019 EASL-AASLD HBV

Markus Cornberg1,2,3, Anna Suk-Fong Lok4, Norah A Terrault5

  • 1Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.

Hepatology (Baltimore, Md.)
|November 13, 2019
PubMed

Insights

Achieving a functional cure for chronic hepatitis B virus (HBV) infection is possible. The primary goal is sustained HBsAg loss with undetectable HBV DNA post-treatment, establishing a new standard for HBV cure clinical trials.

Area of Science:

  • Hepatology
  • Virology
  • Clinical Trial Design

Background:

  • Chronic hepatitis B virus (HBV) infection remains a significant global health challenge.
  • Current treatments focus on viral suppression, but a functional cure is the ultimate therapeutic goal.
  • Defining clear endpoints for clinical trials is crucial for developing curative therapies.

Purpose of the Study:

  • To establish consensus on endpoints for clinical trials targeting a functional cure for chronic HBV.
  • To define criteria for assessing treatment efficacy and approving new diagnostic assays.
  • To guide the design of future clinical trials for HBV and hepatitis D virus (HDV) co-infection.

Main Methods:

  • A consensus conference involving diverse stakeholders (academia, industry, regulatory agencies, patient groups) in March 2019.
  • Discussion and agreement on key definitions and primary endpoints for HBV cure trials.
  • Consideration of criteria for new assay validation and patient populations for initial trials.

Main Results:

  • Agreement reached that 'functional cure' (sustained HBsAg loss + undetectable HBV DNA 6 months post-treatment) is achievable.
  • Proposed primary endpoint for Phase 3 HBV trials: functional cure, with HBsAg loss in ≥30% of patients as an acceptable response rate.
  • Sustained virologic suppression (undetectable HBV DNA without HBsAg loss) defined as an intermediate goal.
  • Validity in predicting HBsAg loss is the key criterion for approving new HBV assays.
  • Recommended patient populations for initial functional cure trials include treatment-naïve or virally suppressed HBeAg-positive/negative chronic hepatitis B patients.
  • Safety standard: new treatments must be as safe as current nucleos(t)ide analogues.
  • Primary endpoint for HDV co-infection trials: undetectable HDV RNA 6 months post-treatment cessation.

Conclusions:

  • Functional cure, defined by sustained HBsAg loss and undetectable HBV DNA post-treatment, is the primary goal for HBV cure.
  • Sustained undetectable HBV DNA without HBsAg loss post-treatment is an important intermediate goal.
  • Consensus provides a clear framework for advancing HBV functional cure research and clinical trials.

Keywords:
Hepatitis Dantiviral therapyhepatitis B surface antigenimmune modulatory therapynucleos(t)ide analogues

More Related Videos

A Three-Dimensional Spheroid Model to Investigate the Tumor-Stromal Interaction in Hepatocellular Carcinoma12:24

A Three-Dimensional Spheroid Model to Investigate the Tumor-Stromal Interaction in Hepatocellular Carcinoma

Published on: September 30, 2021

5.9K
Analysis of HBV-Specific CD4 T-cell Responses and Identification of HLA-DR-Restricted CD4 T-Cell Epitopes Based on a Peptide Matrix10:37

Analysis of HBV-Specific CD4 T-cell Responses and Identification of HLA-DR-Restricted CD4 T-Cell Epitopes Based on a Peptide Matrix

Published on: October 20, 2021

3.3K

Related Concept Videos

Effect of Hepatic Disease on Pharmacokinetics: Pathophysiologic Assessment and Liver Function Test01:22

Effect of Hepatic Disease on Pharmacokinetics: Pathophysiologic Assessment and Liver Function Test

In clinical practice, the direct measurement of hepatic blood flow to evaluate liver function presents significant challenges due to the intricate and specialized nature of the necessary techniques. Consequently, healthcare professionals often rely on empirical estimates derived from thorough patient examinations and liver function tests to gauge liver health. Among the tools at their disposal, the Child–Pugh and MELD scoring systems stand out for their ability to categorize and assess...
149
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
115
Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
10.1K
Chronic Pancreatitis II: Collaborative Care01:29

Chronic Pancreatitis II: Collaborative Care

The management of chronic pancreatitis is multifaceted, involving a comprehensive approach that includes thorough assessment, diagnostic testing, and a variety of management strategies.
Assessment:
269
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
4.5K
Effect of Hepatic Disease on Pharmacokinetics: Dose Adjustments Due to Hepatic Impairment01:08

Effect of Hepatic Disease on Pharmacokinetics: Dose Adjustments Due to Hepatic Impairment

Hepatic impairment, characterized by decreased liver function, does not uniformly mandate adjustments in drug dosage. Whether dosage modifications are necessary depends on various factors related to the drug's metabolism and elimination pathways. If a drug is primarily excreted via the kidneys and bypasses significant hepatic processing, if it undergoes minimal metabolic transformation in the liver, or if it is volatile and primarily expelled through the lungs, dose adjustments may not be...
217