EMA opens a public consultation on its Concept paper for the HBV guideline revision

The EMA has opened a public consultation on its draft Concept paper on the revision of the guideline on the Clinical evaluation of medicinal products intended for treatment of hepatitis B, with a deadline set on 30 April 2024.

As per the draft concept paper, the scope of the future revision of the guideline could focus on the following points:

• Clinical trial requirements including trials that aim to demonstrate the efficacy of treatments aiming at achieving functional cure, including finite and combination treatment regimens.
• Update recommendations for primary efficacy endpoints to include endpoints relevant to achieving viral suppression or functional cure.
• Efficacy and safety considerations when stopping suppressive NUC treatments in clinical trials aimed at evaluating regimens intended to achieve functional cure. 
• Considerations specific to the development of agents with novel mechanisms of action. 
• Statistical analyses in trials that evaluate finite treatment regimens.
• Definitions of HBV cure, diagnostic criteria, and patient characteristics.
• Editorial and structural changes to improve readability.

The finalisation and adoption of the final concept paper is planned for May 2024.

Reference link: EMA Concept paper on the revision of the guideline on the Clinical evaluation of medicinal products intended for treatment of hepatitis B