Clinical evaluation of direct acting antiviral agents intended for treatment of chronic hepatitis C - Scientific guideline

This document provides guidance on the clinical development of compounds for the treatment of chronic hepatitis C. It focuses on direct-acting anti-viral agents.

Keywords: Hepatitis C, chronic hepatitis C (CHC), direct antivirals, interferon, ribavirin, transplantation, standard of care (SOC), hepatitis C virus (HCV) RNA

Current effective version - currently under revision, see below

Guideline on the clinical evaluation of direct acting antiviral agents intended for treatment of chronic Hepatitis C - First version

Adopted Reference Number: EMEA/CHMP/EWP/30039/2008 Legal effective date: 01/11/2009

Document history - Revision 1

Draft guideline on the clinical evaluation of direct acting antivirals for the treatment of chronic hepatitis - Revision 1

Draft: consultation closed Consultation dates: 07/07/2016 to 31/12/2016 Reference Number: EMEA/CHMP/EWP/30039/2008 Rev. 1 Summary:

This draft guideline replaces the CHMP’s Guideline on the clinical evaluation of direct acting antiviral agents intended for treatment of chronic hepatitis C (EMEA/CHMP/EWP/30039/2008). There have been considerable developments in the field of hepatitis C virus (HCV) therapy since the adoption of EMEA/CHMP/EWP/30039/2008. Since 2013 direct acting antivirals (DAAs) have been approved for the treatment of chronic HCV infections within interferon-free combination regimens. Therefore this revision of the prior guidance concerns the development of DAA-only regimens.

Draft guideline on clinical evaluation of medicinal products for the treatment of chronic hepatitis C

Draft: consultation closed Consultation dates: 20/01/2011 to 31/08/2011 Reference Number: EMEA/CHMP/51240/2011

Concept paper on the need for revision of the guideline on the clinical development of medicinal products for the treatment of Hepatitis C

Draft: consultation closed Consultation dates: 22/04/2010 to 31/07/2010 Reference Number: EMA/CHMP/EWP/825749/2009

Document history - First version (current)

Guideline on the clinical evaluation of direct acting antiviral agents intended for treatment of chronic Hepatitis C - First version

Adopted Reference Number: EMEA/CHMP/EWP/30039/2008 Legal effective date: 01/11/2009

Overview of comments received on draft guideline on the clinical evaluation of direct acting antiviral agents intended for treatment of chronic Hepatitis C (EMEA/CHMP/EWP/30039/2008)

Reference Number: EMEA/CHMP/EWP/144962/2009

Draft guideline on the clinical evaluation of direct acting antiviral agents intended for treatment of chronic Hepatitis C

Draft: consultation closed Reference Number: EMEA/CHMP/EWP/30039/2008

Concept paper on the clinical development of medicinal products for the treatment of Hepatitis C infection

Reference Number: EMEA/CHMP/EWP/156308/2007