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

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Current effective version

Adopted guideline

Currently under revision - see below

Reference numberCHMP/EWP/30039/2008
Effective from01/11/2009
KeywordsHepatitis C, chronic hepatitis C (CHC), direct antivirals, interferon, ribavirin, transplantation, standard of care (SOC), hepatitis C virus (HCV) RNA
DescriptionThis document provides guidance on the clinical development of compounds for the treatment of chronic hepatitis C. It focuses on direct-acting anti-viral agents.

Document history

Revision 1

In progress

Draft guideline (second version)


Draft guideline

Concept paper

Published: 07/07/2016


Published: 14/02/2011

Published: 30/04/2010

First version

Current version

Adopted guideline

Overview of comments

Draft guideline

Concept paper

In operation: 01/11/2009–present

Published: 23/04/2009

Published: 24/04/2008

Published: 26/04/2007

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