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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
English (EN) (139.06 KB - PDF)
Document history - Revision 1
Draft guideline on the clinical evaluation of direct acting antivirals for the treatment of chronic hepatitis - Revision 1
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.
English (EN) (201.83 KB - PDF)
Draft guideline on clinical evaluation of medicinal products for the treatment of chronic hepatitis C
English (EN) (223.02 KB - PDF)
Concept paper on the need for revision of the guideline on the clinical development of medicinal products for the treatment of Hepatitis C
English (EN) (75.17 KB - PDF)
Document history - First version (current)
Guideline on the clinical evaluation of direct acting antiviral agents intended for treatment of chronic Hepatitis C - First version
English (EN) (139.06 KB - PDF)
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)
English (EN) (305.49 KB - PDF)
Draft guideline on the clinical evaluation of direct acting antiviral agents intended for treatment of chronic Hepatitis C
English (EN) (125.92 KB - PDF)
Concept paper on the clinical development of medicinal products for the treatment of Hepatitis C infection
English (EN) (37.6 KB - PDF)
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