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.


Posted on the EMA website on 7 July 2016