FDA: Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment

This guidance provides recommendations for the development of direct-acting antiviral agents (DAAs) regulated within the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA) for the treatment of chronic hepatitis C (CHC) infection. For the purpose of this guidance, we define direct-acting hepatitis C virus (HCV) antivirals as agents that interfere with specific steps in the HCV replication cycle through a direct interaction with the HCV polyprotein and its cleavage products.