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

摘要

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. This guidance is intended to serve as a focus for continued discussions among the review divisions, pharmaceutical sponsors, the academic community, and the public. The organization of the guidance parallels the development plan for a particular drug or biologic. This guidance does not address the development of immune-based agents for the treatment of HCV infection such as new interferon products. Therapeutics without antiviral mechanisms intended to mitigate or reverse clinical or pathophysiological outcomes of CHC, such as prevention of hepatocellular carcinoma (HCC), reversal of fibrosis, or treatment of acute hepatitis C, are not addressed in this guidance.