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

The purpose of this guidance is to assist sponsors in the clinical development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C (CHC) from the preinvestigational new drug application (pre-IND) through the new drug application (NDA) and postmarketing stages. For the purposes of this guidance, we define direct-acting hepatitis C virus (HCV) antivirals as drugs that interfere with specific steps in the HCV replication cycle through a direct interaction with the HCV genome, polyprotein, or its polyprotein cleavage products. Specifically, this guidance addresses the FDA’s current thinking regarding the overall development program and clinical trial designs to support DAA drugs. This draft guidance is intended to serve as a focus for continued discussions among the Division of Antiviral Products (DAVP), pharmaceutical sponsors, the academic community, and the public. The organization of the guidance parallels the development plan for a particular drug or biologic.