FDA Guidance on Hep C Drug Development

FDA has released a guidance on “Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment.” The document covers the development of such products, including clinical trial designs, from the pre-IND through the NDA and postmarketing stages. The agency defines direct-acting hepatitis C virus (HCV) antivirals as drugs that interfere with specific steps in the HCV replication cycle through direct interaction with the HCV genome, polyprotein, or polyprotein cleavage products. The guidance does not address drugs that target host functions necessary for viral replication or of immune-based drugs for the treatment of HCV infection such as new interferon drugs. It also does not address treatment of acute hepatitis C or the use of therapeutics without antiviral mechanisms intended to mitigate or reverse clinical or pathophysiological outcomes of chronic hepatits C, such as prevention of hepatocellular carcinoma or reversal of fibrosis.