FDA Finalizes Guidance on Developing DAA Drugs for Hepatitis C

This week the Food and Drug Administration (FDA) announced the availability of a guidance for industry on developing direct-acting antiviral (DAA) drugs to treat hepatitis C virus (HCV) infection. Notice was published in the Federal Register on November 6, 2017.

The purpose of the guidance, entitled “Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment,” is to assist sponsors in the clinical development of DAA drugs for the treatment of chronic HCV from the pre-investigational new drug application (pre-IND) stage through the new drug application (NDA) and post-marketing stages. Important issues addressed in this guidance include: trial design options, choice of noninferiority margins for active-controlled phase 3 trials in the evaluation of interferon (IFN)-free regimens, and trial design options and safety evaluations for specific populations including patients with decompensated cirrhosis, patients either pre- or post-liver transplant, and patients with chronic kidney disease and clinical virology considerations.

This guidance finalizes the draft guidance of the same name issued on May 4, 2016 and on which FDA sought comment. The guidance published this week took into consideration comments received on that draft guidance. 

This development supports strategies and actions set forth in the National Viral Hepatitis Action Plan, which calls for conducting research leading to new or improved viral hepatitis vaccines, diagnostic tests, and treatments and the optimal use of existing tools to prevent, detect, and treat viral hepatitis as well as supporting the research and development of new HCV therapies that are safer, more effective, and accessible for a larger proportion of persons with HCV.