A final guidance on Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment recently published. The guidance can be found athttps://www.fda.gov/ucm/
This guidance assists sponsors in the clinical development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C (CHC) from the pre-investigational new drug application stage through the new drug application and post-marketing stages. This guidance finalizes the draft guidance of the same name issued in May 2016. Major changes from the draft include the following:
This guidance assists sponsors in the clinical development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C (CHC) from the pre-investigational new drug application stage through the new drug application and post-marketing stages. This guidance finalizes the draft guidance of the same name issued in May 2016. Major changes from the draft include the following:
- Modification of several sections to focus on interferon-free DAA regimens.
- Additional clarification on trial designs for combinations of investigational DAAs with or without ribavirin.
- Additional clarification on the recommended trial population to include patients with clinical or laboratory evidence of CHC disease.
- Additional details on DAA drug development in patients with decompensated cirrhosis.
- Additional clarification on efficacy endpoints.
Office of Health and Constituent Affairs
Food and Drug Administration
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
Division of Antiviral Products
Food and Drug Administration
Visit the FDA Patient Network for more Information about the Hepatitis Liaison Program
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