FDA published a final guidance on Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment. The guidance can be found at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm225333.pdf
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 This guidance finalizes the draft guidance of the same name issued in May 2016.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.