FDA Hepatitis Update - Revised draft guidance on clinical development of treatment for chronic hepatitis C

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Title: FDA Hepatitis Update - Revised draft guidance on clinical development of treatment for chronic hepatitis C

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The Food and Drug Administration (FDA) has published draft guidance to assist sponsors in the clinical development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C (CHC) from the initial pre­-investigational new drug application (pre-IND) through the new drug application (NDA) and postmarketing stages.

You can read the draft guidance at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM225333.pdf

Although comments on guidance may be submitted at any time, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, please  submit either electronic or written comments on the draft guidance by December 23, 2013.

Comments may be submitted electronically at http://www.regulations.gov. Alternatively, written comments can be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

This guidance revises the draft guidance for industry entitled “Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment” issued in September 2010. Significant changes in this revision include:

• Details on phase 2 and phase 3 trial design options for the evaluation of interferon (IFN)-free and IFN-containing regimens in treatment-naïve and treatment-experienced populations, including DAA-experienced populations.
• Revised primary endpoint to sustained virologic response at 12 weeks post-treatment cessation.
• Greater emphasis on DAA drug development in special populations including trial design options for human immunodeficiency virus/hepatitis C virus co-infected patients, patients with decompensated cirrhosis, and patients pre- or post-liver transplant.
• More details on clinical virology considerations for DAA drugs.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

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