The Food and Drug Administration (FDA) has published draft guidance to assist sponsors in the clinical development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C from the initial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

This guidance revises the draft guidance for industry entitled "Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment" issued in September 2010.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.

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