FDA Updates Guidance on HCV Drug Development

Companies developing direct-acting antiviral hepatitis C drugs should factor in interferon treatment when designing clinical trials, the FDA said last week.

Revised draft guidance from the agency on direct-acting antiviral development introduced new recommendations for how to design clinical trials around interferon-free drug regimens as well as the impact of combination regimens on patients suffering from a combination of HCV, HIV and chronic kidney disease. The guidance was last updated in 2013.

The new document provides additional details on how to design Phase 2 and Phase 3 trials for IFN-free drug regimens in newly diagnosed patients as well as those who have previously undergone HCV treatment.