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Home » FDA Updates Guidance on HCV Drug Development
FDA Updates Guidance on HCV Drug Development
May 9, 2016
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Revised draft guidance from the agency on direct-acting antiviral development introduced new recommendations for how to design clinical trials around interferon-free drug regimens as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.
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