Rethinking the HCV roadmap

The regulatory environment for hepatitis C therapies is approaching an inflection point where decisions about clinical trial design requirements - or the failure to make them - could have a major impact on the development of new therapies.

Faced with a profusion of compounds in the clinic, including several poised to enter Phase III trials, and a complex, evolving medical environment, sponsors are looking to FDA for guidance about the populations they will need to study prior to approval, acceptable efficacy endpoints, and strategies for testing combinations of novel compounds. ...