New DAA FDA Guidance March 2012

Provided by NATAP

Reported by Jules Levin

presented by Russell Fleischer, PA-C, MPH, Senior Clinical Analyst, Division of Antiviral Products, US Food and Drug Administration, at the AASLD special topic meeting March 16-17 2012 in Atlanta

You have attended this conference or know already about the talk. I have attached the slide presentation but you can view the webcast & hear the talk on the AASLD website in the Liver Learning Portal.

from Jules: The language used in this presentation makes it clear in general guidance is fluid but the FDA also clearly steps into new territory with this new guidance saying they will consider historical controls for IFN-free regimens in phase 3, but didn't go beyond that. Inclusion of specifically mentioned special populations are encouraged, see slides. The biopsy discussion is interesting.

I have highlighted immediately below key points & slides presented, followed by the full slide presentation.

"I want to briefly update you on some of the activities we are engaged in around updating our HCV DAA guidance and what these changes may mean for the future development of DAA therapies. At the end I will discuss fast track as Ray asked me too, and I think there are some misconceptions about what this designation actually means."

Phase 3 trials should enroll adequate numbers of patients representative of the disease demographics: "we want to see" African-Americans, Latinos, compensated Cirrhotics, and "we want to open the door to 2 populations typically excluded from clinical trials": IVDU/opiate substitution.

For IFN-contraindicated we understand you cant randomize them to interferon "so if we have an IFN-free regimen thats going forward we are considering single arm historical control trials, if the phase 2 data is supportable of that approach, its probably only going to fly for really short duration regimens. This will work until 1 or 2 regimens are approved and then they will work as de facto standards of care, then we'll probably go with non-inferiority vs standard of care; another option would be an immediate vs deferred PBO controlled standard of care"

Continue to the Slide Presentation …