BioCentury
ARTICLE | Politics & Policy

FDA updates HCV guidance

May 4, 2016 1:42 AM UTC

FDA released new draft guidance on developing direct-acting antivirals (DAAs) for HCV. The guidance now reflects the availability of interferon (IFN)-free or IFN-sparing regimens as standard-of-care. The document revises draft guidance released in October 2013, when there were no approved IFN-free HCV regimens.

The new guidance recommends against studying an IFN-containing regimen in a DAA treatment-naive population, and sections of the guidance have been modified to focus on IFN-free DAA regimens. The document also includes more details on Phase II and III trial designs to evaluate IFN-free regimens, and specifies that sponsors should conduct at least one active-control, Phase III study comparing an investigational compound with an approved HCV therapy. ...