MATERIALS AND LINKS Meeting Information: Agenda Participant List Presentations: Veronica Miller Jeffrey Murray  Nina Mani  Ira Jacobson  Filip Josephson  Jules Levin Discussion: Discussion Slide

Background:

Approval of two direct acting antivirals (DAAs) has resulted in a new standard of care for treating and possibly "curing" hepatitis C viral (HCV) infection. This in turn has meant a rethinking of the control arm for trials of investigational DAAs, either with or without pegIFN and ribavirin, both within the US and abroad where these approved drugs may not be/become available. 

The October 18, 2011 meeting sponsored by the Forum was designed to facilitate consensus on issues with the choice of control arm in HCV trials and was attended by representatives from regulatory agencies (US, EMA, Health Canada), NIH, academia, pharmaceutical companies, and patient advocates.

Objectives:
1. Clarify the role of the peg-interferon/ribavirin control arm in DAA
    trials
2. Discuss of the role and composition of the control arm in interferon-free DAA only  combination
    trials, either with or without ribavirin
3. Discuss the impact of availability or lack thereof,  of approved DAAs as well peg-interferon/ribavirin
    in DAA trials conducted internationally

Status:
The meeting was held on Tuesday, October 18, 2011 at UC Washington Center, Washington DC.