Advancing HCV Drug Development: A Collaborative Approach

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DEC-06-10 A public meeting on HCV drug development was held Monday, December 6, 2010, in Washington, DC.

Materials and Links

Partcipant Survey Responses

Veronica Miller
Jeff Murray
Leonard Seef
Ann Kwong
Filip Josephson
Peyton Meyers
Ira Jacobson
Jean-Michel Pawlotsky

Click here to view the meeting webcast

The Forum sponsored a Public Meeting to discuss HCV drug development. New trial information presented at AASLD, draft FDA guidance and recent opinions from EMA have provided the necessary background to discuss trial designs with direct acting antivirals (DAAs) for treatment of chronic HCV infection.

The Forum held this meeting to obtain public comments regarding future trial designs and endpoints, including evaluation of interferon and/or ribavirin sparing regimens and the use of two or more DAAs in treatment-naïve and treatment-experienced trials and in special populations. Additional issues encountered during the drug development process were also discussed.

The Forum brought together stakeholders from industry, patient advocates, academia, and regulators to discuss issues in clinical development of DAAs.

The Steering Committee for this project includes:

Ann Kwong - Vertex
Dale Kempf - Abbott
Filip Josephson - EMA
Ira Jacobson - Cornell University, School of Medicine
Isabel Najera - Roche
Jean-Michel Pawlotsky - Henri Mondor Hospital
Jules O'Rear - FDA
Jur Strobos - Forum for Collaborative HIV Research
Kimberly Struble - FDA
Nina Mani -Forum for Collaborative HIV Research
Stuart Ray - Johns Hopkins University, School of Medicine
Tracy Swan - Treatment Action Group
Veronica Miller - Forum for Collaborative HIV Research