MAR-30-11 The Sixth HCV Drug Development Advisory Group Meeting: Issues in Clinical Trial Design with DAAs was held to discuss a number of topics including issues in deep sequencing technologies and its possible clinical utility; development of a HCV drug resistance table and chart to facilitate drug resistance monitoring; a proposal for new clinical trial related definitions and nomenclature; issues in DAA combination trials; considerations for trials in HIV/HCV co-infected patients and in liver transplant patients; and ethical and feasibility issues in conducting trials in countries where new DAAs are approved or available.
Background:
Materials and LinksPresentations: |
The HCV Drug Resistance Advisory Group (HCV DRAG) is an outgrowth of a proposal from the 1st International Workshop on Hepatitis C: Resistance and New Compounds in October 2006.
Objectives:
The objective of the HCV DRAG is to bring together parties interested in and working in HCV drug resistance to continue discussions focused on issues pertinent to HCV drug/biologic development and resistance testing.
The goals are to produce consensus recommendations of appropriate methodology for HCV resistance testing for drug/biologic development and for clinical practice; and to provide scientific guidance to facilitate discussion between industry and regulatory agencies in areas of HCV drug resistance.
Status: HCV Drug Development Overview
The sixth HCV DrAG meeting was held on March 30, 2011 in Berlin, Germany.
The Steering Committee for this project includes:
Ira Jacobson - Cornell University, School of MedicineDale Kempf - Abbott
Ann Kwong - Vertex
Veronica Miller - Forum for Collaborative HIV Research
Filip Josephson- EMA
Isabel Najera - Roche
Jules O'Rear - FDA
Jean-Michel Pawlotsky - Henri Mondor Hospital
Stuart Ray - Johns Hopkins University, School of Medicine
Kimberly Struble - FDA
Tracy Swan - Treatment Action Group
