NOV-2-10 The Fifth HCV Drug Resistance Advisory Group (HCV DRAG) meeting was held to discuss a number of topics related to clinical development of small molecule DAAs as well as combinations of DAAs, and issues in Special Populations.

 

Background:

Materials and Links Agenda Participant List Presentations: Dale Kempf - Introduction Gaston Picchio - HCV RNA Viral Load Assays: Consensus on how to report results Jeff Murray - Bridging the Data Gap: From Discovery to Approval Mark Antell - People with Bleeding Disorders and HCV Dale Kempf - Notes

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 fifth HCV DRAG meeting was held on November 2, 2010.

  HCV RNA Viral Load Assays:Consensus on how to report results

The Steering Committee for this project includes:

Ira Jacobson - Cornell University, School of Medicine
Dale 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