NOV-3-09 The Fourth HCV Drug Resistance Advisory Group (HCV DRAG) meeting was held to discuss HCV drug resistance issues for directly acting antivirals in clinical trials. 

 

Background:

Materials and Links Agenda Participant List Presentations: Dale Kempf - Introduction Russ Fleischer - FDA Perspectives Michelle Berrey - Considerations for trials with two or more DAA Isabel Najera - Recommendations from the Phenotype Analysis Working Group Lynda Dee - US HCV EAP Characteristics Rafael Crabbe - Clinial Trials in Special Patient Populations

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:

The fourth HCV DRAG meeting was held on November 3, 2009.

UPCOMING: Select members of the HCV DRAG group will be hosting "Frontiers in Drug Development for Viral Hepatitis Education Roundtable" on December 8, 2009 at the HEP DART Conference being held in Hawaii from 6-10 December.

 

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
Nathalie Morgensztejn - EMEA

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