HCV Drug Development Advisory Group
The HCV Drug Development Advisory Group (DrAG)
is an outgrowth of a proposal from the 1st International Workshop on Hepatitis
C: Resistance and New Compounds in October 2006. Composed of representatives
from the U.S. and European regulatory agencies, academia, patient advocates and
industry, the HCV DrAG provides a uniquely unbiased forum for discussion and
consensus building on drug development-related issues.
Goal and Objectives
The goal of the HCV DrAG is to bring together parties interested in and
working on various aspects of HCV drug development on a continuing basis to
discuss issues pertinent in the field. The HCV DrAG objectives are to produce
consensus recommendations on a variety of issues in HCV drug development
ranging from appropriate methodology for HCV resistance testing to providing
scientific guidance for clinical trial design by facilitating discussions among
The HCV DrAG Steering Committee represent the DrAG's constituent groups and
determines issues that are appropriate for review by the DrAG.
HCV DrAG Sponsors
The HCV DrAG is funded through unrestricted donations from pharmaceutical
and diagnostic companies.
The HCV DrAG consists of a series of working groups that develop recommendations and provide guidance in the areas of drug resistance, clinical trial design and trial definitions. Current working groups of the HCV DrAG include: Drug Resistance Working Group, Educational Slide Set Working Group, Definitions Working Group, and Clinical Working Group.
Lontok E, Mani N, Harrington PR, Miller V. Closing in on the target: sustained
virologic response in hepatitis C virus genotype 1 infection response-guided
therapy. Clinical Infectious Diseases. 2013 May;56(10):1466-70.
The HCV DrAG convenes twice a year to discuss emerging issues in the field of HCV drug development. See below for more information on the most recent DrAG meeting.