The HCV Forum was initiated in 2007 and completed in 2017.

Background

The HCV Drug Development Advisory Group (HCV Forum, formerly the HCV DrAG) was 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 Forum provided a uniquely unbiased forum for discussion and consensus building on drug development-related issues.

Goal and Objectives

The goal of the HCV Forum was 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 Forum objectives were 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 all stakeholders.

Leadership

The HCV Forum Steering Committee represented the HCV Forum's constituent groups and determined issues that were appropriate for review by the Forum.  

HCV Forum Sponsors

The HCV Forum was funded through unrestricted donations from pharmaceutical and diagnostic companies. 

Working Groups

The HCV Forum consisted of a series of working groups that developed recommendations and provided guidance in the areas of drug resistance, clinical trial design and trial definitions.

Publications

Miller V, Harrington P, Howe A, Kieffer T, Lennerstrand J, Lenz O, Lontok E, McPhee F, Mo H, Parkin N, Pilot-Matias T. Reply. Hepatology (2016) 64 (2): 698‐699

Lontok E, Harrington P, Howe A, Kieffer T, Lennerstrand J, Lenz O, McPhee F, Mo H, Parkin N, Pilot-Matias T, Miller V. Hepatitis C Virus Drug Resistance-associated Substitutions: State of the Art Summary. Hepatology (2015) 62 (5):1623-1632

Panneer N, Lontok E, Branson BM, Teo CG, Dan C, Parker M, Stekler JD, DeMaria A Jr, Miller V. HIV and Hepatitis C virus Infection in the United States: Whom and How to Test. Clin Infect Dis. (2014) 59 (6):875-82

Hutchison C, Kwong A, Ray S, Struble K, Swan T, Miller V. Accelerating Drug Development Through Collaboration: The Hepatitis C Drug Development Advisory Group.Clinical Pharmacology and Therapeutics. 2014 June; doi:10.1038/clpt.2014.113

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. 

Wedemeyer H, Jensen DM, Godofsky E, Mani N, Pawlotsky JM, Miller V; Definitions/NomenclatureWorking Group* of the HCV DrAG (HCV Drug Development Advisory Group), under the auspices of the Forum for Collaborative HIV Research. Recommendations for standardized nomenclature and definitions of viral response in trials of hepatitis C virus investigational agents. Hepatology. 2012 Dec;56(6):2398-403. 

Clinically Relevant HCV Drug Resistance Mutations Figure and Tables
(Updated) HCV Phenotype Working Group, HCV Drug Development Advisory Group. Annals of the Forum for Collaborative HIV Research. 2012. Volume 14 (2): 1-10 

Kwong AD, Najera I, Bechtel J, Bowden S, Fitzgibbon J, Harrington P, Kempf D, Kieffer TL, Koletzki D, Kukolj G, Lim S, Pilot-Matias T, Lin K, Mani N, Mo H, O'Rear J, Otto M, Parkin N, Pawlotsky JM, Petropoulos C, Picchio G, Ralston R, Reeves JD, Schooley RT, Seiwert S, Standring D, Stuyver L, Sullivan J, Miller V; Forum for Collaborative Human Immunodeficiency Virus Research; HCV Drug Development Advisory Group (HCV DRAG); Sequence Analysis Working Group (SAWG); Phenotype Analysis Working Group (PAWG). Sequence and phenotypic analysis for resistance monitoring in hepatitis C virus drug development: recommendations from the HCV DRAG. Gastroenterology. 2011 Mar;140(3):755-60.