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MATERIALS AND LINKS Meeting Information: Agenda Participant List Presentations: Opening Nina Mani
Review of Meeting Goals Donald Jensen Veronica Miller Heiner Wedemeyer Session 1 Isabel Najera (Moderator) Veronica Miller (Moderator) Richard Barnard Fiona McPhee Matthias Gotte Neil Parkin Patrick Harrington Jacqueline Reeves Tara Kieffer Leen-Jan vanDoorn Session 2 Jean-Michel Pawlotsky (Moderator) John Sullivan-Bolyai (Moderator) Douglas Dieterich Patrick Harrington Eric Hughes Filip Josephson Johan Lennerstrand Patrick Harrington Luis Mendao Kim Struble Bill Symonds Session 3 Donald Jensen (Moderator) Heiner Wedemeyer (Moderator) Filip Josephson Gaston Picchio Kim Struble Tracy Swan Session 4 Geoff Dusheiko (Moderator) Robert Kauffman (Moderator) Barry Bernstein Xavier Forns Patrick Harrington Filip Josephson Kim Struble Tracy Swan Session 5 Veronica Miller (Moderator) Carol Brosgart Donald Jensen Luis Mendao Jean-Michel Pawlotsky Session 6 Veronica Miller (Moderator) Carol Brosgart Donald Jensen Sandra Lehrman Jean-Michel Pawlotsky Tracy Swan Session 7 Veronica Miller (Moderator) Douglas Mayers Jean-Michel Pawlotsky Kim Struble Tracy Swan
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APR-17-12 On April 17th, the Forum for Collaborative HIV Research convened the 8th HCV Drug Development Advisory Group (DrAG) Meeting in Barcelona, in conjunction with the 47th annual European Association for the Study of the Liver (EASL) conference.
The meeting focused on a range of issues including a brief discussion of the EASL poster and submitted Hepatology manuscript on DrAG recommended virologic response nomenclature (Nomenclature and Definitions Working Group). All companies and academics publishing data from HCV trials are asked to start using the suggested nomenclature so that meaningful and reliable data analysis can be performed across trials going forward.
The Phenotype Working Group announced their readiness to move forward with publication of the figure and table detailing HCV drug resistance mutations for approved and investigational DAAs in the Forum’s online publication, Annals of the Forum for Collaborative HIV Research. The materials will be available by mid-June, 2012.
Other discussion topics included inclusion/exclusion criteria for treatment experienced subjects in trials; the definition of interferon incapable/intolerant subjects; and drug-drug interaction studies required at time of NDA submission. To allow for meaningful comparisons between results from different HCV treatment outcome databases worldwide, members stressed the need for harmonization with regard to the categories and temporality of data capture in the databases.
The meeting ended with a discussion of the future research and public health agenda for HCV prevention and treatment.
Two proposed future HCV roundtables on inclusion of intravenous drug users in trials and evaluating cause of liver-related injury among patients with chronic HCV trials were received favorably.
65 individuals representing regulatory agencies, industry, academia, treatment, and advocacy, attended the meeting.
Background:
The
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.
The goal of HCV DrAG is to bring together parties interested in and
working on various aspects of HCV drug/biologic drug development on a
continuing basis to discuss issues pertinent in the field.
Objectives:
The DrAG objectives are to produce consensus recommendations on a variety of issues in HCV drug/biologic development ranging from appropriate methodology for HCV resistance testing to providing scientific guidance for clinical trial design by facilitating discussions among all stakeholders (industry, academia, patient advocates and regulatory agencies)..
Status:
The meeting was held on Tuesday, April 17, 2012 at the AC Hotel Barcelona Forum in Barcelona, Spain.
The Steering Committee for this project includes:
Patrick Harrington, PhDDaria Hazuda, PhD
Ira Jacobson, MD
Donald Jensen, MD, FACP
Filip Josephson, MD, PhD
*Robert Kaufmann, MD, PhD
Ann Kwong, PhD
Nina Mani, PhD, MPH
Veronica Miller, PhD
Jeffrey Murray, MD, MPH
Isabel Najera, PhD
*Jean-Michel Pawlotsky, MD, PhD
Stuart Ray, MD
Kimberly Struble, PharmD
Tracy Swan
Heiner Wedemeyer, MD
* Co-Chairs
** Past Co-Chair
