MATERIALS AND LINKS • Program • Participant List Presentations: • Veronica Miller • Richard J.O. Barnard • Gregory Dore • Jag Khalsa • Scott Holmberg • HCV Target

The Forum for Collaborative HIV Research convened the 9th HCV Drug Development Advisory Group (DrAG) Meeting in Boston, in conjunction with the 63rd annual American Association for the Study Liver Diseases (AASLD) conference.

The meeting focused on a broad range of issues and included a brief discussion on the importance of sensitive viral load cut-off values and timing of viral load measurements in interferon containing and interferon-free trials, and the role of resistance testing in trials and in the real world.

Clinician and advocacy perspectives were sought on the appropriate time for drug-drug interaction studies during drug development such that data obtained can be used to guide proper dosing of HCV investigational agents in diverse populations.  In the context of HIV co infection and well managed HIV infection, clinicians and patients discussed the degree of risk they were willing to take to treat the HCV infection.

The Clinical Working Group discussions included:

• Unveiling of a new international network to evaluate investigational HCV agents in IDUs, and federal research efforts that facilitate research in this population;
• Barriers (perceived and real) to recruiting IDUs in trials;
• The current status of SVR12 as a primary endpoint in trials and of control regimens in interferon-free trials was reaffirmed;
• Issues (trial-related: pre- and post-approval, drug labeling and reimbursement) that could facilitate access to interferon free agents for people who urgently need them.

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 wil be held on Thursday, November 8, 2012 at Fenway Health in Boston, MA.

The Steering Committee for this project includes:

Patrick Harrington, PhD
Daria 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