NOV-08-12  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.

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.

OCT-17-11   The October 17, 2011 meeting entitled "HCV Drug Access for People with Bleeding Disorders" was the first in a series of meetings that will try and address issues associated with providing access to, if indicated, combination interferon-free experimental direct acting antivirals (DAAs).

The meeting was sponsored by the Forum, and was attended by representatives from regulatory agencies, academia, hemophilia treatment centers, non-profits associated with database management for those affected with bleeding and blood clotting disorders, community medical practitioners, patient advocates and pharmaceutical companies.

OCT-18-11 The October 18, 2011 meeting sponsored by the Forum was designed to facilitate consensus on issues with the choice of control arm in HCV trials and was attended by representatives from regulatory agencies (US, EMA, Health Canada), NIH, academia, pharmaceutical companies, and patient advocates. 

MAR-30-11 The Sixth HCV Drug Development Advisory Group Meeting: Issues in Clinical Trial Design with DAAs was held to discuss a number of topics including issues in deep sequencing technologies and its possible clinical utility; development of a HCV drug resistance table and chart to facilitate drug resistance monitoring; a proposal for new clinical trial related definitions and nomenclature; issues in DAA combination trials; considerations for trials in HIV/HCV co-infected patients and in liver transplant patients; and ethical and feasibility issues in conducting trials in countries where new DAAs are approved or available.

MAR-04-11 The HCV DrAG's Sequence and Phenotypic Analysis for Resistance Monitoring in Hepatitis C Virus Drug Development: Recommendations From the HCV DRAG is published in the March 2011 issue of Gastroenterology. Full publication available through Gastroenterology.