MAY-02-12 The Hepatitis C Drug Development Advisory Group's (HCV DrAG) Definitions and Nomenclature Working Group (DNWG) presented a poster titled "Consensus Recommendations for Virologic Nomenclature in DAA Clinical Trials" at the 2012 European Association for the Study of the Liver (EASL) meeting in Barcelona, Spain. The work presented in this poster is in response to the need for a more intuitive and flexible virologic nomenclature capable of adapting to continuing advances in HCV drug development. Assistance in standardization was provided by members of the HCV DrAG, a project of the Forum for Collaborative HIV Research with participation from the American Association of Liver Diseases, European Association for the Study of Liver Diseases and the Infectious Diseases Society of America.
The proposed virologic response terminology for key decision points in trials (with and without lead-in treatment) is based on assay–specified lower limit of quantitation cut-off. This allows responses to be categorized as either quantifiable or unquantifiable HCV RNA, with unquantifiable responses further divided based on whether target HCV RNA was detected or not detected. The unified reporting recommendations will facilitate interpretation of results across clinical trials and greatly simplify and facilitate future adaptations of virologic response terms in HCV trials, especially as time-critical treatment parameters are shortened. The proposed nomenclature will also be helpful in developing treatment guidelines for use in clinical practice.
