Recommendations for standardized nomenclature and definitions of viral response in trials of hepatitis C virus investigational agents

摘要: Outdated virological response terms used at key trial timepoints in clinical trials with first-generation direct-acting antivirals plus pegylated interferon and ribavirin have failed to keep pace hepatitis C virus (HCV) drug development. A more intuitive flexible nomenclature capable of adapting continuing advances HCV development is needed. Assistance standardization the field was provided by members Hepatitis Virus Drug Development Advisory Group, a project Forum for Collaborative HIV Research participation from American Association Study Liver Diseases, European liver, Infectious Diseases Society America. Our proposed descriptive, decision points (with without lead-in treatment) based on an assay-specified lower limit quantitation cutoff. This allows responses be categorized as either quantifiable or unquantifiable RNA, further divided whether target RNA detected not detected. The unified reporting recommendations will facilitate interpretation results across validation new response-guided timepoints. As time-critical treatment parameters are shortened trials, greatly simplify future adaptations terms. also helpful developing guidelines use practice.