Clinical Virology Support for HCV Drug Development
Yupeng He, Liangjun Lu and Akhteruzzaman Molla
from: Hepatitis C: Antiviral Drug Discovery and Development (Edited by: Seng-Lai Tan and Yupeng He). Caister Academic Press, U.K. (2011)
Clinical virology studies are integral to the antiviral drug development and approval process by providing critical information and guidance to allow optimal trial designs, timely treatment decisions, and effective therapy monitoring. A main focus and high priority of clinical virology research is to monitor and characterize the development of viral drug resistance in drug-treated patients. Numerous viral titer, subtype, genotypic (sequencing) and phenotypic assays, both certified and investigational, are currently available for HCV clinical virology usage. Genotypic and phenotypic analyses of baseline, on- and post-treatment clinical samples are critical to detection and monitoring of drug resistance. Characterization of drug resistance in vitro helps to guide design of clinical studies and help predict or interpret in vivo drug resistance. In this chapter we discuss standard guidelines for HCV clinical virology, followed by a review of the different assays and methods required for a clinical virology study. In the last part, we discuss in vitro HCV antiviral drug resistance study methods and results, and their implications for clinical studies read more ...