title: Hepatitis C RNA assay differences in results: Potential implications for shortened therapy and determination of Sustained Virologic Response.
abstract: Approval of Ledipasvir/Sofosbuvir for the treatment of chronic hepatitis C (HCV) includes the truncation of therapy from 12 to 8 weeks in treatment naïve, non-cirrhotic patients with baseline HCV RNA levels <6 million IU/mL (6.8 log10 IU/mL). The aim of this study was to evaluate this clinical cutoff with a different widely used commercially available HCV RNA test. Results from samples tested prospectively with Roche High Pure TaqMan HCV 2.0 test (HPS) were compared to those tested retrospectively with the Abbott RealTime HCV RNA test (ART). Using 6 million IU/mL as the cut-off, pre-treatment results were concordant in 70.4% of cases. When results with the same test measured at screening and baseline, clinical decisions could be impacted in 14.4% and 6.2% of cases for HPS and ART respectively. Using only HCV RNA cutoff of 6 million IU/mL, 29.55% of subjects would receive a different and potentially incorrect treatment duration based solely on HCV RNA test method used. A further 6-14% of subjects would have treatment decision change based on the day the sample was taken.
authors.affiliation: Abbott Laboratories, Abbott Park, IL, USA.
authors.forename: Gavin
authors.initials: G
authors.lastname: Cloherty
authors.affiliation: National Reference Center for Viral Hepatitis B, C and delta, Hopital Henry Mondor, Université Paris-Est, Créteil, France.
authors.forename: Stephane
authors.initials: S
authors.lastname: Chevaliez
authors.affiliation: Medizinische Klinik 1, Universitätsklinikum Frankfurt, Frankfurt am Main, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Sarrazin
authors.affiliation: Abbott Laboratories, Abbott Park, IL, USA.
authors.forename: Christine
authors.initials: C
authors.lastname: Herman
authors.affiliation: Abbott Laboratories, Abbott Park, IL, USA.
authors.forename: Vera
authors.initials: V
authors.lastname: Holzmayer
authors.affiliation: Abbott Laboratories, Abbott Park, IL, USA.
authors.forename: George
authors.initials: G
authors.lastname: Dawson
authors.affiliation: Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Medizinische Hochschule Hannover, Hannover, Germany.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Maasoumy
authors.affiliation: Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Medizinische Hochschule Hannover, Hannover, Germany.
authors.forename: Johannes
authors.initials: J
authors.lastname: Vermehren
authors.affiliation: Medizinische Klinik 1, Universitätsklinikum Frankfurt, Frankfurt am Main, Germany.
authors.forename: Heiner
authors.initials: H
authors.lastname: Wedemeyer
authors.affiliation: Toronto Centre for Liver Disease, Sandra Rotman Centre for Global Health, University of Toronto, Toronto, ON, Canada.
authors.forename: Jordan J
authors.initials: JJ
authors.lastname: Feld
authors.affiliation: National Reference Center for Viral Hepatitis B, C and delta, Hopital Henry Mondor, Université Paris-Est, Créteil, France.
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Pawlotsky
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics*; D019698:Hepatitis C, Chronic / Q000175:diagnosis / Q000188:drug therapy / Q000821:virology*; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods / Q000592:standards; D012367:RNA, Viral; D012372:ROC Curve; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods / Q000592:standards; D012680:Sensitivity and Specificity; D019562:Viral Load / Q000379:methods*
chemical_list: D000998:Antiviral Agents; D012367:RNA, Viral