title: Multi-center evaluation of the Abbott RealTime HCV assay for monitoring patients undergoing antiviral therapy for chronic hepatitis C.
abstract: BACKGROUND
  Hepatitis C virus (HCV) RNA monitoring during antiviral therapy is essential for early prediction of treatment success and failure to peginterferon alfa/ribavirin (PEG-IFN/RBV) therapy.
  
  
  OBJECTIVE
  In this multi-center study we assessed the clinical utility of the Abbott RealTime HCV assay for monitoring patients undergoing antiviral therapy for chronic infection with HCV genotypes (GT) 1-3.
  
  
  METHODS
  We analyzed serum from 361 patients with chronic hepatitis C who had been treated with PEG-IFN/RBV. The predictive value of rapid virologic response (RVR), partial (≥2log(10) decline) and complete (HCV-RNA undetectable) early virologic response (pEVR/cEVR) based on RealTime HCV for achieving sustained virologic response was evaluated. In addition, the utility of RealTime HCV to tailor treatment duration according to individual virologic responses was studied in a subset of 136 GT 1 patients and compared to the reference tests, Versant HCV Quantitative 3.0 (bDNA) and Qualitative (TMA) assay.
  
  
  RESULTS
  At week 4 of therapy, patients with RVR had a 100% and 93.5% probability to achieve an SVR in GT 1 and GT 2/3 patients, respectively. At week 12, patients who did not achieve a pEVR had a 97.2% and 100% probability of not achieving an SVR. In addition, assignment of GT 1 patients to abbreviated or extended treatment durations based on low baseline HCV-RNA (<800,000IU/mL) and RVR or pEVR was highly concordant between RealTime HCV and bDNA/TMA assays (97.8% and 91.9%, respectively).
  
  
  CONCLUSIONS
  The RealTime HCV assay is suitable for monitoring virologic response to PEG-INF/RBV therapy and tailoring treatment duration accordingly.
authors.affiliation: Medizinische Klinik 1, Klinikum der J.W. Goethe-Universität, Frankfurt am Main, Germany.
authors.forename: Johannes
authors.initials: J
authors.lastname: Vermehren
authors.forename: Ming-Lung
authors.initials: ML
authors.lastname: Yu
authors.forename: Alexander
authors.initials: A
authors.lastname: Monto
authors.forename: Joseph D
authors.initials: JD
authors.lastname: Yao
authors.forename: Christopher
authors.initials: C
authors.lastname: Anderson
authors.forename: Rasa
authors.initials: R
authors.lastname: Bertuzis
authors.forename: George
authors.initials: G
authors.lastname: Schneider
authors.forename: Christoph
authors.initials: C
authors.lastname: Sarrazin
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use; D016903:Drug Monitoring / Q000379:methods*; D005260:Female; D005838:Genotype; D060005:Genotyping Techniques; D016174:Hepacivirus / Q000235:genetics*; D019698:Hepatitis C, Chronic / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011933:Reagent Kits, Diagnostic; D012008:Recurrence; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D011933:Reagent Kits, Diagnostic