title: Real-time PCR assays for hepatitis C virus RNA (genotype 1) is useful for evaluating virological response to the treatment with peginterferon-alpha2b and ribavirin.
abstract: BACKGROUND
  The real-time PCR, such as Abbott RealTime assay, have replaced end-point PCR, such as Amplicor assays, for the measurement of HCV RNA. However, 'response-guided therapy' to use on-treatment response for tailoring the duration of treatment with peginterferon-alpha and ribavirin has not been fully evaluated for real-time PCR.
  
  
  METHODS
  43 patients with HCV genotype 1 (24 who had complete early virological responses (cEVR) on Amplicor assay and received 48-week therapy, and 19 who had late virological responses (LVR) and received 72-week therapy) were recruited. Using a RealTime assay, we retrospectively measured HCV RNA in stored sera.
  
  
  RESULTS
  In 10 samples obtained during therapy, HCV RNA was undetectable on the Amplicor assay, but detectable on the RealTime assay. Among patients with cEVR on the Amplicor assay, those with detectable HCV RNA on the RealTime assay at week 12 were less likely to have a sustained virological response (SVR) than those without (2/4 vs 17/20, p = 0.116). Among patients with LVR on the Amplicor assay, those with HCV RNA detectable on the RealTime assay at week 24 were significantly less likely to have SVR than those without (1/4 vs 12/15, p = 0.041).
  
  
  CONCLUSIONS
  The RealTime assay may be useful for tailoring duration of treatment for the patient with HCV genotype 1.
authors.affiliation: Department of Hepatology, Osaka City University, Graduate School of Medicine, Japan.
authors.forename: Mika
authors.initials: M
authors.lastname: Nakaya
authors.affiliation: Department of Hepatology, Osaka City University, Graduate School of Medicine, Japan.
authors.forename: Masaru
authors.initials: M
authors.lastname: Enomoto
authors.affiliation: Department of Hepatology, Osaka City University, Graduate School of Medicine, Japan.
authors.forename: Hideki
authors.initials: H
authors.lastname: Fujii
authors.affiliation: Department of Hepatology, Osaka City University, Graduate School of Medicine, Japan.
authors.forename: Sawako
authors.initials: S
authors.lastname: Kobayashi
authors.affiliation: Department of Hepatology, Osaka City University, Graduate School of Medicine, Japan.
authors.forename: Shuji
authors.initials: S
authors.lastname: Iwai
authors.affiliation: Department of Hepatology, Osaka City University, Graduate School of Medicine, Japan.
authors.forename: Hiroyasu
authors.initials: H
authors.lastname: Morikawa
authors.affiliation: Department of Hepatology, Osaka City University, Graduate School of Medicine, Japan.
authors.forename: Akihiro
authors.initials: A
authors.lastname: Tamori
authors.affiliation: Department of Hepatology, Osaka City University, Graduate School of Medicine, Japan.
authors.forename: Hiroki
authors.initials: H
authors.lastname: Sakaguchi
authors.affiliation: Department of Hepatology, Osaka City University, Graduate School of Medicine, Japan.
authors.forename: Norifumi
authors.initials: N
authors.lastname: Kawada
mesh_terms: D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000145:classification / Q000235:genetics*; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D012367:RNA, Viral / Q000032:analysis*; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods*; D011994:Recombinant Proteins / Q000008:administration & dosage; D012189:Retrospective Studies; D012254:Ribavirin / Q000008:administration & dosage*
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b