title: Abbott RealTime PCR assay is useful for evaluating virological response to antiviral treatment for chronic hepatitis C.
abstract: This study was done to evaluate the utility of the Abbott RealTime PCR assay (ART) for the monitoring of chronic hepatitis C patients. The serum samples of 183 patients infected with hepatitis C virus (HCV) genotype 1b who had completed a 48-week period of pegylated interferon (PEG-IFN) alpha-2b plus ribavirin treatment were prospectively analyzed. Serum HCV RNA levels were measured both by ART and by the Roche COBAS Amplicor Monitor test, version2.0 (CAM) at baseline and at weeks 4, 12, 24, 36, and 48 of treatment, and at 24 weeks after the end of treatment (EOT). A significant positive correlation of pretreatment HCV RNA levels was found between ART and CAM (r = 0.595, P < 0.0001). Of the 183 patients, 66 (36.0%) achieved a sustained virological response (SVR). The logarithmic decline of the HCV RNA level from the pretreatment level determined by ART in SVR patients was significantly higher than that in non-SVR patients at all time points tested. The logarithmic decline determined by CAM in SVR patients was significantly higher than that in non-SVR patients only at week 4, but there was no significant difference at other weeks. Of 124 patients who were HCV RNA-negative at EOT by ART, 58 (46.8%) had a relapse of viremia at 24 weeks after EOT, whereas 77 of 143 patients (53.8%) who were HCV RNA-negative at EOT by CAM had a relapse. The relapse rate was lower when determined by ART than by CAM, but not significantly so. ART is more useful than CAM for evaluating the virological response to antiviral treatment for chronic hepatitis C.
authors.affiliation: Department of General Internal Medicine, Kyushu University Hospital, Higashi-Ku, Fukuoka 812-8582, Japan. ikezaki@gim.med.kyushu-u.ac.jp
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Ikezaki
authors.forename: Norihiro
authors.initials: N
authors.lastname: Furusyo
authors.forename: Takeshi
authors.initials: T
authors.lastname: Ihara
authors.forename: Takeo
authors.initials: T
authors.lastname: Hayashi
authors.forename: Eiichi
authors.initials: E
authors.lastname: Ogawa
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Toyoda
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Taniai
authors.forename: Mosaburo
authors.initials: M
authors.lastname: Kainuma
authors.forename: Masayuki
authors.initials: M
authors.lastname: Murata
authors.forename: Jun
authors.initials: J
authors.lastname: Hayashi
mesh_terms: D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D005260:Female; D016174:Hepacivirus / Q000235:genetics*; D019698:Hepatitis C, Chronic / Q000097:blood / Q000188:drug therapy* / Q000821:virology*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000627:therapeutic use; D012367:RNA, Viral / Q000097:blood; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods*; D011994:Recombinant Proteins / Q000627:therapeutic use; D012254:Ribavirin / Q000627:therapeutic use; D018709:Statistics, Nonparametric; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects / Q000379:methods
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