title: Rapid virological response assessment by Abbott RealTime hepatitis C virus assay for predicting sustained virological responses in patients with hepatitis C virus genotype 1 treated with pegylated-interferon and ribavirin.
abstract: The lower limits of virus detection of hepatitis C virus (HCV) RNA detection assays are continuously improving. We aimed to assess the utility of more precise definition of 4(th) week viral load [rapid virological response (RVR)] in predicting sustained virological response (SVR) in HCV genotype 1 patients treated with pegylated-interferon (PEG-IFN) and ribavirin. Clinical data of treatment-naïve HCV genotype 1 patients were retrospectively collected from 2009 to 2014. Patients were grouped according to 4(th) week viral load as follows: undetectable (n = 90) and detectable but not quantifiable (< 12 IU/mL, n = 27). All patients received PEG-IFNα-2a or -2b and ribavirin for 24 weeks. Serum HCV RNA levels were measured by Abbott RealTime (ART; Abbott Molecular, Abbott Park, IL, USA) HCV assay. SVR was 95.5% and 63% in the undetectable group and < 12 IU/mL group of 4(th) week viral load, respectively. The between-group difference in SVR was significant (p < 0.001). We determined 4(th) week viral load was independently associated with SVR (odds ratio = 19.28; p = 0.002) and a good predictor of SVR [area under the curve (AUC) = 0.775; p = 0.001]. ART HCV assays had a stronger SVR predictive value in HCV genotype 1 patients, indicating that only the undetectable group of 4(th) week viral load patients measured by ART HCV assay should be considered for shorter treatment time (24 weeks) with PEG-IFN and ribavirin.
authors.affiliation: Department of Gastroenterology, Changhua Christian Hospital, Changhua, Taiwan, ROC.
authors.forename: Pei-Yuan
authors.initials: PY
authors.lastname: Su
authors.affiliation: Department of Gastroenterology, Changhua Christian Hospital, Changhua, Taiwan, ROC.
authors.forename: Hsu-Heng
authors.initials: HH
authors.lastname: Yen
authors.affiliation: Department of Gastroenterology, Changhua Christian Hospital, Changhua, Taiwan, ROC.
authors.forename: Yu-Chun
authors.initials: YC
authors.lastname: Hsu
authors.affiliation: Department of Gastroenterology, Changhua Christian Hospital, Changhua, Taiwan, ROC.
authors.forename: Shun-Sheng
authors.initials: SS
authors.lastname: Wu
authors.affiliation: Internal Medicine Research Center, Changhua Christian Hospital, Changhua, Taiwan, ROC.
authors.forename: Chew-Teng
authors.initials: CT
authors.lastname: Kor
authors.affiliation: Department of Gastroenterology, Changhua Christian Hospital, Changhua, Taiwan, ROC; School of Medicine, Chung Shan Medical University, Taichung, Taiwan, ROC. Electronic address: u9883002@cmu.edu.tw.
authors.forename: Wei-Wen
authors.initials: WW
authors.lastname: Su
mesh_terms: D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics*; D019698:Hepatitis C, Chronic / Q000097:blood / Q000188:drug therapy* / Q000821:virology*; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D012372:ROC Curve; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods*; D011994:Recombinant Proteins / Q000627:therapeutic use; D012254:Ribavirin / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a
keywords: Abbott RealTime hepatitis C virus assay; Hepatitis C virus; Rapid virological response; Sustained virological response