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Journal of Clinical Microbiology, February 2009, p. 385-389, Vol. 47, No. 2
0095-1137/09/$08.00+0 doi:10.1128/JCM.01753-08
Copyright © 2009, American Society for Microbiology. All Rights Reserved.
Abbott RealTime Hepatitis C Virus (HCV) and Roche Cobas AmpliPrep/Cobas TaqMan HCV Assays for Prediction of Sustained Virological Response to Pegylated Interferon and Ribavirin in Chronic Hepatitis C Patients 
Kentaro Matsuura,1,2
Yasuhito Tanaka,1*
Izumi Hasegawa,3
Tomoyoshi Ohno,3
Hiroshi Tokuda,4
Fuat Kurbanov,1
Fuminaka Sugauchi,2
Shunsuke Nojiri,2
Takashi Joh,2 and
Masashi Mizokami5
Department of Clinical Molecular Informative Medicine, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan,1 Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan,2 Department of Gastroenterology, Social Insurance Chukyo Hospital, Nagoya, Japan,3 Department of Internal Medicine, Nagoya City Johoku Hospital, Nagoya, Japan,4 Research Center for Hepatitis and Immunology, Kohnodai Hospital International Medical Center of Japan, Ichikawa, Japan5
Received 10 September 2008/ Returned for modification 15 November 2008/ Accepted 8 December 2008
Two commercial real-time PCR assays are currently available for sensitive hepatitis C virus (HCV) RNA quantification: the Abbott RealTime HCV assay (ART) and Roche Cobas AmpliPrep/Cobas TaqMan HCV assay (CAP/CTM). We assessed whether the two real-time PCR assays were more effective than Roche Cobas Amplicor HCV Monitor test, v.2.0 (CAM) for prediction of the sustained virological response (SVR) to pegylated interferon (PEG-IFN) plus ribavirin (RBV) in chronic hepatitis C. Sixty patients chronically infected with HCV genotype 1b (37 males and 23 females, 53 ± 12 years of age) were treated with PEG-IFN
2b plus RBV for 48 weeks. Stored specimens at nine time points for each patient (at baseline, on treatment, and 24 weeks after treatment) were tested by the two real-time PCR assays and CAM. Twenty-six (43.3%) patients reached SVR. The positive predictive values (PPVs) for SVR of undetectable HCV RNA at week 12 by CAM, ART, and CAP/CTM were 74.3%, 88.0%, and 95.2%, respectively. An undetectable HCV RNA level by CAM, ART, and CAP/CTM correctly predicted SVR at week 4 in 100%, 100%, and 100% of patients, at weeks 5 to 8 in 91.7%, 100%, and 100% of patients, at weeks 9 to 12 in 55.6%, 75%, and 87.5% of patients, and at weeks 13 to 24 in 0%, 26.7%, and 40% of patients, respectively. Of 16 patients who relapsed after treatment, HCV RNA was detectable in 2 patients at the end of treatment by CAP/CTM but undetectable by ART and CAM. HCV RNA tests using ART and CAP/CTM are considered to be more effective at predicting SVR than CAM, and the PPV for SVR was slightly higher in CAP/CTM than in ART.
* Corresponding author. Mailing address: Department of Clinical Molecular Informative Medicine, Nagoya City University Graduate School of Medical Sciences, Kawasumi, Mizuho, Nagoya 467-8601, Japan. Phone: 81-52-853-8292. Fax: 81-52-842-0021. E-mail: ytanaka{at}med.nagoya-cu.ac.jp
Published ahead of print on 17 December 2008.
Journal of Clinical Microbiology, February 2009, p. 385-389, Vol. 47, No. 2
0095-1137/09/$08.00+0 doi:10.1128/JCM.01753-08
Copyright © 2009, American Society for Microbiology. All Rights Reserved.
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