TY - JOUR
T1 - Comparison of the Abbott RealTime HCV and Roche COBAS Ampliprep/COBAS TaqMan HCV assays for the monitoring of sofosbuvir-based therapy
AU - Ogawa, Eiichi
AU - Furusyo, Norihiro
AU - Murata, Masayuki
AU - Shimizu, Motohiro
AU - Toyoda, Kazuhiro
AU - Hotta, Taeko
AU - Uchiumi, Takeshi
AU - Hayashi, Jun
N1 - Funding Information:
We are grateful to Takeo Hayashi, Fujiko Mitsumoto- Kaseida, Koji Takayama, Kazuya Ura and Sho Yamasaki for their assistance with data collection and to Yoshitaka Etoh for his excellent lab work from the Department of General Internal Medicine, Kyushu University Hospital. We are also grateful to Dongchon Kang from the Department of Clinical Chemistry and Laboratory of Medicine, Kyushu University Hospital. NF has received grants from Taisho Toyama Pharmaceutical Co., Daiichi Sankyo Co., Chugai Pharmaceutical Co., Mitsubishi Tanabe Pharma Co., Bristol-Myers Squibb and Janssen Pharmaceutical KK. The other authors declare that they have no conflicts of interest. This work was supported by JSPS KAKENHI Grant Number 15K19586.
Publisher Copyright:
©2017 International Medical Press.
Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 2017
Y1 - 2017
N2 - Background: On-treatment HCV kinetics play an invaluable role in evaluating the efficacy of interferon-based therapies. However, the importance of HCV RNA monitoring has not been well discussed concerning treatment with sofosbuvir (SOF)-based regimens, especially for the utility of the Abbott RealTime HCV (ART) assay. Methods: This study consisted of 151 patients infected with HCV genotype-1 or -2, including patients with prior treatment-experience or cirrhosis. HCV genotype-1 patients were treated with SOF/ledipasvir and genotype-2 patients with SOF/ribavirin, both for 12 weeks. Serial measurements of HCV RNA were performed with both the ART and COBAS AmpliPrep/COBAS TaqMan v2.0 (CAP/CTM) assays simultaneously at weeks 0, 1, 2, 4, 6, 8, 10 and 12 of treatment. Results: The rates of HCV RNA target not detected (TND) by ART were significantly lower than those by CAP/CTM between weeks 2 and 12 (end of treatment [EOT]), irrespective of prior treatment-experience or cirrhosis. 11 (11.6%) genotype-1 and 8 (14.3%) genotype-2 patients did not achieve HCV RNA TND by ART at EOT, in contrast to all having HCV RNA TND by CAP/CTM; however, all achieved sustained virological response. The time at which HCV RNA became TND or unquantifiable was not associated with treatment outcome by either the ART or CAP/CTM assay. Conclusions: Over 10% of the patients continued to have detectable HCV RNA by ART at EOT, irrespective of HCV genotype, prior treatment-experience and/or cirrhosis. However, prolonged residual HCV RNA was not associated with treatment failure.
AB - Background: On-treatment HCV kinetics play an invaluable role in evaluating the efficacy of interferon-based therapies. However, the importance of HCV RNA monitoring has not been well discussed concerning treatment with sofosbuvir (SOF)-based regimens, especially for the utility of the Abbott RealTime HCV (ART) assay. Methods: This study consisted of 151 patients infected with HCV genotype-1 or -2, including patients with prior treatment-experience or cirrhosis. HCV genotype-1 patients were treated with SOF/ledipasvir and genotype-2 patients with SOF/ribavirin, both for 12 weeks. Serial measurements of HCV RNA were performed with both the ART and COBAS AmpliPrep/COBAS TaqMan v2.0 (CAP/CTM) assays simultaneously at weeks 0, 1, 2, 4, 6, 8, 10 and 12 of treatment. Results: The rates of HCV RNA target not detected (TND) by ART were significantly lower than those by CAP/CTM between weeks 2 and 12 (end of treatment [EOT]), irrespective of prior treatment-experience or cirrhosis. 11 (11.6%) genotype-1 and 8 (14.3%) genotype-2 patients did not achieve HCV RNA TND by ART at EOT, in contrast to all having HCV RNA TND by CAP/CTM; however, all achieved sustained virological response. The time at which HCV RNA became TND or unquantifiable was not associated with treatment outcome by either the ART or CAP/CTM assay. Conclusions: Over 10% of the patients continued to have detectable HCV RNA by ART at EOT, irrespective of HCV genotype, prior treatment-experience and/or cirrhosis. However, prolonged residual HCV RNA was not associated with treatment failure.
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U2 - 10.3851/IMP3085
DO - 10.3851/IMP3085
M3 - Article
C2 - 27632789
AN - SCOPUS:85015967342
VL - 22
SP - 61
EP - 70
JO - Antiviral Therapy
JF - Antiviral Therapy
SN - 1359-6535
IS - 1
ER -