Comparison of the Abbott RealTime HCV and Roche COBAS Ampliprep/COBAS TaqMan HCV Assays for the Monitoring of Sofosbuvir-Based Therapy

DOI Web Site PubMed 被引用文献2件 参考文献23件
  • Eiichi Ogawa
    Department of General Internal Medicine, Kyushu University Hospital, Fukuoka, Japan
  • Norihiro Furusyo
    Department of General Internal Medicine, Kyushu University Hospital, Fukuoka, Japan
  • Masayuki Murata
    Department of General Internal Medicine, Kyushu University Hospital, Fukuoka, Japan
  • Motohiro Shimizu
    Department of General Internal Medicine, Kyushu University Hospital, Fukuoka, Japan
  • Kazuhiro Toyoda
    Department of General Internal Medicine, Kyushu University Hospital, Fukuoka, Japan
  • Taeko Hotta
    Department of Clinical Chemistry and Laboratory of Medicine, Kyushu University Hospital, Fukuoka, Japan
  • Takeshi Uchiumi
    Department of Clinical Chemistry and Laboratory of Medicine, Kyushu University Hospital, Fukuoka, Japan
  • Jun Hayashi
    Kyushu General Internal Medicine Center, Haradoi Hospital, Fukuoka, Japan

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<jats:sec><jats:title>Background</jats:title><jats:p> 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. </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> 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. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> 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. </jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p> 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. </jats:p></jats:sec>

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