Comparison of three quantitative HCV RNA assays in samples from HCV genotype 1- or 4-infected patients treated with the NS3/4A protease inhibitor simeprevir |
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| Institution: | 1. Janssen Infectious Diseases BVBA, Beerse, Belgium;2. J.W. Goethe University, Medizinische Klinik 1, Frankfurt, Germany;3. Abbott Molecular, Des Plaines, IL, USA;4. Janssen Research & Development LLC, Titusville, NJ, USA;1. Division of Global Public Health, University of California San Diego, San Diego, USA;2. School of Social and Community Medicine, University of Bristol, UK;3. Kirby Institute, UNSW Australia, Sydney, Australia;4. Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, UK;5. Queen Mary’s University of London, UK;6. Glasgow Caledonian University, UK;7. Health Protection Scotland, UK;8. Guy’s and St Thomas’s NHS Foundation Trust, London, UK;9. Public Health England, UK;1. Sorbonne Universités, UPMC Univ Paris 06, INSERM, Institut Pierre Louis d’épidémiologie et de Santé Publique (IPLESP UMRS 1136), F75013 Paris, France;2. AP-HP, Groupe Hospitalier Pitié-Salpêtrière, Service de Virologie, Paris, France;3. IAME, UMR1137, INSERM, Université Paris Diderot Sorbonne Paris Cité, AP-HP, Laboratoire de Virologie, Hôpital Bichat-Claude Bernard, Paris, France;4. INSERM U941, Université Paris Diderot, Laboratoire de Virologie, AP-HP, Hôpital Saint-Louis, Paris, France;5. CNR VIH, AP-HP, Paris, France;1. Immunology Section, Liver Diseases Branch, NIDDK, National Institutes of Health, DHHS, Bethesda, MD 20892, USA;1. Yunnan Key Laboratory of Vaccine Research & Development on Severe Infectious Diseases, Institute of Medical Biology, Chinese Academy of Medicine Science and Peking Union Medical College, Kunming 650118, China;2. Department of Infectious Diseases of Kunming Children’s Hospital, Kunming 650,034, China |
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| Abstract: | BackgroundMonitoring HCV RNA levels during treatment is an important tool for managing protease-inhibitor-based regimens, and different assays used in clinical practice can impact treatment decisions.ObjectivesThe concordance of three HCV RNA assays was determined, and their impact on treatment decisions assessed using samples from HCV genotype (GT) 1- and GT4-infected patients treated with the NS3/4A inhibitor simeprevir in combination with pegylated interferon-α/ribavirin.Study designPlasma samples collected during the simeprevir Phase III studies QUEST-1 and QUEST-2 (GT1), and RESTORE (GT4) were analyzed with the Roche High-Pure-System COBAS® TaqMan® HCV v2.0 (HPS), the Roche AmpliPrep COBAS® TaqMan® HCV v2.0 (CAP), and the Abbott RealTime HCV (ART) assay.ResultsIn GT1, of the 440 samples, 81% were undetectable (rapid virological response; RVR) by HPS at Week 4, 76% by CAP and 44% by ART. In GT4 (103 samples), RVR rates were 67% by HPS and 24% by ART. HCV RNA <25 IU/mL at Week 4 was observed for 95–96% and 92% GT1 samples and 86% and 74% GT4 samples by HPS/CAP and ART, respectively. At Week 12, assay concordance for undetectability was high in GT1 and GT4, (95–98% and 93%, respectively).ConclusionsWhile different HCV RNA assays can lead to substantially different RVR rates, a good concordance was observed with a cut-off of 25 IU/mL. Sustained virologic response rates among GT1 patients achieving RVR or <25 IU/mL at Week 4 were high and similar between assays used. At later time points, when viremia is low, assay concordance was high. |
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| Keywords: | Simeprevir HCV genotype 1 and 4 DAA HCV RNA quantification Response-guided treatment Assay concordance |
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