{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,22]],"date-time":"2025-10-22T10:33:46Z","timestamp":1761129226814},"reference-count":26,"publisher":"American Society for Microbiology","issue":"4","license":[{"start":{"date-parts":[[2015,4,1]],"date-time":"2015-04-01T00:00:00Z","timestamp":1427846400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["J Clin Microbiol"],"published-print":{"date-parts":[[2015,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:p>\n            Protease inhibitor (PI)-based response-guided triple therapies for hepatitis C virus (HCV) infection are still widely used. Noncirrhotic treatment-naive and prior relapser patients receiving telaprevir-based treatment are eligible for shorter, 24-week total therapy if HCV RNA is undetectable at both weeks 4 and 12. In this study, the concordance in HCV RNA assessments between the Roche High Pure System\/Cobas TaqMan and Abbott RealTi\n            <jats:italic>m<\/jats:italic>\n            e HCV RNA assays and the impacts of different HCV RNA cutoffs on treatment outcome were evaluated. A total of 2,629 samples from 663 HCV genotype 1 patients receiving telaprevir\/pegylated interferon\/ribavirin in OPTIMIZE were analyzed using the High Pure System and reanalyzed using Abbott RealTi\n            <jats:italic>m<\/jats:italic>\n            e (limits of detection, 15.1 IU\/ml versus 8.3 IU\/ml; limits of quantification, 25 IU\/ml versus 12 IU\/ml, respectively). Overall, good concordance was observed between the assays. Using undetectable HCV RNA at week 4, 34% of the patients would be eligible for shorter treatment duration with Abbott RealTi\n            <jats:italic>m<\/jats:italic>\n            e versus 72% with the High Pure System. However, using &lt;12 IU\/ml for Abbott RealTi\n            <jats:italic>m<\/jats:italic>\n            e, a similar proportion (74%) would be eligible. Of the patients receiving 24-week total therapy, 87% achieved a sustained virologic response with undetectable HCV RNA by the High Pure System or &lt;12 IU\/ml by Abbott RealTi\n            <jats:italic>m<\/jats:italic>\n            e; however, 92% of the patients with undetectable HCV RNA by Abbott RealTi\n            <jats:italic>m<\/jats:italic>\n            e achieved a sustained virologic response. Using undetectable HCV RNA as the cutoff, the more sensitive Abbott RealTi\n            <jats:italic>m<\/jats:italic>\n            e assay would identify fewer patients eligible for shorter treatment than the High Pure System. Our data confirm the &lt;12-IU\/ml cutoff, as previously established in other studies of the Abbott RealTi\n            <jats:italic>m<\/jats:italic>\n            e assay, to determine eligibility for shortened PI-based HCV treatment. (The study was registered with ClinicalTrials.gov under registration no. NCT01241760.)\n          <\/jats:p>","DOI":"10.1128\/jcm.03030-14","type":"journal-article","created":{"date-parts":[[2015,2,5]],"date-time":"2015-02-05T05:09:34Z","timestamp":1423112974000},"page":"1264-1269","update-policy":"http:\/\/dx.doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":12,"title":["An OPTIMIZE Study Retrospective Analysis for Management of Telaprevir-Treated Hepatitis C Virus (HCV)-Infected Patients by Use of the Abbott RealTi\n            <i>m<\/i>\n            e HCV RNA Assay"],"prefix":"10.1128","volume":"53","author":[{"given":"Christoph","family":"Sarrazin","sequence":"first","affiliation":[{"name":"J. W. Goethe University, Medizinische Klinik 1, Frankfurt, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Inge","family":"Dierynck","sequence":"additional","affiliation":[{"name":"Janssen Infectious Diseases BVBA, Beerse, Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gavin","family":"Cloherty","sequence":"additional","affiliation":[{"name":"Abbott Molecular, Des Plaines, Illinois, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne","family":"Ghys","sequence":"additional","affiliation":[{"name":"Janssen Infectious Diseases BVBA, Beerse, Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katrien","family":"Janssen","sequence":"additional","affiliation":[{"name":"Janssen Infectious Diseases BVBA, Beerse, Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Donghan","family":"Luo","sequence":"additional","affiliation":[{"name":"Janssen Research and Development, LLC, Titusville, New Jersey, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James","family":"Witek","sequence":"additional","affiliation":[{"name":"Janssen Research and Development, LLC, Titusville, New Jersey, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria","family":"Buti","sequence":"additional","affiliation":[{"name":"Hospital Valle Hebron and Ciberehd del Institute Carlos III, Barcelona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gaston","family":"Picchio","sequence":"additional","affiliation":[{"name":"Janssen Research and Development, LLC, Titusville, New Jersey, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sandra","family":"De Meyer","sequence":"additional","affiliation":[{"name":"Janssen Infectious Diseases BVBA, Beerse, Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"235","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2012.02.027"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.dld.2013.07.007"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1012912"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1014463"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1013086"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1010494"},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1009482"},{"key":"e_1_3_2_9_2","volume-title":"INCIVO (telaprevir) tablets. Summary of product characteristics October 2011","author":"European Medicines Agency","year":"2011","unstructured":"European Medicines Agency. 2011. INCIVO (telaprevir) tablets. Summary of product characteristics October 2011. European Medicines Agency, London, United Kingdom. http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_-_Product_Information\/human\/002313\/WC500115529.pdf."},{"key":"e_1_3_2_10_2","volume-title":"Incivek (telaprevir) film coated tablets for oral use: highlights of prescribing information","author":"Vertex Pharmaceuticals, Inc.","year":"2012","unstructured":"Vertex Pharmaceuticals, Inc. 2012. Incivek (telaprevir) film coated tablets for oral use: highlights of prescribing information. Vertex Pharmaceuticals, Inc., Cambridge, MA. http:\/\/pi.vrtx.com\/files\/uspi_telaprevir.pdf."},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1002\/hep.24791"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01320-07"},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01784-12"},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2011.07.007"},{"key":"e_1_3_2_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2013.09.005"},{"key":"e_1_3_2_16_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jviromet.2011.09.024"},{"key":"e_1_3_2_17_2","doi-asserted-by":"publisher","DOI":"10.3851\/IMP2760"},{"key":"e_1_3_2_18_2"},{"key":"e_1_3_2_19_2","volume-title":"Fifth Eur Congr Virol","author":"Braun P","year":"2013","unstructured":"Braun P, Wiesmann F, Berger A, Kaiser R, Naeth G, Ehret R, Knechten H. 2013. Comparison of viral load assays for the quantification of HCV genotypes 1-4 in the setting of low viremic samples, abstr 465. Fifth Eur Congr Virol, Lyon, France, 11 to 14 September 2013."},{"key":"e_1_3_2_20_2","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2013.11.047"},{"key":"e_1_3_2_21_2","volume-title":"COBAS AmpliPrep\/COBAS TaqMan HCV test, v2.0, for use with the High Pure system, package insert","author":"Roche Molecular Systems, Inc","year":"2010","unstructured":"Roche Molecular Systems, Inc. 2010. COBAS AmpliPrep\/COBAS TaqMan HCV test, v2.0, for use with the High Pure system, package insert. Roche Molecular Systems, Inc., Branchburg, NJ."},{"key":"e_1_3_2_22_2","volume-title":"Abbott RealTime HCV package insert","author":"Abbott Molecular, Inc","year":"2011","unstructured":"Abbott Molecular, Inc. 2011. Abbott RealTime HCV package insert. Abbott Molecular, Inc., Des Plaines, IL."},{"key":"e_1_3_2_23_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00755-08"},{"key":"e_1_3_2_24_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.antiviral.2013.05.002"},{"key":"e_1_3_2_25_2","doi-asserted-by":"publisher","DOI":"10.1111\/apt.12544"},{"key":"e_1_3_2_26_2","first-page":"A93","article-title":"Comparative analysis of five viral load assays in quantifying low viremic HCV samples in the range of clinical decision points","volume":"18","author":"Braun P","year":"2013","unstructured":"Braun P, Wiesmann F, Berger A, Kaiser R, Naeth G, Ehret R, Knechten H. 2013. Comparative analysis of five viral load assays in quantifying low viremic HCV samples in the range of clinical decision points. 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