title: An OPTIMIZE study retrospective analysis for management of telaprevir-treated hepatitis C virus (HCV)-infected patients by use of the Abbott RealTime HCV RNA assay.
abstract: 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 RealTime 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 RealTime (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 RealTime versus 72% with the High Pure System. However, using <12 IU/ml for Abbott RealTime, 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 <12 IU/ml by Abbott RealTime; however, 92% of the patients with undetectable HCV RNA by Abbott RealTime achieved a sustained virologic response. Using undetectable HCV RNA as the cutoff, the more sensitive Abbott RealTime assay would identify fewer patients eligible for shorter treatment than the High Pure System. Our data confirm the <12-IU/ml cutoff, as previously established in other studies of the Abbott RealTime assay, to determine eligibility for shortened PI-based HCV treatment. (The study was registered with ClinicalTrials.gov under registration no. NCT01241760.).
authors: J. W. Goethe University, Medizinische Klinik 1, Frankfurt, Germany.
authors: Christoph
authors: C
authors: Sarrazin
authors: Janssen Infectious Diseases BVBA, Beerse, Belgium.
authors: Inge
authors: I
authors: Dierynck
authors: Abbott Molecular, Des Plaines, Illinois, USA.
authors: Gavin
authors: G
authors: Cloherty
authors: Janssen Infectious Diseases BVBA, Beerse, Belgium.
authors: Anne
authors: A
authors: Ghys
authors: Janssen Infectious Diseases BVBA, Beerse, Belgium.
authors: Katrien
authors: K
authors: Janssen
authors: Janssen Research and Development, LLC, Titusville, New Jersey, USA.
authors: Donghan
authors: D
authors: Luo
authors: Janssen Research and Development, LLC, Titusville, New Jersey, USA.
authors: James
authors: J
authors: Witek
authors: Hospital Valle Hebron and Ciberehd del Institute Carlos III, Barcelona, Spain.
authors: Maria
authors: M
authors: Buti
authors: Janssen Research and Development, LLC, Titusville, New Jersey, USA.
authors: Gaston
authors: G
authors: Picchio
authors: Janssen Infectious Diseases BVBA, Beerse, Belgium sdmeyer@its.jnj.com.
authors: Sandra
authors: S
authors: De Meyer
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use*; D016903:Drug Monitoring / Q000379:methods*; D004359:Drug Therapy, Combination / Q000379:methods; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification*; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use; D025202:Molecular Diagnostic Techniques / Q000379:methods; D009842:Oligopeptides / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood*; D012189:Retrospective Studies; D012254:Ribavirin / Q000627:therapeutic use; D016896:Treatment Outcome; D019562:Viral Load / Q000379:methods*
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D009842:Oligopeptides; D012367:RNA, Viral; D012254:Ribavirin; C486464:telaprevir
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