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dc.creatorLepida, Antoniaes
dc.creatorColombo, Massimoes
dc.creatorAbdurakhmanov, Djamales
dc.creatorFerreira, Paulo Abraoes
dc.creatorStrasser, Simone I.es
dc.creatorUrbanek, Petres
dc.creatorMangia, Alessandraes
dc.creatorCalleja, José L.es
dc.creatorIraqi, Wafaees
dc.creatorDeMasi, Ralphes
dc.creatorLonjon-Domanec, Isabellees
dc.creatorMoreno, Christophees
dc.creatorWedemeyer, Heineres
dc.date.accessioned2016-06-21T10:32:23Z
dc.date.available2016-06-21T10:32:23Z
dc.date.issued2015
dc.identifier.citationLepida, A., Colombo, M., Fernández Fernández, I., Abdurakhmanov, D., Ferreira, P.A., Strasser, S.I.,...,Wedemeyer, H. (2015). Final results of the telaprevir access program: Fibroscan values predict safety and efficacy in hepatitis c patients with advanced fibrosis or cirrhosis. PLoS One, 10 (9), e0138503-.
dc.identifier.issn1932-6203es
dc.identifier.urihttp://hdl.handle.net/11441/42513
dc.description.abstractBackground: Liver stiffness determined by transient elastography is correlated with hepatic fibrosis stage and has high accuracy for detecting severe fibrosis and cirrhosis in chronic hepatitis C patients. We evaluated the clinical value of baseline FibroScan values for the prediction of safety and efficacy of telaprevir-based therapy in patients with advanced fibrosis and cirrhosis in the telaprevir Early Access Program HEP3002. Methods: 1,772 patients with HCV-1 and bridging fibrosis or cirrhosis were treated with telaprevir plus pegylated interferon-α and ribavirin (PR) for 12 weeks followed by PR alone, the total treatment duration depending on virological response and previous response type. Liver fibrosis stage was determined either by liver biopsy or by non-invasive markers. 1,282 patients (72%) had disease stage assessed by FibroScan; among those 46% were classified as Metavir F3 at baseline and 54% as F4. Results: Overall, 1,139 patients (64%) achieved a sustained virological response (SVR) by intentionto- treat analysis. Baseline FibroScan values were tested for association with SVR and the occurrence of adverse events. By univariate analysis, higher baseline FibroScan values were predictive of lower sustained virological response rates and treatment-related anemia. By multivariate analysis, FibroScan was no longer statistically significant as an independent predictor, but higher FibroScan values were correlated with the occurrence of infections and serious adverse events. Conclusions: FibroScan has a limited utility as a predictor of safety and efficacy in patients treated with telaprevir-based triple therapy. Nevertheless it can be used in association with other clinical and biological parameters to help determine patients who will benefit from the triple regiments. © 2015 Lepida et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.es
dc.formatapplication/pdfes
dc.language.isoenges
dc.publisherPublic Library of Sciencees
dc.relation.ispartofPLoS One, 10 (9), e0138503-.
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 Internacional*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/*
dc.subjectpeginterferon alphaes
dc.subjectribavirines
dc.subjecttelaprevires
dc.titleFinal results of the telaprevir access program: Fibroscan values predict safety and efficacy in hepatitis c patients with advanced fibrosis or cirrhosises
dc.typeinfo:eu-repo/semantics/articlees
dcterms.identifierhttps://ror.org/03yxnpp24
dc.type.versioninfo:eu-repo/semantics/publishedVersiones
dc.rights.accessRightsinfo:eu-repo/semantics/openAccesses
dc.contributor.affiliationUniversidad de Sevilla. Departamento de Química Orgánica y Farmacéutica
dc.relation.publisherversion10.1371/journal.pone.0138503es
dc.identifier.doihttp://dx.doi.org/ 10.1371/journal.pone.0138503es
idus.format.extent15 p.es
dc.journaltitlePLoS Onees
dc.publication.volumen10es
dc.publication.issue9es
dc.publication.initialPagee0138503es
dc.identifier.idushttps://idus.us.es/xmlui/handle/11441/42513

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