FibroTest is an independent predictor of virologic response in chronic hepatitis C patients retreated with pegylated interferon alfa-2b and ribavirin in the EPIC3 program

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dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.authorPOYNARD, Thierry
dc.contributor.authorMUNTEANU, Mona
dc.contributor.authorCOLOMBO, Massimo
dc.contributor.authorBRUIX, Jordi
dc.contributor.authorSCHIFF, Eugene
dc.contributor.authorTERG, Ruben
dc.contributor.authorFLAMM, Steven
dc.contributor.authorMORENO-OTERO, Ricardo
dc.contributor.authorCARRILHO, Flair
dc.contributor.authorSCHMIDT, Warren
dc.contributor.authorBERG, Thomas
dc.contributor.authorMCGARRITY, Thomas
dc.contributor.authorHEATHCOTE, E. Jenny
dc.contributor.authorGONCALES, Fernando
dc.contributor.authorDIAGO, Moises
dc.contributor.authorCRAXI, Antonio
dc.contributor.authorSILVA, Marcelo
dc.contributor.authorBOPARAI, Navdeep
dc.contributor.authorGRIFFEL, Louis
dc.contributor.authorBURROUGHS, Margaret
dc.contributor.authorBRASS, Clifford
dc.contributor.authorALBRECHT, Janice
dc.date.accessioned2017-11-27T16:27:14Z
dc.date.available2017-11-27T16:27:14Z
dc.date.issued2011
dc.description.abstractBackground & Aims: EPIC-3 is a prospective, international study that has demonstrated the efficacy of PEG-IFN alfa-2b plus weight-based ribavirin in patients with chronic hepatitis C and significant fibrosis who previously failed any interferon-alfa/ribavirin therapy. The aim of the present study was to assess FibroTest (FT), a validated non-invasive marker of fibrosis in treatment-naive patients, as a possible alternative to biopsy as the baseline predictor of subsequent early virologic (EVR) and sustained virologic response (SVR) in previously treated patients. Methods: Of 2312 patients enrolled, 1459 had an available baseline FT, biopsy, and complete data. Uni- (UV) and multi-variable (MV) analyses were performed using FT and biopsy. Results: Baseline characteristics were similar as in the overall population; METAVIR stage: 28% F2, 29% F3, and 43% F4, previous relapsers 29%, previous PEG-IFN regimen 41%, high baseline viral load (BVL) 64%. 506 patients (35%) had undetectable HCV-RNA at TW12 (TW12neg), with 58% achieving SVR. The accuracy of FT was similar to that in naive patients: AUROC curve for the diagnosis of F4 vs F2 = 0.80 (p<0.00001). Five baseline factors were associated (p<0.001) with SVR in UV and MV analyses (odds ratio: UV/MV): fibrosis stage estimated using FT (4.5/5.9) or biopsy (1.5/1.6), genotype 2/3 (4.5/5.1), BVL (1.5/1.3), prior relapse (1.6/1.6), previous treatment with non-PEG-IFN (2.6/2.0). These same factors were associated (p <= 0.001) with EVR. Among patients TW12neg, two independent factors remained highly predictive of SVR by MV analysis (p <= 0.001): genotype 2/3 (odds ratio = 2.9), fibrosis estimated with FT (4.3) or by biopsy (1.5). Conclusions: FibroTest at baseline is a possible non-invasive alternative to biopsy for the prediction of EVR at 12 weeks and SVR, in patients with previous failures and advanced fibrosis, retreated with PEG-IFN alfa-2b and ribavirin.
dc.description.indexMEDLINE
dc.description.sponsorshipSchering-Plough
dc.description.sponsorshipRoche
dc.description.sponsorshipValeant
dc.description.sponsorshipSchering-Plough Research Institute
dc.identifier.citationJOURNAL OF HEPATOLOGY, v.54, n.2, p.227-235, 2011
dc.identifier.doi10.1016/j.jhep.2010.06.038
dc.identifier.issn0168-8278
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/23031
dc.language.isoeng
dc.publisherELSEVIER SCIENCE BV
dc.relation.ispartofJournal of Hepatology
dc.rightsrestrictedAccess
dc.rights.holderCopyright ELSEVIER SCIENCE BV
dc.subjectHepatitis C
dc.subjectNon-responder
dc.subjectRelapser
dc.subjectCirrhosis
dc.subjectFibrosis
dc.subjectBiomarkers, Treatment failure
dc.subjectEarly virologic response
dc.subject.otheroperating characteristic curves
dc.subject.otherliver fibrosis markers
dc.subject.otherbiochemical markers
dc.subject.othernoninvasive biomarkers
dc.subject.otherdiagnostic evaluation
dc.subject.otherrandomized-trial
dc.subject.othertherapy
dc.subject.otherpeginterferon
dc.subject.othervariability
dc.subject.othercombination
dc.subject.wosGastroenterology & Hepatology
dc.titleFibroTest is an independent predictor of virologic response in chronic hepatitis C patients retreated with pegylated interferon alfa-2b and ribavirin in the EPIC3 program
dc.typearticle
dc.type.categoryoriginal article
dc.type.versionpublishedVersion
dspace.entity.typePublication
hcfmusp.affiliation.countryArgentina
hcfmusp.affiliation.countryCanadá
hcfmusp.affiliation.countryAlemanha
hcfmusp.affiliation.countryEstados Unidos
hcfmusp.affiliation.countryEspanha
hcfmusp.affiliation.countryItália
hcfmusp.affiliation.countryFrança
hcfmusp.affiliation.countryisoit
hcfmusp.affiliation.countryisoar
hcfmusp.affiliation.countryisous
hcfmusp.affiliation.countryisofr
hcfmusp.affiliation.countryisoes
hcfmusp.affiliation.countryisode
hcfmusp.affiliation.countryisoca
hcfmusp.author.externalPOYNARD, Thierry:APHP UPMC Liver Ctr, Paris, France
hcfmusp.author.externalMUNTEANU, Mona:APHP UPMC Liver Ctr, Paris, France
hcfmusp.author.externalCOLOMBO, Massimo:Univ Milan, Div Gastroenterol 1, Fdn IRCCS, Maggiore Hosp, Milan, Italy
hcfmusp.author.externalBRUIX, Jordi:Univ Barcelona, Ctr Invest Biomed Red Enfermedades Hepat & Digest, Hosp Clin, Barcelona, Spain
hcfmusp.author.externalSCHIFF, Eugene:Univ Miami, Sch Med, Miami, FL USA
hcfmusp.author.externalTERG, Ruben:Hosp Municipal Gastroenterol Dr Bonorino Udaondo, Buenos Aires, Argentina
hcfmusp.author.externalFLAMM, Steven:Northwestern Univ, Chicago, IL 60611 USA
hcfmusp.author.externalMORENO-OTERO, Ricardo:Hosp Univ Princesa, Madrid, Spain; Inst Salud Carlos III, Ctr Invest Biomed Red Enfermedades Hepat & Digest, Madrid, Spain
hcfmusp.author.externalSCHMIDT, Warren:Univ Iowa Hosp & Clin, Iowa City, IA 52242 USA
hcfmusp.author.externalBERG, Thomas:Univ Med Berlin, Charite, Campus Virchow Klinikum, Berlin, Germany
hcfmusp.author.externalMCGARRITY, Thomas:Milton S Hershey Med Ctr, Hershey, PA USA
hcfmusp.author.externalHEATHCOTE, E. Jenny:Univ Hlth Network, Toronto, ON, Canada
hcfmusp.author.externalGONCALES, Fernando:Univ Estadual Campinas, Dept Clin Med, Fac Med Sci, Campinas, Brazil
hcfmusp.author.externalDIAGO, Moises:Univ Valencia, Gen Hosp, Valencia, Spain
hcfmusp.author.externalCRAXI, Antonio:Univ Palermo, GI & Liver Unit, DIBIMIS, Palermo, Italy
hcfmusp.author.externalSILVA, Marcelo:Hosp Univ Austral, Pilar, Argentina
hcfmusp.author.externalBOPARAI, Navdeep:Schering Plough Res Inst, Kenilworth, NJ USA
hcfmusp.author.externalGRIFFEL, Louis:Schering Plough Res Inst, Kenilworth, NJ USA
hcfmusp.author.externalBURROUGHS, Margaret:Schering Plough Res Inst, Kenilworth, NJ USA
hcfmusp.author.externalBRASS, Clifford:Schering Plough Res Inst, Kenilworth, NJ USA
hcfmusp.author.externalALBRECHT, Janice:Schering Plough Res Inst, Kenilworth, NJ USA
hcfmusp.citation.scopus17
hcfmusp.contributor.author-fmusphcFLAIR JOSE CARRILHO
hcfmusp.description.beginpage227
hcfmusp.description.endpage235
hcfmusp.description.issue2
hcfmusp.description.volume54
hcfmusp.origemWOS
hcfmusp.origem.pubmed21056496
hcfmusp.origem.scopus2-s2.0-78751570909
hcfmusp.origem.wosWOS:000287070400008
hcfmusp.publisher.cityAMSTERDAM
hcfmusp.publisher.countryNETHERLANDS
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