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STARTVerso1: A Randomized Trial of Faldaprevir Plus Pegylated Interferon/Ribavirin for Chronic HCV Genotype-1 Infection

2015-06Journal article Open access
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dc.contributor.authorFerenci, P
dc.contributor.authorAsselah, T
dc.contributor.authorFoster, G
dc.contributor.authorZeuzem, S
dc.contributor.authorSarrazin, C
dc.contributor.authorMoreno, C
dc.contributor.authorOuzan, D
dc.contributor.authorMaevskaya, M
dc.contributor.authorCalinas, F
dc.contributor.authorMorano, L
dc.contributor.authorCrespo, J
dc.contributor.authorDufour, JF
dc.contributor.authorBourlière, M
dc.contributor.authorAgarwal, K
dc.contributor.authorForton, D
dc.contributor.authorSchuchmann, M
dc.contributor.authorZehnter, E
dc.contributor.authorNishiguchi, S
dc.contributor.authorOmata, M
dc.contributor.authorKukolj, G
dc.contributor.authorDatsenko, Y
dc.contributor.authorGarcia, M
dc.contributor.authorScherer, J
dc.contributor.authorQuinson, AM
dc.contributor.authorStern, J
dc.date.accessioned2016-06-07T15:55:21Z
dc.date.available2016-06-07T15:55:21Z
dc.date.issued2015-06
dc.description.abstractBACKGROUND & AIMS: The efficacy and tolerability of faldaprevir, a potent hepatitis C virus (HCV) NS3/4A protease inhibitor, plus peginterferon (PegIFN) and ribavirin (RBV) was assessed in a double-blind, placebo-controlled phase 3 study of treatment-naïve patients with HCV genotype-1 infection. METHODS: Patients were randomly assigned (1:2:2) to PegIFN/RBV plus: placebo (arm 1, n = 132) for 24 weeks; faldaprevir (120 mg, once daily) for 12 or 24 weeks (arm 2, n = 259); or faldaprevir (240 mg, once daily) for 12 weeks (arm 3, n = 261). In arms 2 and 3, patients with early treatment success (HCV-RNA <25 IU/ml at week 4 and undetectable at week 8) stopped all treatment at week 24. Other patients received PegIFN/RBV until week 48 unless they met futility criteria. The primary endpoint was sustained virologic response 12 weeks post-treatment (SVR12). RESULTS: SVR12 was achieved by 52%, 79%, and 80% of patients in arms 1, 2, and 3, respectively (estimated difference for arms 2 and 3 vs. arm 1: 27%, 95% confidence interval 17%-36%; and 29%, 95% confidence interval, 19%-38%, respectively; p < 0.0001 for both). Early treatment success was achieved by 87% (arm 2) and 89% (arm 3) of patients, of whom 86% and 89% achieved SVR12. Adverse event rates were similar among groups; few adverse events led to discontinuation of all regimen components. CONCLUSIONS: Faldaprevir plus PegIFN/RBV significantly increased SVR12, compared with PegIFN/RBV, in treatment-naïve patients with HCV genotype-1 infection. No differences were seen in responses of patients given faldaprevir once daily at 120 or 240 mg.pt_PT
dc.identifier.citationJ Hepatol. 2015 Jun;62(6):1246-55pt_PT
dc.identifier.doi10.1016/j.jhep.2014.12.024pt_PT
dc.identifier.urihttp://hdl.handle.net/10400.17/2513
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherElsevierpt_PT
dc.relationNCT01343888pt_PT
dc.subjectAdultpt_PT
dc.subjectAntiviral Agents/administration & dosagept_PT
dc.subjectDouble-Blind Methodpt_PT
dc.subjectDrug Therapy, Combinationpt_PT
dc.subjectFemalept_PT
dc.subjectGenotypept_PT
dc.subjectHepacivirus/classificationpt_PT
dc.subjectHepatitis C, Chronic/virologypt_PT
dc.subjectHumanspt_PT
dc.subjectInterferon-alpha/administration & dosagept_PT
dc.subjectMalept_PT
dc.subjectMiddle Agedpt_PT
dc.subjectOligopeptides/administration & dosagept_PT
dc.subjectPolyethylene Glycols/administration & dosagept_PT
dc.subjectRNA, Viral/bloodpt_PT
dc.subjectRecombinant Proteins/administration & dosagept_PT
dc.subjectRibavirin/administration & dosagept_PT
dc.subjectThiazoles/administration & dosagept_PT
dc.subjectCHLC GASpt_PT
dc.subjectAntiviral Agents/adverse effectspt_PT
dc.subjectHepacivirus/drug effectspt_PT
dc.subjectHepacivirus/geneticspt_PT
dc.subjectHepatitis C, Chronic/drug therapypt_PT
dc.subjectInterferon-alpha/adverse effectspt_PT
dc.subjectOligopeptides/adverse effectspt_PT
dc.subjectPolyethylene Glycols/adverse effectspt_PT
dc.subjectRecombinant Proteins/adverse effectspt_PT
dc.subjectRibavirin/adverse effectspt_PT
dc.subjectThiazoles/adverse effectspt_PT
dc.titleSTARTVerso1: A Randomized Trial of Faldaprevir Plus Pegylated Interferon/Ribavirin for Chronic HCV Genotype-1 Infectionpt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.endPage1255pt_PT
oaire.citation.issue6pt_PT
oaire.citation.startPage1246pt_PT
oaire.citation.titleJournal of Hepatologypt_PT
oaire.citation.volume62pt_PT
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT

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