Show simple item record

dc.contributor.authorFerenci, P
dc.contributor.authorAsselah, T
dc.contributor.authorFoster, GR
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, LE
dc.contributor.authorCrespo, J
dc.contributor.authorDufour, J-F
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, A-M
dc.contributor.authorStern, JO
dc.contributor.authorSTARTVerso1 Study Group,
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.
dc.format.extent1246 - 1255
dc.relation.ispartofJ Hepatol
dc.subjectClinical trial
dc.subjectEarly treatment success
dc.subjectNS3/4A protease inhibitor
dc.subjectPhase 3
dc.subjectAntiviral Agents
dc.subjectDouble-Blind Method
dc.subjectDrug Therapy, Combination
dc.subjectHepatitis C, Chronic
dc.subjectMiddle Aged
dc.subjectPolyethylene Glycols
dc.subjectRNA, Viral
dc.subjectRecombinant Proteins
dc.titleSTARTVerso1: A randomized trial of faldaprevir plus pegylated interferon/ribavirin for chronic HCV genotype-1 infection.
dc.typeJournal Article
dc.relation.isPartOfJ Hepatol
dc.relation.isPartOfJ Hepatol
dc.relation.isPartOfJ Hepatol
pubs.organisational-group/Queen Mary University of London
pubs.organisational-group/Queen Mary University of London/Faculty of Medicine & Dentistry
pubs.organisational-group/Queen Mary University of London/Faculty of Medicine & Dentistry/Blizard Institute
pubs.organisational-group/Queen Mary University of London/Faculty of Medicine & Dentistry/Blizard Institute/Immunobiology

Files in this item


There are no files associated with this item.

This item appears in the following Collection(s)

Show simple item record

Return to top