Publication:
Short article: Faldaprevir, deleobuvir and ribavirin in IL28B non-CC patients with HCV genotype-1a infection included in the SOUND-C3 phase 2b study.

cris.virtualsource.author-orcid1db177e5-b0b4-4b1c-b039-8b18d729f454
dc.contributor.authorZeuzem, Stefan
dc.contributor.authorMantry, Parvez
dc.contributor.authorSoriano, Vicente
dc.contributor.authorBuynak, Robert J
dc.contributor.authorDufour, Jean-François
dc.contributor.authorPockros, Paul J
dc.contributor.authorWright, David
dc.contributor.authorAngus, Peter
dc.contributor.authorButi, Maria
dc.contributor.authorStern, Jerry O
dc.contributor.authorKadus, Werner
dc.contributor.authorVinisko, Richard
dc.contributor.authorBöcher, Wulf
dc.contributor.authorMensa, Federico J
dc.date.accessioned2024-10-24T19:02:42Z
dc.date.available2024-10-24T19:02:42Z
dc.date.issued2016-08
dc.description.abstractBACKGROUND SOUND-C3 was a multicentre, open-label, phase 2b study exploring the safety and efficacy of the interferon-free combination of faldaprevir (an NS3/A4 protease inhibitor), deleobuvir (BI 207127, a non-nucleoside polymerase inhibitor) and ribavirin in treatment-naive patients with chronic hepatitis C virus (HCV) genotype-1 infection. Results in patients with HCV genotype-1b and in IL28B CC genotype patients with HCV genotype-1a have been described previously. This report describes the results in IL28B non-CC genotype patients with HCV genotype-1a. METHODS Patients were randomized to receive faldaprevir 120 mg once daily with deleobuvir at either 800 mg twice daily (b.i.d.; N=26) or 600 mg three times daily (t.i.d.; N=25), and weight-based ribavirin for 24 weeks. The primary endpoint was sustained virological response 12 weeks after treatment (SVR12). RESULTS In each group, five patients completed 24 weeks of treatment. SVR12 rates were 19% (5/26) and 8% (2/25) in the b.i.d. and t.i.d. groups, respectively. On-treatment breakthrough [50% (13/26) and 68% (17/25) in the b.i.d. and t.i.d. groups, respectively] was the most frequent reason for not achieving SVR12. Adverse events led to premature treatment discontinuation in six (23%) patients in the b.i.d. group and in two patients (8%) in the t.i.d. group. The majority of adverse events were mild or moderate; the most frequently reported were nausea (67%), fatigue (35%) and diarrhoea (35%). CONCLUSION In this small study, the interferon-free regimen of faldaprevir, deleobuvir and ribavirin resulted in high rates of virological breakthrough and low rates of SVR12 in IL28B non-CC genotype patients infected with genotype-1a HCV (http://www.clinicaltrials.gov NCT01132313).
dc.description.numberOfPages4
dc.description.sponsorshipDepartement Klinische Forschung, Hepatologie Forschung
dc.identifier.doi10.7892/boris.93550
dc.identifier.pmid27140229
dc.identifier.publisherDOI10.1097/MEG.0000000000000649
dc.identifier.urihttps://boris-portal.unibe.ch/handle/20.500.12422/148441
dc.language.isoen
dc.publisherLippincott Williams & Wilkins
dc.relation.ispartofEuropean journal of gastroenterology & hepatology
dc.relation.issn0954-691X
dc.relation.organizationDCD5A442BBC5E17DE0405C82790C4DE2
dc.relation.organizationDCD5A442C6DFE17DE0405C82790C4DE2
dc.subject.ddc600 - Technology::610 - Medicine & health
dc.titleShort article: Faldaprevir, deleobuvir and ribavirin in IL28B non-CC patients with HCV genotype-1a infection included in the SOUND-C3 phase 2b study.
dc.typearticle
dspace.entity.typePublication
dspace.file.typetext
oaire.citation.endPage926
oaire.citation.issue8
oaire.citation.startPage923
oaire.citation.volume28
oairecerif.author.affiliationDepartement Klinische Forschung, Hepatologie Forschung
oairecerif.author.affiliation2Universitätsklinik für Viszerale Chirurgie und Medizin, Hepatologie
oairecerif.author.affiliation3Universitätsklinik für Viszerale Chirurgie und Medizin, Hepatologie
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unibe.description.ispublishedpub
unibe.eprints.legacyId93550
unibe.journal.abbrevTitleEur J Gastroenterol Hepatol
unibe.refereedTRUE
unibe.subtype.articlejournal

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