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HCVerso1 and 2: Faldaprevir with Deleobuvir (BI 207127) and Ribavirin for Treatment-Naïve Patients with Chronic Hepatitis C Virus Genotype-1b Infection

2016Journal article Open access
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dc.contributor.authorSarrazin, C
dc.contributor.authorCastelli, F
dc.contributor.authorAndreone, P
dc.contributor.authorButi, M
dc.contributor.authorColombo, M
dc.contributor.authorPol, S
dc.contributor.authorCalinas, F
dc.contributor.authorPuoti, M
dc.contributor.authorOlveira, A
dc.contributor.authorShiffman, M
dc.contributor.authorStern, J
dc.contributor.authorKukolj, G
dc.contributor.authorRoehrle, M
dc.contributor.authorAslanyan, S
dc.contributor.authorDeng, Q
dc.contributor.authorVinisko, R
dc.contributor.authorMensa, F
dc.contributor.authorNelson, D
dc.date.accessioned2016-12-09T11:27:17Z
dc.date.available2016-12-09T11:27:17Z
dc.date.issued2016
dc.description.abstractThe interferon-free combination of once-daily faldaprevir 120 mg, twice-daily deleobuvir 600 mg, and weight-based ribavirin was evaluated in two Phase III studies (HCVerso1, HCVerso2) in hepatitis C virus genotype-1b-infected, treatment-naïve patients, including those ineligible for peginterferon (HCVerso2). Patients without cirrhosis were randomized to 16 weeks (Arm 1; n=208 HCVerso1, n=213 HCVerso2) or 24 weeks (Arm 2; n=211 in both studies) of faldaprevir + deleobuvir + ribavirin. Patients with compensated cirrhosis received open-label faldaprevir + deleobuvir + ribavirin for 24 weeks (Arm 3; n=51, n=72). Primary endpoints were comparisons of adjusted sustained virologic response (SVR) rates with historical rates: 71% (HCVerso1) and 68% (HCVerso2). Adjusted SVR12 rates were significantly greater than historical controls for Arms 1 and 2 in HCVerso2 (76%, 95% confidence interval [CI] 71-81, P=0.002; 81%, 95% CI 76-86, P<0.0001) and Arm 2 in HCVerso1 (81%, 95% CI 77-86, P<0.0001), but not for Arm 1 of HCVerso1 (72%, 95% CI 66-77, P=0.3989). Unadjusted SVR12 rates in Arms 1, 2, and 3 were 71.6%, 82.5%, and 72.5%, respectively, in HCVerso1 and 75.6%, 82.0%, and 73.6%, respectively, in HCVerso2. Virologic breakthrough and relapse occurred in 24-week arms in 8%-9% and 1% of patients, respectively, and in 16-week arms in 7%-8% and 9%-11% of patients, respectively. The most common adverse events were nausea (46%-61%) and vomiting (29%-35%). Adverse events resulted in discontinuation of all medications in 6%-8% of patients. In treatment-naïve patients with hepatitis C virus genotype-1b infection, with or without cirrhosis, faldaprevir + deleobuvir + ribavirin treatment for 24 weeks resulted in adjusted SVR12 rates significantly higher than historical controls.pt_PT
dc.identifier.citationClin Exp Gastroenterol. 2016 Nov 24;9:351-363pt_PT
dc.identifier.doi10.2147/CEG.S111116pt_PT
dc.identifier.urihttp://hdl.handle.net/10400.17/2589
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherDovepresspt_PT
dc.subjectCHLC GASpt_PT
dc.subjectChronic Hepatitis Cpt_PT
dc.subjectNS3 Protease Inhibitorpt_PT
dc.subjectNonnucleoside Polymerase Inhibitorpt_PT
dc.subjectCirrhosispt_PT
dc.subjectAntiviralpt_PT
dc.titleHCVerso1 and 2: Faldaprevir with Deleobuvir (BI 207127) and Ribavirin for Treatment-Naïve Patients with Chronic Hepatitis C Virus Genotype-1b Infectionpt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.endPage363pt_PT
oaire.citation.startPage351pt_PT
oaire.citation.titleClinical and Experimental Gastroenterologypt_PT
oaire.citation.volume9pt_PT
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT

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