Please use this identifier to cite or link to this item: https://hdl.handle.net/20.500.12530/24060
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dc.contributor.authorSarrazin, Christoph
dc.contributor.authorManns, Michael
dc.contributor.authorCalleja, Jose Luis
dc.contributor.authorGarcia-Samaniego, Javier
dc.contributor.authorForns, Xavier
dc.contributor.authorKaste, Renee
dc.contributor.authorBai, Xiaofei
dc.contributor.authorWu, Jing
dc.contributor.authorStern, Jerry O
dc.date.accessioned2019-06-28T14:05:02Z-
dc.date.available2019-06-28T14:05:02Z-
dc.date.issued2016
dc.identifier.citationPLoS ONE.2016;(11)12:e0168544
dc.identifier.urihttps://hdl.handle.net/20.500.12530/24060-
dc.description.abstractThis study evaluated the interferon-free, oral combination of deleobuvir (non-nucleoside HCV NS5-RNA-polymerase inhibitor) and faldaprevir (HCV NS3/4A-protease inhibitor) with ribavirin in patients with HCV genotype-1b and moderate (Child-Pugh B [CPB], n = 17) or mild hepatic impairment (Child-Pugh A [CPA], n = 18). Patients received faldaprevir 120 mg and deleobuvir (600 mg [CPA], 400 mg [CPB]) twice-daily with weight-based ribavirin for 24 weeks. Baseline characteristics were similar between groups. Among CPA patients, 13/18 completed treatment; discontinuations were for adverse events (AEs, n = 1), lack of efficacy (n = 3) and withdrawal (n = 1). Among CPB patients, 8/17 completed treatment; discontinuations were for AEs (n = 6), withdrawal (n = 1) and 'other' (n = 2). Sustained virologic response at post-treatment Week 12 (SVR12) was achieved by 11 (61%) CPA patients (95% confidence interval: 38.6%-83.6%) and 9 (53%) CPB patients (95% confidence interval: 29.2%-76.7%), including most CPA (11/16) patients with Week 4 HCV RNA <25 IU.mL-1 (target detected or not detected) and most CPB (8/9) patients with Week 4 HCV RNA <25 IU.mL-1 (target not detected); 0/4 CPB patients with Week 4 HCV RNA <25 IU.mL-1 (target detected) achieved SVR12. The most common AEs in both groups were nausea, diarrhoea and vomiting. Serious AEs were observed in 9 (53%) CPB patients and 1 (6%) CPA patient. Plasma trough concentrations of deleobuvir and faldaprevir were not substantially different between the CPA and CPB groups. In conclusion, in this small study the safety and efficacy profiles for 24 weeks of treatment with faldaprevir+deleobuvir+ribavirin in patients with mild or moderate hepatic impairment were consistent with the safety and efficacy profile of this regimen in non-cirrhotic patients. Faldaprevir+deleobuvir+ribavirin resulted in SVR12 in 53-61% of patients: proportions achieving SVR4 but not SVR12 were higher than in non-cirrhotic patients and overall response rates were lower than rates reported with other all-oral regimens in patients with cirrhosis.
dc.language.isoeng
dc.rightsopenAccess-
dc.subject.meshAcrylates
dc.subject.meshAdolescent
dc.subject.meshAdult
dc.subject.meshAged
dc.subject.meshAntiviral Agents
dc.subject.meshBenzimidazoles
dc.subject.meshDrug Therapy, Combination
dc.subject.meshFemale
dc.subject.meshFollow-Up Studies
dc.subject.meshGenotype
dc.subject.meshHepacivirus
dc.subject.meshHepatitis C, Chronic
dc.subject.meshHumans
dc.subject.meshLiver Cirrhosis
dc.subject.meshMale
dc.subject.meshMiddle Aged
dc.subject.meshOligopeptides
dc.subject.meshPrognosis
dc.subject.meshRNA, Viral
dc.subject.meshRibavirin
dc.subject.meshThiazoles
dc.subject.meshViral Load
dc.subject.meshYoung Adult
dc.titleHCVerso3: An Open-Label, Phase IIb Study of Faldaprevir and Deleobuvir with Ribavirin in Hepatitis C Virus Genotype-1b-Infected Patients with Cirrhosis and Moderate Hepatic Impairment.
dc.typeArtículo
dc.identifier.pubmedID28030579
dc.format.volume11
dc.format.pagee0168544
dc.identifier.e-issn1932-6203
dc.identifier.journalPloS one
dc.identifier.doi10.1371/journal.pone.0168544
dc.format.number12
dc.identifier.pmcPMC5193411
dc.pubmedtypeClinical Trial, Phase II
dc.pubmedtypeJournal Article
dc.pubmedtypeMulticenter Study
Appears in Collections:Fundaciones e Institutos de Investigación > IIS H. U. La Paz > Artículos
Hospitales > H. U. La Paz > Artículos

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