Please use this identifier to cite or link to this item: https://hdl.handle.net/20.500.12530/23247
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dc.contributor.authorZeuzem, Stefan
dc.contributor.authorSoriano, Vicente
dc.contributor.authorAsselah, Tarik
dc.contributor.authorGane, Edward J
dc.contributor.authorBronowicki, Jean-Pierre
dc.contributor.authorAngus, Peter
dc.contributor.authorLohse, Ansgar W
dc.contributor.authorStickel, Felix
dc.contributor.authorMüllhaupt, Beat
dc.contributor.authorRoberts, Stuart
dc.contributor.authorSchuchmann, Marcus
dc.contributor.authorManns, Michael
dc.contributor.authorBourlière, Marc
dc.contributor.authorButi, Maria
dc.contributor.authorStern, Jerry O
dc.contributor.authorGallivan, John-Paul
dc.contributor.authorVoss, Florian
dc.contributor.authorSabo, John P
dc.contributor.authorBöcher, Wulf
dc.contributor.authorMensa, Federico J
dc.date.accessioned2019-06-28T13:52:35Z-
dc.date.available2019-06-28T13:52:35Z-
dc.date.issued2015-02
dc.identifier.citationAntimicrob. Agents Chemother..2015 Feb;(59)2:1282-91
dc.identifier.urihttps://hdl.handle.net/20.500.12530/23247-
dc.description.abstractPatients with advanced hepatic fibrosis or cirrhosis with chronic hepatitis C virus (HCV) infection represent an unmet need. The HCV NS3/4A inhibitor, faldaprevir, was evaluated in combination with the nonnucleoside NS5B inhibitor, deleobuvir, with or without ribavirin in treatment-naive patients with HCV genotype 1 infection in the SOUND-C2 study. Here, the efficacy and safety of this interferon-free regimen in a subset of patients with advanced liver fibrosis, including those with compensated cirrhosis, were assessed. Patients (n=362) were randomized to once-daily faldaprevir with either twice-daily (BID) or three-times-daily (TID) deleobuvir for 16 (TID16W), 28 (TID28W and BID28W), or 40 (TID40W) weeks with or without ribavirin (TID28W-NR). Patients were classified according to fibrosis stage (F0 to F2 versus F3 to F4) and the presence of cirrhosis (yes/no). In total, 85 (24%) patients had advanced fibrosis/cirrhosis (F3 to F4) and 33 (9%) had cirrhosis. Within each treatment arm, differences in rates of sustained virologic response 12 weeks after completion of treatment (SVR12) between patients with mild to moderate fibrosis (F0 to F2) versus F3 to F4 did not show a consistent pattern and were not statistically significant (63% versus 47% for TID16W, 53% versus 76% for TID28W, 48% versus 67% for TID40W, 70% versus 67% for BID28W, and 40% versus 36% for TID28W-NR, respectively; P > 0.05 for each arm). The most frequent adverse events in patients with/without cirrhosis were gastrointestinal and skin events, which were mostly mild or moderate in intensity. The degree of liver fibrosis did not appear to affect the probability of achieving SVR12 following treatment with the interferon-free regimen of faldaprevir, deleobuvir, and ribavirin. (This study has been registered at ClinicalTrials.gov under registration no. NCT01132313.).
dc.language.isoeng
dc.rightsopenAccess-
dc.subject.meshAcrylates
dc.subject.meshAdult
dc.subject.meshAged
dc.subject.meshAged, 80 and over
dc.subject.meshAntiviral Agents
dc.subject.meshBenzimidazoles
dc.subject.meshFemale
dc.subject.meshHepatitis C, Chronic
dc.subject.meshHumans
dc.subject.meshLiver Cirrhosis
dc.subject.meshMale
dc.subject.meshMiddle Aged
dc.subject.meshOligopeptides
dc.subject.meshRibavirin
dc.subject.meshThiazoles
dc.subject.meshYoung Adult
dc.titleEfficacy and safety of faldaprevir, deleobuvir, and ribavirin in treatment-naive patients with chronic hepatitis C virus infection and advanced liver fibrosis or cirrhosis.
dc.typeArtículo
dc.identifier.pubmedID25512403
dc.format.volume59
dc.format.page1282-91
dc.identifier.e-issn1098-6596
dc.identifier.journalAntimicrobial agents and chemotherapy
dc.identifier.doi10.1128/AAC.04383-14
dc.format.number2
dc.identifier.pmcPMC4335863
dc.pubmedtypeJournal Article
dc.pubmedtypeRandomized Controlled Trial
dc.pubmedtypeResearch Support, Non-U.S. Gov't
Appears in Collections:Hospitales > H. U. La Paz > Artículos

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