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dc.contributor.authorFoster, GRen_US
dc.contributor.authorAgarwal, Ken_US
dc.contributor.authorCramp, MEen_US
dc.contributor.authorMoreea, Sen_US
dc.contributor.authorBarclay, Sen_US
dc.contributor.authorCollier, Jen_US
dc.contributor.authorBrown, ASen_US
dc.contributor.authorRyder, SDen_US
dc.contributor.authorUstianowski, Aen_US
dc.contributor.authorForton, DMen_US
dc.contributor.authorFox, Ren_US
dc.contributor.authorGordon, Fen_US
dc.contributor.authorRosenberg, WMen_US
dc.contributor.authorMutimer, DJen_US
dc.contributor.authorDu, Jen_US
dc.contributor.authorGilbert, CLen_US
dc.contributor.authorAsante-Appiah, Een_US
dc.contributor.authorWahl, Jen_US
dc.contributor.authorRobertson, MNen_US
dc.contributor.authorBarr, Een_US
dc.contributor.authorHaber, Ben_US
dc.date.accessioned2018-05-04T07:42:27Z
dc.date.available2018-01-08en_US
dc.date.issued2018-06en_US
dc.date.submitted2018-03-29T14:33:41.703Z
dc.identifier.urihttp://qmro.qmul.ac.uk/xmlui/handle/123456789/36723
dc.description.abstractMany direct-acting antiviral regimens have reduced activity in people with hepatitis C virus (HCV) genotype (GT) 3 infection and cirrhosis. The C-ISLE study assessed the efficacy and safety of elbasvir/grazoprevir (EBR/GZR) plus sofosbuvir (SOF) with and without ribavirin (RBV) in compensated cirrhotic participants with GT3 infection. This was a phase 2, randomized, open-label study. Treatment-naive participants received EBR/GZR + SOF + RBV for 8 weeks or EBR/GZR + SOF for 12 weeks, and peginterferon/RBV treatment-experienced participants received EBR/GZR + SOF ± RBV for 12 weeks or EBR/GZR + SOF for 16 weeks. The primary endpoint was HCV RNA <15 IU/mL 12 weeks after the end of treatment (sustained virologic response at 12 weeks [SVR12]). Among treatment-naive participants, SVR12 was 91% (21/23) in those treated with RBV for 8 weeks and 96% (23/24) in those treated for 12 weeks. Among treatment-experienced participants, SVR12 was 94% (17/18) and 100% (17/17) in the 12-week arm, with and without RBV, respectively, and 94% (17/18) in the 16-week arm. Five participants failed to achieve SVR: 2 relapsed (both in the 8-week arm), 1 discontinued due to vomiting/cellulitis (16-week arm), and 2 discontinued (consent withdrawn/lost to follow-up). SVR12 was not affected by the presence of resistance-associated substitutions (RASs). There was no consistent change in insulin resistance, and 5 participants reported serious adverse events (pneumonia, chest pain, opiate overdose, cellulitis, decreased creatinine). High efficacy was demonstrated in participants with HCV GT3 infection and cirrhosis. Treatment beyond 12 weeks was not required, and efficacy was maintained regardless of baseline RASs. CONCLUSION: Data from this study support the use of EBR/GZR plus SOF for 12 weeks without RBV for treatment-naive and peginterferon/RBV-experienced people with GT3 infection and cirrhosis (ClinicalTrials.gov NCT02601573). (Hepatology 2018;67:2113-2126).en_US
dc.description.sponsorshipMerck & Co., Incen_US
dc.format.extent2113 - 2126en_US
dc.languageengen_US
dc.relation.ispartofHepatologyen_US
dc.rightsThis is the peer reviewed version of the following article: Foster, Graham R., et al. "Elbasvir/Grazoprevir and Sofosbuvir for HCV Genotype 3 Infection With Compensated Cirrhosis: A Randomized Trial." Hepatology (2018)., which has been published in final form at https://doi.org/10.1002/hep.29852. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving.
dc.subjectAdulten_US
dc.subjectAgeden_US
dc.subjectAntiviral Agentsen_US
dc.subjectBenzofuransen_US
dc.subjectDrug Combinationsen_US
dc.subjectFemaleen_US
dc.subjectGenotypeen_US
dc.subjectHepacivirusen_US
dc.subjectHepatitis C, Chronicen_US
dc.subjectHumansen_US
dc.subjectImidazolesen_US
dc.subjectLiver Cirrhosisen_US
dc.subjectMaleen_US
dc.subjectMiddle Ageden_US
dc.subjectQuinoxalinesen_US
dc.subjectRibavirinen_US
dc.subjectSofosbuviren_US
dc.titleElbasvir/grazoprevir and sofosbuvir for hepatitis C virus genotype 3 infection with compensated cirrhosis: A randomized trial.en_US
dc.typeArticle
dc.rights.holder© 2018 by the American Association for the Study of Liver Diseases.
dc.identifier.doi10.1002/hep.29852en_US
pubs.author-urlhttps://www.ncbi.nlm.nih.gov/pubmed/29473975en_US
pubs.issue6en_US
pubs.notesNot knownen_US
pubs.publication-statusPublisheden_US
pubs.volume67en_US
dcterms.dateAccepted2018-01-08en_US


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