Show simple item record

dc.contributor.authorAsselah, Ten_US
dc.contributor.authorMoreno, Cen_US
dc.contributor.authorSarrazin, Cen_US
dc.contributor.authorGschwantler, Men_US
dc.contributor.authorFoster, GRen_US
dc.contributor.authorCraxí, Aen_US
dc.contributor.authorBuggisch, Pen_US
dc.contributor.authorSanai, Fen_US
dc.contributor.authorBicer, Cen_US
dc.contributor.authorLenz, Oen_US
dc.contributor.authorVan Dooren, Gen_US
dc.contributor.authorNalpas, Cen_US
dc.contributor.authorLonjon-Domanec, Ien_US
dc.contributor.authorSchlag, Men_US
dc.contributor.authorButi, Men_US
dc.date.accessioned2017-06-01T08:30:26Z
dc.date.available2016-11-25en_US
dc.date.issued2017en_US
dc.date.submitted2017-05-10T10:11:58.382Z
dc.identifier.urihttp://qmro.qmul.ac.uk/xmlui/handle/123456789/23465
dc.description.abstractBACKGROUND: HCV GT4 accounts for up to 20% of HCV infections worldwide. Simeprevir, given for 12 weeks as part of a 24- or 48-week combination regimen with PR is approved for the treatment of chronic HCV GT4 infection. Primary study objectives were assessment of efficacy and safety of simeprevir plus PR in treatment-naïve patients with HCV GT4 treated for 12 weeks. Primary efficacy outcome was sustained virologic response 12 weeks post-treatment (SVR12). Additional objectives included investigation of potential associations of rapid virologic response and baseline factors with SVR12. METHODS: This multicentre, open-label, single-arm study (NCT01846832) evaluated efficacy and safety of simeprevir plus PR in 67 patients with HCV GT4 infection. Patients were treatment-naïve, aged 18-70 years with METAVIR F0-F2 fibrosis. Patients with early virologic response (HCV RNA <25 IU/mL [detectable/undetectable in IL28B CC patients or undetectable in IL28B CT/TT patients] at Week 2 and undetectable at Weeks 4 and 8) were eligible to stop all treatment at the end of Week 12, otherwise PR therapy was continued to Week 24. RESULTS: Of 67 patients treated, 34 (51%) qualified for 12-week treatment including all but one patient with IL28B CC genotype (14/15). All patients in the 12-week group had undetectable HCV RNA at end of treatment, and 97% (33/34) achieved SVR12. No new safety signals with simeprevir plus PR were identified. The proportion of patients experiencing Grade 3-4 adverse events was lower in the 12-week group than in the 24-week group. CONCLUSIONS: Our findings on simeprevir plus PR therapy shortened to 12 weeks in patients with HCV GT4 infection with favourable baseline characteristics and displaying early on-treatment virologic response are encouraging. No new safety signals were associated with simeprevir plus PR in this study. TRIAL REGISTRATION: NCT01846832.en_US
dc.description.sponsorshipThe study described in this manuscript (HPC3014; NCT01846832) was sponsored by Janssen Pharmaceuticals. The funder was involved in study design, data collection and analysis, decision to publish, and preparation of the manuscript. Editorial support was provided by Ian Grieve (Medical Writer at Zoetic Science, an Ashfield Company, part of UDG Healthcare plc, Macclesfield, UK); this support was funded by Janssen Pharmaceuticals. This does not alter our adherence to PLOS ONE policies on sharing data and materials.en_US
dc.format.extente0168713 - ?en_US
dc.languageengen_US
dc.relation.ispartofPLoS Oneen_US
dc.rightsThis is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
dc.subjectAdolescenten_US
dc.subjectAdulten_US
dc.subjectAgeden_US
dc.subjectAntiviral Agentsen_US
dc.subjectDrug Therapy, Combinationen_US
dc.subjectFemaleen_US
dc.subjectGenotypeen_US
dc.subjectHepacivirusen_US
dc.subjectHepatitis Cen_US
dc.subjectHumansen_US
dc.subjectInterferon-alphaen_US
dc.subjectInterleukinsen_US
dc.subjectMaleen_US
dc.subjectMiddle Ageden_US
dc.subjectPolyethylene Glycolsen_US
dc.subjectRecombinant Proteinsen_US
dc.subjectRibavirinen_US
dc.subjectSimepreviren_US
dc.subjectViral Loaden_US
dc.subjectYoung Adulten_US
dc.titleEfficacy of a 12-Week Simeprevir Plus Peginterferon/Ribavirin (PR) Regimen in Treatment-Naïve Patients with Hepatitis C Virus (HCV) Genotype 4 (GT4) Infection and Mild-To-Moderate Fibrosis Displaying Early On-Treatment Virologic Response.en_US
dc.typeArticle
dc.rights.holder© 2017 Asselah et al.
dc.identifier.doi10.1371/journal.pone.0168713en_US
pubs.author-urlhttps://www.ncbi.nlm.nih.gov/pubmed/28056030en_US
pubs.issue1en_US
pubs.notesNo embargoen_US
pubs.publication-statusPublished onlineen_US
pubs.volume12en_US
dcterms.dateAccepted2016-11-25en_US


Files in this item

Thumbnail

This item appears in the following Collection(s)

Show simple item record