Show simple item record

 
dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorAsselah, Tarik
dc.contributor.authorMoreno, Christophe
dc.contributor.authorSarrazin, Christoph
dc.contributor.authorGschwantler, Michael
dc.contributor.authorFoster, Graham R.
dc.contributor.authorCraxí, Antonio
dc.contributor.authorButi Ferret, Maria
dc.date.accessioned2021-04-22T07:54:10Z
dc.date.available2021-04-22T07:54:10Z
dc.date.issued2017-01-05
dc.identifier.citationAsselah T, Moreno C, Sarrazin C, Gschwantler M, Foster GR, Craxí A, et al. Efficacy 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. Grebely J, editor. PLoS One. 2017 Jan 5;12(1):e0168713.
dc.identifier.issn1932-6203
dc.identifier.urihttp://hdl.handle.net/11351/5893
dc.descriptionAdverse events; Liver diseases; Protease inhibitor therapy
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.
dc.language.isoeng
dc.publisherPublic Library of Science
dc.relation.ispartofseriesPLoS ONE;12(1)
dc.rightsAttribution 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.sourceScientia
dc.subjectFetge - Malalties
dc.subjectMedicaments - Administració
dc.subject.meshLiver Diseases
dc.subject.mesh/drug therapy
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
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1371/journal.pone.0168713
dc.subject.decsenfermedades hepáticas
dc.subject.decs/farmacoterapia
dc.relation.publishversionhttps://journals.plos.org/plosone/article?id=10.1371/journal.pone.0168713
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.organismesInstitut Català de la Salut
dc.contributor.authoraffiliation[Asselah T] Hepatology Department, Beaujon Hospital, University of Paris, Paris, France. [Moreno C] CUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium. [Sarrazin C] Johann Wolfgang Goethe University Hospital, Medizinische Klinik 1, Frankfurt am Main, Germany. [Gschwantler M] Department of Internal Medicine IV, Wilhelminenspital, Vienna, Austria. [Foster GR] Queen Mary Hospital, University of London, Barts Health, London, United Kingdom. [Craxí A] Sezione di Gastroenterologia & Epatologia, Di.Bi.M.I.S., University of Palermo, Palermo, Italy. [Buti M] Unitat d'Hepatologia, Vall d’Hebron Hospital, Barcelona, Spain. Ciberehd del Instituto Carlos III
dc.identifier.pmid28056030
dc.identifier.wos000391639100010
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


Files in this item

Thumbnail

This item appears in the following Collection(s)

Show simple item record