dc.contributor | Vall d'Hebron Barcelona Hospital Campus |
dc.contributor.author | Moreno, Christophe |
dc.contributor.author | Sarrazin, Christoph |
dc.contributor.author | Gschwantler, Michael |
dc.contributor.author | Foster, Graham R. |
dc.contributor.author | Craxi, Antonio |
dc.contributor.author | Asselah, Tarik |
dc.contributor.author | Buti Ferret, Maria |
dc.date.accessioned | 2021-04-22T07:54:10Z |
dc.date.available | 2021-04-22T07:54:10Z |
dc.date.issued | 2017-01-05 |
dc.identifier.citation | Asselah 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.issn | 1932-6203 |
dc.identifier.uri | https://hdl.handle.net/11351/5893 |
dc.description | Adverse events; Liver diseases; Protease inhibitor therapy |
dc.description.abstract | Background
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.iso | eng |
dc.publisher | Public Library of Science |
dc.relation.ispartofseries | PLoS ONE;12(1) |
dc.rights | Attribution 4.0 International |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ |
dc.source | Scientia |
dc.subject | Fetge - Malalties |
dc.subject | Medicaments - Administració |
dc.subject.mesh | Liver Diseases |
dc.subject.mesh | /drug therapy |
dc.title | 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 |
dc.type | info:eu-repo/semantics/article |
dc.identifier.doi | 10.1371/journal.pone.0168713 |
dc.subject.decs | enfermedades hepáticas |
dc.subject.decs | /farmacoterapia |
dc.relation.publishversion | https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0168713 |
dc.type.version | info:eu-repo/semantics/publishedVersion |
dc.audience | Professionals |
dc.contributor.organismes | Institut 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.pmid | 28056030 |
dc.identifier.wos | 000391639100010 |
dc.rights.accessrights | info:eu-repo/semantics/openAccess |