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

Antonio Craxi, Isabelle Lonjon-Domanec, Michael Gschwantler, Maria Buti, Michael Schlag, Maria Buti, Gino Van Dooren, Catherine Nalpas, Ceyhun Bicer, Oliver Lenz, Peter Buggisch, Christoph Sarrazin, Graham R. Foster, Faisal Sanai, Tarik Asselah, Christophe Moreno

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6 Citazioni (Scopus)

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.
Lingua originaleEnglish
pagine (da-a)e0168713-
Numero di pagine16
RivistaPLoS One
Volume12
Stato di pubblicazionePublished - 2017

All Science Journal Classification (ASJC) codes

  • Biochemistry, Genetics and Molecular Biology(all)
  • Agricultural and Biological Sciences(all)
  • General

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    Craxi, A., Lonjon-Domanec, I., Gschwantler, M., Buti, M., Schlag, M., Buti, M., Van Dooren, G., Nalpas, C., Bicer, C., Lenz, O., Buggisch, P., Sarrazin, C., Foster, G. R., Sanai, F., Asselah, T., & Moreno, C. (2017). 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. PLoS One, 12, e0168713-.