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  3. Efficacy, safety, and pharmacokinetics of simeprevir, daclatasvir, and ribavirin in patients with recurrent hepatitis C virus genotype 1b infection after orthotopic liver transplantation: The Phase II SATURN study

Efficacy, safety, and pharmacokinetics of simeprevir, daclatasvir, and ribavirin in patients with recurrent hepatitis C virus genotype 1b infection after orthotopic liver transplantation: The Phase II SATURN study

Fecha de publicación:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Forns, X
  • Herzer, K
  • Sterneck, M
  • Donato, MF
  • Andreone, P
  • Fagiuoli, S
  • Cieciura, T
  • Durlik, M
  • Calleja, JL
  • Mariño Z
  • Shukla, U
  • Verbinnen, T
  • Lenz, O
  • Ouwerkerk-Mahadevan, S
  • Peeters, M
  • Janssen, K
  • Kalmeijer, R
  • Jessner, W

Grupos

Abstract

Background: Recurrent hepatitis C virus (HCV) infection following liver transplantation is associated with accelerated progression to graft failure and reduced patient survival. Methods: The Phase II, open-label SATURN study (NCT01938625) investigated the combination of simeprevir (SMV), daclatasvir (DCV), and ribavirin (RBV) administered for 24weeks in 35 patients with recurrent HCV genotype (GT) 1b infection after orthotopic liver transplantation (OLT). Results: High rates of both on-treatment and sustained virologic response 12weeks after end of treatment (SVR12) were achieved in patients who were either treatment-naive or had failed post-OLT treatment with peginterferon and RBV. Overall, 91% of patients (32/35) achieved SVR12. The combination was generally well tolerated, with an adverse event profile consistent with that observed in previous clinical trials of SMV or DCV separately. Co-administration of SMV with cyclosporine resulted in significantly increased SMV plasma exposures, which was not the case with the co-administration of SMV with tacrolimus. Therefore, the concomitant use of SMV with cyclosporine is not recommended. Conclusion: The interferon-free combination of SMV, DCV, and RBV administered for 24weeks was shown to be effective and well tolerated in the treatment of post-OLT HCV GT1b-infected patients.

Datos de la publicación

ISSN/ISSNe:
1398-2273, 1399-3062

TRANSPLANT INFECTIOUS DISEASE  WILEY

Tipo:
Article
Páginas:
-
PubMed:
28295849
Factor de Impacto:
0,882 SCImago ℠
Cuartil:
Q2 SCImago ℠

Citas Recibidas en Web of Science: 8

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Keywords

  • daclatasvir; hepatitis C virus; liver transplantation; ribavirin; simeprevir

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