Premium
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
Author(s) -
Forns Xavier,
Berenguer Marina,
Herzer Kerstin,
Sterneck Martina,
Donato Maria Francesca,
Andreone Pietro,
Fagiuoli Stefano,
Cieciura Tomasz,
Durlik Magdalena,
Calleja Jose Luis,
Mariño Zoe,
Shukla Umesh,
Verbinnen Thierry,
Lenz Oliver,
OuwerkerkMahadevan Sivi,
Peeters Monika,
Janssen Katrien,
Kalmeijer Ronald,
Jessner Wolfgang
Publication year - 2017
Publication title -
transplant infectious disease
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.69
H-Index - 67
eISSN - 1399-3062
pISSN - 1398-2273
DOI - 10.1111/tid.12696
Subject(s) - medicine , daclatasvir , simeprevir , ribavirin , gastroenterology , hepatitis c virus , hepatitis c , liver transplantation , sofosbuvir , transplantation , virology , virus
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 ( NCT 01938625) investigated the combination of simeprevir ( SMV ), daclatasvir ( DCV ), and ribavirin ( RBV ) administered for 24 weeks 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 12 weeks after end of treatment ( SVR 12) were achieved in patients who were either treatment‐naïve or had failed post‐ OLT treatment with peginterferon and RBV . Overall, 91% of patients (32/35) achieved SVR 12. 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 24 weeks was shown to be effective and well tolerated in the treatment of post‐ OLT HCV GT 1b‐infected patients.