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.

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 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 ( SVR12) 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 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 24 weeks was shown to be effective and well tolerated in the treatment of post- OLT HCV GT1b-infected patients. [ABSTRACT FROM AUTHOR]