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

Media type: E-Article
Title: 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
Contributor: 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; Ouwerkerk‐Mahadevan, Sivi; Peeters, Monika; Janssen, Katrien; Kalmeijer, Ronald; Jessner, Wolfgang
Published: Wiley, 2017
Published in: Transplant Infectious Disease, 19 (2017) 3
Language: English
DOI: 10.1111/tid.12696
ISSN: 1398-2273; 1399-3062
Keywords: Infectious Diseases ; Transplantation
Origination:
Footnote:
Description: <jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>Recurrent hepatitis C virus (<jats:styled-content style="fixed-case">HCV</jats:styled-content>) infection following liver transplantation is associated with accelerated progression to graft failure and reduced patient survival.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>The Phase <jats:styled-content style="fixed-case">II</jats:styled-content>, open‐label <jats:styled-content style="fixed-case">SATURN</jats:styled-content> study (<jats:styled-content style="fixed-case">NCT</jats:styled-content>01938625) investigated the combination of simeprevir (<jats:styled-content style="fixed-case">SMV</jats:styled-content>), daclatasvir (<jats:styled-content style="fixed-case">DCV</jats:styled-content>), and ribavirin (<jats:styled-content style="fixed-case">RBV</jats:styled-content>) administered for 24 weeks in 35 patients with recurrent <jats:styled-content style="fixed-case">HCV</jats:styled-content> genotype (<jats:styled-content style="fixed-case">GT</jats:styled-content>) 1b infection after orthotopic liver transplantation (<jats:styled-content style="fixed-case">OLT</jats:styled-content>).</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>High rates of both on‐treatment and sustained virologic response 12 weeks after end of treatment (<jats:styled-content style="fixed-case">SVR</jats:styled-content>12) were achieved in patients who were either treatment‐naïve or had failed post‐<jats:styled-content style="fixed-case">OLT</jats:styled-content> treatment with peginterferon and <jats:styled-content style="fixed-case">RBV</jats:styled-content>. Overall, 91% of patients (32/35) achieved <jats:styled-content style="fixed-case">SVR</jats:styled-content>12. The combination was generally well tolerated, with an adverse event profile consistent with that observed in previous clinical trials of <jats:styled-content style="fixed-case">SMV</jats:styled-content> or <jats:styled-content style="fixed-case">DCV</jats:styled-content> separately. Co‐administration of <jats:styled-content style="fixed-case">SMV</jats:styled-content> with cyclosporine resulted in significantly increased <jats:styled-content style="fixed-case">SMV</jats:styled-content> plasma exposures, which was not the case with the co‐administration of <jats:styled-content style="fixed-case">SMV</jats:styled-content> with tacrolimus. Therefore, the concomitant use of <jats:styled-content style="fixed-case">SMV</jats:styled-content> with cyclosporine is not recommended.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>The interferon‐free combination of <jats:styled-content style="fixed-case">SMV</jats:styled-content>,<jats:styled-content style="fixed-case"> DCV</jats:styled-content>, and <jats:styled-content style="fixed-case">RBV</jats:styled-content> administered for 24 weeks was shown to be effective and well tolerated in the treatment of post‐<jats:styled-content style="fixed-case">OLT HCV GT</jats:styled-content>1b‐infected patients.</jats:p></jats:sec>

Search in field:

Recently searched for: