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
Liver Unit, Hospital Clinic, IDIBAPS and CIBEREHD, University of Barcelona, Barcelona, Spain.
Department of Digestive Diseases, Hepatology and Liver Transplantation Unit, La Fe University Hospital and CIBEREHD, Valencia, Spain.
Transpl Infect Dis. 2017 Jun;19(3). doi: 10.1111/tid.12696. Epub 2017 May 4.
Recurrent hepatitis C virus (HCV) infection following liver transplantation is associated with accelerated progression to graft failure and reduced patient survival.
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).
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.
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.
肝移植后丙型肝炎病毒（HCV）复发感染与移植肝衰竭加速进展及患者生存率降低相关。
II期开放标签SATURN研究（NCT01938625）在35例原位肝移植（OLT）后复发HCV基因1b型（GT1b）感染的患者中，研究了simeprevir（SMV）、daclatasvir（DCV）和利巴韦林（RBV）联合用药24周的情况。
既往未经治疗或OLT后聚乙二醇干扰素和RBV治疗失败的患者在治疗期间及治疗结束后12周持续病毒学应答（SVR12）率均很高。总体而言，91%的患者（32/35）实现了SVR12。该联合用药一般耐受性良好，不良事件谱与既往单独进行的SMV或DCV临床试验中观察到的一致。SMV与环孢素合用导致SMV血浆暴露量显著增加，而SMV与他克莫司合用则不然。因此，不建议SMV与环孢素同时使用。
在OLT后HCV GT1b感染患者的治疗中，SMV、DCV和RBV联合使用24周且不含干扰素，显示出有效且耐受性良好。
