| Literature DB >> 27203857 |
Sandra Beinhardt1, Ramona Al Zoairy2, Peter Ferenci1, Karin Kozbial1, Clarissa Freissmuth1, Rafael Stern1, Albert Friedrich Stättermayer1, Rudolf Stauber3, Michael Strasser4, Heinz Zoller2, Bruno Watschinger5, Alice Schmidt5, Michael Trauner1, Harald Hofer1, Andreas Maieron6.
Abstract
DAA-based regimens for chronic hepatitis C infection encourage treatment of "difficult-to-treat" cohorts. This study investigated efficacy and safety of DAA-based regimens in HCV patients on dialysis or postkidney or liver/kidney transplantation. Twenty-five patients treated with DAA combinations were evaluated: 10 were on dialysis (eight: hemodialysis, two: peritoneal dialysis), eight were kidney transplant recipients, and seven were liver/kidney transplant recipients. Except for one patient treated with daclatasvir ([DCV]/60 mg/QD)/simeprevir ([SMV]/150 mg/QD), the others received sofosbuvir-based regimens ([SOF];400 mg/QD) combined with SMV:eight, DCV:13 or either ledipasvir ([LDV]90 mg/QD), ribavirin ([RBV];weight based) or pegylated interferon/RBV. HCV-RNA was determined by Abbott RealTime (LLOQ]:12 IU/ml) or Roche AmpliPrep/COBAS TaqMan assay (LLOQ:15 IU/ml); treatment response evaluated every 4 weeks, at the end of treatment, and 4 and 12 weeks thereafter. Twenty-four (96%) patients achieved SVR 12/24 (ITT-analysis). Mean treatment duration was 15.1 ± 5.1 weeks (±SD), and two patients terminated prematurely - both reached SVR12. Six patients were hospitalized due to complications of underlying disease. One patient achieved SVR24 but was re-infected (week 27). Kidney function remained stable; serum creatinine increased in only one patient - SOF was reduced to 400 mg/48 h. Treatment with DAA combinations in renally impaired HCV patients is highly effective and well tolerated. These findings call for further controlled trials and data from real-life cohorts.Entities:
Keywords: IFN-free; chronic kidney disease (CKD); dialysis; direct-acting antivirals (DAA); end-stage renal disease (ESRD); renal transplantation
Mesh:
Substances:
Year: 2016 PMID: 27203857 DOI: 10.1111/tri.12799
Source DB: PubMed Journal: Transpl Int ISSN: 0934-0874 Impact factor: 3.782