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DAA‐based antiviral treatment of patients with chronic hepatitis C in the pre‐ and postkidney transplantation setting
Authors:Sandra Beinhardt  Ramona Al Zoairy  Peter Ferenci  Karin Kozbial  Clarissa Freissmuth  Rafael Stern  Albert Friedrich Stättermayer  Rudolf Stauber  Michael Strasser  Heinz Zoller  Bruno Watschinger  Alice Schmidt  Michael Trauner  Harald Hofer  Andreas Maieron
Affiliation:1. Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria;2. Division of Gastroenterology and Hepatology, Department of Medicine II, Medical University of Innsbruck, Innsbruck, Tirol, Austria;3. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Graz, Graz, Austria;4. Department of Gastroenterology and Hepatology, Paracelsus Medical University Salzburg, Salzburg, Austria;5. Division of Nephrology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria;6. Department of Gastroenterology, Elisabethinen Hospital, Linz, Austria
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.
Keywords:chronic kidney disease (CKD)  dialysis  direct‐acting antivirals (DAA)  end‐stage renal disease (ESRD)  IFN‐free  renal transplantation
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