title: DAA-based antiviral treatment of patients with chronic hepatitis C in the pre- and postkidney transplantation setting.
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.
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
authors.forename: Sandra
authors.initials: S
authors.lastname: Beinhardt
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Medicine II, Medical University of Innsbruck, Innsbruck, Tirol, Austria.
authors.forename: Ramona
authors.initials: R
authors.lastname: Al Zoairy
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
authors.forename: Peter
authors.initials: P
authors.lastname: Ferenci
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
authors.forename: Karin
authors.initials: K
authors.lastname: Kozbial
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
authors.forename: Clarissa
authors.initials: C
authors.lastname: Freissmuth
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
authors.forename: Rafael
authors.initials: R
authors.lastname: Stern
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
authors.forename: Albert Friedrich
authors.initials: AF
authors.lastname: Stättermayer
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
authors.forename: Rudolf
authors.initials: R
authors.lastname: Stauber
authors.affiliation: Department of Gastroenterology and Hepatology, Paracelsus Medical University Salzburg, Salzburg, Austria.
authors.forename: Michael
authors.initials: M
authors.lastname: Strasser
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Medicine II, Medical University of Innsbruck, Innsbruck, Tirol, Austria.
authors.forename: Heinz
authors.initials: H
authors.lastname: Zoller
authors.affiliation: Division of Nephrology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
authors.forename: Bruno
authors.initials: B
authors.lastname: Watschinger
authors.affiliation: Division of Nephrology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
authors.forename: Alice
authors.initials: A
authors.lastname: Schmidt
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
authors.forename: Michael
authors.initials: M
authors.lastname: Trauner
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
authors.forename: Harald
authors.initials: H
authors.lastname: Hofer
authors.affiliation: Department of Gastroenterology, Elisabethinen Hospital, Linz, Austria.
authors.forename: Andreas
authors.initials: A
authors.lastname: Maieron
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000627:therapeutic use; D002219:Carbamates; D015331:Cohort Studies; D004359:Drug Therapy, Combination; D005260:Female; D005449:Fluorenes / Q000627:therapeutic use; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000601:surgery; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D007668:Kidney / Q000473:pathology; D007677:Kidney Function Tests; D016030:Kidney Transplantation; D008099:Liver / Q000473:pathology; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D011184:Postoperative Period; D057234:Preoperative Period; D011759:Pyrrolidines; D012367:RNA, Viral / Q000235:genetics; D006435:Renal Dialysis; D051437:Renal Insufficiency / Q000601:surgery*; D000069616:Simeprevir / Q000627:therapeutic use; D000069474:Sofosbuvir / Q000627:therapeutic use; D014633:Valine / Q000031:analogs & derivatives
chemical_list: D000998:Antiviral Agents; D001562:Benzimidazoles; D002219:Carbamates; D005449:Fluorenes; D007093:Imidazoles; D007166:Immunosuppressive Agents; D011759:Pyrrolidines; D012367:RNA, Viral; C586541:ledipasvir; D000069616:Simeprevir; D014633:Valine; C549273:daclatasvir; D000069474:Sofosbuvir
keywords: IFN-free; chronic kidney disease (CKD); dialysis; direct-acting antivirals (DAA); end-stage renal disease (ESRD); renal transplantation