title: Sofosbuvir-Based Antiviral Therapy Is Highly Effective In Recurrent Hepatitis C in Liver Transplant Recipients: Canadian Multicenter "Real-Life" Experience.
abstract: This study evaluates the efficacy, safety, and tolerability of regimens containing sofosbuvir (SOF) in the treatment of hepatitis C virus (HCV) recurrence in all genotypes in patients outside of clinical trials in all Canadian transplant centers.
  
  
  
  One hundred twenty liver transplantation recipients from across Canada with HCV recurrence were started on SOF-based regimens (SOF + simeprevir ± ribavirin (RBV), n = 53; SOF + pegylated interferon + RBV, n = 25; SOF + RBV, n = 36; and SOF + ledipasvir, n = 6) between January and November 2014. Mean age 58 ± 6.85 years, majority (83%) were genotype 1, male (81%), and treatment experienced (82%). Twenty-seven percent had fibrosing cholestatic hepatitis/early aggressive HCV in the graft, and 48% had F3/4 fibrosis. The primary outcomes included patient and graft survival, on- and end-of-treatment response and sustained virological response at 12 weeks after treatment end (SVR12), and adverse events.
  
  
  
  One hundred thirteen of 120 (94%) patients were HCV RNA undetectable at end of treatment, and SVR12 was achieved in 102/120 (85%) patients, with 7 relapses, 1 nonresponder, and 10 deaths (liver-related complications). Sixty-three percent had HCV RNA levels below the lower limit of quantification at week 4. Serum creatinine levels remained stable throughout the treatment. Severe anemia occurred in 13% of patients, primarily in RBV-based regimens.
  
  
  
  Sofosbuvir-based antiviral therapy for HCV recurrence after liver transplantation was well tolerated, with an overall high SVR12 rate (85%) including patients with severe disease recurrence and F3-4 cirrhosis. The response rate was higher (91%) in mild HCV recurrence, suggesting earlier treatment might be beneficial.
authors.affiliation: 1 Multiorgan Transplant, University Health Network/Toronto General Hospital, University of Toronto, Toronto, ON, Canada. 2 Liver Unit, Department of Medicine, Université de Montréal, Montréal, Québec, Canada. 3 Department of Gastroenterology, London Health Sciences, University of Western Ontario, London, ON, Canada. 4 King Saud University, Riyadh, Saudi Arabia. 5 Department of Hepatology, Dalhousie University/Queen Elizabeth II health Science Center, Halifax, NS, Canada. 6 Department of Gastroenterology, University of British Columbia and Vancouver General Hospital, Vancouver, BC, Canada. 7 Solid organ Transplantation, University of British Columbia and Vancouver General Hospital, Vancouver, BC, Canada. 8 Department of Gastroenterology and Hepatology, University of McGill, Montreal, Québec, Canada. 9 Department of Gastroenterology and Hepatology, University of Calgary, Calgary, AB, Canada. 10 Division of Gastroenterology and Liver Unit, University of Alberta, Edmonton, AB, Canada. 11 Department of Gastroenterology, Memorial University, St. John's, NL, Canada. 12 Division of Infectious diseases, University of Ottawa, Ottawa, ON, Canada. 13 Division of Gastroenterology, Dalhousie University/Queen Elizabeth II Health Science Center, Halifax, NS, Canada.
authors.forename: Nabiha
authors.initials: N
authors.lastname: Faisal
authors.forename: Marc
authors.initials: M
authors.lastname: Bilodeau
authors.forename: Bandar
authors.initials: B
authors.lastname: Aljudaibi
authors.forename: Geri
authors.initials: G
authors.lastname: Hirsch
authors.forename: Eric M
authors.initials: EM
authors.lastname: Yoshida
authors.forename: Trana
authors.initials: T
authors.lastname: Hussaini
authors.forename: Maged P
authors.initials: MP
authors.lastname: Ghali
authors.forename: Stephen E
authors.initials: SE
authors.lastname: Congly
authors.forename: Mang M
authors.initials: MM
authors.lastname: Ma
authors.forename: Jennifer
authors.initials: J
authors.lastname: Leonard
authors.forename: Curtis
authors.initials: C
authors.lastname: Cooper
authors.forename: Kevork
authors.initials: K
authors.lastname: Peltekian
authors.forename: Eberhard L
authors.initials: EL
authors.lastname: Renner
authors.forename: Leslie B
authors.initials: LB
authors.lastname: Lilly
mesh_terms: D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage*; D001706:Biopsy; D002170:Canada; D003404:Creatinine / Q000097:blood; D005260:Female; D005355:Fibrosis; D005838:Genotype; D005919:Glomerular Filtration Rate; D006526:Hepatitis C / Q000188:drug therapy* / Q000601:surgery; D006801:Humans; D007372:Interferons / Q000008:administration & dosage; D007668:Kidney / Q000503:physiopathology; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012367:RNA, Viral / Q000032:analysis; D012008:Recurrence; D012254:Ribavirin / Q000008:administration & dosage; D000069616:Simeprevir / Q000008:administration & dosage; D000069474:Sofosbuvir / Q000008:administration & dosage*
chemical_list: D000998:Antiviral Agents; D012367:RNA, Viral; D012254:Ribavirin; D007372:Interferons; D000069616:Simeprevir; D003404:Creatinine; D000069474:Sofosbuvir