Sofosbuvir-Based Antiviral Therapy Is Highly Effective In Recurrent Hepatitis C in Liver Transplant Recipients: Canadian Multicenter “Real-Life” Experience Nabiha Faisal, MD, 1 Marc Bilodeau, MD, 2 Bandar Aljudaibi, MD, 3,4 Geri Hirsch, MSN, 5 Eric M. Yoshida, MD, MHSc, 6 Trana Hussaini, PharmD, 7 Maged P. Ghali, MD, 8 Stephen E. Congly, MD, 9 Mang M. Ma, MD, 10 Jennifer Leonard, MD, 11 Curtis Cooper, MD, 12 Kevork Peltekian, MD, 13 Eberhard L. Renner, MD, 1 and Leslie B. Lilly, MD 1 Background. 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. Methods. 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. Results. 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 pa- tients, primarily in RBV-based regimens. Conclusions. Sofosbuvir-based antiviral therapy for HCV recurrence after liver transplan- tation 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. (Transplantation 2016;100: 1059–1065) Received 20 July 2015. Revision received 29 December 2015. Accepted 2 January 2016. 1 Multiorgan Transplant, University Health Network/Toronto General Hospital, Uni- versity 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 Sci- ence Center, Halifax, NS, Canada. N.F., M.B., B.A., G.H., T.H., S.C., N.S.N., K.P., and L.B.L. have no relevant disclosures. E.Y. has been a clinical investigator of clinical trials funded by: Gilead Inc, Boeringher Ingelheim Inc, Merck Inc, Abbvie Inc, Hoffman LaRoche Inc, Janssen Inc, Vertex Inc. He has received honoraria for CME lectures from Gilead Canada, Merck Canada, Vertex Canada. He has received honoraria for lectures presented at Advisory Board Meetings of Boeringher Ingelheim Canada, Hoffman LaRoche Canada, Abbvie Canada, Celgene Canada. He has received honoraria for membership of a compassionate release adjudication committee from Gilead Canada. P.G. has been a Consultant Gilead; Advisory board—Merck and Gilead for the last 2 years. J.L. is a member of the Advisory Board for Astellas and Abbvie. E.R. is consulting for Astellas, Gambro, Gilead, Jansen, Novartis, Roche, Vertex. He is a speaker for Astellas and Novartis. He is also a member of scientific committee SUSTAIN (Novartis). He gets research support (unrestricted) by Novartis and Roche. He has just initiated a clinical study which is supported by Gilead. N.F. participated in data collection, compiling and analyzing, and drafting of the article. M.B. participated in the data collection and compiling from the respective center. B.A. participated in the data collection and compiling from the respective center. G.H. participated in the data collection and compiling from the respective center. E.M.Y. participated in the peer reviewing the article. T.H. participated in data collection and compiling from respective center and also in peer reviewing the article. M.P.G. participated in data collection and compiling from the respective center. S.E.C. participated in data collection and compiling from the respective center. M.M.M. participated in data collection and compiling from the respective center. J.L. participated in data collection and compiling from the respective center. C.C. participated in data collection and compiling from the respective center. K.P. participated in data collection and compiling from the respective center. E.L.R. participated in research design. L.B.L. developed the main concept, peer review, and finalizing the article. Correspondence: Nabiha Faisal, MD, FCPS, Multiorgan Transplant, University Health Network/Toronto General Hospital, University of Toronto, 917-35 Thorncliffe Park Drive, Toronto, Ontario, Canada M4H 1J3. (nabiha. faisal@gmail.com). Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved. ISSN: 0041-1337/16/10005-1059 DOI: 10.1097/TP.0000000000001126 Original Clinical ScienceçLiver Transplantation ■ May 2016 ■ Volume 100 ■ Number 5 www.transplantjournal.com 1059 Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved.