title: Efficacy and Tolerability of Pegylated Interferon and Ribavirin in Combination with Simeprevir to Treat Hepatitis C Virus Infections After Living Donor Liver Transplantation.
abstract: Pegylated interferon and ribavirin plus simeprevir therapy (simeprevir-based triple therapy) has been recently introduced, providing excellent results for nontransplant patients with hepatitis C virus (HCV) infection. However, there are limited data available on its effect on liver transplant recipients. In the present study, we evaluated the efficacy and tolerability of simeprevir-based triple therapy in liver transplant recipients. We treated 9 liver transplant recipients for genotype 1b HCV reinfection with simeprevir-based triple therapy. The efficacy and adverse effects were evaluated until 24 weeks after therapy. All recipients continued immunosuppressive therapy at the same dose as that before therapy induction. Seven of the 9 recipients (77.8%) achieved sustained virological response at 24 weeks. Two recipients (22.2%) experienced viral breakthrough (BT) at 12 and 16 weeks; NS3 HCV mutations conferring resistance to simeprevir were detected in both these patients after BT. Anemia was the most common adverse effect, requiring ribavirin dose reduction and blood transfusion. However, all recipients, except those with BT, completed the 24-week therapy. No recipient experienced cellular rejection during therapy. In conclusion, simeprevir-based triple therapy exhibited high efficacy and tolerability in liver transplant recipients with genotype 1b HCV reinfection.
authors.affiliation: 1 Department of Gastroenterology, Hepatology, Graduate School of Biomedical Sciences, Nagasaki University , Nagasaki, Japan .
authors.forename: Satoshi
authors.initials: S
authors.lastname: Miuma
authors.affiliation: 1 Department of Gastroenterology, Hepatology, Graduate School of Biomedical Sciences, Nagasaki University , Nagasaki, Japan .|3 Department of Gastroenterology, Nagasaki Harbor Medical Center City Hospital , Nagasaki, Japan .
authors.forename: Tatsuki
authors.initials: T
authors.lastname: Ichikawa
authors.affiliation: 1 Department of Gastroenterology, Hepatology, Graduate School of Biomedical Sciences, Nagasaki University , Nagasaki, Japan .
authors.forename: Hisamitsu
authors.initials: H
authors.lastname: Miyaaki
authors.affiliation: 1 Department of Gastroenterology, Hepatology, Graduate School of Biomedical Sciences, Nagasaki University , Nagasaki, Japan .
authors.forename: Masafumi
authors.initials: M
authors.lastname: Haraguchi
authors.affiliation: 1 Department of Gastroenterology, Hepatology, Graduate School of Biomedical Sciences, Nagasaki University , Nagasaki, Japan .
authors.forename: Yoko
authors.initials: Y
authors.lastname: Tamada
authors.affiliation: 1 Department of Gastroenterology, Hepatology, Graduate School of Biomedical Sciences, Nagasaki University , Nagasaki, Japan .
authors.forename: Hidetaka
authors.initials: H
authors.lastname: Shibata
authors.affiliation: 1 Department of Gastroenterology, Hepatology, Graduate School of Biomedical Sciences, Nagasaki University , Nagasaki, Japan .
authors.forename: Naota
authors.initials: N
authors.lastname: Taura
authors.affiliation: 2 Department of Surgery, Graduate School of Biomedical Sciences, Nagasaki University , Nagasaki, Japan .
authors.forename: Akihiko
authors.initials: A
authors.lastname: Soyama
authors.affiliation: 2 Department of Surgery, Graduate School of Biomedical Sciences, Nagasaki University , Nagasaki, Japan .
authors.forename: Masaaki
authors.initials: M
authors.lastname: Hidaka
authors.affiliation: 2 Department of Surgery, Graduate School of Biomedical Sciences, Nagasaki University , Nagasaki, Japan .
authors.forename: Mitsuhisa
authors.initials: M
authors.lastname: Takatsuki
authors.affiliation: 2 Department of Surgery, Graduate School of Biomedical Sciences, Nagasaki University , Nagasaki, Japan .
authors.forename: Susumu
authors.initials: S
authors.lastname: Eguchi
authors.affiliation: 1 Department of Gastroenterology, Hepatology, Graduate School of Biomedical Sciences, Nagasaki University , Nagasaki, Japan .
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Nakao
mesh_terms: D000328:Adult; D000368:Aged; D015415:Biomarkers; D004252:DNA Mutational Analysis; D024882:Drug Resistance, Viral; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000187:drug effects* / Q000235:genetics; D006526:Hepatitis C / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D056747:Immunomodulation / Q000187:drug effects; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016031:Liver Transplantation; D019520:Living Donors; D008297:Male; D008875:Middle Aged; D009154:Mutation; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D012254:Ribavirin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069616:Simeprevir / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load; D017361:Viral Nonstructural Proteins / Q000235:genetics; D012697:Serine Endopeptidases; D043583:Nucleoside-Triphosphatase; D053487:DEAD-box RNA Helicases; D000085242:Viral Proteases
chemical_list: D015415:Biomarkers; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011092:Polyethylene Glycols; D011994:Recombinant Proteins; D012254:Ribavirin; D000069616:Simeprevir; D017361:Viral Nonstructural Proteins; C084422:NS3 protein, hepatitis C virus; D012697:Serine Endopeptidases; D043583:Nucleoside-Triphosphatase; D053487:DEAD-box RNA Helicases; D000085242:Viral Proteases; C417083:peginterferon alfa-2b