title: Sofosbuvir plus ledispasvir for recurrent hepatitis C in liver transplant recipients.
abstract: Hepatitis C virus (HCV) recurrence after liver transplantation (LT) is associated with worse outcomes. The combination of ledipasvir (LDV) and sofosbuvir (SOF) has been approved for HCV treatment after LT, but there are limited data on the effectiveness and safety of LDV/SOF in the "real-world" setting. This multicenter study is the largest report to date on the effectiveness and safety of LDV/SOF in the post-LT setting. A total of 204 patients (72% male, 68% Caucasian, 66% genotype [GT] 1a, 21% METAVIR F3-F4, 49% treatment-experienced) were treated with LDV/SOF. The mean duration from LT to treatment initiation was 4.8 years. The overall sustained virological response rate 12 weeks after completion of therapy (SVR12) was 96%. Patients treated with 8 or 12 weeks of LDV/SOF without RBV experienced an SVR12 rate of 100% and 96%, respectively. Calcineurin inhibitors were used in 89% of patients, and 32% of patients underwent adjustment in immunosuppression during treatment. One episode of mild rejection, responsive to an increase in immunosuppression dosage, was observed. There was no graft loss attributed to HCV treatment. Four deaths occurred unrelated to HCV treatment, and no significant serious adverse events were documented. In conclusion, SOF and LDV with or without RBV for 8, 12, or 24 weeks in post-LT patients was effective and safe with a high SVR12 rate across a spectrum of GTs and stages of fibrosis. Liver Transplantation 22 1536-1543 2016 AASLD.
authors.affiliation: Medstar Georgetown Transplant Institute, Georgetown University School of Medicine, Washington, DC. ryan.m.kwok.mil@mail.mil.
authors.forename: Ryan M
authors.initials: RM
authors.lastname: Kwok
authors.affiliation: Oregon Health and Science University, Portland, OR.
authors.forename: Joseph
authors.initials: J
authors.lastname: Ahn
authors.affiliation: Division of Liver Diseases and Recanati-Miller Transplant Institute, Mount Sinai Medical Center, New York, NY.
authors.forename: Thomas D
authors.initials: TD
authors.lastname: Schiano
authors.affiliation: Center for Liver Diseases, Department of Medicine, The University of Chicago Medical Center, Chicago, IL.
authors.forename: Helen S
authors.initials: HS
authors.lastname: Te
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Medicine, University of Maryland School of Medicine, Baltimore, MD.
authors.forename: Darryn R
authors.initials: DR
authors.lastname: Potosky
authors.affiliation: University of Minnesota Medical School, Minneapolis, MN.
authors.forename: Amber
authors.initials: A
authors.lastname: Tierney
authors.affiliation: Medstar Georgetown Transplant Institute, Georgetown University School of Medicine, Washington, DC.
authors.forename: Rohit
authors.initials: R
authors.lastname: Satoskar
authors.affiliation: Medstar Georgetown Transplant Institute, Georgetown University School of Medicine, Washington, DC.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Robertazzi
authors.affiliation: Medstar Georgetown Transplant Institute, Georgetown University School of Medicine, Washington, DC.
authors.forename: Colleen
authors.initials: C
authors.lastname: Rodigas
authors.affiliation: Medstar Georgetown Transplant Institute, Georgetown University School of Medicine, Washington, DC.
authors.forename: Michelle
authors.initials: M
authors.lastname: Lee Sang
authors.affiliation: Oregon Health and Science University, Portland, OR.
authors.forename: Joshua
authors.initials: J
authors.lastname: Wiegel
authors.affiliation: Division of Liver Diseases and Recanati-Miller Transplant Institute, Mount Sinai Medical Center, New York, NY.
authors.forename: Neal
authors.initials: N
authors.lastname: Patel
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Medicine, University of Maryland School of Medicine, Baltimore, MD.
authors.forename: Janet
authors.initials: J
authors.lastname: Gripshover
authors.affiliation: University of Minnesota Medical School, Minneapolis, MN.
authors.forename: Mohamed A
authors.initials: MA
authors.lastname: Hassan
authors.affiliation: Division of Liver Diseases and Recanati-Miller Transplant Institute, Mount Sinai Medical Center, New York, NY.
authors.forename: Andrea
authors.initials: A
authors.lastname: Branch
authors.affiliation: Medstar Georgetown Transplant Institute, Georgetown University School of Medicine, Washington, DC.
authors.forename: Coleman I
authors.initials: CI
authors.lastname: Smith
mesh_terms: D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D065095:Calcineurin Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use; D004338:Drug Combinations; D004359:Drug Therapy, Combination / Q000009:adverse effects; D005260:Female; D005449:Fluorenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006084:Graft Rejection / Q000188:drug therapy / Q000209:etiology; D016174:Hepacivirus / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D007165:Immunosuppression Therapy; D016031:Liver Transplantation / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D064792:Pragmatic Clinical Trials as Topic; D012008:Recurrence; D012189:Retrospective Studies; D012254:Ribavirin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069474:Sofosbuvir; D014542:Uridine Monophosphate / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000998:Antiviral Agents; D001562:Benzimidazoles; D065095:Calcineurin Inhibitors; D004338:Drug Combinations; D005449:Fluorenes; C000595958:ledipasvir, sofosbuvir drug combination; D012254:Ribavirin; D014542:Uridine Monophosphate; D000069474:Sofosbuvir