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Sofosbuvir plus ledispasvir for recurrent hepatitis C in liver transplant recipients
Author(s) -
Kwok Ryan M.,
Ahn Joseph,
Schiano Thomas D.,
Te Helen S.,
Potosky Darryn R.,
Tierney Amber,
Satoskar Rohit,
Robertazzi Suzanne,
Rodigas Colleen,
Lee Sang Michelle,
Wiegel Joshua,
Patel Neal,
Gripshover Janet,
Hassan Mohamed A.,
Branch Andrea,
Smith Coleman I.
Publication year - 2016
Publication title -
liver transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.814
H-Index - 150
eISSN - 1527-6473
pISSN - 1527-6465
DOI - 10.1002/lt.24614
Subject(s) - medicine , sofosbuvir , liver transplantation , gastroenterology , hepatitis c , virology , chronic hepatitis , transplantation , ribavirin , virus
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 .