Sofosbuvir plus ledispasvir for recurrent hepatitis C in liver transplant recipients

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” sett...

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Bibliographic Details
Published in:Liver transplantation 2016-11, Vol.22 (11), p.1536-1543
Main Authors: 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.
Format: Article
Language:English
Subjects:
Aged
Antiviral Agents - administration & dosage
Antiviral Agents - adverse effects
Antiviral Agents - therapeutic use
Benzimidazoles - administration & dosage
Benzimidazoles - adverse effects
Benzimidazoles - therapeutic use
Calcineurin Inhibitors - administration & dosage
Calcineurin Inhibitors - therapeutic use
Drug Combinations
Drug Therapy, Combination - adverse effects
Female
Fluorenes - administration & dosage
Fluorenes - adverse effects
Fluorenes - therapeutic use
Graft Rejection - drug therapy
Graft Rejection - etiology
Hepacivirus - isolation & purification
Hepatitis
Hepatitis C, Chronic - complications
Hepatitis C, Chronic - drug therapy
Hepatitis C, Chronic - virology
Humans
Immunosuppression
Liver Transplantation - adverse effects
Male
Middle Aged
Pragmatic Clinical Trials as Topic
Recurrence
Retrospective Studies
Ribavirin - administration & dosage
Ribavirin - adverse effects
Ribavirin - therapeutic use
Transplants & implants
Uridine Monophosphate - administration & dosage
Uridine Monophosphate - adverse effects
Uridine Monophosphate - analogs & derivatives
Uridine Monophosphate - therapeutic use
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Summary: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.
ISSN:1527-6465
1527-6473
DOI:10.1002/lt.24614