Sofosbuvir plus ledispasvir for recurrent hepatitis C in liver transplant recipients

Ryan M. Kwok, Joseph Ahn, Thomas D. Schiano, Helen S. Te, Darryn R. Potosky, Amber Tierney, Rohit Satoskar, Suzanne Robertazzi, Colleen Rodigas, Michelle Lee Sang, Joshua Wiegel, Neal Patel, Janet Gripshover, Mohamed A. Hassan, Andrea Branch, Coleman I. Smith

Research output: Contribution to journalArticle

34 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1536-1543
Number of pages8
JournalLiver Transplantation
Volume22
Issue number11
DOIs
StatePublished - Nov 1 2016

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Hepatitis C
Liver Transplantation
Liver
Hepacivirus
Immunosuppression
Therapeutics
Safety
Transplant Recipients
Sofosbuvir
Multicenter Studies
sofosbuvir drug combination ledipasvir
Fibrosis
Genotype
Transplants
Recurrence

ASJC Scopus subject areas

  • Surgery
  • Hepatology
  • Transplantation

Cite this

Kwok, R. M., Ahn, J., Schiano, T. D., Te, H. S., Potosky, D. R., Tierney, A., ... Smith, C. I. (2016). Sofosbuvir plus ledispasvir for recurrent hepatitis C in liver transplant recipients. Liver Transplantation, 22(11), 1536-1543. https://doi.org/10.1002/lt.24614

Sofosbuvir plus ledispasvir for recurrent hepatitis C in liver transplant recipients. / 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.

In: Liver Transplantation, Vol. 22, No. 11, 01.11.2016, p. 1536-1543.

Research output: Contribution to journalArticle

Kwok, RM, Ahn, J, Schiano, TD, Te, HS, Potosky, DR, Tierney, A, Satoskar, R, Robertazzi, S, Rodigas, C, Lee Sang, M, Wiegel, J, Patel, N, Gripshover, J, Hassan, MA, Branch, A & Smith, CI 2016, 'Sofosbuvir plus ledispasvir for recurrent hepatitis C in liver transplant recipients', Liver Transplantation, vol. 22, no. 11, pp. 1536-1543. https://doi.org/10.1002/lt.24614
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. / Sofosbuvir plus ledispasvir for recurrent hepatitis C in liver transplant recipients. In: Liver Transplantation. 2016 ; Vol. 22, No. 11. pp. 1536-1543.
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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.",
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