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Efficacy and Safety of Direct Acting Antivirals in Kidney Transplant Recipients with Chronic Hepatitis C Virus Infection

The prevalence of Hepatitis C Virus (HCV) infection is significantly higher in patients with end-stage renal disease compared to the general population and poses important clinical challenges in patients who undergo kidney transplantation. Historically, interferon-based treatment options have been l...

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Autores principales: Lin, Ming V., Sise, Meghan E., Pavlakis, Martha, Amundsen, Beth M., Chute, Donald, Rutherford, Anna E., Chung, Raymond T., Curry, Michael P., Hanifi, Jasmine M., Gabardi, Steve, Chandraker, Anil, Heher, Eliot C., Elias, Nahel, Riella, Leonardo V.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4945034/
https://www.ncbi.nlm.nih.gov/pubmed/27415632
http://dx.doi.org/10.1371/journal.pone.0158431
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author Lin, Ming V.
Sise, Meghan E.
Pavlakis, Martha
Amundsen, Beth M.
Chute, Donald
Rutherford, Anna E.
Chung, Raymond T.
Curry, Michael P.
Hanifi, Jasmine M.
Gabardi, Steve
Chandraker, Anil
Heher, Eliot C.
Elias, Nahel
Riella, Leonardo V.
author_facet Lin, Ming V.
Sise, Meghan E.
Pavlakis, Martha
Amundsen, Beth M.
Chute, Donald
Rutherford, Anna E.
Chung, Raymond T.
Curry, Michael P.
Hanifi, Jasmine M.
Gabardi, Steve
Chandraker, Anil
Heher, Eliot C.
Elias, Nahel
Riella, Leonardo V.
author_sort Lin, Ming V.
collection PubMed
description The prevalence of Hepatitis C Virus (HCV) infection is significantly higher in patients with end-stage renal disease compared to the general population and poses important clinical challenges in patients who undergo kidney transplantation. Historically, interferon-based treatment options have been limited by low rates of efficacy and significant side effects, including risk of precipitating rejection. Limited data exist on the use of all-oral, interferon-free direct-acting antiviral (DAA) therapies in kidney transplant recipients. In this study, we performed a retrospective chart review with prospective clinical follow-up of post-kidney transplant patients treated with DAA therapies at three major hospitals in Boston, MA. A total of 24 kidney recipients with HCV infection received all-oral DAA therapy post-transplant. Patients were predominantly male (79%) with a median age of 60 years (range 34–70 years), median creatinine of 1.2 mg/dL (0.66–1.76), and 42% had advanced fibrosis or cirrhosis. The majority had HCV genotype 1a infection (58%). All patients received full-dose sofosbuvir; it was paired with simeprevir (9 patients without and 3 patients with ribavirin), ledipasvir (7 patients without and 1 patient with ribavirin) or ribavirin alone (4 patients). The overall sustained virologic response (SVR12) was 91% (21 out of 23 patients). One patient achieved SVR4 but demised prior to SVR12 check point due to treatment unrelated cause. Two treatment failures were successfully retreated with alternative DAA regimens and achieved SVR. Both initials failures occurred in patients with advanced fibrosis or cirrhosis, with genotype 1a infection, and prior HCV treatment failure. Adverse events were reported in 11 patients (46%) and were managed clinically without discontinuation of therapy. Calcineurin inhibitor trough levels did not significantly change during therapy. In this multi-center series of patients, all-oral DAA therapy appears to be safe and effective in post-kidney transplant patients with chronic HCV infection.
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spelling pubmed-49450342016-08-08 Efficacy and Safety of Direct Acting Antivirals in Kidney Transplant Recipients with Chronic Hepatitis C Virus Infection Lin, Ming V. Sise, Meghan E. Pavlakis, Martha Amundsen, Beth M. Chute, Donald Rutherford, Anna E. Chung, Raymond T. Curry, Michael P. Hanifi, Jasmine M. Gabardi, Steve Chandraker, Anil Heher, Eliot C. Elias, Nahel Riella, Leonardo V. PLoS One Research Article The prevalence of Hepatitis C Virus (HCV) infection is significantly higher in patients with end-stage renal disease compared to the general population and poses important clinical challenges in patients who undergo kidney transplantation. Historically, interferon-based treatment options have been limited by low rates of efficacy and significant side effects, including risk of precipitating rejection. Limited data exist on the use of all-oral, interferon-free direct-acting antiviral (DAA) therapies in kidney transplant recipients. In this study, we performed a retrospective chart review with prospective clinical follow-up of post-kidney transplant patients treated with DAA therapies at three major hospitals in Boston, MA. A total of 24 kidney recipients with HCV infection received all-oral DAA therapy post-transplant. Patients were predominantly male (79%) with a median age of 60 years (range 34–70 years), median creatinine of 1.2 mg/dL (0.66–1.76), and 42% had advanced fibrosis or cirrhosis. The majority had HCV genotype 1a infection (58%). All patients received full-dose sofosbuvir; it was paired with simeprevir (9 patients without and 3 patients with ribavirin), ledipasvir (7 patients without and 1 patient with ribavirin) or ribavirin alone (4 patients). The overall sustained virologic response (SVR12) was 91% (21 out of 23 patients). One patient achieved SVR4 but demised prior to SVR12 check point due to treatment unrelated cause. Two treatment failures were successfully retreated with alternative DAA regimens and achieved SVR. Both initials failures occurred in patients with advanced fibrosis or cirrhosis, with genotype 1a infection, and prior HCV treatment failure. Adverse events were reported in 11 patients (46%) and were managed clinically without discontinuation of therapy. Calcineurin inhibitor trough levels did not significantly change during therapy. In this multi-center series of patients, all-oral DAA therapy appears to be safe and effective in post-kidney transplant patients with chronic HCV infection. Public Library of Science 2016-07-14 /pmc/articles/PMC4945034/ /pubmed/27415632 http://dx.doi.org/10.1371/journal.pone.0158431 Text en © 2016 Lin et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Lin, Ming V.
Sise, Meghan E.
Pavlakis, Martha
Amundsen, Beth M.
Chute, Donald
Rutherford, Anna E.
Chung, Raymond T.
Curry, Michael P.
Hanifi, Jasmine M.
Gabardi, Steve
Chandraker, Anil
Heher, Eliot C.
Elias, Nahel
Riella, Leonardo V.
Efficacy and Safety of Direct Acting Antivirals in Kidney Transplant Recipients with Chronic Hepatitis C Virus Infection
title Efficacy and Safety of Direct Acting Antivirals in Kidney Transplant Recipients with Chronic Hepatitis C Virus Infection
title_full Efficacy and Safety of Direct Acting Antivirals in Kidney Transplant Recipients with Chronic Hepatitis C Virus Infection
title_fullStr Efficacy and Safety of Direct Acting Antivirals in Kidney Transplant Recipients with Chronic Hepatitis C Virus Infection
title_full_unstemmed Efficacy and Safety of Direct Acting Antivirals in Kidney Transplant Recipients with Chronic Hepatitis C Virus Infection
title_short Efficacy and Safety of Direct Acting Antivirals in Kidney Transplant Recipients with Chronic Hepatitis C Virus Infection
title_sort efficacy and safety of direct acting antivirals in kidney transplant recipients with chronic hepatitis c virus infection
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4945034/
https://www.ncbi.nlm.nih.gov/pubmed/27415632
http://dx.doi.org/10.1371/journal.pone.0158431
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