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A prospective study of daclatasvir and sofosbuvir in chronic HCV-infected kidney transplant recipients
BACKGROUND: Only a few prospective trials exist regarding the use of novel direct-acting antiviral agents (DAAs) in kidney transplant recipients (KTR) with chronic hepatitis C virus (HCV) infection. METHODS: This prospective single-center trial evaluated treatment with daclatasvir (DCV) and sofosbuv...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6360788/ https://www.ncbi.nlm.nih.gov/pubmed/30717681 http://dx.doi.org/10.1186/s12882-019-1218-0 |
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author | Duerr, Michael Schrezenmeier, Eva V. Lehner, Lukas J. Bergfeld, Léon Glander, Petra Marticorena Garcia, Stephan R. Althoff, Christian E. Sack, Ingolf Brakemeier, Susanne Eckardt, Kai-Uwe Budde, Klemens Halleck, Fabian |
author_facet | Duerr, Michael Schrezenmeier, Eva V. Lehner, Lukas J. Bergfeld, Léon Glander, Petra Marticorena Garcia, Stephan R. Althoff, Christian E. Sack, Ingolf Brakemeier, Susanne Eckardt, Kai-Uwe Budde, Klemens Halleck, Fabian |
author_sort | Duerr, Michael |
collection | PubMed |
description | BACKGROUND: Only a few prospective trials exist regarding the use of novel direct-acting antiviral agents (DAAs) in kidney transplant recipients (KTR) with chronic hepatitis C virus (HCV) infection. METHODS: This prospective single-center trial evaluated treatment with daclatasvir (DCV) and sofosbuvir (SOF) over 12 weeks in 16 adult chronic HCV infected KTR and eGFR > 30 ml/min/1.73m(2). Primary endpoint was sustained virological response 12 weeks after end of therapy (SVR12). Beside baseline liver biopsy, hepatic function and glucose metabolism were regularly assessed. RESULTS: Four of 16 study patients had previously failed interferon-based HCV treatment. Liver biopsy showed mostly moderate fibrosis score before therapy with DCV/SOF was initiated at a median of 10.3 years after transplantation. In total, 15 of 16 KTR achieved SVR12. One patient showed early viral relapse because of resistance-associated variants (RAVs) in the HCV NS5A region. Rescue treatment with SOF/velpatasvir/voxilaprevir resulted in SVR12. DAAs treatment led to significant improvement of liver metabolism and glucose tolerance accompanied with no therapy-associated major adverse events and excellent tolerability. CONCLUSIONS: Our study demonstrates safety, efficacy and functional benefit of DCV/SOF treatment in KTR with chronic HCV infection. We provide data on rescue strategies for treatment failures due to present RAVs and amelioration of hepatic function and glucose tolerance. TRIAL REGISTRATION: Registry name: European Clinical Trials Register; Trial registry number (Eudra-CT): 2014–004551-32, Registration date: Aug 28th 2015. |
format | Online Article Text |
id | pubmed-6360788 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-63607882019-02-08 A prospective study of daclatasvir and sofosbuvir in chronic HCV-infected kidney transplant recipients Duerr, Michael Schrezenmeier, Eva V. Lehner, Lukas J. Bergfeld, Léon Glander, Petra Marticorena Garcia, Stephan R. Althoff, Christian E. Sack, Ingolf Brakemeier, Susanne Eckardt, Kai-Uwe Budde, Klemens Halleck, Fabian BMC Nephrol Research Article BACKGROUND: Only a few prospective trials exist regarding the use of novel direct-acting antiviral agents (DAAs) in kidney transplant recipients (KTR) with chronic hepatitis C virus (HCV) infection. METHODS: This prospective single-center trial evaluated treatment with daclatasvir (DCV) and sofosbuvir (SOF) over 12 weeks in 16 adult chronic HCV infected KTR and eGFR > 30 ml/min/1.73m(2). Primary endpoint was sustained virological response 12 weeks after end of therapy (SVR12). Beside baseline liver biopsy, hepatic function and glucose metabolism were regularly assessed. RESULTS: Four of 16 study patients had previously failed interferon-based HCV treatment. Liver biopsy showed mostly moderate fibrosis score before therapy with DCV/SOF was initiated at a median of 10.3 years after transplantation. In total, 15 of 16 KTR achieved SVR12. One patient showed early viral relapse because of resistance-associated variants (RAVs) in the HCV NS5A region. Rescue treatment with SOF/velpatasvir/voxilaprevir resulted in SVR12. DAAs treatment led to significant improvement of liver metabolism and glucose tolerance accompanied with no therapy-associated major adverse events and excellent tolerability. CONCLUSIONS: Our study demonstrates safety, efficacy and functional benefit of DCV/SOF treatment in KTR with chronic HCV infection. We provide data on rescue strategies for treatment failures due to present RAVs and amelioration of hepatic function and glucose tolerance. TRIAL REGISTRATION: Registry name: European Clinical Trials Register; Trial registry number (Eudra-CT): 2014–004551-32, Registration date: Aug 28th 2015. BioMed Central 2019-02-04 /pmc/articles/PMC6360788/ /pubmed/30717681 http://dx.doi.org/10.1186/s12882-019-1218-0 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Research Article Duerr, Michael Schrezenmeier, Eva V. Lehner, Lukas J. Bergfeld, Léon Glander, Petra Marticorena Garcia, Stephan R. Althoff, Christian E. Sack, Ingolf Brakemeier, Susanne Eckardt, Kai-Uwe Budde, Klemens Halleck, Fabian A prospective study of daclatasvir and sofosbuvir in chronic HCV-infected kidney transplant recipients |
title | A prospective study of daclatasvir and sofosbuvir in chronic HCV-infected kidney transplant recipients |
title_full | A prospective study of daclatasvir and sofosbuvir in chronic HCV-infected kidney transplant recipients |
title_fullStr | A prospective study of daclatasvir and sofosbuvir in chronic HCV-infected kidney transplant recipients |
title_full_unstemmed | A prospective study of daclatasvir and sofosbuvir in chronic HCV-infected kidney transplant recipients |
title_short | A prospective study of daclatasvir and sofosbuvir in chronic HCV-infected kidney transplant recipients |
title_sort | prospective study of daclatasvir and sofosbuvir in chronic hcv-infected kidney transplant recipients |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6360788/ https://www.ncbi.nlm.nih.gov/pubmed/30717681 http://dx.doi.org/10.1186/s12882-019-1218-0 |
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