An interferon-free antiviral regimen for HCV after liver transplantation.

Background Hepatitis C virus (HCV) infection is the leading indication for liver transplantation worldwide, and interferon-containing regimens are associated with low response rates owing to treatment-limiting toxic effects in immunosuppressed liver-transplant recipients. We evaluated the interferon...

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Autores: Kwo, Paul Y., Mantry, Parvez S., Coakley, Eoin, Te, Helen S., Vargas, Hugo E., Brown, Robert, Gordon, Fredric, Levitsky, Josh, Terrault, Norah A., Burton, James R., Xie, Wangang, Setze, Carolyn, Badri, Prajakta, Pilot Matias, Tami, Vilchez, Regis A., Forns, Xavier
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2014
País:España
Recursos:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/119393
Acesso em linha:https://hdl.handle.net/2445/119393
Access Level:acceso abierto
Palavra-chave:Virus de l'hepatitis C
Trasplantament hepàtic
Medicaments antivírics
Hepatitis C virus
Hepatic transplantation
Antiviral agents
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spelling An interferon-free antiviral regimen for HCV after liver transplantation.Kwo, Paul Y.Mantry, Parvez S.Coakley, EoinTe, Helen S.Vargas, Hugo E.Brown, RobertGordon, FredricLevitsky, JoshTerrault, Norah A.Burton, James R.Xie, WangangSetze, CarolynBadri, PrajaktaPilot Matias, TamiVilchez, Regis A.Forns, XavierVirus de l'hepatitis CTrasplantament hepàticMedicaments antivíricsHepatitis C virusHepatic transplantationAntiviral agentsBackground Hepatitis C virus (HCV) infection is the leading indication for liver transplantation worldwide, and interferon-containing regimens are associated with low response rates owing to treatment-limiting toxic effects in immunosuppressed liver-transplant recipients. We evaluated the interferon-free regimen of the NS5A inhibitor ombitasvir coformulated with the ritonavir-boosted protease inhibitor ABT-450 (ABT-450/r), the nonnucleoside NS5B polymerase inhibitor dasabuvir, and ribavirin in liver-transplant recipients with recurrent HCV genotype 1 infection. Methods We enrolled 34 liver-transplant recipients with no fibrosis or mild fibrosis, who received ombitasvir-ABT-450/r (at a once-daily dose of 25 mg of ombitasvir, 150 mg of ABT-450, and 100 mg of ritonavir), dasabuvir (250 mg twice daily), and ribavirin for 24 weeks. Selection of the initial ribavirin dose and subsequent dose modifications for anemia were at the investigator's discretion. The primary efficacy end point was a sustained virologic response 12 weeks after the end of treatment. Results Of the 34 study participants, 33 had a sustained virologic response at post-treatment weeks 12 and 24, for a rate of 97% (95% confidence interval, 85 to 100). The most common adverse events were fatigue, headache, and cough. Five patients (15%) required erythropoietin; no patient required blood transfusion. One patient discontinued the study drugs owing to adverse events after week 18 but had a sustained virologic response. Blood levels of calcineurin inhibitors were monitored, and dosages were modified to maintain therapeutic levels; no episode of graft rejection was observed during the study. Conclusions Treatment with the multitargeted regimen of ombitasvir-ABT-450/r and dasabuvir with ribavirin was associated with a low rate of serious adverse events and a high rate of sustained virologic response among liver-transplant recipients with recurrent HCV genotype 1 infection, a historically difficult-to-treat populationMassachusetts Medical Society2014info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/119393Articles publicats en revistes (Medicina)reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésReproducció del document publicat a: https://doi.org/10.1056/NEJMoa1408921New England Journal of Medicine, 2014, vol. 371, num. 25, p. 2375-2382https://doi.org/10.1056/NEJMoa1408921(c) Massachusetts Medical Society, 2014info:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/1193932026-05-27T06:46:51Z
dc.title.none.fl_str_mv An interferon-free antiviral regimen for HCV after liver transplantation.
title An interferon-free antiviral regimen for HCV after liver transplantation.
spellingShingle An interferon-free antiviral regimen for HCV after liver transplantation.
Kwo, Paul Y.
Virus de l'hepatitis C
Trasplantament hepàtic
Medicaments antivírics
Hepatitis C virus
Hepatic transplantation
Antiviral agents
title_short An interferon-free antiviral regimen for HCV after liver transplantation.
title_full An interferon-free antiviral regimen for HCV after liver transplantation.
title_fullStr An interferon-free antiviral regimen for HCV after liver transplantation.
title_full_unstemmed An interferon-free antiviral regimen for HCV after liver transplantation.
title_sort An interferon-free antiviral regimen for HCV after liver transplantation.
dc.creator.none.fl_str_mv Kwo, Paul Y.
Mantry, Parvez S.
Coakley, Eoin
Te, Helen S.
Vargas, Hugo E.
Brown, Robert
Gordon, Fredric
Levitsky, Josh
Terrault, Norah A.
Burton, James R.
Xie, Wangang
Setze, Carolyn
Badri, Prajakta
Pilot Matias, Tami
Vilchez, Regis A.
Forns, Xavier
author Kwo, Paul Y.
author_facet Kwo, Paul Y.
Mantry, Parvez S.
Coakley, Eoin
Te, Helen S.
Vargas, Hugo E.
Brown, Robert
Gordon, Fredric
Levitsky, Josh
Terrault, Norah A.
Burton, James R.
Xie, Wangang
Setze, Carolyn
Badri, Prajakta
Pilot Matias, Tami
Vilchez, Regis A.
Forns, Xavier
author_role author
author2 Mantry, Parvez S.
Coakley, Eoin
Te, Helen S.
Vargas, Hugo E.
Brown, Robert
Gordon, Fredric
Levitsky, Josh
Terrault, Norah A.
Burton, James R.
Xie, Wangang
Setze, Carolyn
Badri, Prajakta
Pilot Matias, Tami
Vilchez, Regis A.
Forns, Xavier
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Virus de l'hepatitis C
Trasplantament hepàtic
Medicaments antivírics
Hepatitis C virus
Hepatic transplantation
Antiviral agents
topic Virus de l'hepatitis C
Trasplantament hepàtic
Medicaments antivírics
Hepatitis C virus
Hepatic transplantation
Antiviral agents
description Background Hepatitis C virus (HCV) infection is the leading indication for liver transplantation worldwide, and interferon-containing regimens are associated with low response rates owing to treatment-limiting toxic effects in immunosuppressed liver-transplant recipients. We evaluated the interferon-free regimen of the NS5A inhibitor ombitasvir coformulated with the ritonavir-boosted protease inhibitor ABT-450 (ABT-450/r), the nonnucleoside NS5B polymerase inhibitor dasabuvir, and ribavirin in liver-transplant recipients with recurrent HCV genotype 1 infection. Methods We enrolled 34 liver-transplant recipients with no fibrosis or mild fibrosis, who received ombitasvir-ABT-450/r (at a once-daily dose of 25 mg of ombitasvir, 150 mg of ABT-450, and 100 mg of ritonavir), dasabuvir (250 mg twice daily), and ribavirin for 24 weeks. Selection of the initial ribavirin dose and subsequent dose modifications for anemia were at the investigator's discretion. The primary efficacy end point was a sustained virologic response 12 weeks after the end of treatment. Results Of the 34 study participants, 33 had a sustained virologic response at post-treatment weeks 12 and 24, for a rate of 97% (95% confidence interval, 85 to 100). The most common adverse events were fatigue, headache, and cough. Five patients (15%) required erythropoietin; no patient required blood transfusion. One patient discontinued the study drugs owing to adverse events after week 18 but had a sustained virologic response. Blood levels of calcineurin inhibitors were monitored, and dosages were modified to maintain therapeutic levels; no episode of graft rejection was observed during the study. Conclusions Treatment with the multitargeted regimen of ombitasvir-ABT-450/r and dasabuvir with ribavirin was associated with a low rate of serious adverse events and a high rate of sustained virologic response among liver-transplant recipients with recurrent HCV genotype 1 infection, a historically difficult-to-treat population
publishDate 2014
dc.date.none.fl_str_mv 2014
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/119393
url https://hdl.handle.net/2445/119393
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: https://doi.org/10.1056/NEJMoa1408921
New England Journal of Medicine, 2014, vol. 371, num. 25, p. 2375-2382
https://doi.org/10.1056/NEJMoa1408921
dc.rights.none.fl_str_mv (c) Massachusetts Medical Society, 2014
info:eu-repo/semantics/openAccess
rights_invalid_str_mv (c) Massachusetts Medical Society, 2014
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Massachusetts Medical Society
publisher.none.fl_str_mv Massachusetts Medical Society
dc.source.none.fl_str_mv Articles publicats en revistes (Medicina)
reponame:Dipòsit Digital de la UB
instname:Universidad de Barcelona
instname_str Universidad de Barcelona
reponame_str Dipòsit Digital de la UB
collection Dipòsit Digital de la UB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15.300724

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