Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis

[Background & Aims] Although off-label use of sofosbuvir-containing regimens occurs regularly in patients with hepatitis C virus (HCV) infection undergoing dialysis for severe renal impairment or end-stage renal disease (ESRD), these regimens are not licensed for this indication, and there is an...

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Autores: Borgia, Sergio M., Dearden, Janet, Yoshida, Eric M., Shafran, Stephen D., Brown, Ashley, Ben-Ari, Ziv, Cramp, Matthew E., Cooper, Curtis, Foxton, Matthew, Fernández-Rodríguez, Conrado M., Esteban, Rafael, Hyland, Robert, Lu, Sophia, Kirby, Brian J., Meng, Amy, Markova, Svetlana, Dvory-Sobol, Hadas, Osinusi, Anu O., Bruck, Rafael, Ampuero, Javier, Ryder, Stephen D., Agarwal, Kosh, Fox, Raymond, Shaw, David, Haider, Shariq, Willems, Bernard, Lurie, Yoav, Calleja, José Luis, Gane, Edward J.
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2019
País:España
Institución:Consejo Superior de Investigaciones Científicas (CSIC)
Repositorio:DIGITAL.CSIC. Repositorio Institucional del CSIC
OAI Identifier:oai:digital.csic.es:10261/213341
Acceso en línea:http://hdl.handle.net/10261/213341
Access Level:acceso abierto
Palabra clave:Direct-acting antivirals
ESRD
Severe renal impairment
Chronic hepatitis C infection
HCV, SVR12, drug safety
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spelling Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysisBorgia, Sergio M.Dearden, JanetYoshida, Eric M.Shafran, Stephen D.Brown, AshleyBen-Ari, ZivCramp, Matthew E.Cooper, CurtisFoxton, MatthewFernández-Rodríguez, Conrado M.Esteban, RafaelHyland, RobertLu, SophiaKirby, Brian J.Meng, AmyMarkova, SvetlanaDvory-Sobol, HadasOsinusi, Anu O.Bruck, RafaelAmpuero, JavierRyder, Stephen D.Agarwal, KoshFox, RaymondShaw, DavidHaider, ShariqWillems, BernardLurie, YoavCalleja, José LuisGane, Edward J.Direct-acting antiviralsESRDSevere renal impairmentChronic hepatitis C infectionHCV, SVR12, drug safety[Background & Aims] Although off-label use of sofosbuvir-containing regimens occurs regularly in patients with hepatitis C virus (HCV) infection undergoing dialysis for severe renal impairment or end-stage renal disease (ESRD), these regimens are not licensed for this indication, and there is an absence of dosing recommendations in this population. This study evaluated the safety and efficacy of sofosbuvir/velpatasvir in patients with HCV infection with ESRD undergoing dialysis.[Methods] In this phase II, single-arm study, 59 patients with genotype 1–6 HCV infection with ESRD undergoing hemodialysis or peritoneal dialysis received open-label sofosbuvir/velpatasvir (400 mg/100 mg) once daily for 12 weeks. Patients were HCV treatment naive or treatment experienced without cirrhosis or with compensated cirrhosis. Patients previously treated with any HCV NS5A inhibitor were not eligible. The primary efficacy endpoint was the proportion of patients achieving sustained virologic response (SVR) 12 weeks after discontinuation of treatment (SVR12). The primary safety endpoint was the proportion of patients who discontinued study drug due to adverse events.[Results] Overall, 56 of 59 patients achieved SVR12 (95%; 95% CI 86–99%). Of the 3 patients who did not achieve SVR12, 2 patients had virologic relapse determined at post-treatment Week 4 (including 1 who prematurely discontinued study treatment), and 1 patient died from suicide after achieving SVR through post-treatment Week 4. The most common adverse events were headache (17%), fatigue (14%), nausea (14%), and vomiting (14%). Serious adverse events were reported for 11 patients (19%), and all were deemed to be unrelated to sofosbuvir/velpatasvir.[Conclusions] Treatment with sofosbuvir/velpatasvir for 12 weeks was safe and effective in patients with ESRD undergoing dialysis.[Lay summary] Sofosbuvir/velpatasvir is a combination direct-acting antiviral that is approved for treatment of patients with hepatitis C virus (HCV) infection. Despite the lack of dosing recommendations, sofosbuvir-containing regimens (including sofosbuvir/velpatasvir) are frequently used for HCV-infected patients undergoing dialysis. This study evaluated the safety and efficacy of sofosbuvir/velpatasvir for 12 weeks in patients with HCV infection who were undergoing dialysis. Treatment with sofosbuvir/velpatasvir was safe and well tolerated, resulting in a cure rate of 95% in patients with HCV infection and end-stage renal disease.Clinical Trial Number: NCT03036852.Peer reviewedElsevierConsejo Superior de Investigaciones Científicas [https://ror.org/02gfc7t72]202020202019info:eu-repo/semantics/articlehttp://purl.org/coar/resource_type/c_6501Publisher's versioninfo:eu-repo/semantics/publishedVersionhttp://hdl.handle.net/10261/213341reponame:DIGITAL.CSIC. Repositorio Institucional del CSICinstname:Consejo Superior de Investigaciones Científicas (CSIC)Ingléshttps://doi.org/10.1016/j.jhep.2019.05.028Síinfo:eu-repo/semantics/openAccessoai:digital.csic.es:10261/2133412026-05-22T06:33:51Z
dc.title.none.fl_str_mv Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis
title Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis
spellingShingle Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis
Borgia, Sergio M.
Direct-acting antivirals
ESRD
Severe renal impairment
Chronic hepatitis C infection
HCV, SVR12, drug safety
title_short Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis
title_full Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis
title_fullStr Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis
title_full_unstemmed Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis
title_sort Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis
dc.creator.none.fl_str_mv Borgia, Sergio M.
Dearden, Janet
Yoshida, Eric M.
Shafran, Stephen D.
Brown, Ashley
Ben-Ari, Ziv
Cramp, Matthew E.
Cooper, Curtis
Foxton, Matthew
Fernández-Rodríguez, Conrado M.
Esteban, Rafael
Hyland, Robert
Lu, Sophia
Kirby, Brian J.
Meng, Amy
Markova, Svetlana
Dvory-Sobol, Hadas
Osinusi, Anu O.
Bruck, Rafael
Ampuero, Javier
Ryder, Stephen D.
Agarwal, Kosh
Fox, Raymond
Shaw, David
Haider, Shariq
Willems, Bernard
Lurie, Yoav
Calleja, José Luis
Gane, Edward J.
author Borgia, Sergio M.
author_facet Borgia, Sergio M.
Dearden, Janet
Yoshida, Eric M.
Shafran, Stephen D.
Brown, Ashley
Ben-Ari, Ziv
Cramp, Matthew E.
Cooper, Curtis
Foxton, Matthew
Fernández-Rodríguez, Conrado M.
Esteban, Rafael
Hyland, Robert
Lu, Sophia
Kirby, Brian J.
Meng, Amy
Markova, Svetlana
Dvory-Sobol, Hadas
Osinusi, Anu O.
Bruck, Rafael
Ampuero, Javier
Ryder, Stephen D.
Agarwal, Kosh
Fox, Raymond
Shaw, David
Haider, Shariq
Willems, Bernard
Lurie, Yoav
Calleja, José Luis
Gane, Edward J.
author_role author
author2 Dearden, Janet
Yoshida, Eric M.
Shafran, Stephen D.
Brown, Ashley
Ben-Ari, Ziv
Cramp, Matthew E.
Cooper, Curtis
Foxton, Matthew
Fernández-Rodríguez, Conrado M.
Esteban, Rafael
Hyland, Robert
Lu, Sophia
Kirby, Brian J.
Meng, Amy
Markova, Svetlana
Dvory-Sobol, Hadas
Osinusi, Anu O.
Bruck, Rafael
Ampuero, Javier
Ryder, Stephen D.
Agarwal, Kosh
Fox, Raymond
Shaw, David
Haider, Shariq
Willems, Bernard
Lurie, Yoav
Calleja, José Luis
Gane, Edward J.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Consejo Superior de Investigaciones Científicas [https://ror.org/02gfc7t72]
dc.subject.none.fl_str_mv Direct-acting antivirals
ESRD
Severe renal impairment
Chronic hepatitis C infection
HCV, SVR12, drug safety
topic Direct-acting antivirals
ESRD
Severe renal impairment
Chronic hepatitis C infection
HCV, SVR12, drug safety
description [Background & Aims] Although off-label use of sofosbuvir-containing regimens occurs regularly in patients with hepatitis C virus (HCV) infection undergoing dialysis for severe renal impairment or end-stage renal disease (ESRD), these regimens are not licensed for this indication, and there is an absence of dosing recommendations in this population. This study evaluated the safety and efficacy of sofosbuvir/velpatasvir in patients with HCV infection with ESRD undergoing dialysis.
publishDate 2019
dc.date.none.fl_str_mv 2019
2020
2020
dc.type.none.fl_str_mv info:eu-repo/semantics/article
http://purl.org/coar/resource_type/c_6501
Publisher's version
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/10261/213341
url http://hdl.handle.net/10261/213341
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv https://doi.org/10.1016/j.jhep.2019.05.028
Sí
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv reponame:DIGITAL.CSIC. Repositorio Institucional del CSIC
instname:Consejo Superior de Investigaciones Científicas (CSIC)
instname_str Consejo Superior de Investigaciones Científicas (CSIC)
reponame_str DIGITAL.CSIC. Repositorio Institucional del CSIC
collection DIGITAL.CSIC. Repositorio Institucional del CSIC
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15.812429

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