‘Real-life’ experience with direct-acting antiviral agents for HCV after kidney transplant

Autores
Fabrizi, Fabrizio; Alonso, Cristina; Palazzo, Ana; Anders, Margarita; Reggiardo, María Virginia; Cheinquer, Hugo; Videla Zuain, Maria Grazia; Figueroa, Sebastian; Mendizabal, Manuel; Silva, Marcelo; Ridruejo, Ezequiel
Año de publicación
2021
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Introductions and Objectives: The introduction of direct-acting antiviral (DAA) agents promises to change dramatically the management of hepatitis C in kidney transplant recipients, a patient group where the treatment of hepatitis C is historically challenging. The purpose of the current study was to assess (in a ?real-life? setting) the safety and efficacy of all-oral, interferon-free, direct-acting antiviral agents in kidney transplant recipients with HCV. Material and Methods: We performed a single-arm, multi-center study in a cohort (n = 95) of kidney transplant recipients who underwent antiviral therapy with DAAs. The primary end-point was sustained virologic response (SVR) (serum HCV RNA < 15 IU/mL, 12 weeks after treatment ended; SVR12). We recorded data on on-treatment adverse events (AEs), serious AEs, and laboratory abnormalities. Results: Various regimens were adopted at the discretion of the treating physician: elbasvir/grazoprevir (n = 11), paritaprevir/ritonavir/ombitasvir/dasabuvir (PrOD) regimens ± ribavirin (n = 23), and sofosbuvir-based regimens ± ribavirin (n = 61). The SVR12 rate was 93.7% (89/95) (95% CI, 88%; 98%), according to intention-to-treat analysis; three patients without viral response (n = 3) were found. Ribavirin was administered in 8 (8.4%) allograft recipients. The frequency of drop-outs was 4.2% (4/95) (95% CI, 0.2%; 8.2%); these were related to arthralgia/myalgia (n = 2), fatigue (n = 1), and lowered estimated glomerular filtration rate (eGFR) (n = 1). There were no differences with regard to serum creatinine and eGFR before and after antiviral therapy and during follow-up in the whole cohort. The patient who interrupted antiviral treatment due to raised serum creatinine was on sofosbuvir/daclatasvir regimen; one of the four drop-outs obtained SVR. Conclusions: All-oral, interferon-free therapy with DAAs for chronic HCV after kidney transplantation was effective and well-tolerated in a ?real?life? clinical setting. Identical results have been observed in patients with intact kidneys or advanced chronic kidney disease. Careful evaluation of kidney function over follow-up in kidney transplant recipients who received DAAs regimens is recommended. Clinical trials aimed to assess whether sustained viral response translates into improved patient/graft survival are under way.
Fil: Fabrizi, Fabrizio. IRCCS Ca’ Granda Foundation and Maggiore Policlinico Hospital; Italia
Fil: Alonso, Cristina. Universidad Austral. Hospital Universitario Austral; Argentina
Fil: Palazzo, Ana. Gobierno de la Provincia de Tucumán. Hospital Ángel Padilla; Argentina
Fil: Anders, Margarita. Hospital Aleman; Argentina
Fil: Reggiardo, María Virginia. Provincia de Santa Fe. Ministerio de Salud y Medio Ambiente - Rosario. Hospital Provincial del Centenario; Argentina
Fil: Cheinquer, Hugo. Universidade Federal do Rio Grande do Sul; Brasil
Fil: Videla Zuain, Maria Grazia. Gobierno de la Ciudad de Buenos Aires. Hospital "Dr. Abel Zubizarreta"; Argentina
Fil: Figueroa, Sebastian. Hospital Dr. Arturo Oñativia - Salta Capital.; Argentina
Fil: Mendizabal, Manuel. Universidad Austral. Hospital Universitario Austral; Argentina
Fil: Silva, Marcelo. Universidad Austral. Hospital Universitario Austral; Argentina
Fil: Ridruejo, Ezequiel. Universidad Austral. Hospital Universitario Austral; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. CEMIC-CONICET. Centro de Educaciones Médicas e Investigaciones Clínicas "Norberto Quirno". CEMIC-CONICET; Argentina
Materia
ANTIVIRAL AGENTS
CHRONIC KIDNEY DISEASE
HEPATITIS C
KIDNEY TRANSPLANT
VIRAL RESPONSE
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/231388
Acceder
id CONICETDig_0158370ed32c5b3fdf5ad4bf1e26da69
oai_identifier_str oai:ri.conicet.gov.ar:11336/231388
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling ‘Real-life’ experience with direct-acting antiviral agents for HCV after kidney transplantFabrizi, FabrizioAlonso, CristinaPalazzo, AnaAnders, MargaritaReggiardo, María VirginiaCheinquer, HugoVidela Zuain, Maria GraziaFigueroa, SebastianMendizabal, ManuelSilva, MarceloRidruejo, EzequielANTIVIRAL AGENTSCHRONIC KIDNEY DISEASEHEPATITIS CKIDNEY TRANSPLANTVIRAL RESPONSEhttps://purl.org/becyt/ford/3.2https://purl.org/becyt/ford/3Introductions and Objectives: The introduction of direct-acting antiviral (DAA) agents promises to change dramatically the management of hepatitis C in kidney transplant recipients, a patient group where the treatment of hepatitis C is historically challenging. The purpose of the current study was to assess (in a ?real-life? setting) the safety and efficacy of all-oral, interferon-free, direct-acting antiviral agents in kidney transplant recipients with HCV. Material and Methods: We performed a single-arm, multi-center study in a cohort (n = 95) of kidney transplant recipients who underwent antiviral therapy with DAAs. The primary end-point was sustained virologic response (SVR) (serum HCV RNA < 15 IU/mL, 12 weeks after treatment ended; SVR12). We recorded data on on-treatment adverse events (AEs), serious AEs, and laboratory abnormalities. Results: Various regimens were adopted at the discretion of the treating physician: elbasvir/grazoprevir (n = 11), paritaprevir/ritonavir/ombitasvir/dasabuvir (PrOD) regimens ± ribavirin (n = 23), and sofosbuvir-based regimens ± ribavirin (n = 61). The SVR12 rate was 93.7% (89/95) (95% CI, 88%; 98%), according to intention-to-treat analysis; three patients without viral response (n = 3) were found. Ribavirin was administered in 8 (8.4%) allograft recipients. The frequency of drop-outs was 4.2% (4/95) (95% CI, 0.2%; 8.2%); these were related to arthralgia/myalgia (n = 2), fatigue (n = 1), and lowered estimated glomerular filtration rate (eGFR) (n = 1). There were no differences with regard to serum creatinine and eGFR before and after antiviral therapy and during follow-up in the whole cohort. The patient who interrupted antiviral treatment due to raised serum creatinine was on sofosbuvir/daclatasvir regimen; one of the four drop-outs obtained SVR. Conclusions: All-oral, interferon-free therapy with DAAs for chronic HCV after kidney transplantation was effective and well-tolerated in a ?real?life? clinical setting. Identical results have been observed in patients with intact kidneys or advanced chronic kidney disease. Careful evaluation of kidney function over follow-up in kidney transplant recipients who received DAAs regimens is recommended. Clinical trials aimed to assess whether sustained viral response translates into improved patient/graft survival are under way.Fil: Fabrizi, Fabrizio. IRCCS Ca’ Granda Foundation and Maggiore Policlinico Hospital; ItaliaFil: Alonso, Cristina. Universidad Austral. Hospital Universitario Austral; ArgentinaFil: Palazzo, Ana. Gobierno de la Provincia de Tucumán. Hospital Ángel Padilla; ArgentinaFil: Anders, Margarita. Hospital Aleman; ArgentinaFil: Reggiardo, María Virginia. Provincia de Santa Fe. Ministerio de Salud y Medio Ambiente - Rosario. Hospital Provincial del Centenario; ArgentinaFil: Cheinquer, Hugo. Universidade Federal do Rio Grande do Sul; BrasilFil: Videla Zuain, Maria Grazia. Gobierno de la Ciudad de Buenos Aires. Hospital "Dr. Abel Zubizarreta"; ArgentinaFil: Figueroa, Sebastian. Hospital Dr. Arturo Oñativia - Salta Capital.; ArgentinaFil: Mendizabal, Manuel. Universidad Austral. Hospital Universitario Austral; ArgentinaFil: Silva, Marcelo. Universidad Austral. Hospital Universitario Austral; ArgentinaFil: Ridruejo, Ezequiel. Universidad Austral. Hospital Universitario Austral; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. CEMIC-CONICET. Centro de Educaciones Médicas e Investigaciones Clínicas "Norberto Quirno". CEMIC-CONICET; ArgentinaMexican Association of Hepatology2021-11info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/231388Fabrizi, Fabrizio; Alonso, Cristina; Palazzo, Ana; Anders, Margarita; Reggiardo, María Virginia; et al.; ‘Real-life’ experience with direct-acting antiviral agents for HCV after kidney transplant; Mexican Association of Hepatology; Annals of Hepatology; 25; 100337; 11-2021; 1-71665-2681CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/doi/10.1016/j.aohep.2021.100337info:eu-repo/semantics/altIdentifier/url/https://www.sciencedirect.com/science/article/pii/S1665268121000363info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-nd/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-10-15T14:43:51Zoai:ri.conicet.gov.ar:11336/231388instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-10-15 14:43:51.787CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv ‘Real-life’ experience with direct-acting antiviral agents for HCV after kidney transplant
title ‘Real-life’ experience with direct-acting antiviral agents for HCV after kidney transplant
spellingShingle ‘Real-life’ experience with direct-acting antiviral agents for HCV after kidney transplant
Fabrizi, Fabrizio
ANTIVIRAL AGENTS
CHRONIC KIDNEY DISEASE
HEPATITIS C
KIDNEY TRANSPLANT
VIRAL RESPONSE
title_short ‘Real-life’ experience with direct-acting antiviral agents for HCV after kidney transplant
title_full ‘Real-life’ experience with direct-acting antiviral agents for HCV after kidney transplant
title_fullStr ‘Real-life’ experience with direct-acting antiviral agents for HCV after kidney transplant
title_full_unstemmed ‘Real-life’ experience with direct-acting antiviral agents for HCV after kidney transplant
title_sort ‘Real-life’ experience with direct-acting antiviral agents for HCV after kidney transplant
dc.creator.none.fl_str_mv Fabrizi, Fabrizio
Alonso, Cristina
Palazzo, Ana
Anders, Margarita
Reggiardo, María Virginia
Cheinquer, Hugo
Videla Zuain, Maria Grazia
Figueroa, Sebastian
Mendizabal, Manuel
Silva, Marcelo
Ridruejo, Ezequiel
author Fabrizi, Fabrizio
author_facet Fabrizi, Fabrizio
Alonso, Cristina
Palazzo, Ana
Anders, Margarita
Reggiardo, María Virginia
Cheinquer, Hugo
Videla Zuain, Maria Grazia
Figueroa, Sebastian
Mendizabal, Manuel
Silva, Marcelo
Ridruejo, Ezequiel
author_role author
author2 Alonso, Cristina
Palazzo, Ana
Anders, Margarita
Reggiardo, María Virginia
Cheinquer, Hugo
Videla Zuain, Maria Grazia
Figueroa, Sebastian
Mendizabal, Manuel
Silva, Marcelo
Ridruejo, Ezequiel
author2_role author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv ANTIVIRAL AGENTS
CHRONIC KIDNEY DISEASE
HEPATITIS C
KIDNEY TRANSPLANT
VIRAL RESPONSE
topic ANTIVIRAL AGENTS
CHRONIC KIDNEY DISEASE
HEPATITIS C
KIDNEY TRANSPLANT
VIRAL RESPONSE
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.2
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv Introductions and Objectives: The introduction of direct-acting antiviral (DAA) agents promises to change dramatically the management of hepatitis C in kidney transplant recipients, a patient group where the treatment of hepatitis C is historically challenging. The purpose of the current study was to assess (in a ?real-life? setting) the safety and efficacy of all-oral, interferon-free, direct-acting antiviral agents in kidney transplant recipients with HCV. Material and Methods: We performed a single-arm, multi-center study in a cohort (n = 95) of kidney transplant recipients who underwent antiviral therapy with DAAs. The primary end-point was sustained virologic response (SVR) (serum HCV RNA < 15 IU/mL, 12 weeks after treatment ended; SVR12). We recorded data on on-treatment adverse events (AEs), serious AEs, and laboratory abnormalities. Results: Various regimens were adopted at the discretion of the treating physician: elbasvir/grazoprevir (n = 11), paritaprevir/ritonavir/ombitasvir/dasabuvir (PrOD) regimens ± ribavirin (n = 23), and sofosbuvir-based regimens ± ribavirin (n = 61). The SVR12 rate was 93.7% (89/95) (95% CI, 88%; 98%), according to intention-to-treat analysis; three patients without viral response (n = 3) were found. Ribavirin was administered in 8 (8.4%) allograft recipients. The frequency of drop-outs was 4.2% (4/95) (95% CI, 0.2%; 8.2%); these were related to arthralgia/myalgia (n = 2), fatigue (n = 1), and lowered estimated glomerular filtration rate (eGFR) (n = 1). There were no differences with regard to serum creatinine and eGFR before and after antiviral therapy and during follow-up in the whole cohort. The patient who interrupted antiviral treatment due to raised serum creatinine was on sofosbuvir/daclatasvir regimen; one of the four drop-outs obtained SVR. Conclusions: All-oral, interferon-free therapy with DAAs for chronic HCV after kidney transplantation was effective and well-tolerated in a ?real?life? clinical setting. Identical results have been observed in patients with intact kidneys or advanced chronic kidney disease. Careful evaluation of kidney function over follow-up in kidney transplant recipients who received DAAs regimens is recommended. Clinical trials aimed to assess whether sustained viral response translates into improved patient/graft survival are under way.
Fil: Fabrizi, Fabrizio. IRCCS Ca’ Granda Foundation and Maggiore Policlinico Hospital; Italia
Fil: Alonso, Cristina. Universidad Austral. Hospital Universitario Austral; Argentina
Fil: Palazzo, Ana. Gobierno de la Provincia de Tucumán. Hospital Ángel Padilla; Argentina
Fil: Anders, Margarita. Hospital Aleman; Argentina
Fil: Reggiardo, María Virginia. Provincia de Santa Fe. Ministerio de Salud y Medio Ambiente - Rosario. Hospital Provincial del Centenario; Argentina
Fil: Cheinquer, Hugo. Universidade Federal do Rio Grande do Sul; Brasil
Fil: Videla Zuain, Maria Grazia. Gobierno de la Ciudad de Buenos Aires. Hospital "Dr. Abel Zubizarreta"; Argentina
Fil: Figueroa, Sebastian. Hospital Dr. Arturo Oñativia - Salta Capital.; Argentina
Fil: Mendizabal, Manuel. Universidad Austral. Hospital Universitario Austral; Argentina
Fil: Silva, Marcelo. Universidad Austral. Hospital Universitario Austral; Argentina
Fil: Ridruejo, Ezequiel. Universidad Austral. Hospital Universitario Austral; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. CEMIC-CONICET. Centro de Educaciones Médicas e Investigaciones Clínicas "Norberto Quirno". CEMIC-CONICET; Argentina
description Introductions and Objectives: The introduction of direct-acting antiviral (DAA) agents promises to change dramatically the management of hepatitis C in kidney transplant recipients, a patient group where the treatment of hepatitis C is historically challenging. The purpose of the current study was to assess (in a ?real-life? setting) the safety and efficacy of all-oral, interferon-free, direct-acting antiviral agents in kidney transplant recipients with HCV. Material and Methods: We performed a single-arm, multi-center study in a cohort (n = 95) of kidney transplant recipients who underwent antiviral therapy with DAAs. The primary end-point was sustained virologic response (SVR) (serum HCV RNA < 15 IU/mL, 12 weeks after treatment ended; SVR12). We recorded data on on-treatment adverse events (AEs), serious AEs, and laboratory abnormalities. Results: Various regimens were adopted at the discretion of the treating physician: elbasvir/grazoprevir (n = 11), paritaprevir/ritonavir/ombitasvir/dasabuvir (PrOD) regimens ± ribavirin (n = 23), and sofosbuvir-based regimens ± ribavirin (n = 61). The SVR12 rate was 93.7% (89/95) (95% CI, 88%; 98%), according to intention-to-treat analysis; three patients without viral response (n = 3) were found. Ribavirin was administered in 8 (8.4%) allograft recipients. The frequency of drop-outs was 4.2% (4/95) (95% CI, 0.2%; 8.2%); these were related to arthralgia/myalgia (n = 2), fatigue (n = 1), and lowered estimated glomerular filtration rate (eGFR) (n = 1). There were no differences with regard to serum creatinine and eGFR before and after antiviral therapy and during follow-up in the whole cohort. The patient who interrupted antiviral treatment due to raised serum creatinine was on sofosbuvir/daclatasvir regimen; one of the four drop-outs obtained SVR. Conclusions: All-oral, interferon-free therapy with DAAs for chronic HCV after kidney transplantation was effective and well-tolerated in a ?real?life? clinical setting. Identical results have been observed in patients with intact kidneys or advanced chronic kidney disease. Careful evaluation of kidney function over follow-up in kidney transplant recipients who received DAAs regimens is recommended. Clinical trials aimed to assess whether sustained viral response translates into improved patient/graft survival are under way.
publishDate 2021
dc.date.none.fl_str_mv 2021-11
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/231388
Fabrizi, Fabrizio; Alonso, Cristina; Palazzo, Ana; Anders, Margarita; Reggiardo, María Virginia; et al.; ‘Real-life’ experience with direct-acting antiviral agents for HCV after kidney transplant; Mexican Association of Hepatology; Annals of Hepatology; 25; 100337; 11-2021; 1-7
1665-2681
CONICET Digital
CONICET
url http://hdl.handle.net/11336/231388
identifier_str_mv Fabrizi, Fabrizio; Alonso, Cristina; Palazzo, Ana; Anders, Margarita; Reggiardo, María Virginia; et al.; ‘Real-life’ experience with direct-acting antiviral agents for HCV after kidney transplant; Mexican Association of Hepatology; Annals of Hepatology; 25; 100337; 11-2021; 1-7
1665-2681
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/doi/10.1016/j.aohep.2021.100337
info:eu-repo/semantics/altIdentifier/url/https://www.sciencedirect.com/science/article/pii/S1665268121000363
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
application/pdf
dc.publisher.none.fl_str_mv Mexican Association of Hepatology
publisher.none.fl_str_mv Mexican Association of Hepatology
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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