‘Real-life’ experience with direct-acting antiviral agents for HCV after kidney transplant
Autor(a) principal: | |
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Data de Publicação: | 2021 |
Outros Autores: | , , , , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UFRGS |
Texto Completo: | http://hdl.handle.net/10183/247677 |
Resumo: | 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 sofosbuvirbased 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 dropouts 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. |
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Fabrizi, FabrizioAlonso, CristinaPalazzo, AnaAnders, MargaritaReggiardo, María VirginiaCheinquer, HugoZuain, María Grazia VidelaFigueroa, SebastiánMendizábal, ManuelSilva, Marcelo OscarRidruejo, EzequielLatin American Liver Research, Educational and Awareness Network (LALREAN)2022-08-21T04:39:29Z20211665-2681http://hdl.handle.net/10183/247677001148081Introductions 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 sofosbuvirbased 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 dropouts 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.application/pdfengAnnals of hepatology. Ciudad de México. Vol. 5 (Nov./Dec. 2021), 100337, 7 p.AntiviraisInsuficiência renal crônicaHepatite CTransplante de rimResposta viral sustentadaAntiviral agentsChronic kidney diseaseHepatitis CKidney transplantViral response‘Real-life’ experience with direct-acting antiviral agents for HCV after kidney transplantEstrangeiroinfo:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UFRGSinstname:Universidade Federal do Rio Grande do Sul (UFRGS)instacron:UFRGSTEXT001148081.pdf.txt001148081.pdf.txtExtracted Texttext/plain34900http://www.lume.ufrgs.br/bitstream/10183/247677/2/001148081.pdf.txtd0d6ae6b8e00cbbcb44efb51bd472a1eMD52ORIGINAL001148081.pdfTexto completo (inglês)application/pdf546799http://www.lume.ufrgs.br/bitstream/10183/247677/1/001148081.pdf4a0d50b55bebf1d21bfd193f5fcdfc71MD5110183/2476772022-08-22 04:35:14.576018oai:www.lume.ufrgs.br:10183/247677Repositório de PublicaçõesPUBhttps://lume.ufrgs.br/oai/requestopendoar:2022-08-22T07:35:14Repositório Institucional da UFRGS - Universidade Federal do Rio Grande do Sul (UFRGS)false |
dc.title.pt_BR.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 Antivirais Insuficiência renal crônica Hepatite C Transplante de rim Resposta viral sustentada 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 |
author |
Fabrizi, Fabrizio |
author_facet |
Fabrizi, Fabrizio Alonso, Cristina Palazzo, Ana Anders, Margarita Reggiardo, María Virginia Cheinquer, Hugo Zuain, María Grazia Videla Figueroa, Sebastián Mendizábal, Manuel Silva, Marcelo Oscar Ridruejo, Ezequiel Latin American Liver Research, Educational and Awareness Network (LALREAN) |
author_role |
author |
author2 |
Alonso, Cristina Palazzo, Ana Anders, Margarita Reggiardo, María Virginia Cheinquer, Hugo Zuain, María Grazia Videla Figueroa, Sebastián Mendizábal, Manuel Silva, Marcelo Oscar Ridruejo, Ezequiel Latin American Liver Research, Educational and Awareness Network (LALREAN) |
author2_role |
author author author author author author author author author author author |
dc.contributor.author.fl_str_mv |
Fabrizi, Fabrizio Alonso, Cristina Palazzo, Ana Anders, Margarita Reggiardo, María Virginia Cheinquer, Hugo Zuain, María Grazia Videla Figueroa, Sebastián Mendizábal, Manuel Silva, Marcelo Oscar Ridruejo, Ezequiel Latin American Liver Research, Educational and Awareness Network (LALREAN) |
dc.subject.por.fl_str_mv |
Antivirais Insuficiência renal crônica Hepatite C Transplante de rim Resposta viral sustentada |
topic |
Antivirais Insuficiência renal crônica Hepatite C Transplante de rim Resposta viral sustentada Antiviral agents Chronic kidney disease Hepatitis C Kidney transplant Viral response |
dc.subject.eng.fl_str_mv |
Antiviral agents Chronic kidney disease Hepatitis C Kidney transplant Viral response |
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 sofosbuvirbased 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 dropouts 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.issued.fl_str_mv |
2021 |
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2022-08-21T04:39:29Z |
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Estrangeiro info:eu-repo/semantics/article |
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Annals of hepatology. Ciudad de México. Vol. 5 (Nov./Dec. 2021), 100337, 7 p. |
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