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

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 t...

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Autores principales:	Fabrizio Fabrizi, Cristina Alonso, Ana Palazzo, Margarita Anders, Maria Virginia Reggiardo, Hugo Cheinquer, Maria Grazia Videla Zuain, Sebastian Figueroa, Manuel Mendizabal, Marcelo Silva, Ezequiel Ridruejo
Formato:	article
Lenguaje:	EN
Publicado:	Elsevier 2021
Materias:	Antiviral agents Chronic kidney disease Hepatitis C Kidney transplant Viral response Specialties of internal medicine RC581-951
Acceso en línea:	https://doaj.org/article/a10a721d539a4ef798649bedda9515fc
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spelling	oai:doaj.org-article:a10a721d539a4ef798649bedda9515fc2021-11-18T04:46:00Z‘Real-life’ experience with direct-acting antiviral agents for HCV after kidney transplant1665-268110.1016/j.aohep.2021.100337https://doaj.org/article/a10a721d539a4ef798649bedda9515fc2021-11-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S1665268121000363https://doaj.org/toc/1665-2681Introductions 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.Fabrizio FabriziCristina AlonsoAna PalazzoMargarita AndersMaria Virginia ReggiardoHugo CheinquerMaria Grazia Videla ZuainSebastian FigueroaManuel MendizabalMarcelo SilvaEzequiel RidruejoElsevierarticleAntiviral agentsChronic kidney diseaseHepatitis CKidney transplantViral responseSpecialties of internal medicineRC581-951ENAnnals of Hepatology, Vol 25, Iss , Pp 100337- (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Antiviral agents Chronic kidney disease Hepatitis C Kidney transplant Viral response Specialties of internal medicine RC581-951
spellingShingle	Antiviral agents Chronic kidney disease Hepatitis C Kidney transplant Viral response Specialties of internal medicine RC581-951 Fabrizio Fabrizi Cristina Alonso Ana Palazzo Margarita Anders Maria Virginia Reggiardo Hugo Cheinquer Maria Grazia Videla Zuain Sebastian Figueroa Manuel Mendizabal Marcelo Silva Ezequiel Ridruejo ‘Real-life’ experience with direct-acting antiviral agents for HCV after kidney transplant
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.
format	article
author	Fabrizio Fabrizi Cristina Alonso Ana Palazzo Margarita Anders Maria Virginia Reggiardo Hugo Cheinquer Maria Grazia Videla Zuain Sebastian Figueroa Manuel Mendizabal Marcelo Silva Ezequiel Ridruejo
author_facet	Fabrizio Fabrizi Cristina Alonso Ana Palazzo Margarita Anders Maria Virginia Reggiardo Hugo Cheinquer Maria Grazia Videla Zuain Sebastian Figueroa Manuel Mendizabal Marcelo Silva Ezequiel Ridruejo
author_sort	Fabrizio Fabrizi
title	‘Real-life’ experience with direct-acting antiviral agents for HCV after kidney transplant
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
publisher	Elsevier
publishDate	2021
url	https://doaj.org/article/a10a721d539a4ef798649bedda9515fc
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‘Real-life’ experience with direct-acting antiviral agents for HCV after kidney transplant

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