‘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...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2021-11-01
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| Series: | Annals of Hepatology |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1665268121000363 |
| _version_ | 1818568971836719104 |
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| 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 |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-12-14T06:41:57Z |
| format | Article |
| id | doaj.art-a10a721d539a4ef798649bedda9515fc |
| institution | Directory Open Access Journal |
| issn | 1665-2681 |
| language | English |
| last_indexed | 2024-12-14T06:41:57Z |
| publishDate | 2021-11-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Annals of Hepatology |
| spelling | doaj.art-a10a721d539a4ef798649bedda9515fc2022-12-21T23:13:11ZengElsevierAnnals of Hepatology1665-26812021-11-0125100337‘Real-life’ experience with direct-acting antiviral agents for HCV after kidney transplantFabrizio Fabrizi0Cristina Alonso1Ana Palazzo2Margarita Anders3Maria Virginia Reggiardo4Hugo Cheinquer5Maria Grazia Videla Zuain6Sebastian Figueroa7Manuel Mendizabal8Marcelo Silva9Ezequiel Ridruejo10Nephrology Division, IRCCS Ca’ Granda Foundation and Maggiore Policlinico Hospital, Milano, Italy; Corresponding author at: Divisione Nefrologica, Ospedale Maggiore, Padiglione Croff, Via Commenda 15, 20122, Milano, Italy.Hepatology and Liver Transplant Unit, Hospital Universitario Austral, Pilar, Provincia de Buenos Aires, ArgentinaGastroenterology and Hepatology Division, Hospital Padilla, Tucumàn, ArgentinaGastroenterology and Hepatology Division, Hospital Alemàn, Ciudad de Buenos Aires, ArgentinaGastroenterology and Hepatology Division, Hospital Provincial del Centenario, Rosario, ArgentinaGastroenterology and Hepatology Division, Universidad de Federal do Rio Grande do Sul, Porto Alegre, BrazilGastroenterology and Hepatology Division, Hospital Zubizarreta, Ciudad de Buenos Aires, ArgentinaGastroenterology and Hepatology Division, Hospital Arturo Onativia, Salta, ArgentinaHepatology and Liver Transplant Unit, Hospital Universitario Austral, Pilar, Provincia de Buenos Aires, ArgentinaHepatology and Liver Transplant Unit, Hospital Universitario Austral, Pilar, Provincia de Buenos Aires, ArgentinaHepatology and Liver Transplant Unit, Hospital Universitario Austral, Pilar, Provincia de Buenos Aires, Argentina; Hepatology Section, Department of Medicine, Centro de Educaciòn Medica e Investigaciones Clinicas Norberto Quirno “CEMIC”, Ciudad Autònoma de Buenos Aires, ArgentinaIntroductions 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.http://www.sciencedirect.com/science/article/pii/S1665268121000363Antiviral agentsChronic kidney diseaseHepatitis CKidney transplantViral response |
| spellingShingle | 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 Annals of Hepatology Antiviral agents Chronic kidney disease Hepatitis C Kidney transplant Viral response |
| title | ‘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_short | ‘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 |
| topic | Antiviral agents Chronic kidney disease Hepatitis C Kidney transplant Viral response |
| url | http://www.sciencedirect.com/science/article/pii/S1665268121000363 |
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