‘Real-life’ experience with direct-acting antiviral agents for hepatitis C virus in end-stage renal disease

Rebeca García-Agudo, Sami Aoufi-Rabih, Mercedes Salgueira-Lazo, Carmen González-Corvillo, Fabrizio Fabrizi

Research output: Contribution to journalArticle

Abstract

Background and Aims: The advent of direct-acting antiviral agents promises to change the management of hepatitis C in patients with end-stage renal disease, a patient group where the treatment of hepatitis C was historically challenging. We investigated the safety and efficacy of all-oral, interferon-free direct-acting antiviral agents for the treatment of hepatitis C in a ‘real-world’ group of patients with end-stage renal disease. Methods: We performed a single-arm, multi-centre study in a cohort (n=30) of patients with advanced chronic kidney disease (mostly on dialysis) who underwent antiviral therapy with direct-acting antiviral agents. The primary end-point was sustained virologic response (serum hepatitis C virus RNA < 15 mIU/mL, 12 weeks after treatment ended). We collected data on on-treatment adverse events, serious adverse events and laboratory abnormalities. Results: In total, 23 (77%) and 7 (23%) patients underwent regular dialysis and had chronic kidney disease at pre-dialysis stage, respectively. Six regimens were adopted: elbasvir/grazoprevir (n = 6), ledipasvir/sofosbuvir ± ribavirin (n = 4), PrOD regimens ± ribavirin (n = 10), simeprevir + daclatasvir (n = 3), sofosbuvir + daclatasvir ± ribavirin (n = 3), sofosbuvir + ribavirin (n = 4). The SVR12 rate was 90% (95% confidence interval, 74%; 96%). A total of 27 (90%) patients achieved SVR12; there were three virologic failures – two were non-responders and one had a viral breakthrough while on therapy. Adverse events occurred in 53% (16/30) (95% confidence interval, 0.39; 0.73) of patients and were managed clinically without discontinuation of therapy or hospitalization. The most common adverse event was anaemia (n = 12) that required blood transfusions in seven individuals; deterioration of kidney function occurred in one (14%). Conclusion: All-oral, interferon-free therapy with direct-acting antiviral agents for chronic hepatitis C virus in advanced chronic kidney disease was effective and well tolerated in a ‘real-life’ clinical setting. Careful monitoring of haemoglobin and serum creatinine during therapy with direct-acting antiviral agents is suggested. Studies are under way to address whether sustained viral response translates into better survival in this population.

Original languageEnglish
Pages (from-to)363-370
JournalInternational Journal of Artificial Organs
Volume41
Issue number7
DOIs
Publication statusPublished - 2018

Fingerprint

Antiviral agents
Viruses
Hepacivirus
Chronic Kidney Failure
Antiviral Agents
Ribavirin
Dialysis
Interferons
Hepatitis C
Chronic Renal Insufficiency
Therapeutics
Hemoglobin
RNA
Deterioration
Blood
Confidence Intervals
Creatinine
Hemoglobins
Chronic Hepatitis C
Monitoring

Keywords

  • Antiviral agents
  • chronic kidney failure
  • dialysis
  • hepatitis C
  • renal dialysis

ASJC Scopus subject areas

  • Bioengineering
  • Medicine (miscellaneous)
  • Biomaterials
  • Biomedical Engineering

Cite this

‘Real-life’ experience with direct-acting antiviral agents for hepatitis C virus in end-stage renal disease. / García-Agudo, Rebeca; Aoufi-Rabih, Sami; Salgueira-Lazo, Mercedes; González-Corvillo, Carmen; Fabrizi, Fabrizio.

In: International Journal of Artificial Organs, Vol. 41, No. 7, 2018, p. 363-370.

Research output: Contribution to journalArticle

García-Agudo, Rebeca ; Aoufi-Rabih, Sami ; Salgueira-Lazo, Mercedes ; González-Corvillo, Carmen ; Fabrizi, Fabrizio. / ‘Real-life’ experience with direct-acting antiviral agents for hepatitis C virus in end-stage renal disease. In: International Journal of Artificial Organs. 2018 ; Vol. 41, No. 7. pp. 363-370.
@article{a978e8e2398a41c19d9714444a5deb5b,
title = "‘Real-life’ experience with direct-acting antiviral agents for hepatitis C virus in end-stage renal disease",
abstract = "Background and Aims: The advent of direct-acting antiviral agents promises to change the management of hepatitis C in patients with end-stage renal disease, a patient group where the treatment of hepatitis C was historically challenging. We investigated the safety and efficacy of all-oral, interferon-free direct-acting antiviral agents for the treatment of hepatitis C in a ‘real-world’ group of patients with end-stage renal disease. Methods: We performed a single-arm, multi-centre study in a cohort (n=30) of patients with advanced chronic kidney disease (mostly on dialysis) who underwent antiviral therapy with direct-acting antiviral agents. The primary end-point was sustained virologic response (serum hepatitis C virus RNA < 15 mIU/mL, 12 weeks after treatment ended). We collected data on on-treatment adverse events, serious adverse events and laboratory abnormalities. Results: In total, 23 (77{\%}) and 7 (23{\%}) patients underwent regular dialysis and had chronic kidney disease at pre-dialysis stage, respectively. Six regimens were adopted: elbasvir/grazoprevir (n = 6), ledipasvir/sofosbuvir ± ribavirin (n = 4), PrOD regimens ± ribavirin (n = 10), simeprevir + daclatasvir (n = 3), sofosbuvir + daclatasvir ± ribavirin (n = 3), sofosbuvir + ribavirin (n = 4). The SVR12 rate was 90{\%} (95{\%} confidence interval, 74{\%}; 96{\%}). A total of 27 (90{\%}) patients achieved SVR12; there were three virologic failures – two were non-responders and one had a viral breakthrough while on therapy. Adverse events occurred in 53{\%} (16/30) (95{\%} confidence interval, 0.39; 0.73) of patients and were managed clinically without discontinuation of therapy or hospitalization. The most common adverse event was anaemia (n = 12) that required blood transfusions in seven individuals; deterioration of kidney function occurred in one (14{\%}). Conclusion: All-oral, interferon-free therapy with direct-acting antiviral agents for chronic hepatitis C virus in advanced chronic kidney disease was effective and well tolerated in a ‘real-life’ clinical setting. Careful monitoring of haemoglobin and serum creatinine during therapy with direct-acting antiviral agents is suggested. Studies are under way to address whether sustained viral response translates into better survival in this population.",
keywords = "Antiviral agents, chronic kidney failure, dialysis, hepatitis C, renal dialysis",
author = "Rebeca Garc{\'i}a-Agudo and Sami Aoufi-Rabih and Mercedes Salgueira-Lazo and Carmen Gonz{\'a}lez-Corvillo and Fabrizio Fabrizi",
year = "2018",
doi = "10.1177/0391398818763478",
language = "English",
volume = "41",
pages = "363--370",
journal = "International Journal of Artificial Organs",
issn = "0391-3988",
publisher = "Wichtig Publishing",
number = "7",

}

TY - JOUR

T1 - ‘Real-life’ experience with direct-acting antiviral agents for hepatitis C virus in end-stage renal disease

AU - García-Agudo, Rebeca

AU - Aoufi-Rabih, Sami

AU - Salgueira-Lazo, Mercedes

AU - González-Corvillo, Carmen

AU - Fabrizi, Fabrizio

PY - 2018

Y1 - 2018

N2 - Background and Aims: The advent of direct-acting antiviral agents promises to change the management of hepatitis C in patients with end-stage renal disease, a patient group where the treatment of hepatitis C was historically challenging. We investigated the safety and efficacy of all-oral, interferon-free direct-acting antiviral agents for the treatment of hepatitis C in a ‘real-world’ group of patients with end-stage renal disease. Methods: We performed a single-arm, multi-centre study in a cohort (n=30) of patients with advanced chronic kidney disease (mostly on dialysis) who underwent antiviral therapy with direct-acting antiviral agents. The primary end-point was sustained virologic response (serum hepatitis C virus RNA < 15 mIU/mL, 12 weeks after treatment ended). We collected data on on-treatment adverse events, serious adverse events and laboratory abnormalities. Results: In total, 23 (77%) and 7 (23%) patients underwent regular dialysis and had chronic kidney disease at pre-dialysis stage, respectively. Six regimens were adopted: elbasvir/grazoprevir (n = 6), ledipasvir/sofosbuvir ± ribavirin (n = 4), PrOD regimens ± ribavirin (n = 10), simeprevir + daclatasvir (n = 3), sofosbuvir + daclatasvir ± ribavirin (n = 3), sofosbuvir + ribavirin (n = 4). The SVR12 rate was 90% (95% confidence interval, 74%; 96%). A total of 27 (90%) patients achieved SVR12; there were three virologic failures – two were non-responders and one had a viral breakthrough while on therapy. Adverse events occurred in 53% (16/30) (95% confidence interval, 0.39; 0.73) of patients and were managed clinically without discontinuation of therapy or hospitalization. The most common adverse event was anaemia (n = 12) that required blood transfusions in seven individuals; deterioration of kidney function occurred in one (14%). Conclusion: All-oral, interferon-free therapy with direct-acting antiviral agents for chronic hepatitis C virus in advanced chronic kidney disease was effective and well tolerated in a ‘real-life’ clinical setting. Careful monitoring of haemoglobin and serum creatinine during therapy with direct-acting antiviral agents is suggested. Studies are under way to address whether sustained viral response translates into better survival in this population.

AB - Background and Aims: The advent of direct-acting antiviral agents promises to change the management of hepatitis C in patients with end-stage renal disease, a patient group where the treatment of hepatitis C was historically challenging. We investigated the safety and efficacy of all-oral, interferon-free direct-acting antiviral agents for the treatment of hepatitis C in a ‘real-world’ group of patients with end-stage renal disease. Methods: We performed a single-arm, multi-centre study in a cohort (n=30) of patients with advanced chronic kidney disease (mostly on dialysis) who underwent antiviral therapy with direct-acting antiviral agents. The primary end-point was sustained virologic response (serum hepatitis C virus RNA < 15 mIU/mL, 12 weeks after treatment ended). We collected data on on-treatment adverse events, serious adverse events and laboratory abnormalities. Results: In total, 23 (77%) and 7 (23%) patients underwent regular dialysis and had chronic kidney disease at pre-dialysis stage, respectively. Six regimens were adopted: elbasvir/grazoprevir (n = 6), ledipasvir/sofosbuvir ± ribavirin (n = 4), PrOD regimens ± ribavirin (n = 10), simeprevir + daclatasvir (n = 3), sofosbuvir + daclatasvir ± ribavirin (n = 3), sofosbuvir + ribavirin (n = 4). The SVR12 rate was 90% (95% confidence interval, 74%; 96%). A total of 27 (90%) patients achieved SVR12; there were three virologic failures – two were non-responders and one had a viral breakthrough while on therapy. Adverse events occurred in 53% (16/30) (95% confidence interval, 0.39; 0.73) of patients and were managed clinically without discontinuation of therapy or hospitalization. The most common adverse event was anaemia (n = 12) that required blood transfusions in seven individuals; deterioration of kidney function occurred in one (14%). Conclusion: All-oral, interferon-free therapy with direct-acting antiviral agents for chronic hepatitis C virus in advanced chronic kidney disease was effective and well tolerated in a ‘real-life’ clinical setting. Careful monitoring of haemoglobin and serum creatinine during therapy with direct-acting antiviral agents is suggested. Studies are under way to address whether sustained viral response translates into better survival in this population.

KW - Antiviral agents

KW - chronic kidney failure

KW - dialysis

KW - hepatitis C

KW - renal dialysis

UR - http://www.scopus.com/inward/record.url?scp=85045088873&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85045088873&partnerID=8YFLogxK

U2 - 10.1177/0391398818763478

DO - 10.1177/0391398818763478

M3 - Article

AN - SCOPUS:85045088873

VL - 41

SP - 363

EP - 370

JO - International Journal of Artificial Organs

JF - International Journal of Artificial Organs

SN - 0391-3988

IS - 7

ER -