Pegylated Interferon Mono-Therapy of Chronic Hepatitis C in the Dialysis Population

Systematic Review and Meta-Analysis

Fabrizio Fabrizi, Vivek Dixit, Piergiorgio Messa, Paul Martin

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

The medical literature on mono-therapy with pegylated interferon for chronic hepatitis C in dialysis patients is mostly based on small clinical studies and the efficacy and safety of such approach is still unclear. A systematic review of the literature with a meta-analysis of clinical studies was performed in order to evaluate the efficacy and safety of mono-therapy with pegylated interferon of chronic hepatitis C in patients on regular dialysis. The primary outcome was sustained viral response (as a measure of efficacy); the secondary outcome was drop-out rate (as a measure of tolerability). The random-effects model of Der Simonian and Laird was used, with heterogeneity and sensitivity analyses. Twenty-four clinical studies (N=744 unique patients) were retrieved; five (21%) being randomized controlled trials. The summary estimate for sustained viral response and drop-out rate was 0.40 (95% confidence interval [CI], 0.35; 0.46) and 0.14 (95% CI, 0.09; 0.20), respectively. The most frequent side-effects requiring discontinuation of treatment were hematological (31/83=37%) and gastrointestinal (9/31=10.8%). Meta-regression analysis showed a detrimental role of ageing on the frequency of sustained virological response (P=0.01); drop-out rate was greater in diabetics (P<0.005). Important heterogeneity was seen with regard to drop-out rate only. In summary, pegylated interferon monotherapy of hepatitis C in dialysis patients resulted unsatisfactory in terms of efficacy and safety. Studies with novel direct-acting antiviral agents in combination with pegylated interferon and ribavirin for the treatment of hepatitis C virus in dialysis population are under way.

Original languageEnglish (US)
Pages (from-to)611-621
Number of pages11
JournalTherapeutic Apheresis and Dialysis
Volume19
Issue number6
DOIs
StatePublished - Dec 1 2015

Fingerprint

Chronic Hepatitis C
Interferons
Meta-Analysis
Dialysis
Safety
Population
Confidence Intervals
Ribavirin
Therapeutics
Hepatitis C
Hepacivirus
Antiviral Agents
Randomized Controlled Trials
Regression Analysis
Clinical Studies

Keywords

  • Dialysis
  • Drop-out
  • Hepatitis C
  • Pegylated interferon
  • Virological response

ASJC Scopus subject areas

  • Hematology
  • Nephrology

Cite this

Pegylated Interferon Mono-Therapy of Chronic Hepatitis C in the Dialysis Population : Systematic Review and Meta-Analysis. / Fabrizi, Fabrizio; Dixit, Vivek; Messa, Piergiorgio; Martin, Paul.

In: Therapeutic Apheresis and Dialysis, Vol. 19, No. 6, 01.12.2015, p. 611-621.

Research output: Contribution to journalArticle

@article{6889b8dacd8a462ca2112b1fdbb7daa8,
title = "Pegylated Interferon Mono-Therapy of Chronic Hepatitis C in the Dialysis Population: Systematic Review and Meta-Analysis",
abstract = "The medical literature on mono-therapy with pegylated interferon for chronic hepatitis C in dialysis patients is mostly based on small clinical studies and the efficacy and safety of such approach is still unclear. A systematic review of the literature with a meta-analysis of clinical studies was performed in order to evaluate the efficacy and safety of mono-therapy with pegylated interferon of chronic hepatitis C in patients on regular dialysis. The primary outcome was sustained viral response (as a measure of efficacy); the secondary outcome was drop-out rate (as a measure of tolerability). The random-effects model of Der Simonian and Laird was used, with heterogeneity and sensitivity analyses. Twenty-four clinical studies (N=744 unique patients) were retrieved; five (21{\%}) being randomized controlled trials. The summary estimate for sustained viral response and drop-out rate was 0.40 (95{\%} confidence interval [CI], 0.35; 0.46) and 0.14 (95{\%} CI, 0.09; 0.20), respectively. The most frequent side-effects requiring discontinuation of treatment were hematological (31/83=37{\%}) and gastrointestinal (9/31=10.8{\%}). Meta-regression analysis showed a detrimental role of ageing on the frequency of sustained virological response (P=0.01); drop-out rate was greater in diabetics (P<0.005). Important heterogeneity was seen with regard to drop-out rate only. In summary, pegylated interferon monotherapy of hepatitis C in dialysis patients resulted unsatisfactory in terms of efficacy and safety. Studies with novel direct-acting antiviral agents in combination with pegylated interferon and ribavirin for the treatment of hepatitis C virus in dialysis population are under way.",
keywords = "Dialysis, Drop-out, Hepatitis C, Pegylated interferon, Virological response",
author = "Fabrizio Fabrizi and Vivek Dixit and Piergiorgio Messa and Paul Martin",
year = "2015",
month = "12",
day = "1",
doi = "10.1111/1744-9987.12318",
language = "English (US)",
volume = "19",
pages = "611--621",
journal = "Therapeutic Apheresis and Dialysis",
issn = "1744-9979",
publisher = "Wiley-Blackwell",
number = "6",

}

TY - JOUR

T1 - Pegylated Interferon Mono-Therapy of Chronic Hepatitis C in the Dialysis Population

T2 - Systematic Review and Meta-Analysis

AU - Fabrizi, Fabrizio

AU - Dixit, Vivek

AU - Messa, Piergiorgio

AU - Martin, Paul

PY - 2015/12/1

Y1 - 2015/12/1

N2 - The medical literature on mono-therapy with pegylated interferon for chronic hepatitis C in dialysis patients is mostly based on small clinical studies and the efficacy and safety of such approach is still unclear. A systematic review of the literature with a meta-analysis of clinical studies was performed in order to evaluate the efficacy and safety of mono-therapy with pegylated interferon of chronic hepatitis C in patients on regular dialysis. The primary outcome was sustained viral response (as a measure of efficacy); the secondary outcome was drop-out rate (as a measure of tolerability). The random-effects model of Der Simonian and Laird was used, with heterogeneity and sensitivity analyses. Twenty-four clinical studies (N=744 unique patients) were retrieved; five (21%) being randomized controlled trials. The summary estimate for sustained viral response and drop-out rate was 0.40 (95% confidence interval [CI], 0.35; 0.46) and 0.14 (95% CI, 0.09; 0.20), respectively. The most frequent side-effects requiring discontinuation of treatment were hematological (31/83=37%) and gastrointestinal (9/31=10.8%). Meta-regression analysis showed a detrimental role of ageing on the frequency of sustained virological response (P=0.01); drop-out rate was greater in diabetics (P<0.005). Important heterogeneity was seen with regard to drop-out rate only. In summary, pegylated interferon monotherapy of hepatitis C in dialysis patients resulted unsatisfactory in terms of efficacy and safety. Studies with novel direct-acting antiviral agents in combination with pegylated interferon and ribavirin for the treatment of hepatitis C virus in dialysis population are under way.

AB - The medical literature on mono-therapy with pegylated interferon for chronic hepatitis C in dialysis patients is mostly based on small clinical studies and the efficacy and safety of such approach is still unclear. A systematic review of the literature with a meta-analysis of clinical studies was performed in order to evaluate the efficacy and safety of mono-therapy with pegylated interferon of chronic hepatitis C in patients on regular dialysis. The primary outcome was sustained viral response (as a measure of efficacy); the secondary outcome was drop-out rate (as a measure of tolerability). The random-effects model of Der Simonian and Laird was used, with heterogeneity and sensitivity analyses. Twenty-four clinical studies (N=744 unique patients) were retrieved; five (21%) being randomized controlled trials. The summary estimate for sustained viral response and drop-out rate was 0.40 (95% confidence interval [CI], 0.35; 0.46) and 0.14 (95% CI, 0.09; 0.20), respectively. The most frequent side-effects requiring discontinuation of treatment were hematological (31/83=37%) and gastrointestinal (9/31=10.8%). Meta-regression analysis showed a detrimental role of ageing on the frequency of sustained virological response (P=0.01); drop-out rate was greater in diabetics (P<0.005). Important heterogeneity was seen with regard to drop-out rate only. In summary, pegylated interferon monotherapy of hepatitis C in dialysis patients resulted unsatisfactory in terms of efficacy and safety. Studies with novel direct-acting antiviral agents in combination with pegylated interferon and ribavirin for the treatment of hepatitis C virus in dialysis population are under way.

KW - Dialysis

KW - Drop-out

KW - Hepatitis C

KW - Pegylated interferon

KW - Virological response

UR - http://www.scopus.com/inward/record.url?scp=84983134145&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84983134145&partnerID=8YFLogxK

U2 - 10.1111/1744-9987.12318

DO - 10.1111/1744-9987.12318

M3 - Article

VL - 19

SP - 611

EP - 621

JO - Therapeutic Apheresis and Dialysis

JF - Therapeutic Apheresis and Dialysis

SN - 1744-9979

IS - 6

ER -