Interferon monotherapy of chronic hepatitis C in dialysis patients: meta-analysis of clinical trials

January 2, 2008

Journal of Viral Hepatitis 15 (2), 79–88.

doi:10.1111/j.1365-2893.2007.00907.x

Abstract

Interferon monotherapy of chronic hepatitis C in dialysis patients:

meta-analysis of clinical trials

F. Fabrizi1,21Division of Nephrology, Maggiore Hospital, IRCCS, Milan,

Italy2Division of Digestive Diseases, UCLA School of Medicine, Los Angeles, CA,

USA, V. Dixit33Division of Liver Diseases, Mount Sinai School of Medicine, New

York, USA, P. Messa22Division of Digestive Diseases, UCLA School of Medicine,

Los Angeles, CA, USA and P. 22Division of Digestive Diseases, UCLA School

of Medicine, Los Angeles, CA, USA1Division of Nephrology, Maggiore Hospital,

IRCCS, Milan, Italy; 2Division of Digestive Diseases, UCLA School of Medicine,

Los Angeles, CA, USA; and 3Division of Liver Diseases, Mount Sinai School of

Medicine, New York, USA

Dr Fabrizio Fabrizi, Divisione di Nefrologia e Dialisi, Ospedale Maggiore,

IRCCS, Pad. Croff, Via Commenda 15, Milan 20122, Italy. Tel.: 02 55034552; fax:

02 55034550, E-mail: fabrizi@...

CKD, chronic kidney disease; EBR, end-of-treatment biochemical response; EVR,

end-of-treatment virological response; HCV, hepatitis C virus; IFN, interferon;

SBR, sustained biochemical response; SVR, sustained virological response.

Abstract

Summary. The efficacy of monotherapy with interferon (IFN) (conventional or

pegylated IFN) in dialysis patients with chronic hepatitis C remains unclear,

although a number of clinical trials have been published addressing this issue.

The aim of the study was to evaluate the efficacy and safety of monotherapy by

conventional or pegylated IFN in dialysis patients with chronic hepatitis C by

performing a systematic review of the literature with a meta-analysis of

clinical trials. The primary outcome was sustained virological response (SVR; as

a measure of efficacy), and the secondary outcome was drop-out rate (as a

measure of tolerability). We used the random-effects model of Der Simonian and

Laird, with heterogeneity and sensitivity analyses. We identified 28 clinical

trials (645 unique patients), of which six (21.4%) had a controlled design. In

the group of trials based on conventional IFN, the summary estimate for SVR and

drop-out rate was 39% [95% confidence interval (CI) 32–46] and 19% (95% CI

13–26) respectively. The summary estimate for SVR rate in patients with the

hepatitis C virus genotype 1 was 33% (95% CI 19–47). In the subset of trials

using pegylated IFN, the summary estimate for SVR and drop-out rate was 31% (95%

CI 7–55) and 27% (95% CI 1–52) respectively. The most frequent side-effects

requiring interruption of treatment were flu-like symptoms, and gastrointestinal

and haematological changes. A relationship between age and drop-out rate was

found, even if no statistical significance was reached (P = 0.064). The studies

were heterogeneous with regard to SVR and drop-out rate. No publication bias was

observed. One-third of dialysis patients with chronic hepatitis C were

successfully treated with conventional or pegylated IFN monotherapy. Preliminary

evidence does not support additional benefit due to monotherapy with pegylated

IFN on the viral response in the chronic kidney disease (CKD) population.

Tolerance to IFN monotherapy was unsatisfactory, particularly to pegylated IFN.

The optimal antiviral treatment of chronic hepatitis C in dialysis populations

is currently under active investigation.

http://www.blackwell-synergy.com/doi/abs/10.1111/j.1365-2893.2007.00907.x

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January 2, 2008