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.

Pegylated Interferon Mono-Therapy of Chronic Hepatitis C in the Dialysis Population: Systematic Review and Meta-Analysis / F. Fabrizi, V. Dixit, P. Messa, P. Martin. - In: THERAPEUTIC APHERESIS AND DIALYSIS. - ISSN 1744-9979. - 19:6(2015), pp. 611-621. [10.1111/1744-9987.12318]

Pegylated Interferon Mono-Therapy of Chronic Hepatitis C in the Dialysis Population: Systematic Review and Meta-Analysis

P. Messa;
2015

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.
Dialysis; Drop-out; Hepatitis C; Pegylated interferon; Virological response
Settore MED/14 - Nefrologia
Article (author)
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/588639
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