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.
authors.affiliation: Division of Nephrology and Dialysis, Maggiore Hospital and IRCCS Foundation, Milano, Italy.
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Fabrizi
authors.affiliation: Division of Hepatology, University School of Medicine, Miami, FL, USA.
authors.forename: Vivek
authors.initials: V
authors.lastname: Dixit
authors.affiliation: Division of Nephrology and Dialysis, Maggiore Hospital and IRCCS Foundation, Milano, Italy.
authors.forename: Piergiorgio
authors.initials: P
authors.lastname: Messa
authors.affiliation: Division of Hepatology, University School of Medicine, Miami, FL, USA.
authors.forename: Paul
authors.initials: P
authors.lastname: Martin
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use*; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D006435:Renal Dialysis
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha
keywords: Dialysis; Drop-out; Hepatitis C; Pegylated interferon; Virological response