title: Interferon monotherapy of chronic hepatitis C in dialysis patients: meta-analysis of clinical trials.
abstract: 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.
authors.affiliation: Division of Nephrology, Maggiore Hospital, IRCCS, Milan, Italy. fabrizi@policlinico.mi.it
authors.forename: F
authors.initials: F
authors.lastname: Fabrizi
authors.forename: V
authors.initials: V
authors.lastname: Dixit
authors.forename: P
authors.initials: P
authors.lastname: Messa
authors.forename: P
authors.initials: P
authors.lastname: Martin
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004341:Drug Evaluation; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D007372:Interferons / Q000627:therapeutic use*; D007676:Kidney Failure, Chronic / Q000150:complications / Q000628:therapy*; D011092:Polyethylene Glycols / Q000737:chemistry; D006435:Renal Dialysis; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D011092:Polyethylene Glycols; D007372:Interferons