Background: Iron supplementation is the cornerstone of anaemia management in haemodialysis (HD) patients. However, efficacy and safety of intravenous (IV) iron therapy in hepatitis C virus (HCV)-positive HD patients is yet to be elucidated. Methods: Sixty-six maintenance HD patients with suboptimal response to recombinant human erythropoietin (rh-EPO) were administered IV iron. Each patient received 100 mg/session IV iron sucrose for ten consecutive HD sessions and then the dose was decreased to 50-100 mg weekly or biweekly. Patients were followed for haemoglobin (Hb), ferritin, rh-EPO dose requirements, transaminase levels, and adverse drug reactions. Results: Baseline demographic and clinical characteristics, as well as Hb, ferritin, transaminase levels, rh-EPO and iron doses were similar between HCV-positive (n = 32) and HCV-negative patients (n = 29). After 5 months of follow-up, a significant increase in ferritin and Hb levels and decrease in rh-EPO doses were observed in both groups. The incidence of adverse drug reactions was not associated with HCV serology. Significant elevation in both alanine and aspartate aminotransferase levels were detected in HCV-positive patients. Conclusion: This study has shown that IV iron administration reverses suboptimal response to rh-EPO administration in HD patients regardless of HCV serology. There is however subtle increase of transaminase levels in HCV-positive patients. Further studies are warranted to reveal the impact of variation in serum transaminase levels during IV iron administration in HCV-positive HD patients. Copyright (C) 2005 S. Karger AG, Basel.