The tolerance and efficacy of interferon-alpha in haemodialysis patients with HCV infection: a multicentre, prospective study

Background. A prospective multicentre study was initiated in HCV-infected h aemodialysis patients to assess the tolerance and efficacy of alpha -2b int erferon. Methods. We had planned to include 120 patients with HCV RNA detectable by polymerase chain reaction (PCR) (Amplicor Roche) and histologically documen ted chronic hepatitis. The dose of alpha -interferon was 3 million units (M U) three times weekly (TTW) to be reduced to 1.5 MU TTW in case of side-eff ects. Tolerance was evaluated monthly; virological efficacy was evaluated b y PCR. A liver biopsy was performed at month 18 (MIS). Results. (a) Tolerance. After 37 patients had been included, the study was discontinued by the promoting institution because of severe side-effects re quiring that treatment be stopped in 19 patients. The side-effects were: ca rdiac (4) neuropsychiatric (2), digestive (3), acute necrosis of the graft (1), severe asthenia (9), minor side-effects were observed in 22 patients. A complete 12-month course was completed in 12 patients for the 3 MW TTW do se and in sis patients for the 1.5 MU TTW reduced doss. Normal ALT level (O R, 0.16; CI 95%, 0.03-0.89) at inclusion was associated with interruption o f treatment (univariate analysis). (b) Efficacy. Sustained virological resp onse was observed in only seven (18.9%), of the 18 patients who completed t he treatment (38%). Increased ALT at inclusion (OR, 1.04; CI 95%, 1.01-1.09 ) and cumulated doses of interferon (OR, 1.01, CT 95% 1.004-1.026) were joi ntly associated with a sustained response, while positive PCR at M2 was str ongly predictive of treatment failure. Conclusion: Tolerance of interferon is poor in haemodialysis patients. Sust ained response is fairly high in patients who have 12 months of treatment a nd seems to be based on the immune status of the patients (ALT) and the cum ulative doses of interferon.