Nephrol Dial Transplant (2001) 16: 1017-1023
© 2001 European Renal Association-European Dialysis and Transplant Association
The tolerance and efficacy of interferon-
in haemodialysis patients with HCV infection: a multicentre, prospective study
1 Service d'Hépatologie, Hôpital Beaujon AP-HP, Clichy, 2 Service d'Hépatologie, 3 Service de Virologie, Hôpital Necker AP-HP, Paris, 4 Département de Biostatistiques et Information Médicale, Hôpital St Louis AP-HP, Paris, 5 Service d'Hépatologie, Hopital de Bicêtre AP-HP, Le Kremlin Bicêtre, 6 Service d'Hépatologie, Hôpital Pellegrin Bordeaux, 7 Service d'Anatomie et de Cytologie Pathologiques, Hôpital Beaujon AP-HP, Clichy, 8 Service d'Anatomo-pathologie, Hôpital Necker AP-HP, Paris and 9 Direction Régionale de la Recherche Clinique, AP-HP, Hôpital Saint Louis, Paris, France
Background. A prospective multicentre study was initiated in HCV-infected haemodialysis patients to assess the tolerance and efficacy of 
-2b interferon.
Methods. We had planned to include 120 patients with HCV RNA detectable by polymerase chain reaction (PCR) (Amplicor Roche) and histologically documented chronic hepatitis. The dose of -interferon was 3 million units (MU) three times weekly (TTW), to be reduced to 1.5 MU TTW in case of side-effects. Tolerance was evaluated monthly; virological efficacy was evaluated by PCR. A liver biopsy was performed at month 18 (M18).
Results. (a) Tolerance. After 37 patients had been included, the study was discontinued by the promoting institution because of severe side-effects requiring that treatment be stopped in 19 patients. The side-effects were: cardiac (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 MU TTW dose and in six patients for the 1.5 MU TTW reduced dose. Normal ALT level (OR, 0.16; CI 95%, 0.03–0.89) at inclusion was associated with interruption of treatment (univariate analysis). (b) Efficacy. Sustained virological response was observed in only seven (18.9%), of the 18 patients who completed the treatment (38%). Increased ALT at inclusion (OR, 1.04; CI 95%, 1.01–1.09) and cumulated doses of interferon (OR, 1.01; CI 95%, 1.004–1.026) were jointly associated with a sustained response, while positive PCR at M2 was strongly predictive of treatment failure.
Conclusion: Tolerance of interferon is poor in haemodialysis patients. Sustained response is fairly high in patients who have 12 months of treatment and seems to be based on the immune status of the patients (ALT) and the cumulative doses of interferon.
Keywords: hepatitis C virus; interferon-; polymerase chain reaction; prospective multicentre study; side-effects; virological efficacy
Correspondence and offprint requests to: Dr Françoise Degos, Service d'Hépatologie, Hôpital Beaujon, 100 Bd du Gl Leclerc, F-92110 Clichy, France.
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