Virological and histological responses to one year alpha-interferon-2a in hemodialyzed patients with chronic hepatitis C

Background: alpha -Interferon-2a (IFN alpha) alone is a therapy of limited proven benefit for non-uremic patients with chronic hepatitis C virus (HCV) infection. In dialyzed patients, such an effect is suggested on small shor t-term studies without sufficient clinical and virologic follow-up to docum ent any sustained effect. Protocol: Twelve chronically hemodialyzed patient s with chronic hepatitis C and waiting for renal transplantation were inclu ded in a prospective open study of treatment with IFN alpha. We used, as di d others, doses of 3 million units (MU), three times a week, but for a long er period of treatment of 12 months. Follow-up was continued for 6 months a fter the end of IFN alpha in order to document any sustained biochemical, v irological and histological responses. Results: Aminotransferase levels ret urned to the normal range within 1-2 months of treatment in all patients in whom they had been elevated at baseline. At 1 month of treatment, serum HC V-RNA was not detected in 5 (41%) patients and in 9 (75%) at 12 months. A s ustained virological response was documented in 4 (33%) patients 6 months a fter the end of treatment. Relapse occurred in 5 patients within 2 months a fter IFN alpha withdrawal. HCV genotype was not predictive of any sustained response. At inclusion, using the histologic Metavir scoring system, half of the patients had low-grade cytolytic activity and none had cirrhosis. Af ter IFN alpha, liver biopsy specimens were available from 9 patients and sh owed histologic improvement in 3. IFNa tolerance was poor, inducing a 5% me an weight loss and the acute rejection of two nonfunctioning kidney grafts. Conclusion: This study documents that administration of IFN alpha at 3 MU three times a week, for 12 months, in hemodialysis patients with chronic he patitis C was efficient for clearing the serum of HCV-RNA in 75% of the pat ients. A sustained response was maintained in one third of these patients a fter cessation of IFN alpha, and was predicted by the early serum clearance of the virus within the first 2 months of treatment. We confirm that a 12- month treatment period carries a higher sustained response rate than shorte r treatment periods. These encouraging results call for larger studies in u remic patients, using IFN alpha alone or in association with new antiviral drugs. Copyright (C) 2001 S. Karger AG, Basel.