A DOUBLE-BLIND CONTROLLED TRIAL OF RECOMBINANT INTERFERON-ALPHA-2B INHEMODIALYSIS-PATIENTS WITH CHRONIC HEPATITIS-C VIRUS-INFECTION AND ABNORMAL AMINOTRANSFERASE LEVELS

The efficacy and safety of recombinant interferon-alpha 2b (rIFN-alpha 2b) was evaluated in a double-blind controlled trial comprising 23 ha emodialysis patients with antibodies to hepatitis C virus (anti-HCV), detectable serum HCV RNA by polymerase chain reaction and chronic alan ine aminotransferase elevation. The patients were randomly assigned to receive rIFN-alpha 2b at a dose of 1.5 MU (increasing to 3 MU if no r esponse was observed) (Group I: n = 14) or identical placebo (Group II : n = 9), for 6 months, A biochemical response (normal alanine aminotr ansferase) was observed in 10 patients (71.4%) from Group I and in one patient (11.1%) from Group II (P < 0.01) at the end of therapy, and i n four patients from Group I (28.6%) and in none from Group II (NS) 12 months after therapy, Virological response (HCV RNA negative) was obs erved in four patients (28.6%) from Group I and in none from Group II (NS) at the end of therapy, and in two patients (14.2%) from Group I a nd in none from Group II (NS) 12 months after therapy, Interferon dose s were 1.5 MU in 12 patients and 3 MU in two patients. Therapy interru ption owing to severe side-effects was necessary in three patients (21 .4%) from Group I and in two patients (22.2%) from Group II. Although long-term statistical differences were not observed, these results sug gest that rIFN-alpha 2b at a low dose is a reasonable and well tolerat ed therapeutic approach for haemodialysis patients with chronic hepati tis C.