ALPHA-INTERFERON THERAPY IN DANISH HEMOPHILIAC PATIENTS WITH CHRONIC HEPATITIS-C - RESULTS OF A RANDOMIZED CONTROLLED OPEN-LABEL STUDY COMPARING 2 DIFFERENT MAINTENANCE REGIMENS FOLLOWING STANDARD INTERFERON-ALPHA-2B TREATMENT

Following a survey among all Danish haemophiliac patients 49 HIV-negat ive patients with chronic hepatitis C were offered enrollment in a ran domized controlled open label study comparing two different maintenanc e regimens following standard interferon-alpha-2b treatment. Dose modi fications and treatment discontinuation were based upon changes in tra nsaminase levels. Forty-seven patients enrolled received 3 MU of alpha interferon thrice weekly (TIW) for 3 months. Twenty-six nonresponders had their dose increased to 6 MU TIW for an additional 3 months, whil e 21 responding patients continued on 3 MU TIW. At 6 months, 25 patien ts with a complete or a partial biochemical response were randomly all ocated to either a fixed dose regimen (13 patients) (3 or 6 MU thrice weekly) or an individualized dose regimen (12 patients) tapering inter feron dose from 3 or 6 MU by one-third every 2 months if transaminases were persistently normal. The remaining 22 biochemical nonresponders were followed for an additional 6 months without further treatment. Af ter 12 months of treatment, 18 patients (38%) had a virological respon se, irrespective of regimen, and seven patients (16%) had a sustained virological and biochemical response after 6 months of follow up. Over all, the individualized treatment regimen did not seem to offer any ad vantage over the fixed dose regimen. The response to alpha interferon treatment in Danish haemophiliac patients with chronic hepatitis C imm ediately after treatment is comparable to that obtained in previous st udies among nonhaemophiliacs. However, a sustained virological and bio chemical response was seen in only 16% of treated patients.