MULTICENTER RANDOMIZED, CONTROLLED-STUDY OF INTRAMUSCULAR ADMINISTRATION OF INTERFERON-BETA FOR THE TREATMENT OF CHRONIC HEPATITIS-C

The intramuscular administration of interferon-beta (IFN-beta) at a do sage of 6 million units three times per week for 6 months has been eva luated in 90 patients included in a multicenter, randomized, controlle d trial for the treatment of chronic hepatitis C, Transaminase levels were significantly reduced in IFN-beta-treated patients (p = 0.015) an d were significantly lower with respect to those of the untreated cont rols (p = 0.040 at 6 months). Four treated (8%) and one untreated (2.5 %) patients had normal transaminase values after 6 months, At study en d (12 months), three quarters of the IFN-beta-treated patients had sus tained transaminase normalization, whereas the untreated case had rela psed, Hepatitis C viremia was cleared in 6 (12%) treated patients but in none of the untreated controls (p = 0.058), Side effects of IFN-bet a were infrequent (a mild nu-like syndrome in <10%, asthenia in 16%, a norexia in 8%, headaches and weight loss in 8%, and hair loss in 4%), Leukocyte and platelet counts decreased during IFN-beta treatment, but no dose modifications were necessary, Such decreases were not statist ically significant when compared with the levels in the untreated cont rols. Intramuscular IFN-beta at the dosage used has little efficacy in the treatment of chronic hepatitis C, Because of IFN-beta tolerance, higher doses and alternate routes of injection might prove beneficial for the treatment of this disease.