title: Multicenter randomized, controlled study of intramuscular administration of interferon-beta for the treatment of chronic hepatitis C.
abstract: The intramuscular administration of interferon-beta (IFN-beta) at a dosage of 6 million units three times per week for 6 months has been evaluated in 90 patients included in a multicenter, randomized, controlled trial for the treatment of chronic hepatitis C. Transaminase levels were significantly reduced in IFN-beta-treated patients (p = 0.015) and were significantly lower with respect to those of the untreated controls (p = 0.040 at 6 months). Four treated (8%) and one untreated (2.5%) patients had normal transaminase values after 6 months. At study end (12 months), three quarters of the IFN-beta-treated patients had sustained transaminase normalization, whereas the untreated case had relapsed. Hepatitis C viremia was cleared in 6 (12%) treated patients but in none of the untreated controls (p = 0.058). Side effects of IFN-beta were infrequent (a mild flu-like syndrome in < 10%, asthenia in 16%, anorexia 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 statistically significant when compared with the levels in the untreated controls. 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.
authors.affiliation: Hospital Juan Canalejo, A Coruña, Madrid, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Castro
authors.forename: D
authors.initials: D
authors.lastname: Suárez
authors.forename: L
authors.initials: L
authors.lastname: Inglada
authors.forename: E
authors.initials: E
authors.lastname: Carballo
authors.forename: A
authors.initials: A
authors.lastname: Domínguez
authors.forename: M
authors.initials: M
authors.lastname: Diago
authors.forename: J
authors.initials: J
authors.lastname: Such
authors.forename: J A
authors.initials: JA
authors.lastname: Del Olmo
authors.forename: A
authors.initials: A
authors.lastname: Pérez-Mota
authors.forename: J
authors.initials: J
authors.lastname: Pedreira
authors.forename: J A
authors.initials: JA
authors.lastname: Quiroga
authors.forename: V
authors.initials: V
authors.lastname: Carreño
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D005260:Female; D006526:Hepatitis C / Q000188:drug therapy*; D006801:Humans; D007273:Injections, Intramuscular; D016899:Interferon-beta / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D000637:Transaminases / Q000378:metabolism; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D016899:Interferon-beta; D000637:Transaminases