Pizzarelli, G. and Di Gregorio, Franco and Romeo, M. A. and Carboni, F. and Gallisai, Domenico Pietro Paolo and Solinas, Antonio and Malaguarnera, Mariano and Musumeci, Salvatore (1999) Interferon-alpha therapy in Sicilian and Sardinian polytransfused thalassemic patients with chronic hepatitis C. Biodrugs, Vol. 12 (1), p. 55-63. eISSN 1179-190X. Article.
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OBJECTIVE: Our study was designed to evaluate the effects of 2 dosage schedules of recombinant interferon (IFN)-alpha (IFNalpha-2a and IFNalpha-2b) in reducing serum ALT and eradicating serum hepatitis C virus (HCV) RNA in beta-thalassaemic patients with chronic hepatitis C.
DESIGN: 38 Sicilian beta-thalassaemic patients (22 males and 16 females) received intramuscular IFNalpha-2a (Roferon-A((R)); Roche) 5 MU/m(2) 3 times weekly for 6 months, followed by 3 MU/m(2) 3 times weekly for a further 6 months. 13 Sardinian beta-thalassaemic patients (7 males and 6 females) received intramuscular IFNalpha-2b (Intron(R); Schering-Plough) 3 MU/m(2) 3 times weekly for 12 months. Parallel control groups (n = 20 and n = 8, respectively) did not receive IFNalpha. All patients received continuous subcutaneous desferoxamine infusion.
RESULTS: 24 (63%) Sicilian patients had a positive clinical response to IFNalpha-2a therapy. Two different patterns of response were apparent: (i) early and progressive decrease in ALT values until stable normalisation; and (ii) slower reduction of ALT values, which fluctuated on the way to normalisation. Five (21%) patients relapsed during the 12-month follow-up period. ALT levels decreased early in 5 (38%) Sardinian patients and one patient (20%) relapsed during the 12-month follow-up period. In the control groups, ALT values spontaneously normalised in 3 (10%) untreated patients. None of the patients treated with IFNalpha developed anti-IFNalpha antibodies. Viral clearance was demonstrated in 19 (50%) of 38 patients in the Sicilian group and 4 of 13 patients (31%) in the Sardinian group.
CONCLUSION: Treatment with intramuscular recombinant IFNalpha-2a 5 MU/m(2) 3 times weekly for 6 months, followed by 3 MU/m(2) 3 times weekly for 6 months, appeared to be more effective than intramuscular IFNalpha-2b 3 MU/m(2) 3 times weekly for 12 months.
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