G. Pizzarelli et al., Interferon-alpha therapy in Sicilian and Sardinian polytransfused thalassaemic patients with chronic hepatitis C, BIODRUGS, 12(1), 1999, pp. 55-63
Objective: Our study was designed to evaluate the effects of 2 dosage sched
ules of recombinant interferon (IFN)-alpha (IFN alpha-2 alpha and IFN alpha
-2b) in reducing serum ALT and eradicating serum hepatitis C virus (HCV) RN
A in P-thalassaemic patients with chronic hepatitis C.
Design: 38 Sicilian beta-thalassaemic patients (22 males and 16 females) re
ceived intramuscular IFN alpha-2a (Roferon-A(R); Roche) 5 MU/m(2) 3 times w
eekly for 6 months, followed by 3 MU/m2 3 times weekly for a further 6 mont
hs. 13 Sardinian beta-thalassaemic patients (7 males and 6 females) receive
d intramuscular IFN alpha-2b (Intron(R); Schering-Plough) 3 MU/m2 3 times w
eekly for 12 months. Parallel control groups (n = 20 and n = 8, respectivel
y) did not receive IFN alpha. All patients received continuous subcutaneous
desferoxamine infusion.
Results: 24 (63%) Sicilian patients had a positive clinical response to IFN
alpha-2a therapy. Two different patterns of response were apparent: (i) ea
rly and progressive decrease in ALT values until stable normalisation; and
(ii) slower reduction of ALT values, which fluctuated on the way to normali
sation. Five (21%) patients relapsed during the 12-month follow-up period.
ALT levels decreased early in 5 (38%) Sardinian patients and one patient (2
0%) relapsed during the 12-month follow-up period. In the control groups, A
LT values spontaneously normalised in 3 (10%) untreated patients. None of t
he patients treated with IFNa developed anti-IFN alpha antibodies. Viral cl
earance was demonstrated in 19 (50%) of 38 patients in the Sicilian group a
nd 4 of 13 patients (31%) in the Sardinian group.
Conclusion: Treatment with intramuscular recombinant IFN alpha-2a 5 MU/m(2)
3 times weekly for 6 months, followed by 3 MU/m(2) 3 times weekly for 6 mo
nths, appeared to be more effective than intramuscular IFN alpha-2b 3 MU/m(
2) 3 times weekly for 12 months.