R. Siciliano et al., AN INTERMEDIATE-DOSE OF ALPHA-RECOMBINANT INTERFERON-2A FOR CHRONIC HEPATITIS-C WITH NONSEVERE HISTOLOGICAL PATTERN, Clinical drug investigation, 14(3), 1997, pp. 200-205
In the light of recent research, which suggests an interferon (IFN) th
erapy schedule on the basis of single patient characteristics (e.g. hi
stological pattern, viral genotype) and the cost/benefits of such ther
apy, we studied the efficacy and tolerability of an intermediate dose
(4.5MU 3 times a week) of alpha-recombinant interferon-2a (alpha-r IFN
-2a) in 28 patients with histologically proven chronic hepatitis C, 20
were hepatitis C virus (HCV)-RNA+ve, 5 were HCV-RNA-ve, and in 3 pati
ents HCV-RNA status was not carried out. The viral genotypes were: 13
(65%) 1b, 2 (10%) 1a, 1 (5%) 1a + 1b, 3 (15%) 2a, 1 (5%) 3a; histologi
cal pattern: 21 (75%) mild chronic active hepatitis (CAH), 7 (25%) mod
erate CAH. 4.5MU of alpha-r IFN-2a were given 3 times a week for 6 mon
ths, followed by 3MU 3 times a week for 6 months. Six patients (21.4%)
had a biochemical and virological sustained response (SR), 8 patients
(28%) had ALT normalisation during therapy (transient complete respon
se [TCR]) followed by relapse, 3 patients (10.7%) had a TCR with break
through (BT), 4 patients (14.3%) had a partial response (PR) and 7 pat
ients (25%) were nonresponders (NR). We observed persistent HCV-RNA se
rum loss in all patients with SR, transient HCV-RNA serum loss in 8 pa
tients with TCR, TCR and BT and PR; in 5 patients who were NR no HCV-R
NA serum loss occurred. The prevalence of HCV genotype 1b and the dura
tion of disease in SR and NR groups showed a significant difference. M
oreover, we found a significant correlation between prevalence of HCV
genotype 1b and type of response (r=0.899, p < 0.05) between mean age
in the different patient groups and prevalence of HCV genotype 1b(r=0.
881, p < 0.05), and between disease duration and type of response (r=0
.874, p < 0.05). The schedule we used can be considered as well tolera
ted and efficacious at least in chronic hepatitis C with nonsevere his
tological pattern, with an HCV genotype other than 1b.