A. Frosi et al., INTERFERON-ALPHA AND INTERFERON-BETA IN CHRONIC HEPATITIS-C - EFFICACY AND TOLERABILITY - A COMPARATIVE PILOT-STUDY, Clinical drug investigation, 9(4), 1995, pp. 226-231
The efficacy and tolerability of interferon-alpha and -beta (IFN alpha
, IFN beta) in the treatment of hepatitis C virus (HCV)-related chroni
c hepatitis were compared. 20 consecutive patients with elevated alani
ne aminotransferase (ALT) levels for at least 6 months, anti-HCV posit
ivity, and a recent hepatic biopsy indicating chronic hepatitis were r
ecruited. 10 patients were randomised to receive natural fibroblast IF
N beta and 10 to receive lymphoblastoid IFN alpha, both at a dose of 3
million units 3 times weekly for 6 months given as subcutaneous injec
tions. Responses were classified as complete when ALT normalised and p
artial when ALT was reduced by at least 50% at the end of IFN treatmen
t; a sustained response was defined as no new increase in ALT in the r
esponders in the 6 months after treatment suspension. There were 4 com
plete and 3 partial responses in the IFN beta group compared with 5 an
d 1, respectively, in the IFN alpha group. Three of the complete respo
nses in the former group and 4 in the latter group were sustained, but
none of the partial responses were. After discontinuation of IFN, HCV
-RNA polymerase chain reaction (PCR) test remained negative only in pa
tients with a sustained response. None of the differences were statist
ically significant. Adverse effects were observed in 8 of the subjects
given IFN beta and in 7 who received IFN alpha. All IFN alpha-treated
patients but only 4 IFN beta-treated patients had 3 or more associate
d adverse effects. Furthermore, in the IFN beta group fever occurred o
nly in the first week of treatment and leucopenia was much less freque
nt (2 of 10 vs 6 of 10 in the IFN alpha arm). These results suggest th
at the efficacy of natural IFN beta administered subcutaneously approa
ches that of IFN alpha in the treatment of chronic hepatitis C, and th
at the impact of treatment in terms of adverse effects is possibly les
s.