G. Bresci et al., High-dose interferon plus ribavirin in chronic hepatitis C not responding to recombinant alpha-interferon, DIG LIVER D, 32(8), 2000, pp. 703-707
Background. Recently, the combination treatment of recombinant alpha-interf
eron plus ribavirin has been proposed for chronic hepatitis C patients unre
sponsive to previous therapy with recombinant alpha-interferon alone.
Aim. To determine the effectiveness of the combination therapy for the re-t
reatment of chronic hepatitis C patients unresponsive to previous interfero
n therapy Immediate and long-term follow-up data are reported.
Patients and Methods. A series of 100 patients with chronic hepatitis C not
responding to recombinant alpha-interferon 3 MU tiw, were randomly assigne
d to two groups of 50 patients each: Group A, treated with recombinant alph
a-interferon therapy for an additional six months but at a double dosage (6
MU tiw) in association with ribavirin. Group B, same treatment as group A
but without ribavirin. All patients responsive to therapy were then followe
d-up for at least 12 months. At the end of the treatment and at the end of
the follow-up period, we distinguished between complete responses (return t
o normal of alanine aminotransferase with undetectable serum HCV-RNA) and b
iochemical responses (return to normal of alanine aminotransferase still wi
th detectable viraemia).
Results. Side-effects were observed only in patients treated with recombina
nt alpha-interferon plus ribavirin: 12% discontinued the therapy due to hae
molytic anaemia. In group A, the percentages of end-of-treatment complete r
esponse, end-of-treatment biochemical response, sustained complete response
, and sustained biochemical response, were 38%, 20%, 8%, and 14%, respectiv
ely whilst in group B, these percentages were 12%, 16%, 6%, and 16%, respec
tively.
Conclusion. The results indicate that in patients with chronic hepatitis C
unresponsive to previous recombinant alpha-interferon therapy, re-treatment
with higher recombinant alpha-interferon doses, either alone or in combina
tion with ribavirin, lead to mild long-term benefit. However the satisfacto
ry end of treatment complete response in group A suggests that a significan
t percentage of patients are sensitive to the combination therapy; and that
a more aggressive therapeutic protocol in this selected subset of patients
could result in a larger number of long-lasting responses leading, in turn
, to a more favourable cost-effect ratio.