RIBAVIRIN-INTERFERON VS INTERFERON ([alpha]2b-IFN) ALONE IN NON
RESPONDERS TO [alpha]-IFN IN CHRONIC HEPATITIS C
Author: French Multicenter Study Group under the coordination
of S. Pol, P. Berthelot and C. Brechot, Hopital Necker, Paris,
France.
Aim. To compare the combination of [alpha]2b-IFN-Ribavirin to
[alpha]2b-IFN alone in non responders to a previous standard
6-month course of 3 MU [alpha]2b-IFN.
Therapeutic schedule. 127 patients (83 men, 44 women, including
34 cirrhosis) were randomized to receive a long and reinforced
[alpha]2b-IFN treatment (6 MU 6 months then 3 MU 6 months thrice
weekly subcutaneously) in combination (n=62) or not (n=65) with
Ribavirin (at a daily dosage of 1.0 or 1.2 gm according to the body
weight < or > 70 kg for 4 months: 2 months alone and 2 months
in combination with [alpha]2b-IFN). Efficacy was defined by the
percentage of normal aminotransferase activities and by the
disappearance of HCV RNA by PCR and bDNA test during and at the end
of therapy and 6 months after the end of the 12-month course of
[alpha]2b-IFN therapy.
Results. A significant decrease in aminotransferase was observed
after 2 months in patients receiving Ribavirin (92 vs. 149 IU/I
initially) as in those treated by [alpha]2b-IFN alone (86 vs. 141
IU/I). After 3 months of therapy, normal aminotransferase was
observed in 35% in both groups. Tolerance of the combination was
fair: hemolysis (-0.45 of Hb between M4 and M0), toxiderma (n=3),
gingivitis (n=3) and cough (n=3) were related to Ribavirin and
usually self-limited. Treatment withdrawal was necessary in 8
patients treated by the combination and in 6 patients with
[alpha]2b-IFN alone.
A negative PCR at month 4 was observed in 33.3% of patients who
were given the combination and in 37.7% of those who received
[alpha]2b-IFN alone. At the end of [alpha]2b-IFN, HCV RNA was not
detected in 14.0% of patients who received Ribavirin and in 7.6%
(NS) of those who did not. The 36 evaluable patients who had a
six-month follow-up after the end of treatment all had detectable
HCV RNA.
Conclusion. This large controlled study: 1. shows an overall
good tolerance to the sequential combination
Ribavirin-[alpha]2b-IFN and 2. provides however no indication for
an improved rate of primary or long term response with the
combination in non responders to [alpha]2b-IFN since most of
patients had no long term response
Source: American Association for the Study of Liver Diseases
- 1996 Annual Meeting
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