Report from EASL; The European Association for the Study of the Liver Conference, Rotterdam, April 28-May 3, 2000 - Report 10
RANDOMIZED,
CONTROLLED PILOT TRIAL OF INTERFERON (IFN) WITH OR WITHOUT THYMOSINa1 (TA1) IN
NAŠVE CHRONIC HEPATITIS C (CHC)
A
GRAMENZI, L DI GIAMMARINO, C CURSARO, F FELLINE, S TALARICO, A D'ERRICO, R
Carella, M Biselli, P Andreone, M Bernardi
Dept. di Medicina Interna, Cardioangiologia ed Epatologia, Italy, University of
Bologna
The aims
of the study are to evaluate the efficacy of the addition of TA1, an
immunomodulatory peptide, to the standard treatment for CHC. 41 naÔve patients
with histologically proven CHC were randomized to IFNa2b (3MU tiw) + TA1 (0.9
mg/m2 twice weekly) or IFN alone at the same dose for 6 months. All patients
were followed for 6 months after treatment stopping. Biochemical (ALT values)
and virologic (HCV-RNA) responses to treatment were evaluated.
Intent-To-Treat
Analysis
|
|
IFN
(n=19) |
IFN+TA1 |
p |
|
End-Of-Treatment: |
|
|
|
|
Biochemical
response |
7
(37%) |
14
(64%) |
0.058 |
|
Virologic
response |
2
(11%) |
8
(36%) |
Ns
(not significant) |
|
End
of Follow-up: |
|
|
|
|
Biochemical
response |
4
(21%) |
7
(32%) |
ns |
|
Virologic
response |
3
(16%) |
3
(14%) |
Ns |
The
Histologic Activity Index improvement, as evidenced by a decrease of more than
two points, occurred in the combination therapy more frequently than in the IFN
group. In particular, a significant improvement of the fibrosis score was seen
only in the combination therapy group (1.9±1 vs 1.4±1;
p=0.04).
The
authors concluded further studies involving longer duration and/or varied dosing
are needed.