Hepatitis
C
Italian Hepatitis C trial and Thailand
Hepatitis C trial, Interim Results
Italian hepatitis C trial #1 (106)
This was an open-label, phase 2 study of CHC patients using
a combination of Zadaxin and lymphoblastoid IFNα
(L-IFNα).
| Patients and
protocol: |
| • |
Enrolled patients
had biochemical-, histological-, and serological-confirmed
CHC |
| • |
15 patients
entered into the study |
| |
| – |
4 previous IFNα-2b
therapy failures |
| – |
13/15 patients were
genotype 1b (least responsive to interferon therapy) |
| – |
6 patients with
active cirrhosis |
|
| • |
Initial treatment
of 1-week inductive therapy (1 mg Zadaxin SC, days 1 to
4; 3 MIU L-IFNα
IM, day 4) |
| • |
Maintenance treatment weeks
2 to 52 (1 mg Zadaxin SC, BIW; 3 MIU L-IFNα,
IM, TIW) |
| • |
6-month follow-up
after completion of 12-month treatment period (18 months
total) |
| • |
Response defined
as negative serum HCV RNA by PCR at 12 months |
| • |
Sustained response defined
as negative serum HCV RNA by PCR after a 6-month follow-up |
| Results: |
| • |
After 12-month treatment
period |
| |
| – |
73% (11/15) had loss
of serum HCV RNA |
| – |
2 (of original 4)
were IFNα-2b
failures |
| – |
8 also responded
with normal ALT |
|
| • |
69% (9/13) with HCV type
1b responded to therapy |
| • |
6 months post treatment |
| |
| – |
39% (5/13) responders
with HCV type 1b still negative for serum HCV RNA |
| – |
50% (3/6) with active
cirrhosis responded with loss of HCV RNA |
| – |
33% (2/6) with active
cirrhosis still negative |
| – |
40% (6/15) overall
sustained response |
| – |
5/6 HCV RNA negative
patients at 18 months also had normal ALT levels |
| – |
Patients with sustained
response to treatment showed significant improvement
in HAI after treatment (Knodell HAI; P < 0.05) |
| – |
No major toxicity
observed |
| – |
No patient reduced IFNα-2b
dosage or suspended treatment |
|
In this study, combination treatment for 12 months resulted
in a greater sustained response rate over that seen with 6-month
treatment.
Italian hepatitis C trial #2 (107)
This was a randomized study to compare the efficacy of Zadaxin
plus IFNα-2b combination
treatment with IFNα-2b
monotherapy.
| Patients and
protocol: |
| • |
34 patients |
| • |
Treatment naïve |
| • |
Histologically
proven HCV-positive chronic active hepatitis |
| • |
Persistent
mean ALT = 2 times upper limit of normal |
| • |
17 patients
randomized to receive IFNα-2b
(3 MIU TIW) and Zadaxin (2 mg BIW) for 6 months |
| • |
17 patients received IFNα-2b
alone (3 MIU TIW) |
| • |
12-month posttreatment
follow-up |
| • |
Complete response defined
as normal ALT |
| Results: |
| • |
After 6-month
treatment period |
| |
| – |
71% (12/17) complete
response in patients treated with Zadaxin plus IFNα-2b
combination |
| – |
35% (6/17) complete
response in patients treated with IFNα-2b
alone |
| – |
P = 0.04 |
|
| • |
After 12-month
follow-up |
| |
| – |
29% (5/17) in Zadaxin
plus IFNα-2b
combination group |
| – |
18% (3/17) in IFNα-2b
monotherapy group |
|
Thailand hepatitis C trial, interim results
(109)
This is an ongoing, single-arm study to investigate the efficacy
of Zadaxin plus IFNα-2a
combination treatment in Thai patients with chronic HCV infection.
| Patients and
protocol: |
| • |
12 patients
|
| |
| – |
8 treatment naïve |
| – |
4 nonresponders to
previous IFN therapy |
|
| • |
Histologically
proven HCV-positive acute chronic active hepatitis |
| • |
Patients received IFNα-2a
(3 MIU TIW) and Zadaxin (1.6 mg BIW) for 48 weeks |
| Results: |
| • |
At 24 weeks
|
| |
| – |
33.3% virological
response (HCV RNA negative) |
|
| • |
At 48 weeks |
| |
| – |
45.5% overall virological
response (HCV RNA negative) |
| – |
80% virological response in
naïve patients |
|
Back to top
|
