Genetically
engineered monoclonal antibodies are among the novel treatment strategies for
chronic hepatitis C currently undergoing clinical development.
One
such agent, HCV-AB68 - a human monoclonal antibody against the hepatitis C virus
(HCV) envelope protein - has been shown to neutralize HCV in cell cultures and
in a mouse model.
As
described in the January 2007 Journal of Hepatology, researchers conducted
a Phase I clinical trial to assess the safety, tolerability, and antiviral activity
of HCV-AB68 in patients with chronic hepatitis C.
Results
•
15 study participants received 0.25 mg to 40 mg single-dose infusions of HCV-AB68.
•
In 6 patients, HCV RNA levels transiently decreased by 2-fold to 100-fold from
baseline immediately following infusion, and rebounded to baseline levels within
24-48 hours.
•
HCV-AB68 was well tolerated, with no moderate or serious adverse events reported.
•
25 patients received multiple
doses of HCV-AB68, with 10-120 mg administered once weekly for 3 weeks, then 3
times during the fourth week; subjects were then followed for 3 months.
•
8 out of 25 patients had
at least a 1 log reduction in HCV RNA levels from baseline.
•
17 had at least a 0.75 log
reduction in HCV RNA at one or more time points following HCV-AB68 infusion.
•
Again, no drug-related serious
side effects were reported, and no specific pattern of adverse events was apparent.
Conclusion
"These
data support the investigation of HCV-AB68 in the prevention of recurrent HCV
infection in patients who had received hepatic allografts [liver transplants]
for end-stage liver disease," the authors concluded.
1/12/07
Reference E
Galun, N A Terrault, R Eren, and others. Clinical evaluation (Phase I) of a human
monoclonal antibody against hepatitis C: safety and antiviral activity. Journal
of Hepatology 46(1): 37-44. January 2007.
