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The
Efficacy and Safety of Thymalfasin (Zadaxin) for Chronic Hepatitis
B
Thymalfasin
/ Ta-1 (Zadaxin)
is a 28-amino acid polypeptide that has shown efficacy in the treatment
of chronic hepatitis B virus (HBV) infection. The objective of this
study was to evaluate the long-term, dose-related efficacy and safety
of Ta 1 treatment in chronic hepatitis B patients with positive
HBV-DNA and abnormally high alanine aminotransferase
(ALT) levels.
A
total of 316 patients were randomized to receive either 0.8 or 1.6 mg
of Ta 1 monotherapy for 24 weeks.
Results
· At
the end of the 72-week observation period (12 months after
cessation of therapy), 36.4% of patients in the 1.6-mg treatment
group achieved normalization of ALT, 30% achieved clearance of HBV-DNA by branched DNA vs 15% by transcription-mediated
amplification, and 22.8% achieved clearance of HBe-antigen.
· Patients
in the 0.8-mg treatment group achieved similar efficacy rates, although
patients with advanced
fibrosis demonstrated a significantly better response rate when treated with 1.6 mg
of Ta 1 monotherapy vs 0.8 mg (as determined by intra-group
analysis; patients were not stratified by liver biopsy).
· All
adverse drug
reactions were mild and most
involved the fluctuation of liver enzymes, which was most likely
related to the positive immune effects caused by the response to
Ta 1 treatment.
· Adverse
event incidence was similar in the 1.6- and 0.8-mg treatment groups.
The
authors conclude, “In conclusion, thymalfasin at doses of 0.8 and 1.6 mg exhibits
long-term efficacy against hepatitis B with a good safety profile.”
06/13/05
Reference
S
Lino and others.The efficacy and safety of thymosin alpha-1 in Japanese
patients with chronic hepatitis B; results from a randomized clinical
trial. Journal of Viral Hepatitis 12(3):
300-307. May 2005.
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