BACKGROUND:
Interferon treatment for
chronic hepatitis B has low
efficacy and is associated with serious side effects. It is therefore important to assess the
role of other
drugs in the
treatment of this condition.
AIMS:
To assess the
efficacy and
safety of
thymosin alpha in 20
patients with
hepatitis B-related
liver disease.
METHODS:
Patients with
chronic hepatitis B, HBV
DNA positivity, ALT more than 1.5 times the upper limit of normal and
liver biopsy showing
chronic hepatitis or
cirrhosis were treated with
thymosin alpha 1.6 mg subcutaneously twice a week for 6 months. Biochemical and serological markers were assessed pre-
treatment, immediately post
treatment, and 6 months and 1 year after end of
treatment.
RESULTS:
Of 20
patients, 15 had
chronic hepatitis and 5 had
cirrhosis on
histology; 17 were
HBeAg-positive and 3 were
HBeAg-negative. Eight
patients were
interferon non-responders and 12 were naïve
patients. Four
patients had end-of-
treatment response and two additional
patients had a delayed response within 6 months of
treatment; one responder had a
relapse within 1 year of
treatment. Overall sustained response rate was 25% (5 of 20). No
patient cleared
HBsAg. Reduction in ALT levels was observed
after treatment and persisted one year later. No significant side effects were observed.
CONCLUSION:
Thymosin alpha is a safe and effective alternative
treatment modality in
chronic hepatitis B.