Thymosin a1 treatment of chronic hepatitis B

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Journal of Viral Hepatitis 6 397-403

© Blackwell Science Ltd.

Thymosin a1 treatment of chronic hepatitis B: results of a phase III

multicentre, randomized, double-blind and placebo-controlled study

M. G. Mutchnick1, K. L. 2, E. R. Schiff3, G. D. Cummings1, H. D.

Appelman4, R. R. Peleman1, M. Silva3, K. C. Roach3, F. 2, S.

Milstein2, S. C. Gordon1 and M. N. Ehrinpreis1

Previous clinical trials have suggested that thymosin a1 (Ta1), an

immunomodulatory peptide, may be effective in the treatment of chronic

hepatitis B (CHB). The aim of this study was to determine the efficacy of

Ta1 in a multicentre, placebo-controlled and double-blind study of 97

patients with serum hepatitis B virus (HBV) DNA- and hepatitis B e antigen

(HBeAg)-positive CHB. Patients who had been hepatitis B surface antigen

(HBsAg) positive for at least 12 months entered a 3-month screening period

prior to randomization. Forty-nine patients received Ta1 (1.6 mg) and 48

patients received placebo, twice weekly for 6 months, and were followed-up

for an additional 6 months. At inclusion, both groups were comparable for

age, gender, histological grading, and aminotransferase and HBV DNA levels.

A complete response to treatment, defined as a sustained serum HBV

DNA-negative status (two negative results at least 3 months apart) during

the 12-month study, with negative HBV DNA and HBeAg values at month 12, was

seen in seven (14%) patients given Ta1 and in two (4%) patients treated with

placebo (P = 0.084). Five (10%) patients given Ta1 and four (8%) patients

given placebo exhibited a delayed response (defined as sustained serum HBV

DNA negativity achieved after the 12-month study period with negative HBV

DNA and HBeAg values at the last assessment). A total of 12 (25%) patients

given Ta1 and six (13%) patients given placebo showed a sustained loss of

HBV DNA with a negative HBeAg value during or following the 12-month study

period (P < 0.11). These results do not confirm observations of treatment

efficacy reported in other clinical studies.

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