Thymosin α1 treatment of chronic hepatitis B: results of a phase III multicentre, randomized, double‐blind and placebo‐controlled study

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Abstract
Previous clinical trials have suggested that thymosin α1 (Tα1), 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 Tα1 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 Tα1 (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 Tα1 and in two (4%) patients treated with placebo (P = 0.084). Five (10%) patients given Tα1 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 Tα1 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.