Abstract
Thymosin-α1 (TA1) has been shown to be effective treatment for chronic hepatitis B virus (HBV) infection. This study investigated the immune response after TA1 monotherapy in 25 HBV e antigen (HBeAg)-positive patients randomized to receive either 1.6 mg active TA1 (group A), 1.6 mg recombinant TA1 (group B) or 3.2 mg recombinant TA1 (group C) monotherapy for 52 weeks. The percentages of T-helper 1 (Th1) cytokine-producing T-cells (interleukin-2 [IL-2], interferon-γ [IFN-γ], tumour necrosis factor-α) and Th2 cytokine-producing T-cells (IL-4) were analysed using flow cytometry. In all patients treated with TA1, cytokine levels and the proportion of peripheral blood mononuclear cells producing these cytokines were significantly increased, compared with baseline and healthy controls. The proportions of each cytokine-producing cell increased gradually over time and were restored to normal levels, and proportions of IFN-γ and IL-4-producing cells reached higher levels than in normal (healthy) controls. The results showed that treatment with TA1 increased cytokine production, especially IFN-γ, and higher-dose TA1 exhibited better efficacy against HBV, compared with other treatments studied.
