Efficacy of thymosin alpha-1 and interferon alpha in treatment of chronic viral hepatitis B: A randomized controlled study

AIM: To observe the efficiency and safety of thymosin-alpha 1 treatment in patients with hepatitis B e antigen (HBeAg) and HBV DNA positive chronic hepatitis. METHODS: Sixty-two patients were randomly divided into groups A and B. The patients in group A received subcutaneous injection of 1.6 mg thymosin-alpha 1, twice a week (T-alpha 1 group) for six months, and the patients in group B received 5 MU interferon alpha (IFN-alpha) each day for fifteen days, then three times weekly (IFN-alpha group) for six months. The results between two groups treated with and the group untreated with IFN- alpha which was followed up for 12 mo (historical control group consisting of 30 patients) were compared, and three groups were comparable between each other (P > 0.05) at baseline (age, sex, clinical history biochemical, and serological parameters). RESULTS: At the end of treatment, complete response, which was defined as alanine aminotransferase (ALT) normalization and HBV DNA and HBeAg loss, occurred in 9 of 29 (31.0%) patients in the T-alpha 1 group and in 15 of 33 (45.5%) patients in the IFN-alpha group (chi(2) = 1.36, P > 0.05). After a follow-up period of six months, a complete response was observed in 14 of 29 (48.3%) patients in the T-alpha 1 group and in 9 of 33 (27.3%) patients in the IFN-alpha group (chi(2) = 2.93, P > 0.05). Compared with the results observed in the historical control (HC) group untreated with IFN-alpha which was followed up for 12 mo, the rate of complete response was significantly higher in IFN-alpha group at the end of therapy (1 of 30 vs 15 of 33, 2 chi(2) = 14.72, P < 0.001) and in the T-alpha 1 group at the end of follow-up (1 of 30 vs 14 of 29, chi(2) = 15.71, P < 0.001). In T-alpha 1 and IFN-alpha treatment groups, the area under (the plasma concentration time) curve (AUC) of negative HBV DNA and HBeAg was 34%, 17%, 31% and 19% smaller than that in the HC group. By the end of the follow-up period, the proportions of ALT normalization and negative HBV DNA in the T-alpha 1 group were significantly higher than those in the IFN-alpha and HC groups. The odds of ALT normalization and negative HBV DNA at the end of the follow-up was three-fold higher in the T-alpha 1 group than in the IFN-alpha group. Unlike IFN-alpha, T-alpha 1 was well tolerated by all patients, and no side effects appeared in T-alpha 1 group. CONCLUSION: The results suggest that a 6-mo course of T-alpha 1 therapy is effective and safe in patients with chronic hepatitis B. T-alpha 1 is able to reduce HBV replication in patients with chronic hepatitis B. Furthermore, T-alpha 1 is better tolerated than IFN-alpha and can gradually induce more sustained ALT normalization and HBV DNA and HBeAg loss. However, a response rate of 48.3% is still less ideal. A more effective therapeutic approach warrants further study. (C) 2006 The WJG Press. All rights reserved.