Comparison of the efficacy of thymosin alpha-1 and interferon alpha in the treatment of chronic hepatitis B: A meta-analysis

Chronic hepatitis B virus (HBV) infection is a serious problem because of its worldwide distribution and possible adverse sequelae, such as cirrhosis and hepatocellular carcinoma. Thymosin alpha-1 (T alpha 1) is an immune modifier that has been shown to be effective for chronic hepatitis B (CHB) in some trials. But the trials comparing T alpha 1 vs. interferon alpha (IFN alpha) treatment in CHB have been small and the results have been inconsistent. So we conducted a meta-analysis to compare the efficacy of T alpha 1 and IFN alpha in the treatment of CHB. Generally, four randomized controlled trials including 199 CHB patients who received T alpha 1 or IFN alpha treatment were identified through MEDLINE and EMBASE online search. Virological (for hepatitis B e antigen (HBeAg) positive patients, loss of HBV DNA and HBeAg; for HBeAg negative patients, loss of HBV DNA), biochemical (normalization of transaminases) and complete responses (fulfill criteria of biochemical and virological response simultaneously) were analyzed using the intention-to-treat method. The odds ratio (OR) was used to measure the magnitude of the efficacy. The ORs (95% confidence interval) of the virological response, biochemical response and complete response of Tat over IFNa at the end of 6 months treatment were 0.62 (0.35 1.10) 0.60 (0.341 1.05) and 0.54 (0.30, 0.97), respectively. The ORs (95% confidence interval) of the virological response, biochemical response and complete response of Tat over IFNa at the end of follow-up (6 months post-treatment) were 3.71 (2.05, 6.71), 3.12 (1.74, 5.62) and 2.69 (1.47, 4.91), respectively. These data showed that compared with IFNa, the benefit of Tot I was not immediately significant at the end of therapy, but virological, biochemical and complete response had a tendency to increase or accumulate gradually after the therapy. For three of the four trials that studied HBeA-negative patients, the results are mostly applicable to HBeAg-negative CHB. (C) 2007 Elsevier B.V. All rights reserved.