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 (Talpha1) is an immune modifier that has been shown to be effective for
chronic hepatitis B (CHB) in some trials. But the trials comparing Talpha1 vs.
interferon alpha (IFNalpha) treatment in CHB have been small and the results have been inconsistent. So we conducted a meta-analysis to compare the efficacy of Talpha1 and IFNalpha in the treatment of CHB. Generally, four randomized controlled trials including 199 CHB patients who received Talpha1 or IFNalpha 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 Talpha1 over IFNalpha at the end of 6 months treatment were 0.62 (0.35, 1.10), 0.60 (0.34, 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 Talpha1 over IFNalpha 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 IFNalpha, the benefit of Talpha1 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
HBeAg-negative patients, the results are mostly applicable to
HBeAg-negative CHB.