Comparison of the efficacy of thymosin alpha-1 and interferon alpha in the treatment of chronic hepa

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Comparison of the efficacy of thymosin alpha-1 and interferon alpha in the

treatment of chronic hepatitis B: A meta-analysis

Yong-Feng Yang, a, , Wei Zhaoa, Yan-Dan Zhonga, Yi-Jun Yanga, Ling Shena, Ning

Zhanga and Ping Huanga

aDepartment of Liver Disease, the Second Hospital of Nanjing, affiliated with

Medical School of South-East University, No. 1-1 Zhongfu Road, Nanjing 210003,

Jiangsu Province, China

Received 20 September 2007; accepted 30 October 2007. Available online 26

November 2007.

Abstract

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 (Tá1) is an immune modifier that has

been shown to be effective for chronic hepatitis B (CHB) in some trials. But the

trials comparing Tá1 vs. interferon alpha (IFNá) treatment in CHB have been

small and the results have been inconsistent. So we conducted a meta-analysis to

compare the efficacy of Tá1 and IFNá in the treatment of CHB. Generally, four

randomized controlled trials including 199 CHB patients who received Tá1 or IFNá

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 Tá1 over IFNá 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 Tá1 over IFNá 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 IFNá, the benefit of

Tá1 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.

Keywords: Thymosin; Interferon; Hepatitis B; Meta-analysis

Corresponding author. Tel.: +86 25 83626433; fax: +86 25 83626060.

Antiviral Research

Volume 77, Issue 2, February 2008, Pages 136-141

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