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Current Topics in Virology   Volumes    Volume 8 
Abstract
Thymosin alpha-1 therapy in Chinese patients with chronic hepatitis B: Results from a randomized controlled clinical trial
Jing You, Lin Zhuang, Jun-Hua Huang, Hong-Ying Chen, Bao-Zhang Tang, Meng-Ling Huang, Yong-Liang Ma, Rong-Xue Wu
Pages: 37 - 48
Number of pages: 12
Current Topics in Virology
Volume 8 

Copyright © 2010 Research Trends. All rights reserved

ABSTRACT
 
To observe the efficiency and safety of Thymosin-α1 treatment in patients with chronic hepatitis B. Fifty-six HBeAg-negative and sixty-two HBeAg-positive patients were randomly divided into two groups A and B, received Thymosin-α1 or Interferon alpha for six months respectively. At the end of treatment, complete response (defined as ALT normalization and HBV DNA/HBeAg loss) occurred in 8 of 26 and 9 of 29 in T-α1 group and in 14 of 30 and 15 of 33 in IFN-α group in HBeAg-negative and HBeAg-positive patients respectively (p>0.05). After a 6-month follow-up period, a complete response was observed in 11 of 26 HBeAg-negative and 14 of 29 HBeAg-positive in T-α1 group and in 7 of 30 HBeAg-negative and 9 of 33 HBeAg-positive patients in IFN-α group (p>0.05). Compared with the results observed in untreated patients, the rate of complete response was significantly higher in IFN-α group at the end of therapy (p<0.001) and in T-α1 group at the end of follow-up (p<0.001). Ten of the 12 T-α1 responders experienced sustained undetectable HBV DNA after the 6-month treatment period. Six of the 14 T-α1 non-responders showed delayed response of undetectable HBV DNA during the follow-up period. In HBeAg-positive patients, it is 87.5% and 53.8%. However, the data were 50% and 0%, 59.1% and 0% in IFN-α group, respectively. The rate of delayed response was significantly higher in T-α1 group (p=0.010) and the rate of flare was higher in IFN-α group (p>0.05) during the follow-up period. Unlike IFN-α, T-α1 was well tolerated by all patients, and no side effects appeared in T-α1 group. The results suggest that a 6-months course of T-α1 therapy is effective and safe in patients with chronic hepatitis B. Compared with IFN-α, T-α1 is better tolerated and seems to induce a gradual and more sustained ALT normalization and HBV DNA loss.
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