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Cited 16 time in webofscience Cited 17 time in scopus
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Combination therapy of thymosin alpha-1 and lamivudine for HBeAg positive chronic hepatitis B: A prospective randomized, comparative pilot study

Authors
Lee, Hyun WoongLee, Joung I. I.Um, Soon HoAhn, Sang HoonChang, Hye YoungPark, Yong KwangHong, Sun PyoMoon, Young MyoungHan, Kwang-Hyub
Issue Date
May-2008
Publisher
WILEY
Keywords
chronic hepatitis B; lamivudine; thymosin; treatment
Citation
JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, v.23, no.5, pp.729 - 735
Indexed
SCIE
SCOPUS
Journal Title
JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY
Volume
23
Number
5
Start Page
729
End Page
735
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/17016
DOI
10.1111/j.1440-1746.2008.05387.x
ISSN
0815-9319
Abstract
Background and Aim: Monotherapy of lamivudine, interferon-alpha (IFN-alpha), and thymosin alpha-1 (T alpha 1) is unlikely to be sufficient for the eradication of a chronic hepatitis B virus ( HBV) infection. The aim of our study is to elucidate whether the combination of Ta1 and lamivudine is superior to lamivudine monotherapy in hepatitis B e antigen ( HBeAg) positive naive patients with chronic hepatitis B. Methods: Sixty-seven patients were assigned to two different groups in a randomized manner. The combination group (n = 34) received Ta1 (1.6 mg subcutaneously, twice a week) and lamivudine ( 100 mg orally, daily) for 24 weeks, followed by continuous lamivudine therapy. The monotherapy group ( n = 33) received lamivudine monotherapy continuously. Results: The incidence of HBeAg seroconversion at 24 weeks was 26.5% ( 9/ 34) in the combination group and 6.1% (2/33) in the monotherapy group ( P = 0.024). However, there was no statistically significant difference between 26.5% ( 9/ 34) in the combination group and 12.1% (4/33) in the monotherapy group at 52 weeks ( P = 0.138). The emergence of viral breakthrough gradually increased to 35.3% (12/34) in the combination group, and to 21.2% (7/33) in the monotherapy group at 52 weeks ( P = 0.201). Conclusions: The combination treatment of Ta1 and lamivudine did not have an obvious benefit of virological and biochemical response as compared to the lamivudine monotherapy during the combination period. In addition, after the cessation of Ta1 treatment, the combination therapy did not prevent the occurrence of viral and biochemical breakthroughs.
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