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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
 Hyun Woong Lee  ;  Joung Il Lee  ;  Soon Ho Um  ;  Sang Hoon Ahn  ;  Hye Young Chang  ;  Yong Kwang Park  ;  Sun Pyo Hong  ;  Young Myoung Moon  ;  Kwang-Hyub Han 
Citation
 JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, Vol.23(5) : 729-735, 2008 
Journal Title
JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY
ISSN
 0815-9319 
Issue Date
2008
MeSH
Adjuvants, Immunologic/therapeutic use* ; Adolescent ; Adult ; Antiviral Agents/therapeutic use* ; Drug Therapy, Combination ; Female ; Hepatitis B e Antigens/blood ; Hepatitis B, Chronic/blood ; Hepatitis B, Chronic/drug therapy* ; Humans ; Lamivudine/therapeutic use* ; Male ; Middle Aged ; Pilot Projects ; Prospective Studies ; Thymosin/analogs & derivatives* ; Thymosin/therapeutic use
Keywords
chronic hepatitis B ; lamivudine ; thymosin ; treatment.
Abstract
BACKGROUND AND AIM: Monotherapy of lamivudine, interferon-alpha (IFN-alpha), and thymosin alpha-1 (Talpha1) 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 Talpha1 and lamivudine is superior to lamivudine monotherapy in hepatitis B e antigen (HBeAg) positive naïve 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 Talpha1 (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 Talpha1 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 Talpha1 treatment, the combination therapy did not prevent the occurrence of viral and biochemical breakthroughs.
Full Text
http://onlinelibrary.wiley.com/doi/10.1111/j.1440-1746.2008.05387.x/abstract
DOI
10.1111/j.1440-1746.2008.05387.x
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Ahn, Sang Hoon(안상훈) ORCID logo https://orcid.org/0000-0002-3629-4624
Han, Kwang-Hyub(한광협) ORCID logo https://orcid.org/0000-0003-3960-6539
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/107197
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