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Combination therapy of thymosin alpha‐1 and lamivudine for HBeAg positive chronic hepatitis B: A prospective randomized, comparative pilot study
Author(s) -
Lee Hyun Woong,
Lee Joung Il,
Um Soon Ho,
Ahn Sang Hoon,
Chang Hye Young,
Park Yong Kwang,
Hong Sun Pyo,
Moon Young Myoung,
Han KwangHyub
Publication year - 2008
Publication title -
journal of gastroenterology and hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.214
H-Index - 130
eISSN - 1440-1746
pISSN - 0815-9319
DOI - 10.1111/j.1440-1746.2008.05387.x
Subject(s) - lamivudine , medicine , combination therapy , gastroenterology , hbeag , alpha interferon , seroconversion , hepatitis b , randomized controlled trial , hepatitis b virus , immunology , interferon , virus , hbsag
Background and Aim: Monotherapy of lamivudine, interferon‐alpha (IFN‐α), and thymosin alpha‐1 (Tα1) 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 Tα1 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 Tα1 (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 Tα1 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 Tα1 treatment, the combination therapy did not prevent the occurrence of viral and biochemical breakthroughs.