Combination therapy of thymosin alpha-1 and lamivudine for HBeAg positive chronic hepatitis B

A prospective randomized, comparative pilot study

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

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)729-735
Number of pages7
JournalJournal of Gastroenterology and Hepatology (Australia)
Volume23
Issue number5
DOIs
Publication statusPublished - 2008 Jan 1

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Lamivudine
Hepatitis B e Antigens
Chronic Hepatitis B
Therapeutics
thymalfasin
Virus Diseases
Hepatitis B virus
Interferon-alpha
Incidence

Keywords

  • Chronic hepatitis B
  • Lamivudine
  • Thymosin
  • Treatment

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

Combination therapy of thymosin alpha-1 and lamivudine for HBeAg positive chronic hepatitis B : A prospective randomized, comparative pilot study. / 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, Kwang Hyub.

In: Journal of Gastroenterology and Hepatology (Australia), Vol. 23, No. 5, 01.01.2008, p. 729-735.

Research output: Contribution to journalArticle

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, Kwang Hyub. / Combination therapy of thymosin alpha-1 and lamivudine for HBeAg positive chronic hepatitis B : A prospective randomized, comparative pilot study. In: Journal of Gastroenterology and Hepatology (Australia). 2008 ; Vol. 23, No. 5. pp. 729-735.
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abstract = "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 na{\"i}ve 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.",
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T2 - A prospective randomized, comparative pilot study

AU - Lee, Hyun Woong

AU - Lee, Joung Il

AU - Um, Soon-Ho

AU - Ahn, Sang Hoon

AU - Chang, Hye Young

AU - Park, Yong Kwang

AU - Hong, Sun Pyo

AU - Moon, Young Myoung

AU - Han, Kwang Hyub

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N2 - 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.

AB - 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.

KW - Chronic hepatitis B

KW - Lamivudine

KW - Thymosin

KW - Treatment

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