title: Combination therapy of thymosin alpha-1 and lamivudine for HBeAg positive chronic hepatitis B: A prospective randomized, comparative pilot study.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Internal Medicine, Yonsei University College of Medicine, and Yonsei Institute of Gastroenterology, Seoul, Korea.
authors.forename: Hyun Woong
authors.initials: HW
authors.lastname: Lee
authors.forename: Joung Il
authors.initials: JI
authors.lastname: Lee
authors.forename: Soon Ho
authors.initials: SH
authors.lastname: Um
authors.forename: Sang Hoon
authors.initials: SH
authors.lastname: Ahn
authors.forename: Hye Young
authors.initials: HY
authors.lastname: Chang
authors.forename: Yong Kwang
authors.initials: YK
authors.lastname: Park
authors.forename: Sun Pyo
authors.initials: SP
authors.lastname: Hong
authors.forename: Young Myoung
authors.initials: YM
authors.lastname: Moon
authors.forename: Kwang-Hyub
authors.initials: KH
authors.lastname: Han
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006513:Hepatitis B e Antigens / Q000097:blood; D019694:Hepatitis B, Chronic / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D000077596:Thymalfasin; D013947:Thymosin / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000276:Adjuvants, Immunologic; D000998:Antiviral Agents; D006513:Hepatitis B e Antigens; D019259:Lamivudine; D013947:Thymosin; D000077596:Thymalfasin