A pilot study of thymosin alpha1 therapy for chronic hepatitis B patients.
OBJECTIVE
The efficacy of thymosin alpha 1 (Talpha1) in patients with chronic hepatitis B still requires confirmation. We, therefore, evaluated the efficacy of therapy in patients with chronic hepatitis B.


METHODS
Sixteen patients were randomly assigned into one of two groups, treated with 0.8 mg of Talpha1 (low dose group; n = 8) or 1.6 mg Talpha1 (high dose group; n = 8), administered six times weekly for two weeks, followed by twice weekly for another 22 weeks. Responders were defined as patients having clearance of hepatitis B e antigen by radioimmunoassay and negativity of hepatitis B virus (HBV)-DNA by branched DNA signal amplification and normalization of serum alanine aminotransferase (ALT) 24 months after initiation of Talpha1 therapy. Transient acute exacerbation was defined as an increase of more than 300 IU/I in serum ALT level during Talpha1 therapy.


RESULTS
The response rate was 37.5% (6/16). Talpha1 therapy had a significant effect when, 1) transient acute exacerbation was present (p = 0.0029), 2) the serum HBV-DNA level was < 100 Meq/ml prior to the commencement of Talpha1 therapy (p = 0.0063). The difference between low and high dose groups was not statistically significant (p = 0.608).


CONCLUSIONS
The results of this trial show that: 1) a 24-week course of Talpha1 could be a worthwhile strategy for chronic hepatitis B patients with a serum HBV-DNA level of less than 100 Meq/ml; and 2) patients with a transient acute exacerbation during Talpha1 therapy generally often respond well.
Arase
Yasuji
Y
Department of Gastroenterology, Toranomon Hospital, Tokyo.
Tsubota
Akihito
A
Suzuki
Yoshiyuki
Y
Suzuki
Fumitaka
F
Kobayashi
Masahiro
M
Someya
Takashi
T
Akuta
Norio
N
Hosaka
Tetsuya
T
Saitoh
Satoshi
S
Ikeda
Kenji
K
Kobayashi
Mariko
M
Kumada
Hiromitsu
H
D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000328:Adult; D004305:Dose-Response Relationship, Drug; D005260:Female; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D000077596:Thymalfasin; D013947:Thymosin / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D016896:Treatment Outcome
D000276:Adjuvants, Immunologic; D013947:Thymosin; D000077596:Thymalfasin