Efficacy of Thymosin α1 in patients with chronic hepatitis B: A randomized, controlled trial

Rong Nan Chien, Yun Fan Liaw*, Tse Ching Chen, Chau Ting Yeh, I. Shyan Sheen

*Corresponding author for this work

Research output: Contribution to journalJournal Article peer-review

135 Scopus citations

Abstract

Thymosin α1 (Tα) is an immune modifier that has been shown in a pilot study to be effective for chronic hepatitis B; this requires confirmation. Ninety-eight patients with clinicopathologically proven chronic hepatitis B were randomly allocated to 3 groups: 1) group A received a 26-week course of Tα with a 1.6-mg subcutaneous injection two times a week (T6 group); 2) group B received the same regimen as group A, but Tα therapy extended for 52 weeks (T12 group); and 3) group C served as a control group and was followed up for 18 months without specific treatment (T0 group). The three groups were comparable in clinicohistological features at entry. The complete virological response rate (clearance of serum hepatitis B virus [HBV] DNA and hepatitis B e antigen [HBeAg]) was higher in group A (40.6%) and group B (26.5%) than in group C (9.4%) (group A vs. group C: P = .004; group B vs. group C: P = .068) when assessed 18 months after entry, although complete response rates among these three groups were similar when first assessed at the end of therapy. There was a trend for complete virological response to increase or accumulate gradually after the end of Tα therapy. None of the responders lost hepatitis B surface antigen. Blinded histological assessment showed a significant improvement in treated patients, particularly in lobular necroinflammation and scores excluding fibrosis. No significant side effects were observed. These results suggest that a 26-week course of Tα therapy is effective and safe in patients with chronic hepatitis B.

Original languageEnglish
Pages (from-to)1383-1387
Number of pages5
JournalHepatology
Volume27
Issue number5
DOIs
StatePublished - 1998

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