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

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.