Efficacy of thymosin α-1 plus peginterferon α-2a combination therapy compared with peginterferon α-2a monotherapy in HBeAg-positive chronic hepatitis B: A prospective, multicenter, randomized, open-label study

Abstract

Objective. Thymosin α-1 plus interferon α-2a offers superior efficacy over interferon α-2a alone in patients with chronic hepatitis B. The aim was to compare the antiviral efficacy of thymosin α-1 plus peginterferon α-2a and peginterferon α-2a alone in HBeAg-positive chronic hepatitis B patients. Materials and methods. HBeAg-positive CHB patients were enrolled in this prospective, randomized, open-label study. Fifty-one patients were assigned to either combination (26 patients; 180 μg of peginterferon α-2a weekly for 48 weeks and 1.6 mg of thymosin α-1 twice a week for the first 12 weeks) or monotherapy (25 patients; 180 μg of peginterferon α-2a weekly for 48 weeks) groups. Results. The rates of the combined response, defined as HBeAg seroconversion, HBV DNA suppression, and normalization of serum ALT, were 4/26 (15.4%) and 3/25 (12.0%) for the combination group and the monotherapy group at the end of treatment (p = 0.725), and 6/26 (23.1%) and 5/25 (20.0%) at the end of follow-up (p = 0.789), respectively. Based on multiple logistic regression analysis, a >2 log₁₀ IU/mL reduction of HBV DNA at week 12 was identified as an independent predictor for combined response (OR, 9.72; 95% CI, 1.33–71.06; p = 0.025) at the end of follow-up. A lower pretreatment HBV DNA level (≤7 log₁₀ IU/mL) was another predictor for combined response (OR, 9.64; 95% CI, 1.23–75.32; p = 0.031). No significant differences in adverse events were observed. Conclusions. The short-term addition of thymosin α-1 was not superior to peginterferon α-2a alone in HBeAg-positive CHB patients on the basis of antiviral efficacy.

Key Words::

• chronic hepatitis B
• HBV DNA
• peginterferon α-2a
• thymosin α-1

Acknowledgments

F. Hoffmann-La Roche, Ltd. (Basel, Switzerland) and Sci-Clone Pharmaceuticals (San Mateo, CA) supplied the drugs without any financial support. We thank Dr. Seo-Kyung Hahn (Medical Research Collaborating Center, SNUH) for her assistance with the statistical analysis. Grant Support: This study was supported by the Seoul National University Hospital Research Fund (#06-2006-1649).

Declaration of interest: No conflicts of interest exist.