Research

Efficacy of consensus interferon in treatment of HbeAg-positive chronic hepatitis B: a multicentre, randomized controlled trial

YongLi Zheng^1,5 , LianSan Zhao¹ , TaiXiang Wu² , ShuHua Guo³ , YaGang Chen⁴ and TaoYou Zhou¹

¹  Infectious Disease Centre, West China Hospital, Sichuan University, No. 37, Guo Xue Xiang, Chengdu, Sichuan Province, PR China

²  Department of Epidemiology, West China Hospital of Sichuan University, Chengdu, Sichuan Province, PR China

³  Department of Infectious Diseases, The Second Affiliated Hospital of ChongQing Medical University, ChongQing, PR China

⁴  Center of Infectious Diseases, The First Affiliated Hospital of Medical School of Zhejiang University, Zhejiang Province, PR China

⁵  Department of Infectious Diseases, First People's Hospital of Yibin, No. 65, Wen Xing Street, Yibin, Sichuan Province, PR China

author email corresponding author email

Virology Journal 2009, 6:99doi:10.1186/1743-422X-6-99

Published:	9 July 2009

Abstract

Background

Consensus interferon (CIFN) is a newly developed type I interferon.

Aims

This multicentre, controlled trial was conducted to determine the efficacy of CIFN and to compare it with alpha-1b-interferon (IFN-α1b) in the treatment of patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B.

Methods

144 Patients were randomly assigned to receive 9 μg CIFN (CIFN group) or 50 μg INF-α1b (IFN-alpha group) subcutaneously 3 times weekly for 24 weeks, followed by 24 weeks of observation. Efficacy was assessed by normalization of serum alanine transaminase (ALT) levels and the non-detectability of serum hepatitis B virus DNA or HBeAg at the end of treatment and 24 weeks after stopping treatment.

Results

There was no statistically significant difference in the serological, virological and biochemical parameters between CIFN and IFN-α1b groups at the end of the therapy and follow-up period (p > 0.05). Overall, at the end of treatment, 7.0% (5/71) and 35.2% (25/71) of patients in the CIFN group showed a complete or partial response compared with 7.4% (5/68) and 33.8% (23/68) of the IFN-alpha group (p = 0.10). At 24 weeks after stopping treatment, 6.9% (5/72) and 37.5% (27/72) of patients in the CIFN group showed complete response or partial response compared with 7.1% (5/70) and 34.3% (24/70) of the IFN-alpha group (p = 0.10).

Conclusion

These findings suggest that 9 μg CIFN is effective in the treatment of patients with HBeAg-positive chronic hepatitis B. It can gradually induce ALT normalization and HBV DNA clearance and HBeAg loss or HBeAg/HBeAb seroconversion.