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

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-alpha1b) in the treatment of patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B.

METHODS:

144 Patients were randomly assigned to receive 9 microg CIFN (CIFN group) or 50 microg INF-alpha1b (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-alpha1b 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 microg 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.

• Authors: YongLi Zheng, LianSan Zhao, TaiXiang Wu, ShuHua Guo, YaGang Chen, TaoYou Zhou
• Journal: Virology journal (Virol J) Vol. 6 Pg. 99 (Jul 09 2009) ISSN: 1743-422X [Electronic] England
• PMID: 19586556 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antiviral Agents
• DNA, Viral
• Hepatitis B e Antigens
• Interferon Type I
• Interferon-alpha
• Recombinant Proteins
• interferon alfacon-1
• Alanine Transaminase

Topics

• Adolescent
• Adult
• Alanine Transaminase (blood)
• Antiviral Agents (administration & dosage, therapeutic use)
• DNA, Viral (blood)
• Female
• Hepatitis B e Antigens (blood)
• Hepatitis B virus (drug effects)
• Hepatitis B, Chronic (drug therapy)
• Humans
• Injections, Subcutaneous
• Interferon Type I (administration & dosage, therapeutic use)
• Interferon-alpha (administration & dosage, therapeutic use)
• Male
• Recombinant Proteins
• Treatment Outcome
• Young Adult