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

Author(s): Zheng Y, Zhao L, Wu T, Guo S, Chen Y, Zhou T

Affiliation(s): Infectious Disease Centre, West China Hospital, Sichuan University, No. 37, Guo Xue Xiang, Chengdu, Sichuan Province, PR China. zhyl1973@live.com

Publication date & source: 2009-07-09, Virol J., 6:99.

Publication type: Comparative Study; Multicenter Study; Randomized Controlled Trial

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.

Page last updated: 2009-10-20

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