A Clinic Trial's Design And Execution Of Consensus Interferon In The Treatment Of Chinese Patients With Chronic Hepatitis B

BACKGROUND AND AIMS: Alpha-interferons are the accepted therapy for patients infected with chronic hepatitis B virus (HBV) in China. Consensus interferon (CIFN) is a newly developed type I interferon. It binds with high affinity to type-I IFN receptors and has greater biological activity than naturally occurring IFN-alpha as assessed by its increased antiviral, anti-proliferative, and natural killer cell activities, as well as its stronger IFN-stimulated gene induction. It offers sustained clinical efficacy to patients studied in the Western countries. This randomized, controlled trial was conducted to determine the safety and efficacy of rSIFN-co (CIFN ) at two doses, and to compare it with alpha-1b-interferon (IFN-alpha-1b) in the treatment of patients with chronic hepatitis B.Method: Patients were randomized to receive 9 micrograms rSIFN-co (Group A) or 50 micrograms INF- α lb(Group B) subcutaneously three times a week for 24 weeks, followed by 24 weeks of observation. The patients who relapsed after traditional IFN therapy were re-treated with 15micrograms rSIFN-co (Group C).Efficacy was assessed by normalization of serum transaminase levels and thenon-detectability disappearance of serum hepatitis B virus (HBV)-DNA orHBe-Ag at the end of treatment and at 24 weeks after stopping treatment. Thesafety of CIFN was evaluated by recording the type and severity of adverseeffects.Results: There were no serious adverse effects related to CIFN therapy.Overall, 50.0% (12/24) of patients receiving 9 micrograms CIFN and 45.8%(11/24) of patients receiving 50 micrograms INF- a lb had normalization of serum transaminase levels and disappearance of HBV viremia at the end of treatment, Group C is 2 cases(2/20) . At 24 weeks after stopping treatment,43.5% (10/23) of patients in receiving 9 micrograms CIFN and 52.2% (12/23) of patients receiving 50 micrograms INF- a lb had sustained responses. There is no difference between two Groups at Efficacy and safety (P>0.05). Group C is 1 case(l/6). CONCLUSIONS: These findings suggest that 9 micrograms rSIFN-co(CIFN) is safe and effective in the treatment of patients with chronic hepatitis B.