Clinical evaluation of lamivudine alone or combined with inteferon alpha as antiviral therapy for patients with chronic hepatitis B

Objective To observe and evaluate the safety and efficacy of lamivudine alone or combined with interferon alpha as antiviral therapy for patients with chronic hepatitis B. Methods Sixty four patients were enrolled to receive lamivudine alone, 100mg or 150mg orally, once daily, 54 of whom(84.4%) being treated more than 12 months. Fourty nine patients were enrolled in the combination therapy group. Two weeks after lamivudine treatment, interferon alpha(Intron A or Referon A) was initiated, 3MIU～5MIU intramuscularly or subcutaneously, thrice a week for 24 weeks only, then lamivudine was administered continuously, 38 of whom(77.6%) being treated more than 12 months. All cases were evaluated periodically during the treatment and 4～26 months follow up.Results At month 6, the normalization rates of ALT/AST were 90.6%/92.2% in lamivudine group and 89.8%/93.9% in the combinaiton group, respectively( P 0.05), undetectable rates of serum HBV DNA and HBeAg seroconversion rates were 96.9% and 20.3% in lamivudine group, 98.0% and 28.6% in combination group, respectively( P 0.05). But at month 12, HBeAg seroconversion rates were 31.5%(17/54) in lamivudine group, 55.3 %(21/38) in combination group( P 0.05). It appeared that the rate of HBeAg seroconversion was associated with a higher ALT/AST level and a lower baseline of HBeAg, HBV DNA level. During continueing lamivudine treatment, 9 cases(14.1%) in lamivudine group and 6 cases(12.2%) in the combination group developed YMDD mutation of HBV polymerase.Conclusions The effectiveness and tolerability of combined interferon alpha and lamivudine, worth consideration as a promising antiviral strategy and more satisfactory than lamivudine alone in the treatment of chronic hepatitis B.