Phase III clinical trial of adefovir dipivoxil capsule in patients with HBeAg positive chronic hepatitis B

Objective:To evaluate the efficacy and safety of the domestic adefovir dipivoxil capsule of 10 mg·d-1 in the 48-weeks treatment of chronic hepatitis B patients with HBeAg positive in China.Methods:Study design was a multi-center,randomdy,double blind,placebo controlled study.240 Chinese patients were randomly assigned in a 2∶1 ratio to receive either adefovir dipivoxil or placebo for the first 12 weeks,then patients received open-labelled adefovir dipivoxil for the week 12～48.The primary efficacy endpoint in this study was the log10 reduction of serum HBV DNA from baseline.Secondary endpoints were the rate of patients ALT normalization and the rate of patients with HBeAg loss and HBeAg seroconversion at week 48.Results:At week 12,the logarithmic value of hepatitis B virus(HBV) DNA level in group B was reduced by(3.01±1.34),higher than that of group A(P0.05).At week 48,the logarithmic values of HBV DNA level in group A and B were reduced by(2.73±1.56) and(3.02±1.55),respectively.The rates of HBV DNA undetectable were 27.5% and 31.6%,respectively.The rates of HBeAg loss were 27.5% and 41.2%,respectively.The rate of HBeAg seroconversions were 8.7% and 8.8%,respectively,and the rates of ALT normalization were 81.2% and 82.4%,respectively.There were no severe adverse events.Comparing with baseline levels,the serum creatinine was not changed.Conclusion:Adefovir dipivoxil 10 mg once daily was safe and effective in patients with HBeAg-positive chronic hepatitis B.