ABSTRACT
Objective To evaluate the safety and efficacy of adefovir dipivoxil made in China for treating hepatitis B e antigen(HBeAg)-positive chronic hepatitis B patients.Methods This was a multicenter,double-blinded,randomized controlled trial.Two hundred and thirty-eight patients with HBeAg-positive chronic hepatitis B were assigned to receive either adefovir dipivoxil(10 mg/d,120 patients)or placebo(118 patients)for 12 weeks in 5 medical centers in China.Then,both groups of patients entered 36 weeks open-labeled adefovir dipivoxil treatment phase(10 mg/d),The rates of serum HBV DNA clearances,alanine aminotransferase levels(ALT)normalization,HBeAg loss and anti-HBe seroconversion were evaluated respectively during and post the 48-week treatment.Results After 12 weeks of treatment,the rates of serum HBV DNA clearance(real-time fluorescent quanti- tative polymerase chain reaction,the detection limit was 1?10~4 copy per milliliter),ALT normaliza- tion,HBeAg loss and anti-HBe seroconversion of adefovir dipivoxil group were all significantly higher than those of placebo group(50.0% vs 5.1%,35.0% vs 8.5%,12.5% vs 2.5% and 5.8% vs 0, respectively,x~2=59.89,24.52,P0.05).The safety profile of adefovir dipivoxil was similar to that of placebo. Conclusions The safety profile and efficacy of domestic adefovir dipivoxil for treating HBeAg-positive chronic hepatitis B patients are similar to its counterparts that have been licensed aboard.