Adefovir dipivoxil for the treatment of hepatitis B e antigen-positive chronic hepatitis B in China / 中华传染病杂志

ABSTRACT

Objective To evaluate the efficacy and safety of Adefovir dipivoxil in the 52-week treatment of chronic hepatitis B in China.Methods We randomly assigned 480 patients with chronic hepatitis B who were positive for hepatitis B e antigen(HBeAg)in China.During the first 12-week period,480 patients were randomly to receive either 10 mg of adefovir dipivoxil(ADV)or placebo once daily in a 2:1 ratio and in the second period,all patients were accepted ADV for 18 weeks.In the last 12-week stage,all patients treated by ADV were randomly to receive either 10 mg of ADV or placebo in a 2:1 ratio and patients treated by placebo were accepted ADV.The primary end point was serum HBV DNA change during the treatment.The secondary endpoints were ALT normalization rate,HBeAg loss rate and HBeAg seroconversion rate.Results At week 12,median serum hepatitis B virus(HBV)DNA levels of group AAA(ADV-ADV-ADV)and group AAP(ADV-ADV-Placebo) were reduced 3.4 and 3.3 log copies per milliliter,significantly greater than group PAA(Placebo- ADV-ADV)of 0.1 log copies/ml reduction(P