Clinical study of adefovir dipivoxil for the treatment of chronic hepatitis B

Objective To evaluate the efficacy and safety of adefovir dipivoxil(ADV) for the treatment of chronic hepatitis B(CHB).Methods A randomized,double-blinded and controlled trial was preformed.The trial included two periods for 48 weeks.During the first 12 weeks,96 CHB patients who were positive for hepatitis B e antigen(HBeAg) were randomly devided into the test group(n=64) and the control group(n=32).The patients in the test group were administered with 10 mg of ADV once daily and those in the control group with placebo once daily.In the second period,all patients received 10 mg of open-labeled ADV for 36 weeks.Results At week 12,median serum HBV DNA levels of the patients in the test group decreased by 3.35 log10 copies/ml compared to the baseline level,significantly greater than the levels of the patients in the control group(decreased by 0.73 log10 copies/ml)(P=0.000);31.25% of the patients in the test group had a decrease of HBV DNA levels below the detection limit(less than 5×102 copies/ml),significantly higer than that in the control group(9.38%)(P =0.019);87.50% of the patients in the test group had a decrease of more than 2 log10 in serum HBV DNA levels and 9.38% in the control group compared to the baseline level;ALT normalization was achieved in 57.81% of the patients in the test group,significantly greater than that in the control group(28.13%)(P=0.006).At week 48,median serum HBV DNA levels of the test group and the control group decreased by 5.43 log10 copies/ml and 5.65 log10 copies/ml,respectively,compared to the baseline level;84.38% of the patients in the test group had a decrease of HBV DNA levels below the detection limit,and 81.25% in the control group;89.06% of the patients in the test group had a decrease of more than 2 log10 in serum HBV DNA levels and 8% in the control group compared to the baseline level;ALT normalization was achieved in 70.18% of patients in the test group and 73.33% in the control group.The HBeAg seroconversion rates were 15.09% in the test group and 8% in the control group.No patients in both groups had any adverse event.Conclusion ADV is an effective and safe agent for the treatment of CHB patients.