A CLINICAL STUDY OF HOME-MADE ADEFOVIR DIPIVOXIL IN THE 48-WEEK TREATMENT OF PATIENTS WITH HBEAG-POSITIVE CHRONIC HEPATITIS B

[Objective] To evaluate the efficacy and safety of the home-made adefovir dipivoxil (Daiding) 10mg per day in the 48-week treatment of chronic hepatitis B patients with HBeAg-positive. [Methods] one hundred and eleven patients with HBeAg-positive chronic hepatitis B were randomly divided into group A and B.63 patients in group A were treated with home-made adefovir dipivoxil (Daiding) 10mg per day orally for 48 weeks. 48 patients in group B were treated with Adefovir dipivoxil (Hepsera, GSK) 10mg per day orally for 48 weeks. The patients in both groups were observed before and after treatment for their serum levels of ALT and HBV-DNA, the rates of serum HBV-DNA clearances, ALT normalization, HBeAg loss, HBeAg seroconversion and drug adverse reations. [Results] The decline levels of ALT and HBV-DNA and the rates of serum HBV-DNA clearances, ALT normalization, HBeAg loss, HBeAg seroconversion were increased with prolongation of the treatment period. However, the differences between the two groups were not statistically significant (P﹥0.05). No drug related to renal function impairment was found during the treatment, nine patients had drug adverse reactions in both groups but all were mild. [Conclusion] The efficacy and safety of home-made adefovir dipivoxil (Daiding) for treating HBeAg-positive chronic hepatitis B patients are similar to its foreign counterparts.