Abstract: Objective To assess the long-term efficacy and safety of generic adefovir dipivoxil(ADV) for the treatment of Chinese patients with chronic hepatitis B. Methods<'b> This four-year random, double-blind, controlled study included 240 patients with chronic hepatitis B virus(HBV) infection, 120 received ADV monotherapy. Alanine aminotransferase(ALT) normalization, HBV DNA loss and safety were evaluated every 6 months. Results ALT normalization rate was significantly higher in the ADV group than that in the control group. After 1 year ADV treatment the ALT normalization rate was 76.8% and sustained at 58% for the following 3 years. Complete virological response(HBV DNA<500 IU/L) was observed in 48.3%, 38.3%, 44.2% and 43.3% of the cases during the four years of ADV treatment respectively. The safety profiles showed no significant difference between the ADV and control group, except that only 4 patients had slightly increased(less than 0.5 fold higher than baseline level) creatinine. Conclusion Generic ADV showed the good anti-HBV efficacy and safety during the four years treatment.

Key words: adefovir dipivoxil, chronic hepatitis B, treatment, HBV DNA