Preliminary observation on the efficacy of domestic adefovir dipivoxil in patients with hepatitis B resistant to lamivudine

Objective To evaluate the efficacy and safety of domestic adefovir dipivoxil in patients with hepatitis B resistant to lamivudine. Methods A randomized, double blind, double dummy, active parallel controlled study was conducted in chronic hepatitis B patients with YMDD mutation. Eligible patients stopped lamivudine therapy and were assigned to receive 10 mg of adefovir dipivoxil plus matching placebo once daily or 100 mg of lamivudine plus matching placebo once daily for 48 weeks (ratio, 1∶1). ALT level, serum HBV DNA, and hepatitis B serology markers were measured at regular intervals, the adverse events were recorded. Results 13 patients were received adefovir dipivoxil and 14 patients received lamivudine. After 48 weeks of treatment normalization of ALT levels in patients who received adefovir dipivoxil was 92.9% and in patients who received lamivudine was 42.9%, respectively, P=0.0065. The median decrease in log-transformed HBV DNA levels was greater with adefovir dipivoxil treatment than with lamivudine (3.562±2.289 vs. 1.024±2.797 log copies per milliliter, P0.05). The both rates of HBeAg loss and HBeAg seroconversion were 23.1%(3/13)in adefovir dipivoxil treatment group, in lamivudine treatment group,it were 14.3%(2/14)and 7.1%(1/14), respectively, There was no significant statistical difference in HBeAg loss rate and HBeAg seroconversion rate between two groups. Conclusion Domestic adefovir dipivoxil was well tolerated and safe, and demonstrated a potent antiviral response in lamivudine-resistant patients with chronic hepatitis B.