A randomized, multi-central, controlled study of patients with hepatitis B e antigen-positive chronic hepatitis B treated by adefovir dipivoxil or adefovir dipivoxil plus bicyclol

OBJECTIVE: To evaluate the efficacy and safety profiles of patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) treated with adefovir dipivoxil (ADV) or ADV plus bicyclol, and to optimize the treatment strategy for CHB patients. PATIENTS AND METHODS: A total of 250 patients with HBeAg-positive CHB were randomized to ADV plus bicyclol combination group and ADV monotherapy group. The patients in the ADV plus bicyclol combination therapy group (n = 125) received ADV 10 mg orally q.d. and bicyclol 25 mg orally t.i.d. for 48 weeks, and those in the ADV monotherapy group (n = 125) were administered ADV 10 mg orally q.d. alone for 48 weeks. The serum aminotransferases (ALT/AST), HBV DNA, HBeAg/HBeAb, and liver biopsy were conducted before and after therapy. RESULTS: The serum aminotransferase levels were decreased significantly in both groups. The serum aminotransferase level in ADV plus bicyclol combination therapy group decreased greater than that in ADV monotherapy group (P < 0.01). The virological response rate in ADV plus bicyclol combination therapy group was not significantly different from that in ADV monotherapy group (P > 0.05). After treatment for 48 weeks, the Knodell necroinflammatory score of the two groups were all alleviated significantly, and the Knodell score in the combination group was significantly lower than that in the ADV monotherapy group (P < 0.05). There were no remarkable adverse events probably related to the drug in this study. CONCLUSION: Adefovir dipivoxil plus bicyclol combination therapy is a safe and superior treatment regimen for patients with HBeAg-positive CHB when compared with ADV monotherapy.