Forty-eight-week efficacy of adefovir dipivoxil alone versus combined with lamivudine in treatment of lamivudine-resistant HBeAg-positive chronic hepatitis B

Objective To observe the therapeutic efficacy and safety of adefovir dipivoxil (ADV) alone versus combined with lamivudine (LAM) in the treatment of LAM- resistant HBeAg- positive chronic hepatitis B (CHB) . Methods Forty patients with LAM- resistant HBeAg- positive CHB were randomly assigned to monotherapy group (n = 20) and combination therapy group (n = 20) . The monotherapy group received ADV alone, while the combination therapy group received ADV combined with LAM. After 24 and 48 weeks of treatment, serum HBV DNA level, undetectable HBV DNA rate, HBeAg loss rate, alanine aminotransferase ( ALT) normalization rate, adverse reactions, and drug resistance were assessed. The two groups were compared by t- test for continuous data and chi- square test for categorical data. Results There were no significant differences in sex, age, and pretreatment levels of serum HBV DNA and ALT between the two groups (P > 0. 05) . After 48 weeks of treatment, serum undetectable HBV DNA rate and ALT normalization rate for the combination therapy group were 90% and 95%, respectively, significantly higher than those for the monotherapy group (60% and 65%) (P < 0. 05) ; there was no significant difference in HBeAg loss rate between the combination therapy group and monotherapy group (45% vs 35%, χ2= 0. 417, P =0. 519) . Conclusion ADV alone or combined with LAM has good clinical efficacy in the treatment of LAM- resistant HBeAg- positive CHB. However, the combination therapy can increase undetectable HBV DNA rate and ALT normalization rate and has good safety, and it holds promise for clinical application.