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Objective To evaluate the efficacy of 2-year treatment of interferon alpha combined with lamivudine therapy in chronic hepatitis B patients. Methods From 1999 to 2001 87 patients were enrolled and randomized into two groups.36 patients received interferon alpha and lamivudine simultaneously for 26 weeks,then lamivudine alone for 76 weeks.51 patients received lamivudine alone for 104 weeks.The efficacy was evaluated by biochemical and virological parameters.The YMDD motif was detected in both groups. Results There was no difference between two groups in HBV DNA response ( P =0.24).Proportion of HBeAg/Anti-HBe seroconversion in combination group was significantly higher than lamivudine group (38.9% vs 17.6%)( P =0.03).HBV YMDD mutation rate in combination group was lower than in lamivudine group (22.2% vs 43.1%, P =0.04). Conclusion The efficacy of combination therapy appeares to be better than lamivudine monotherapy.Combination treatment may delay or diminish the development of HBV YMDD mutation.
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1.0 ?10 7 copies/ml than those with lower HBV DNA levels both in combination group and lamivudine group (52.0% vs 25.8%, P= 0.04; 63.2% vs 28.6%, P= 0.03). Necro-inflammatory activity, fibrosis and the expression of HBV DNA showed no correlation with response rate in combination group. Among those who had higher levels of HBV DNA expression, seroconversion rate in combination group is higher than that in lamivudine group (46.2% vs 9.5%, P= 0.03). Conclusions The efficacy of combination therapy appeared to be better in patients with at least moderately elevated baseline ALT, high level of HBV DNA as well as HBV DNA expression in hepatocytes. Combination therapy may delay or diminish the development of YMDD mutation-related resistance to lamivudine.