ABSTRACT
Objective To compare the efficacy and safety of Iamivudine-interferon sequential therapy and lamivudine monotherapy in HBeAg-positive chronic hepatitis B (CHB) patients.MethodsA total of 172 patients with HBeAg-positive CHB were randomized to sequential group (n=83) or lamivudine group (n=89).Sequential group were administrated with lamivudine 100 mg/d and 5 million units interferon alpha 2b subcutaneous injection every other day for 24 weeks were added since week 25 of treatment.Lamivudine group were administrated with lamivudine 100 mg/d for 48 weeks.All subjects were followed up for 24 weeks after drug withdrawal.Measurement data with homogeneity of variance were analyzed by using t test and data with heterogeneity of variance were analyzed by using rank sum test.The comparison of rates was done by chi square test or Fisher exact test.ResultsThe baseline hepatitis B virus (HBV) DNA levels of patients in sequential group and lamivudine group were (7.8±1.0) and (7.9±1.1) lg copy/mL,respectively (P＞0.05),and the baseline alanine aminotransferase (ALT) levels were (210.5 ± 150.1 ) and (211.9 ± 160.9) U/L,respectively (P＞0.05).At the end of treatment,higher ALT levels [(78.4±146.1) vs (36.1±32.4) U/L,P＜0.05)] and HBV DNA levels [(4.5±1.5) vs (3.8±1.3) lg copy/mL,P＜0.05)] levels,lower response rates (65.8％ vs 83.5％,P＜0.05),and similar HBeAg loss rates (31.6％ vs 22.2％,P＞0.05) and HBeAg seroconversion rates (27.6％ vs 16.0％,P＞0.05) were found in sequential group compared with lamivudine group.At the end of follow-up,higher ALT levels [(126.0±143.1) vs (82.7±83.0) U/L,P＜0.05)],similar HBV DNA levels [(5.3±1.5) vs (5.0±1.5) lg copy/mL,P＞0.05)],similar HBeAg loss rates (25.0％ vs 32.3％,P＞0.05) and HBeAg seroconversion rates (25.0 ％ vs 26.2 ％,P＞0.05) were found in sequential group compared with lamivudine group.YMDD motif mutation rate in sequential group was lower than lamivudine group at week 48 of treatment (10.5％ vs 26.9％,P＜0.05).ConclusionsLamivudine-interferon sequential therapy and lamivudine monotherapy are both effective in HBeAg-positive CHB patients,while HBV mutations are reduced in patients with sequential therapy.