Comparison of efficacy of lamivudine plus adefovir dipivoxil de novo combination therapy with optimization monotherapy in patients with decompensated hepatitis B cirrhosis / 重庆医学

ABSTRACT

Objective To compare the efficacy of lamivudine (LAM) plus adefovir dipivoxil (ADV) de novo combination therapy to optimization monotherapy for hepatitis B virus-related compensated cirrhosis,and analyze the prediction factors of early response of antivirus treatment.Methods A total of 158 cases of patients with hepatitis B virus-related compensated cirrhosis were selected and randomly assigned to combined group (n=81) and optimized group (n =77) according to randomized digital table.The patients in the combined group accepted LAM combined ADV.The patients in the optimized group were firstly treated with LAM or ADV,then they were given optimized therapy with ADV or LAM if they had poor response or virological breakthrough at week 24.The clinical efficaeies were compared between the two groups,and the prediction factors of early response were analyzed.Results At week 12,the decline level of HBV DNA in the combined group was higher than that in the optimized group (P＜ 0.05),but no statistically significant difference was found in the negative transformation rate of HBV DNA between the two groups (P＞ 0.418).At week 24,the decline level of HBV DNA,rate of undetectable HBV DNA and rate of complete response were higher than those in the optimized group,and rate of virological breakthrough was lower than that in the optimized group (P＜0.05).At week 48,the decline level and negative transformation rate of HBV DNA,negative transformation rate and seroconversion rate of HBeAg were higher than those in the optimized group,and serum levels of hyaluronic acid and a2-macroglobulin were lower than those in the optimized group (P＜0.05).There was no statistically significant difference in the recover rate of alanine aminotransferase (ALT),rate of complete response and rate of virological breakthrough between the two groups at week 48 (P＞0.05).Logistic regression analysis showed that the complete response at week 24 was correlated with HBV DNA load,expression of HBeAg,level of ALT and initial treatment (P＜0.05).Layered evaluation showed that the rate of early complete response in the combined group was significantly higher than that in the optimized group,regardless of HBV DNA load,expression of HBeAg,and level of ALT (P＜0.05).Conclusion LAM combined with ADV can reduce resistance and improve the rate of early complete response,which has stronger antiviral activity.In addition,it can improve the liver function and partially reverse cirrhosis.