Observation on Efficacy of Adefovir Dipivoxil Combined with Lamivudine for Chronic Hepatitis B Patients with Lamivudine Resistant

Objective To study the therapeutic effect and safety of adefovir dipivoxil(ADV)combined with lamivudine(LAM)for chronic hepatitis B(CHB)patients with lamivudine-resistant.Methods The 102 cases of HBeAg positive CHB patients with LAM resistant were randomly divided into three groups;ADV combined with LAM group(group A,n=38)was treated with ADV 10 mg and LAM 100 mg once daily by orally taken;ADV group(group B,n=42)was given ADV 10 mg/d;LAM group(group C,n=22)was given LAM 100mg/d.After 24,48 and 72-weeks of treatment,serum HBV DNA levels,HBV serologic marker and liver function tests were measured respectively,and safety assessments were also conducted.Results At 24,48 and 72 weeks,the mean reduction and negative rate of HBV DNA were significantly greater in group A and B compared with that in group C(P0.01).The ALT normalization of group A at 24,48 and 72 weeks and group B at 72 weeks were significantly higher than that of group C(P0.01).The mean reduction of HBV DNA at 48 and 72 weeks,HBV DNA negative rate and ALT normalization at 72 weeks were significantly greater in group A than group B(P0.01).There were no significant different among the three groups in the negative rate and seroconversion rate of HBeAg(P0.05).During the treatment,the new resistance mutation rate was lower in group A than group C(P0.05),and there was no severe adverse event related to the investigational product.Conclusion ADV combined with LAM is effective and safe for CHB patients with lamivudine-resistant.