2009Chinese Journal of Clinical HepatologyRequires access

A observation on the efficacy of Adefovir dipivoxil combined with Lamivudine for chronic hepatitis B patients with Lamivudine-resistant

Jinke Li

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Abstract

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 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 ADV10mg and LAM100 mg once daily by orally taken,ADV group(group B,n=42) was given ADV10mg/d and LAM group(group C,n=22) was given LAM100 mg/d.After 24,48 and 72-weeks of treatment,serum HBV DNA levels,HBV serology and liver function tests were measured re spectively,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(P0.05,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(P0.05,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(P0.05,P0.01),there were no significant different between the three groups in the portion of HBeAg loss and HBeAg seroconversion(P0.05).During the treatment,the new resistance mutation rate was lower in group A than group C(P0.05),there was no severe adverse event related to the investigational product.Conclusion ADVcombined with LAM is effective and safe for CHB patients with lamivudine-resistant.

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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 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 ADV10mg and LAM100 mg once daily by orally taken,ADV group(group B,n=42) was given ADV10mg/d and LAM group(group C,n=22) was given LAM100 mg/d.After 24,48 and 72-weeks of treatment,serum HBV DNA levels,HBV serology and liver function tests were measured re spectively,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(P0.05,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(P0.05,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(P0.05,P0.01),there were no significant different between the three groups in the portion of HBeAg loss and HBeAg seroconversion(P0.05).During the treatment,the new resistance mutation rate was lower in group A than group C(P0.05),there was no severe adverse event related to the investigational product.Conclusion ADVcombined with LAM is effective and safe for CHB patients with lamivudine-resistant.

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Available abstract

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 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 ADV10mg and LAM100 mg once daily by orally taken,ADV group(group B,n=42) was given ADV10mg/d and LAM group(group C,n=22) was given LAM100 mg/d.After 24,48 and 72-weeks of treatment,serum HBV DNA levels,HBV serology and liver function tests were measured re spectively,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(P0.05,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(P0.05,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(P0.05,P0.01),there were no significant different between the three groups in the portion of HBeAg loss and HBeAg seroconversion(P0.05).During the treatment,the new resistance mutation rate was lower in group A than group C(P0.05),there was no severe adverse event related to the investigational product.Conclusion ADVcombined with LAM is effective and safe for CHB patients with lamivudine-resistant.

Key concepts: Adefovir, Lamivudine, Gastroenterology, Internal medicine, HBeAg, Medicine, Chronic hepatitis, Liver function

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