De novo combination therapy with lamivudine and adefovir dipivoxil versus entecavir monotherapy for na(i)ve chronic hepatitis B patients with high viral loads

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ZHANG Jian-chun(Department of Infectious Diseases,Jiangyin People's Hospital,Jiangyin 214400,Jiangsu Province,China)
Journal Title:
Chinese Journal of Clinical Infectious Diseases
Volume 05, Issue 03, 2012
Key Word:
Chronic Hepatitis B;Lamivudine;Adefovir dipivoxil;Entecavir;Drug resistance

Abstract: Objective To evaluate the efficacy,drug resistance and safety of combination therapy with lamivudine (LAM) and adefovir dipivoxil (ADV) or entecavir (ETV) monotherapy for chronic hepatitis B (CHB) patients with high viral loads (HBV DNA ≥ 107copies/mL).Methods Seventy CHB patients with high viral loads were collected from Jiangyin People' s Hospital in Jiangsu Province during May 2007 and January 2009.All patients were randomized into combination therapy group and monotherapy group.Combination therapy group was treated with lamivudine ( 100 mg/d) and adefovir dipivoxil ( 10 mg/d) for 96 weeks,and monotherapy group was treated with entecavir (0.5 mg/d) for 96 weeks.x2 test was used to compare the ALT normalization rates,HBV DNA negative rates and HBeAg sernconversion rates between two groups.Results After 96 weeks' treatment,the ALT normalization rate,HBV DNA negative rate and HBeAg seroconversion rate of combination therapy group were 97.1% (34/35),94.3% ( 33/35 )and 48.6% ( 17/35 ),respectively ; those of monotherapy group were 77.1% ( 27/35 ),77.1% ( 27/35 )and 17.1 % (27/35),respectively ; the differences were of statistical significance (x2 =6.248,4.200 and 7.835,P <0.05 or P <0.01 ).There was no virological breakthrough in combination therapy group during 96 weeks' treatment,but it was found that 2 patients had virological breakthrough in monotherapy group and they were ETV-resistant.No severe adverse reaction was found in both groups.Conclusion LAM + ADV combination therapy is better in viral suppression,and has lower resistance and higher HBeAg seroconversion rate than ETV monotherapy for CHB patients with high viral load.

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