Title: Four-year Efficacy and Safety of Adefovir Dipivoxil for the Treatment of Chronic Hepatitis B
Abstract: Objective To assess the long-term efficacy and safety of generic adefovir dipivoxil(ADV) for the treatment of Chinese patients with chronic hepatitis B.Methods This four-year random,double-blind,controlled study included 240 patients with chronic hepatitis B virus(HBV) infection,120 received ADV monotherapy.Alanine aminotransferase(ALT) normalization,HBV DNA loss and safety were evaluated every 6 months.Results ALT normalization rate was significantly higher in the ADV group than that in the control group.After 1 year ADV treatment the ALT normalization rate was 76.8% and sustained at 58% for the following 3 years.Complete virological response(HBV DNA 500 IU/L) was observed in 48.3%,38.3%,44.2% and 43.3% of the cases during the four years of ADV treatment respectively.The safety profiles showed no significant difference between the ADV and control group,except that only 4 patients had slightly increased(less than 0.5 fold higher than baseline level) creatinine.Conclusion Generic ADV showed the good anti-HBV efficacy and safety during the four years treatment.
Publication Year: 2010
Publication Date: 2010-01-01
Language: en
Type: article
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