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( William Sievert ),( Huy Trinh ),( Giampiero Carosi ),( Ulus Akarca ),( Adrian Gadano ),( Francois Habersetzer ),( David Wong ),( Meghan Lovegren ),( Hui Zhang ),( Cyril Llamoso ) 대한간학회 2012 춘·추계 학술대회 (KASL) Vol.2012 No.1
Background: The aim of this study was to elucidate the antiviral efficacy and safety of telbivudine in Korean treatment-naive chronic hepatitis B (CHB) patients. Methods: A total of 143 treatment-naive patients who had been treated with telbivudine for at least 6 months were consecutively enrolled. We determined the cumulative rates of virologic response (<12 IU/ml by PCR assay), serologic response, biochemical response and monitored any side effects. Results: The median age and follow-up duration were 50.7 years and 16.4 (range 6-24 months) months, respectively. Sixty seven patients (46.9%) were positive for HBeAg and the median serum HBV DNA level was 7.23 (range 4.31-8.26) log IU/ml. In HBeAg positive group, the cumulative probabilities of HBV DNA undetectability were 14.9% , 24.6%, 34.4% and 26.3% at 6, 12, 18 and 24 months, respectively. Partial virologic response at 6 months occurred in 82.1% of patients and inadequate virologic response at 6 months in 3.0%. During the follow-up period, 8 patients achieved HBeAg loss and 3 patients achieved HBeAg seroconversion. Meanwhile, in HBeAg-negative group, the cumulative rates of virologic response were 64.5%, 86.4%, 82.1% and 81.3%, respectively and the cumulative rates of biochemical response were 89.5%, 98.3%, 100% and 100%, respectively. Among the all patients, there were 42 cases of virologic breakthrough and 21 cases of genotypic resistance and virologic breakthrough. There were 46 (32.2%) cases of CK elevation and 2 (1.4%) cases of myopathy. However, there was no clinically significant safety issue. Conclusions: In Korean treatment-naive HBeAg-negative CHB patients, telbivudine therapy induced favorable virologic, serologic and biochemical responses.