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KMID : 1040620170230020154
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Clinical and Molecular Hepatology
2017 Volume.23 No. 2 p.154 ~ p.159
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Clinical impact of the early alanine amininotransferase flare during tenofovir monotherapy in treatment-naive patients with chronic hepatitis B
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Seo Hee-Yeon
Lee Han-Ah
Ko Soon-Young
Wang Joon-Ho
Kim Jeong-Han
Choe Won-Hyeok
Kwon So-Young
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Abstract
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Background/Aims: Little is known about the effect of early flares on response during first-line tenofovir disoproxil fumarate (TDF) treatment for chronic hepatitis B (CHB). The aim of this study was to investigate the incidence and outcome of early alanine aminotransferase (ALT) flare in treatment-naive patients with CHB during long-term TDF monotherapy.
Methods: One hundred eighty-one treatment-naive CHB patients were treated with a 300-mg once-daily dose of TDF for more than 12 weeks. Virological markers of hepatitis B virus (HBV) and biochemical data were measured at baseline and every 4-12 weeks during the therapy. The proportion of patients with undetectable HBV DNA level (< 100 copies/mL) was noted.
Results: The median age was 48.3 years and 122 patients (67.4%) were men. Hepatitis B envelope antigen (HBeAg) was positive in 101 patients (55.8%). No patient had cirrhosis. The median follow-up duration was 45 weeks (12-155 weeks). ALT flare (>5 × upper limit of the normal range) occurred in seven patients (3%) without viral breakthrough within the first 8 weeks after the start of TDF monotherapy. Among them, six patients were HBeAg-positive and one patient was HBeAg-negative. All cases of early ALT flares resolved within 4 weeks and virologic response was observed in all patients without interruption or discontinuation of treatment.
Conclusions: Continuous TDF monotherapy was effective and safe in treatment-naive patients with CHB who experienced early ALT flares followed by a decrease in HBV DNA level.
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KEYWORD
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Tenofovir, Chronic hepatitis B
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