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Clinical impact of the early alanine amininotransferase flare during tenofovir monotherapy in treatment-naive patients with chronic hepatitis B

Authors
Seo, Hee YeonLee, Han AhKo, Soon YoungWang, Joon HoKim, Jeong HanChoe, Won HyeokKwon, So Young
Issue Date
Jun-2017
Publisher
KOREAN ASSOC STUDY LIVER
Keywords
Tenofovir; Chronic hepatitis B
Citation
CLINICAL AND MOLECULAR HEPATOLOGY, v.23, no.2, pp.154 - 159
Indexed
SCOPUS
KCI
Journal Title
CLINICAL AND MOLECULAR HEPATOLOGY
Volume
23
Number
2
Start Page
154
End Page
159
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/29401
DOI
10.3350/cmh.2016.0067
ISSN
2287-2728
Abstract
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 x 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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