Clinical impact of the early alanine amininotransferase flare during tenofovir monotherapy in treatment-naïve patients with chronic hepatitis B.
- Author:
Hee Yeon SEO
1
;
Han Ah LEE
;
Soon Young KO
;
Joon Ho WANG
;
Jeong Han KIM
;
Won Hyeok CHOE
;
So Young KWON
Author Information
- Publication Type:Original Article
- Keywords: Tenofovir; Chronic hepatitis B
- MeSH: Alanine Transaminase; Alanine*; DNA; Fibrosis; Follow-Up Studies; Hepatitis B; Hepatitis B virus; Hepatitis B, Chronic*; Hepatitis, Chronic*; Humans; Incidence; Male; Tenofovir*
- From:Clinical and Molecular Hepatology 2017;23(2):154-159
- CountryRepublic of Korea
- Language:English
- 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 × 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.
