Two-year treatment outcome of chronic hepatitis B infection treated with besifovir vs. entecavir: Results from a multicentre study

Title
Two-year treatment outcome of chronic hepatitis B infection treated with besifovir vs. entecavir: Results from a multicentre study
Author
손주현
Keywords
Besifovir; LB80380; Entecavir; Viral suppression; Resistance; Safety
Issue Date
2015-03
Publisher
ELSEVIER SCIENCE BV
Citation
JOURNAL OF HEPATOLOGY, v. 62, NO 3, Page. 526-532
Abstract
Background & Aims: We aimed to compare the viral suppression, safety and rate of drug resistance between besifovir (a new acyclic nucleotide analogue) and entecavir. Methods: Treatment-naive chronic hepatitis B patients receiving besifovir 90 mg (n = 31), 150 mg (n = 28) and entecavir 0.5 mg (n = 30) were monitored for liver biochemistry, viral serology, HBV DNA levels, development of drug resistance mutations, and adverse events throughout 96 weeks of treatment. Results: The mean decline of HBV DNA levels from baseline to week 96 were 5.29, 5.15, and 5.67 logs IU/ml for patients receiving besifovir 90 mg, 150 mg and entecavir 0.5 mg, respectively (p > 0.05). Undetectable HBV DNA (< 20 IU/ml) were achieved in 80.7%, 78.6%, and 80%; ALT normalization in 90.3%, 78.6%, and 93.3%; and loss of HBeAg in 20%, 21.4%, and 22.2% of patients respectively (all p > 0.05). One patient receiving besifovir 90 mg had a virological breakthrough due to drug non-compliance. No patient developed drug resistance mutations. Ten patients had serious adverse events, which were not related to the study medications. The most common side effect related to besifovir was carnitine depletion. Carnitine supplements were prescribed to 83.9% and 100% of patients, who had low carnitine level for any one time during follow-up, receiving besifovir 90 mg and 150 mg respectively. No patient had increased creatinine >0.5 mg/dl from baseline. Conclusions: Besifovir had the same antiviral property as compared to entecavir over 96 weeks of treatment for chronic hepatitis B patients. Besifovir was well tolerated and also had a good clinical safety profile. (C) 2014 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
URI
http://www.sciencedirect.com/science/article/pii/S0168827814007879http://hdl.handle.net/20.500.11754/22964
ISSN
0168-8278; 1600-0641
DOI
10.1016/j.jhep.2014.10.026
Appears in Collections:
COLLEGE OF MEDICINE[S](의과대학) > MEDICINE(의학과) > Articles
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