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Cited 12 time in webofscience Cited 15 time in scopus
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Besifovir Dipivoxil Maleate 144-Week Treatment of Chronic Hepatitis B: An Open-Label Extensional Study of a Phase 3 Trial

Authors
Yim, Hyung JoonKim, WonAhn, Sang HoonYang, Jin MoJang, Jae YoungKweon, Yong OhCho, Yong KyunKim, Yoon JunHong, Gun YoungKim, Dong JoonJung, Young KulUm, Soon HoSohn, Joo HyunLee, Jin WooPark, Sung JaeLee, Byung SeokKim, Ju HyunKim, Hong SooYoon, Seung KewKim, Moon YoungLee, Kwan SikLim, Young SukLee, Wan SikHan, Kwang-Hyub
Issue Date
Aug-2020
Publisher
NLM (Medline)
Citation
American Journal of Gastroenterology, v.115, no.8, pp 1217 - 1225
Pages
9
Indexed
SCIE
SCOPUS
Journal Title
American Journal of Gastroenterology
Volume
115
Number
8
Start Page
1217
End Page
1225
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/33845
DOI
10.14309/ajg.0000000000000605
ISSN
0002-9270
1572-0241
Abstract
INTRODUCTION: Chronic hepatitis B (CHB) remains a major worldwide public health concern. Besifovir dipivoxil maleate (BSV) is a new promising treatment for CHB. However, long-term efficacy and safety have not yet been evaluated. Therefore, the goal of the study is to determine the antiviral efficacy and safety of BSV treatment over a 144-week duration (BSV-BSV) in comparison with those of a sequential treatment with tenofovir disoproxil fumarate (TDF) followed by a 96-week duration BSV administration (TDF-BSV). METHODS: After 48 weeks of a double-blind comparison between BSV and TDF treatments, patients continued the open-label BSV study. We evaluated antiviral efficacy and drug safety up to 144 weeks for BSV-BSV and TDF-BSV groups. The primary endpoint was a virological response (hepatitis B virus DNA < 69 IU/mL). RESULTS: Among the 197 patients enrolled, 170 and 158 patients entered the second-year and third-year open-label phase extensional study, respectively, whereas 153 patients completed the 144-week follow-up. The virological response rate over the 144-week period was 87.7% and 92.1% in BSV-BSV and TDF-BSV groups, respectively (P = 0.36). The rates of ALT normalization and HBeAg seroconversion were similar between the groups. No drug-resistant mutations to BSV were noted. Bone mineral density and renal function were well preserved in the BSV-BSV group and were significantly improved after switching therapy in TDF-BSV patients. DISCUSSION: This extensional study of a phase 3 trial (NCT01937806) suggests that BSV treatment is efficacious and safe for long-term use in treatment-naïve and TDF-experienced patients with CHB.
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Yim, Hyung Joon
Ansan Hospital (Department of Gastroenterology and Hepatology, Ansan Hospital)
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