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Efficacy and Safety of Besifovir Dipivoxil Maleate Compared With Tenofovir Disoproxil Fumarate in Treatment of Chronic Hepatitis B Virus Infectionopen access

Authors
Ahn, Sang HoonKim, WonJung, Young KulYang, Jin MoJang, Jae YoungKweon, Yong OhCho, Yong KyunKim, Yoon JunHong, Gun YoungKim, Dong JoonUm, Soon HoSohn, Joo HyunLee, Jin WooPark, Sung JaeLee, Byung SeokKim, Ju HyunKim, Hong SooYoon, Seung KewKim, Moon YoungYim, Hyung JoonLee, Kwan SikLim, Young SukLee, Wan SikPark, Neung HwaJin, So YoungKim, Kyun-HwanChoi, WonHan, Kwang-Hyub
Issue Date
Aug-2019
Publisher
ELSEVIER SCIENCE INC
Keywords
eGFR; Acyclic Nucleotide Phosphonate; Drug Resistance; Nephrotoxicity
Citation
CLINICAL GASTROENTEROLOGY AND HEPATOLOGY, v.17, no.9, pp 1850 - +
Indexed
SCIE
SCOPUS
Journal Title
CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Volume
17
Number
9
Start Page
1850
End Page
+
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/1760
DOI
10.1016/j.cgh.2018.11.001
ISSN
1542-3565
1542-7714
Abstract
BACKGROUND & AIMS: Besifovir dipivoxil maleate (BSV) has activity against hepatitis B virus (HBV). We performed a phase 3 study to compare the antiviral efficacy and safety of BSV vs tenofovir disoproxil fumarate (TDF) in patients with chronic HBV infection in Korea. METHODS: We conducted a double-blind, non-inferiority trial of 197 patients with chronic HBV infection at 22 sites in South Korea, from November 2013 through February 2016. Patients were randomly assigned to groups given BSV (150 mg, n = 99) or TDF (300 mg, n = 98) for 48 weeks. We evaluated virologic responses to therapy (HBV DNA < 69 IU/mL or 400 copies/ml), bone mineral density (BMD), and renal outcomes for safety analysis. The main efficacy endpoint was the proportion of patients with a virologic response at week 48. After 48 weeks, TDF was switched to BSV (150 mg) for an additional 48 weeks. RESULTS: After 48 weeks of treatment, 80.9% of patients given BSV and 84.9% of patients given TDF met the efficacy endpoint, indicating the non-inferiority of BSV to TDF. At week 96, 87.2% of patients in the BSV-BSV and 85.7% of patients in the TDF-BSV had a virologic response. At week 48, changes in hip and spine BMD differed significantly between the BSV and TDF groups, whereas the estimated glomerular filtration rate in the TDF group was significantly lower than that in the BSV group. However, at 96 weeks, there were no significant differences in BMD and estimated glomerular filtration rate between the BSV-BSV and TDF-BSV groups. CONCLUSIONS: BSV has antiviral efficacy comparable to that of TDF after 48 weeks of treatment, with durable effects for 96 weeks. BSV has a better safety profile than TDF, in terms of bone and renal outcomes.
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Jung, Young Kul
Ansan Hospital (Department of Gastroenterology and Hepatology, Ansan Hospital)
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