110 146

Cited 8 times in

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

DC FieldValueLanguage
dc.contributor.author안상훈-
dc.contributor.author한광협-
dc.date.accessioned2019-12-18T00:22:42Z-
dc.date.available2019-12-18T00:22:42Z-
dc.date.issued2019-
dc.identifier.issn1542-3565-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/173022-
dc.description.abstractBACKGROUND & 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. ClinicalTrials.gov no: NCT01937806.-
dc.description.statementOfResponsibilityopen-
dc.formatapplication/pdf-
dc.languageEnglish-
dc.publisherW.B. Saunders-
dc.relation.isPartOfCLINICAL GASTROENTEROLOGY AND HEPATOLOGY-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.titleEfficacy and Safety of Besifovir Dipivoxil Maleate Compared With Tenofovir Disoproxil Fumarate in Treatment of Chronic Hepatitis B Virus Infection-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorSang Hoon Ahn-
dc.contributor.googleauthorWon Kim-
dc.contributor.googleauthorYoung Kul Jung-
dc.contributor.googleauthorJin Mo Yang-
dc.contributor.googleauthorJae Young Jang-
dc.contributor.googleauthorYong Oh Kweon-
dc.contributor.googleauthorYong Kyun Cho-
dc.contributor.googleauthorYoon Jun Kim-
dc.contributor.googleauthorGun Young Hong-
dc.contributor.googleauthorDong Joon Kim-
dc.contributor.googleauthorSoon Ho Um-
dc.contributor.googleauthorJoo Hyun Sohn-
dc.contributor.googleauthorJin Woo Lee-
dc.contributor.googleauthorSung Jae Park-
dc.contributor.googleauthorByung Seok Lee-
dc.contributor.googleauthorJu Hyun Kim-
dc.contributor.googleauthorHong Soo Kim-
dc.contributor.googleauthorSeung Kew Yoon-
dc.contributor.googleauthorMoon Young Kim-
dc.contributor.googleauthorHyung Joon Yim-
dc.contributor.googleauthorKwan Sik Lee-
dc.contributor.googleauthorYoung Suk Lim-
dc.contributor.googleauthorWan Sik Lee-
dc.contributor.googleauthorNeung Hwa Park-
dc.contributor.googleauthorSo Young Jin-
dc.contributor.googleauthorKyun-Hwan Kim-
dc.contributor.googleauthorWon Choi-
dc.contributor.googleauthorKwang-Hyub Han-
dc.identifier.doi10.1016/j.cgh.2018.11.001-
dc.contributor.localIdA02226-
dc.contributor.localIdA04268-
dc.contributor.localIdA04268-
dc.relation.journalcodeJ02981-
dc.identifier.eissn1542-7714-
dc.identifier.pmid30448598-
dc.subject.keywordAcyclic Nucleotide Phosphonate-
dc.subject.keywordDrug Resistance-
dc.subject.keywordNephrotoxicity-
dc.subject.keywordeGFR-
dc.contributor.alternativeNameAhn, Sang Hoon-
dc.contributor.affiliatedAuthor안상훈-
dc.contributor.affiliatedAuthor한광협-
dc.contributor.affiliatedAuthor한광협-
dc.citation.volume17-
dc.citation.number9-
dc.citation.startPage1850-
dc.citation.endPage1859.e4-
dc.identifier.bibliographicCitationCLINICAL GASTROENTEROLOGY AND HEPATOLOGY, Vol.17(9) : 1850-1859.e4, 2019-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

qrcode

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.