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Continuing besifovir dipivoxil maleate versus switching from tenofovir disoproxil fumarate for treatment of chronic hepatitis B: Results of 192-week phase 3 trial

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dc.contributor.author안상훈-
dc.contributor.author이관식-
dc.contributor.author한광협-
dc.date.accessioned2022-01-26T01:55:52Z-
dc.date.available2022-01-26T01:55:52Z-
dc.date.issued2021-04-
dc.identifier.issn2287-2728-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/187388-
dc.description.abstractBackground/aims: Besifovir dipivoxil maleate (BSV), an acyclic nucleotide phosphonate, shows potent antiviral activity against hepatitis B virus. Our previous 48-week trial revealed that BSV has comparable antiviral efficacy to tenofovir disoproxil fumarate (TDF) and better safety profiles in terms of improved renal and bone safety. This extension study evaluated the prolonged efficacy and safety of BSV in treatment-naive chronic hepatitis B patients. Methods: Patients continued to participate in an open-label BSV study after an initial 48-week double-blind comparison of BSV and TDF treatment. The antiviral efficacy and drug safety was evaluated up to 192 weeks in two groups: patients continuing BSV treatment (BSV-BSV) and patients switching from TDF to BSV after 48 weeks (TDF-BSV). Results: Among 197 patients receiving randomized treatments, 170 (86%) entered the open-label phase and 152 (77%) entered the 192-week extension study. Virological response rates over 192 weeks were 92.50% and 93.06% in the BSV-BSV and TDF-BSV groups, respectively (P=0.90). Hepatitis B envelop antigen seroconversion and alanine aminotransferase normalization rates were similar between the groups (P=0.75 and P=0.36, respectively). There were no drug-resistant mutations to BSV. Bone mineral density and renal function were well preserved in the BSV-BSV group, whereas these initially worsened then recovered after switching therapy in the TDF-BSV group. Conclusion: BSV maintained potent antiviral efficacy after 192 weeks and showed no evidence of drug resistance. BSV was safe, well tolerated, and effective in patients who switched from TDF to BSV. Trial Registration Number: NCT01937806 (date: 10 Sep 2013).-
dc.description.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherKorean Association for the Study of the Liver-
dc.relation.isPartOfCLINICAL AND MOLECULAR HEPATOLOGY-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.subject.MESHAdult-
dc.subject.MESHAntiviral Agents / therapeutic use-
dc.subject.MESHDNA, Viral-
dc.subject.MESHDrug Resistance, Viral-
dc.subject.MESHFemale-
dc.subject.MESHGuanine / analogs & derivatives*-
dc.subject.MESHGuanine / therapeutic use-
dc.subject.MESHHepatitis B e Antigens-
dc.subject.MESHHepatitis B virus-
dc.subject.MESHHepatitis B, Chronic* / drug therapy-
dc.subject.MESHHumans-
dc.subject.MESHMale-
dc.subject.MESHMiddle Aged-
dc.subject.MESHOrganophosphonates / therapeutic use*-
dc.subject.MESHTenofovir / therapeutic use-
dc.subject.MESHTreatment Outcome-
dc.subject.MESHViral Load-
dc.titleContinuing besifovir dipivoxil maleate versus switching from tenofovir disoproxil fumarate for treatment of chronic hepatitis B: Results of 192-week phase 3 trial-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorDo Seon Song-
dc.contributor.googleauthorWon Kim-
dc.contributor.googleauthorSang Hoon Ahn-
dc.contributor.googleauthorHyung Joon Yim-
dc.contributor.googleauthorJae Young Jang-
dc.contributor.googleauthorYoung Oh Kweon-
dc.contributor.googleauthorYong Kyun Cho-
dc.contributor.googleauthorYoon Jun Kim-
dc.contributor.googleauthorGun Young Hong-
dc.contributor.googleauthorDong Joon Kim-
dc.contributor.googleauthorYoung Kul Jung-
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.googleauthorKwan Sik Lee-
dc.contributor.googleauthorYoung Suk Lim-
dc.contributor.googleauthorWan Sik Lee-
dc.contributor.googleauthorJin Mo Yang-
dc.contributor.googleauthorKyun-Hwan Kim-
dc.contributor.googleauthorKwang-Hyub Han-
dc.contributor.googleauthorSoon Ho Um-
dc.identifier.doi10.3350/cmh.2020.0307-
dc.contributor.localIdA02226-
dc.contributor.localIdA02666-
dc.contributor.localIdA04268-
dc.relation.journalcodeJ00557-
dc.identifier.eissn2287-285X-
dc.identifier.pmid33493393-
dc.subject.keywordBesifovir-
dc.subject.keywordBone mineral density-
dc.subject.keywordDrug resistance-
dc.subject.keywordHepatitis B, Chronic-
dc.subject.keywordNephrotoxicity-
dc.contributor.alternativeNameAhn, Sang Hoon-
dc.contributor.affiliatedAuthor안상훈-
dc.contributor.affiliatedAuthor이관식-
dc.contributor.affiliatedAuthor한광협-
dc.citation.volume27-
dc.citation.number2-
dc.citation.startPage346-
dc.citation.endPage359-
dc.identifier.bibliographicCitationCLINICAL AND MOLECULAR HEPATOLOGY, Vol.27(2) : 346-359, 2021-04-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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