Cited 14 times in
Besifovir Dipivoxil Maleate 144-Week Treatment of Chronic Hepatitis B: An Open-Label Extensional Study of a Phase 3 Trial
DC Field | Value | Language |
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dc.contributor.author | 안상훈 | - |
dc.date.accessioned | 2020-12-01T17:09:30Z | - |
dc.date.available | 2020-12-01T17:09:30Z | - |
dc.date.issued | 2020-08 | - |
dc.identifier.issn | 0002-9270 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/180148 | - |
dc.description.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. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Nature Pub. Group | - |
dc.relation.isPartOf | AMERICAN JOURNAL OF GASTROENTEROLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Antiviral Agents / administration & dosage | - |
dc.subject.MESH | Antiviral Agents / therapeutic use* | - |
dc.subject.MESH | Bone Density | - |
dc.subject.MESH | Double-Blind Method | - |
dc.subject.MESH | Drug Administration Schedule | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Guanine / administration & dosage | - |
dc.subject.MESH | Guanine / analogs & derivatives* | - |
dc.subject.MESH | Guanine / therapeutic use | - |
dc.subject.MESH | Hepatitis B virus | - |
dc.subject.MESH | Hepatitis B, Chronic / blood | - |
dc.subject.MESH | Hepatitis B, Chronic / drug therapy* | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Organophosphonates / administration & dosage | - |
dc.subject.MESH | Organophosphonates / therapeutic use* | - |
dc.subject.MESH | Republic of Korea | - |
dc.subject.MESH | Tenofovir / administration & dosage | - |
dc.subject.MESH | Tenofovir / therapeutic use | - |
dc.subject.MESH | Treatment Outcome | - |
dc.subject.MESH | Viral Load | - |
dc.title | Besifovir Dipivoxil Maleate 144-Week Treatment of Chronic Hepatitis B: An Open-Label Extensional Study of a Phase 3 Trial | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Hyung Joon Yim | - |
dc.contributor.googleauthor | Won Kim | - |
dc.contributor.googleauthor | Sang Hoon Ahn | - |
dc.contributor.googleauthor | Jin Mo Yang | - |
dc.contributor.googleauthor | Jae Young Jang | - |
dc.contributor.googleauthor | Yong Oh Kweon | - |
dc.contributor.googleauthor | Yong Kyun Cho | - |
dc.contributor.googleauthor | Yoon Jun Kim | - |
dc.contributor.googleauthor | Gun Young Hong | - |
dc.contributor.googleauthor | Dong Joon Kim | - |
dc.contributor.googleauthor | Young Kul Jung | - |
dc.contributor.googleauthor | Soon Ho Um | - |
dc.contributor.googleauthor | Joo Hyun Sohn | - |
dc.contributor.googleauthor | Jin Woo Lee | - |
dc.contributor.googleauthor | Sung Jae Park | - |
dc.contributor.googleauthor | Byung Seok Lee | - |
dc.contributor.googleauthor | Ju Hyun Kim | - |
dc.contributor.googleauthor | Hong Soo Kim | - |
dc.contributor.googleauthor | Seung Kew Yoon | - |
dc.contributor.googleauthor | Moon Young Kim | - |
dc.contributor.googleauthor | Kwan Sik Lee | - |
dc.contributor.googleauthor | Young Suk Lim | - |
dc.contributor.googleauthor | Wan Sik Lee | - |
dc.contributor.googleauthor | Kwang-Hyub Han | - |
dc.identifier.doi | 10.14309/ajg.0000000000000605 | - |
dc.contributor.localId | A02226 | - |
dc.relation.journalcode | J00081 | - |
dc.identifier.eissn | 1572-0241 | - |
dc.identifier.pmid | 32355123 | - |
dc.contributor.alternativeName | Ahn, Sang Hoon | - |
dc.contributor.affiliatedAuthor | 안상훈 | - |
dc.citation.volume | 115 | - |
dc.citation.number | 8 | - |
dc.citation.startPage | 1217 | - |
dc.citation.endPage | 1225 | - |
dc.identifier.bibliographicCitation | AMERICAN JOURNAL OF GASTROENTEROLOGY, Vol.115(8) : 1217-1225, 2020-08 | - |
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