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 | Yim, Hyung Joon | - |
dc.contributor.author | Kim, Won | - |
dc.contributor.author | Ahn, Sang Hoon | - |
dc.contributor.author | Yang, Jin Mo | - |
dc.contributor.author | Jang, Jae Young | - |
dc.contributor.author | Kweon, Yong Oh | - |
dc.contributor.author | Cho, Yong Kyun | - |
dc.contributor.author | Kim, Yoon Jun | - |
dc.contributor.author | Hong, Gun Young | - |
dc.contributor.author | Kim, Dong Joon | - |
dc.contributor.author | Jung, Young Kul | - |
dc.contributor.author | Um, Soon Ho | - |
dc.contributor.author | Sohn, Joo Hyun | - |
dc.contributor.author | Lee, Jin Woo | - |
dc.contributor.author | Park, Sung Jae | - |
dc.contributor.author | Lee, Byung Seok | - |
dc.contributor.author | Kim, Ju Hyun | - |
dc.contributor.author | Kim, Hong Soo | - |
dc.contributor.author | Yoon, Seung Kew | - |
dc.contributor.author | Kim, Moon Young | - |
dc.contributor.author | Lee, Kwan Sik | - |
dc.contributor.author | Lim, Young Suk | - |
dc.contributor.author | Lee, Wan Sik | - |
dc.contributor.author | Han, Kwang-Hyub | - |
dc.date.available | 2020-12-09T08:50:57Z | - |
dc.date.issued | 2020-08 | - |
dc.identifier.issn | 0002-9270 | - |
dc.identifier.issn | 1572-0241 | - |
dc.identifier.uri | https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/33845 | - |
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.format.extent | 9 | - |
dc.language | 영어 | - |
dc.language.iso | ENG | - |
dc.publisher | NLM (Medline) | - |
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.publisher.location | 미국 | - |
dc.identifier.doi | 10.14309/ajg.0000000000000605 | - |
dc.identifier.scopusid | 2-s2.0-85089171378 | - |
dc.identifier.wosid | 000619500100018 | - |
dc.identifier.bibliographicCitation | American Journal of Gastroenterology, v.115, no.8, pp 1217 - 1225 | - |
dc.citation.title | American Journal of Gastroenterology | - |
dc.citation.volume | 115 | - |
dc.citation.number | 8 | - |
dc.citation.startPage | 1217 | - |
dc.citation.endPage | 1225 | - |
dc.type.docType | Article | - |
dc.description.isOpenAccess | N | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Gastroenterology & Hepatology | - |
dc.relation.journalWebOfScienceCategory | Gastroenterology & Hepatology | - |
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