Besifovir Dipivoxil Maleate 144-Week Treatment of Chronic Hepatitis B: An Open-Label Extensional Study of a Phase 3 Trial
- 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.
- All Author(s)
- H. J. Yim
; W. Kim
; S. H. Ahn
; J. M. Yang
; J. Y. Jang
; Y. O. Kweon
; Y. K. Cho
; Y. J. Kim
; G. Y. Hong
; D. J. Kim
; Y. K. Jung
; S. H. Um
; J. H. Sohn
; J. W. Lee
; S. J. Park
; B. S. Lee
; J. H. Kim
; H. S. Kim
; S. K. Yoon
; M. Y. Kim
; K. S. Lee
; Y. S. Lim
; W. S. Lee
; K. H. Han
- Issued Date
- 2020
- Type
- Article
- Keyword
- Adult; Antiviral Agents/administration & dosage/*therapeutic use; Bone Density; Double-Blind Method; Drug Administration Schedule; Female; Guanine/administration & dosage/*analogs & derivatives/therapeutic use; Hepatitis B virus; Hepatitis B, Chronic/blood/*drug therapy; Humans; Male; Middle Aged; Organophosphonates/administration & dosage/*therapeutic use; Republic of Korea; Tenofovir/administration & dosage/therapeutic use; Treatment Outcome; Viral Load
- ISSN
- 0002-9270
- Citation Title
- The American Journal of Gastroenterology
- Citation Volume
- 115
- Citation Number
- 8
- Citation Start Page
- 1217
- Citation End Page
- 1225
- Language(ISO)
- eng
- DOI
- 10.14309/ajg.0000000000000605
- URI
- http://schca-ir.schmc.ac.kr/handle/2022.oak/1008
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