Besifovir Dipivoxil Maleate 144-Week Treatment of Chronic Hepatitis B: An Open-Label Extensional Study of a Phase 3 Trial
- Title
- Besifovir Dipivoxil Maleate 144-Week Treatment of Chronic Hepatitis B: An Open-Label Extensional Study of a Phase 3 Trial
- Author
- 손주현
- Keywords
- TENOFOVIR DISOPROXIL FUMARATE; VIRUS INFECTION; ENTECAVIR; CIRRHOSIS; LB80380; VACCINATION; LAMIVUDINE; FIBROSIS; REFUGEES; SAFETY
- Issue Date
- 2020-08
- Publisher
- LIPPINCOTT WILLIAMS & WILKINS
- Citation
- AMERICAN JOURNAL OF GASTROENTEROLOGY, v. 115, no. 8, page. 1217-1225
- 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.
- URI
- https://journals.lww.com/ajg/Fulltext/2020/08000/Besifovir_Dipivoxil_Maleate_144_Week_Treatment_of.20.aspxhttps://repository.hanyang.ac.kr/handle/20.500.11754/170270
- ISSN
- 0002-9270; 1572-0241
- DOI
- 10.14309/ajg.0000000000000605
- Appears in Collections:
- COLLEGE OF MEDICINE[S](의과대학) > MEDICINE(의학과) > Articles
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