Besifovir Dipivoxil Maleate 144-Week Treatment of Chronic Hepatitis B: An Open-Label Extensional Study of a Phase 3 Trial

Hyung Joon Yim, Won Kim, Sang Hoon Ahn, Jin Mo Yang, Jae Young Jang, Yong Oh Kweon, Yong Kyun Cho, Yoon Jun Kim, Gun Young Hong, Dong Joon Kim, Young Kul Jung, Soon Ho Um, Joo Hyun Sohn, Jin Woo Lee, Sung Jae Park, Byung Seok Lee, Ju Hyun Kim, Hong Soo Kim, Seung Kew Yoon, Moon Young KimKwan Sik Lee, Young Suk Lim, Wan Sik Lee, Kwang Hyub Han

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)1217-1225
Number of pages9
JournalThe American journal of gastroenterology
Volume115
Issue number8
DOIs
Publication statusPublished - 2020 Aug 1

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Gastroenterology

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    Yim, H. J., Kim, W., Ahn, S. H., Yang, J. M., Jang, J. Y., Kweon, Y. O., Cho, Y. K., Kim, Y. J., Hong, G. Y., Kim, D. J., Jung, Y. K., Um, S. H., Sohn, J. H., Lee, J. W., Park, S. J., Lee, B. S., Kim, J. H., Kim, H. S., Yoon, S. K., ... Han, K. H. (2020). Besifovir Dipivoxil Maleate 144-Week Treatment of Chronic Hepatitis B: An Open-Label Extensional Study of a Phase 3 Trial. The American journal of gastroenterology, 115(8), 1217-1225. https://doi.org/10.14309/ajg.0000000000000605