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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 Kim  ;  Kwan Sik Lee  ;  Young Suk Lim  ;  Wan Sik Lee  ;  Kwang-Hyub Han 
 AMERICAN JOURNAL OF GASTROENTEROLOGY, Vol.115(8) : 1217-1225, 2020-08 
Journal Title
Issue Date
Adult ; Antiviral Agents / administration & dosage ; Antiviral Agents / therapeutic use* ; Bone Density ; Double-Blind Method ; Drug Administration Schedule ; Female ; Guanine / administration & dosage ; Guanine / analogs & derivatives* ; Guanine / therapeutic use ; Hepatitis B virus ; Hepatitis B, Chronic / blood ; Hepatitis B, Chronic / drug therapy* ; Humans ; Male ; Middle Aged ; Organophosphonates / administration & dosage ; Organophosphonates / therapeutic use* ; Republic of Korea ; Tenofovir / administration & dosage ; Tenofovir / therapeutic use ; Treatment Outcome ; Viral Load
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.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
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Ahn, Sang Hoon(안상훈) ORCID logo https://orcid.org/0000-0002-3629-4624
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