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Continuing besifovir dipivoxil maleate versus switching from tenofovir disoproxil fumarate for treatment of chronic hepatitis B: Results of 192-week phase 3 trial

 Do Seon Song  ;  Won Kim  ;  Sang Hoon Ahn  ;  Hyung Joon Yim  ;  Jae Young Jang  ;  Young Oh Kweon  ;  Yong Kyun Cho  ;  Yoon Jun Kim  ;  Gun Young Hong  ;  Dong Joon Kim  ;  Young Kul Jung  ;  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  ;  Jin Mo Yang  ;  Kyun-Hwan Kim  ;  Kwang-Hyub Han  ;  Soon Ho Um 
 CLINICAL AND MOLECULAR HEPATOLOGY, Vol.27(2) : 346-359, 2021-04 
Journal Title
Issue Date
Adult ; Antiviral Agents / therapeutic use ; DNA, Viral ; Drug Resistance, Viral ; Female ; Guanine / analogs & derivatives* ; Guanine / therapeutic use ; Hepatitis B e Antigens ; Hepatitis B virus ; Hepatitis B, Chronic* / drug therapy ; Humans ; Male ; Middle Aged ; Organophosphonates / therapeutic use* ; Tenofovir / therapeutic use ; Treatment Outcome ; Viral Load
Besifovir ; Bone mineral density ; Drug resistance ; Hepatitis B, Chronic ; Nephrotoxicity
Background/aims: Besifovir dipivoxil maleate (BSV), an acyclic nucleotide phosphonate, shows potent antiviral activity against hepatitis B virus. Our previous 48-week trial revealed that BSV has comparable antiviral efficacy to tenofovir disoproxil fumarate (TDF) and better safety profiles in terms of improved renal and bone safety. This extension study evaluated the prolonged efficacy and safety of BSV in treatment-naive chronic hepatitis B patients.

Methods: Patients continued to participate in an open-label BSV study after an initial 48-week double-blind comparison of BSV and TDF treatment. The antiviral efficacy and drug safety was evaluated up to 192 weeks in two groups: patients continuing BSV treatment (BSV-BSV) and patients switching from TDF to BSV after 48 weeks (TDF-BSV).

Results: Among 197 patients receiving randomized treatments, 170 (86%) entered the open-label phase and 152 (77%) entered the 192-week extension study. Virological response rates over 192 weeks were 92.50% and 93.06% in the BSV-BSV and TDF-BSV groups, respectively (P=0.90). Hepatitis B envelop antigen seroconversion and alanine aminotransferase normalization rates were similar between the groups (P=0.75 and P=0.36, respectively). There were no drug-resistant mutations to BSV. Bone mineral density and renal function were well preserved in the BSV-BSV group, whereas these initially worsened then recovered after switching therapy in the TDF-BSV group.

Conclusion: BSV maintained potent antiviral efficacy after 192 weeks and showed no evidence of drug resistance. BSV was safe, well tolerated, and effective in patients who switched from TDF to BSV. Trial Registration Number: NCT01937806 (date: 10 Sep 2013).
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Ahn, Sang Hoon(안상훈) ORCID logo https://orcid.org/0000-0002-3629-4624
Lee, Kwan Sik(이관식) ORCID logo https://orcid.org/0000-0002-3672-1198
Han, Kwang-Hyub(한광협) ORCID logo https://orcid.org/0000-0003-3960-6539
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