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KMID : 1040620210270020346
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Clinical and Molecular Hepatology
2021 Volume.27 No. 2 p.346 ~ p.359
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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
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Song Do-Seon
Kim Won
Ahn Sang-Hoon
Yim Hyung-Joon
Jang Jae-Young
Kweon Young-Oh
Cho Yong-Kyun
Kim Yoon-Jung
Hong Gun-Young
Kim Dong-Joon
Jung Young-Kul
Sohn Joo-Hyun
Lee Jin-Woo
Park Sung-Jae
Lee Byung-Seok
Kim Ju-Hyun
Kim Hong-Soo
Yoon Seung-Kew
Kim Moon-Young
Lee Kwan-Sik
Lim Young-Suk
Lee Wan-Sik
Yang Jin-Mo
Kim Kyun-Hwan
Han Kwang-Hyub
Um Soon-Ho
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Abstract
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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.
Conclusions: 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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KEYWORD
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Besifovir, Hepatitis B, Chronic, Drug resistance, Bone mineral density, Nephrotoxicity
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