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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

Clinical and Molecular Hepatology 2021년 27권 2호 p.346 ~ 359
송도선, 김원, 안상훈, 임형준, 장재영, 권영오, 조용균, 김윤정, 홍건영, 김동준, 정영걸, 손주현, 이진우, 박성재, 이병석, 김주현, 김홍수, 윤승규, 김문영, 이관식, 임영석, 이완식, 양진모, 김균환, 한광협, 엄순호,
소속 상세정보
송도선 ( Song Do-Seon ) - Catholic University College of Medicine St. Vincent’s Hospital Department of Internal Medicine
김원 ( Kim Won ) - Seoul National University College of Medicine SMG-SNU Boramae Medical Center Department of Internal Medicine
안상훈 ( Ahn Sang-Hoon ) - Yonsei University College of Medicine Department of Internal Medicine
임형준 ( Yim Hyung-Joon ) - Korea University College of Medicine Department of Internal Medicine
장재영 ( Jang Jae-Young ) - Soonchunhyang University College of Medicine Department of Internal Medicine
권영오 ( Kweon Young-Oh ) - Kyungpook National University School of Medicine Department of Internal Medicine
조용균 ( Cho Yong-Kyun ) - Sungkyunkwan University School of Medicine Kangbuk Samsung Hospital Department of Internal Medicine
김윤정 ( Kim Yoon-Jung ) - Seoul National University College of Medicine Department of Internal Medicine
홍건영 ( Hong Gun-Young ) - Kwangju Christian Hospital Department of Internal Medicine
김동준 ( Kim Dong-Joon ) - Hallym University College of Medicine Department of Internal Medicine
정영걸 ( Jung Young-Kul ) - Korea University College of Medicine Department of Internal Medicine
손주현 ( Sohn Joo-Hyun ) - Hanyang University College of Medicine Department of Internal Medicine
이진우 ( Lee Jin-Woo ) - Inha University School of Medicine Department of Internal Medicine
박성재 ( Park Sung-Jae ) - Inje University College of Medicine Busan Paik Hospital Department of Internal Medicine
이병석 ( Lee Byung-Seok ) - Chungnam National University School of Medicine Department of Internal Medicine
김주현 ( Kim Ju-Hyun ) - Gachon University College of Medicine Department of Internal Medicine
김홍수 ( Kim Hong-Soo ) - Soonchunhyang University College of Medicine Department of Internal Medicine
윤승규 ( Yoon Seung-Kew ) - Catholic University College of Medicine Seoul St. Mary’s Hospital Department of Internal Medicine
김문영 ( Kim Moon-Young ) - Yonsei University Wonju College of Medicine Department of Internal Medicine
이관식 ( Lee Kwan-Sik ) - Yonsei University College of Medicine Department of Internal Medicine
임영석 ( Lim Young-Suk ) - University of Ulsan College of Medicine Asan Medical Center Department of Gastroenterology
이완식 ( Lee Wan-Sik ) - Chonnam National University Medical School Department of Internal Medicine
양진모 ( Yang Jin-Mo ) - Catholic University College of Medicine St. Vincent’s Hospital Department of Internal Medicine
김균환 ( Kim Kyun-Hwan ) - Sungkyunkwan University School of Medicine Department of Precision Medicine
한광협 ( Han Kwang-Hyub ) - Yonsei University College of Medicine Department of Internal Medicine
엄순호 ( Um Soon-Ho ) - Korea University College of Medicine Department of Internal Medicine

Abstract


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).

키워드

Besifovir; Hepatitis B, Chronic; Drug resistance; Bone mineral density; Nephrotoxicity

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