Clinical and Molecular Hepatology (Jul 2025)
Switching to besifovir in patients with chronic hepatitis B receiving tenofovir disoproxil fumarate: A randomized trial
- Hyung Joon Yim,
- Yeon Seok Seo,
- Ji Hoon Kim,
- Won Kim,
- Young Kul Jung,
- Jae Young Jang,
- Sae Hwan Lee,
- Yun Soo Kim,
- Chang Wook Kim,
- Hyoung Su Kim,
- Jae-Jun Shim,
- Eun-Young Cho,
- In Hee Kim,
- Byung Seok Lee,
- Jeong-Hoon Lee,
- Byung Seok Kim,
- Jeong Won Jang,
- Hyun Woong Lee,
- Jung Hyun Kwon,
- Moon Young Kim,
- Do Seon Song,
- Jung Gil Park,
- Yoon Seok Lee,
- Eileen L. Yoon,
- Han Ah Lee,
- Seong Hee Kang,
- Jin Mo Yang
Affiliations
- Hyung Joon Yim
- Department of Internal Medicine, Korea University Ansan Hospital, Ansanl, Korea
- Yeon Seok Seo
- Department of Internal Medicine, Korea University Anam Hospital, Seoul, Korea
- Ji Hoon Kim
- Department of Internal Medicine, Korea University Guro Hospital, Seoull, Korea
- Won Kim
- Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Korea
- Young Kul Jung
- Department of Internal Medicine, Korea University Ansan Hospital, Ansanl, Korea
- Jae Young Jang
- Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Seoul, Korea
- Sae Hwan Lee
- Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Korea
- Yun Soo Kim
- Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea
- Chang Wook Kim
- Department of Internal Medicine, The Catholic University of Korea, Uijeongbu St. Mary’s Hospital, Uijeongbu, Korea
- Hyoung Su Kim
- Internal Medicine, Hallym University, Kangdong Sacred Heart Hospital, Seoul, Korea
- Jae-Jun Shim
- Department of Internal Medicine, Kyung Hee University Hospital, Seoul, Korea
- Eun-Young Cho
- Department of Internal Medicine, Wonkwang University Hospital, Iksan, Korea
- In Hee Kim
- Department of Internal Medicine, Jeonbuk National University Hospital, Jeonju, Korea
- Byung Seok Lee
- Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Korea
- Jeong-Hoon Lee
- Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea
- Byung Seok Kim
- Department of Internal Medicine, Daegu Catholic University Medical Center, Daegu, Korea
- Jeong Won Jang
- Department of Internal Medicine, The Catholic University of Korea, Seoul St. Mary’s Hospital, Seoul, Korea
- Hyun Woong Lee
- Department of Internal Medicine, Yonsei University Gangnam Severance Hospital, Seoul, Korea
- Jung Hyun Kwon
- Department of Internal Medicine, The Catholic University of Korea, Incheon St. Mary’s Hospital, Incheon, Korea
- Moon Young Kim
- Department of Internal Medicine, Yonsei University Wonju Severance Christian Hospital, Wonju, Korea
- Do Seon Song
- Department of Internal Medicine, The Catholic University of Korea, St. Vincent’s Hospital, Suwon, Korea
- Jung Gil Park
- Department of Internal Medicine, Yeungnam University Hospital, Daegu, Korea
- Yoon Seok Lee
- Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea
- Eileen L. Yoon
- Department of Internal Medicine, Inje University Sanggye Paik Hospital, Seoul, Korea
- Han Ah Lee
- Department of Internal Medicine, Chung-Ang University Hospital, Seoul, Korea
- Seong Hee Kang
- Department of Internal Medicine, Korea University Ansan Hospital, Ansanl, Korea
- Jin Mo Yang
- Department of Internal Medicine, The Catholic University of Korea, St. Vincent’s Hospital, Suwon, Korea
- DOI
- https://doi.org/10.3350/cmh.2024.0819
- Journal volume & issue
-
Vol. 31,
no. 3
pp. 810 – 822
Abstract
Background/Aims Besifovir (BSV) showed comparable antiviral activity and superior safety profiles to tenofovir disoproxil fumarate (TDF) in treatment-naïve chronic hepatitis B (CHB). However, no data are available regarding the antiviral efficacy and safety of BSV in patients with CHB who switched from long-term TDF to BSV. This study aimed to evaluate the outcome of a 48-week BSV therapy in patients with CHB who switched from long-term TDF treatment. Methods In this non-inferiority trial, 153 CHB patients treated with TDF for ≥48 weeks who had hepatitis B virus (HBV) DNA 0.999), with a predefined margin of –0.18. The mean percentage changes in estimated glomerular filtration rates were slightly better in the BSV group (1.67±11.73%) than in the TDF group (–1.24±11.02%). The BSV group showed a significant improvement in bone turnover biomarkers compared to the TDF group; accordingly, hip and spine bone mineral density increased in the BSV group. Conclusions In patients with CHB receiving long-term TDF, switching to BSV may improve renal and bone safety with non-inferior antiviral efficacy compared to that of maintaining TDF.
Keywords
