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
Clin Mol Hepatol 2025;31(3):810-822. Published online January 17, 2025
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 <20 IU/mL were randomized to receive either BSV 150 mg or TDF 300 mg for 48 weeks.
Results The per-protocol analysis included 130 patients (BSV group, 64; TDF group, 66). The median duration of TDF use before enrollment was 4.14 years. After 48 weeks, 100.0% and 98.5% patients in the BSV and TDF groups, respectively, met the primary endpoint (HBV DNA <20 IU/mL), demonstrating the non-inferior antiviral efficacy of BSV to TDF (95% confidence interval –0.01 to 0.04; P>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.
Citations
Citations to this article as recorded by
Correspondence to editorial on “Switching to besifovir in patients with chronic hepatitis B receiving tenofovir disoproxil fumarate: A randomized trial” Hyung Joon Yim, Seong Hee Kang, Young Kul Jung, Jin Mo Yang Clinical and Molecular Hepatology.2026; 32(1): e55. CrossRef
Besifovir: a viable option for long-term disease control in chronic hepatitis B: Editorial on “Switching to besifovir in patients with chronic hepatitis B receiving tenofovir disoproxil fumarate: A randomized trial” Wai-Kay Seto Clinical and Molecular Hepatology.2026; 32(1): 374. CrossRef
Tenofovir amibufenamide in chronic hepatitis B: Lipid changes and 144-week safety with tenofovir disoproxil fumarate-to-tenofovir amibufenamide switch Zhi-Hao Zeng, Jin-Qing Liu, Min Zhang, Cai-Liang Qiu, Zhen-Yu Xu World Journal of Gastroenterology.2025;[Epub] CrossRef
Hyperferritinemia Is Associated with Higher Adiposity, Metabolic Syndrome, and Hepatic Dysfunction, Mainly Affecting Men: A Study in Southern Brazil Késia Zanuzo, Márcia Fernandes Nishiyama, Eloá Angélica Koehnlein, Sabrina Grassiolli Pathophysiology.2025; 32(4): 64. CrossRef
Dual nature of ferritin for hematologic, liver functional, and metabolic parameters in older diabetic patients Jui-Hua Huang, Ren-Hau Li, Leih-Ching Tsai Scientific Reports.2023;[Epub] CrossRef
Prevalence and Crucial Parameters in Diabesity-Related Liver Fibrosis: A Preliminary Study Szymon Suwała, Aleksandra Białczyk, Kinga Koperska, Alicja Rajewska, Magdalena Krintus, Roman Junik Journal of Clinical Medicine.2023; 12(24): 7760. CrossRef
Noninvasive Differential Diagnosis of Liver Iron Contents in Nonalcoholic Steatohepatitis and Simple Steatosis Using Multiecho Dixon Magnetic Resonance Imaging Tae-Hoon Kim, Chang-Won Jeong, Hong Young Jun, Youe Ree Kim, Ju Young Kim, Young Hwan Lee, Kwon-Ha Yoon Academic Radiology.2019; 26(6): 766. CrossRef
Relationship between lifestyle factors and nutritional status and non-alcoholic fatty liver disease among a group of adult Jordanians Reema Fayez Tayyem, Hanaa Mahmoud Al-Dayyat, Yaser Mohammed Rayyan Arab Journal of Gastroenterology.2019; 20(1): 44. CrossRef
The impact of liver steatosis on the ability of serum ferritin levels to be predictive of liver iron concentration in non‐transfusion‐dependent thalassaemia patients Paolo Ricchi, Antonella Meloni, Anna Spasiano, Silvia Costantini, Alessia Pepe, Patrizia Cinque, Aldo Filosa British Journal of Haematology.2018; 180(5): 721. CrossRef
Nonalcoholic Fatty Liver Disease Patrick H. Sweet, Teresa Khoo, Steven Nguyen Primary Care: Clinics in Office Practice.2017; 44(4): 599. CrossRef
Liver ergothioneine accumulation in a guinea pig model of non-alcoholic fatty liver disease. A possible mechanism of defence? Irwin K. Cheah, Richard Tang, Peng Ye, Terry S. Z. Yew, Keith H. C. Lim, Barry Halliwell Free Radical Research.2016; 50(1): 14. CrossRef
Serum ferritin levels predict histological severity in patients with nonalcoholic fatty liver disease in India Pathik Parikh, Jatin Patel, Meghraj Ingle, Prabha Sawant Indian Journal of Gastroenterology.2015; 34(3): 200. CrossRef
Serum ferritin and liver inflammation: which come first? Chicken or egg? Stefano Bellentani Annals of Hepatology.2014; 13(3): 315. CrossRef
First
Prev
