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Clin. Mol. Hepatol., Jan 17 2025, | https://doi.org/10.3350/cmh.2024.0819
Switching to Besifovir in Patients with Chronic Hepatitis B Receiving Tenofovir Disoproxil Fumarate: A Randomized Trial
Hyung Joon Yim1, Yeon Seok Seo2, Ji Hoon Kim3, Won Kim4, Young Kul Jung1, Jae Young Jang5, Sae Hwan Lee6, Yun Soo Kim7, Chang Wook Kim8, Hyoung Su Kim9, Jae-Jun Shim10, Eun-Young Cho11, In Hee Kim12, Byung Seok Lee13, Jeong-Hoon Lee14, Byung Seok Kim15, Jeong Won Jang16, Hyun Woong Lee17, Jung Hyun Kwon18, Moon Young Kim19, Do Seon Song20, Jung Gil Park21, Yoon Seok Lee7, Eileen L. Yoon22,23, Han Ah Lee24, Seong Hee Kang1, Jin Mo Yang20
1Department of Internal Medicine, Korea University Ansan Hospital, Ansan, Korea
2Department of Internal Medicine, Korea University Anam Hospital, Seoul, Korea
3Department of Internal Medicine, Korea University Guro Hospital, Seoul, Korea
4Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Korea
5Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Seoul, Korea
6Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Korea
7Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea
8Department of Internal Medicine, Uijeongbu St.Mary's Hospital, The Catholic University of Korea, Seoul, Korea
9Internal Medicine, Kangdong Sacred Heart Hospital of Hallym University Medical Center, Seoul, Korea
10Department of Internal Medicine, Kyunghee University Hospital, Seoul, Korea
11Department of Internal Medicine, Wonkwang University Hospital, Iksan, Korea
12Department of Internal Medicine, Jeonbuk National University Hospital, Jeonju, Korea
13Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Korea
14Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea
15Department of Internal Medicine, Daegu Catholic University Medical Center, Daegu, Korea
16Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea
17Department of Internal Medicine, Yonsei University Gangnam Severance Hospital, Seoul, Korea
18Department of Internal Medicine, Incheon St. Mary's Hospital, The Catholic University of Korea, Incheon, Korea
19Department of Internal Medicine, Yonsei University Wonju Severance Christian Hospital, Wonju, Korea
20Department of Internal Medicine, St. Vincent's Hospital, The Catholic University of Korea, Suwon, Korea
21Department of Internal Medicine, Yeungnam University Hospital, Daegu, Korea
22Department of Internal Medicine, Inje University Sanggye Paik Hospital, Seoul, Korea
23Department of Internal Medicine, Hanyang University Seoul Hospital, Seoul, Korea
24Department of Internal Medicine, Chung-Ang University Hospital, Seoul, Korea
Correspondence : Hyung Joon Yim, Jin Mo Yang
1Department of Internal Medicine, Korea University Ansan Hospital, Ansan, Korea
2Department of Internal Medicine, Korea University Anam Hospital, Seoul, Korea
3Department of Internal Medicine, Korea University Guro Hospital, Seoul, Korea
4Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Korea
5Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Seoul, Korea
6Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Korea
7Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea
8Department of Internal Medicine, Uijeongbu St.Mary's Hospital, The Catholic University of Korea, Seoul, Korea
9Internal Medicine, Kangdong Sacred Heart Hospital of Hallym University Medical Center, Seoul, Korea
10Department of Internal Medicine, Kyunghee University Hospital, Seoul, Korea
11Department of Internal Medicine, Wonkwang University Hospital, Iksan, Korea
12Department of Internal Medicine, Jeonbuk National University Hospital, Jeonju, Korea
13Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Korea
14Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea
15Department of Internal Medicine, Daegu Catholic University Medical Center, Daegu, Korea
16Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea
17Department of Internal Medicine, Yonsei University Gangnam Severance Hospital, Seoul, Korea
18Department of Internal Medicine, Incheon St. Mary's Hospital, The Catholic University of Korea, Incheon, Korea
19Department of Internal Medicine, Yonsei University Wonju Severance Christian Hospital, Wonju, Korea
20Department of Internal Medicine, St. Vincent's Hospital, The Catholic University of Korea, Suwon, Korea
21Department of Internal Medicine, Yeungnam University Hospital, Daegu, Korea
22Department of Internal Medicine, Inje University Sanggye Paik Hospital, Seoul, Korea
23Department of Internal Medicine, Hanyang University Seoul Hospital, Seoul, Korea
24Department of Internal Medicine, Chung-Ang University Hospital, Seoul, Korea
Correspondence : Hyung Joon Yim, Jin Mo Yang
Abstract
Background/Aims
Besifovir (BSV) showed comparable antiviral activity 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% CI -0.01 to 0.04; P=1.000), 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. ClinicalTrials.gov Identifier: NCT04202536
Besifovir (BSV) showed comparable antiviral activity 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% CI -0.01 to 0.04; P=1.000), 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. ClinicalTrials.gov Identifier: NCT04202536
논문정보
- Research article
- 2025년 01월 (BRIC 등록일 2025-01-22)
- 국내 연구진
- 의약학 > 응용의학
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