Clinical and Molecular Hepatology

"Young Suk Lim"

Original Articles

Viral hepatitis

Continuing besifovir dipivoxil maleate versus switching from tenofovir disoproxil fumarate for treatment of chronic hepatitis B: Results of 192-week phase 3 trial: Do Seon Song, Won Kim, Sang Hoon Ahn, Hyung Joon Yim, Jae Young Jang, Young Oh Kweon, Yong Kyun Cho, Yoon Jun Kim, Gun Young Hong, Dong Joon Kim, Young Kul Jung, Joo Hyun Sohn, Jin-Woo Lee, Sung Jae Park, Byung Seok Lee, Ju Hyun Kim, Hong Soo Kim, Seung Kew Yoon, Moon Young Kim, Kwan Sik Lee, Young Suk Lim, Wan Sik Lee, Jin Mo Yang, Kyun-Hwan Kim, Kwang-Hyub Han, Soon Ho Um; Clin Mol Hepatol 2021;27(2):346-359.
Published online January 25, 2021; DOI: https://doi.org/10.3350/cmh.2020.0307

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).

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
Prodrug strategies in developing antiviral nucleoside analogs
R. Rama Suresh, Tuniyazi Abuduani, Mahesh Kasthuri, Zhe Chen, Zahira Tber, Mohammed Loubidi, HongWang Zhang, Longhu Zhou, Shaoman Zhou, Chenwei Li, Amita Kumari, Sijia Tao, John M. Wiseman, Selwyn J. Hurwitz, Franck Amblard, Raymond F. Schinazi
RSC Medicinal Chemistry.2026; 17(1): 105. CrossRef
Comparison of hepatocellular carcinoma incidence after long-term treatment with besifovir vs. tenofovir AF
Hyuk Kim, Jae-Young Kim, Yoon E. Shin, Hye-Jin Yoo, Jeong-Ju Yoo, Sang Gyune Kim, Young-Seok Kim
Scientific Reports.2025;[Epub] CrossRef
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 Wo
Clinical and Molecular Hepatology.2025; 31(3): 810. CrossRef
Besifovir dipivoxil maleate versus other antivirals in reducing hepatocellular carcinoma in chronic hepatitis B
Jae Seung Lee, Sung Won Lee, Hae Lim Lee, Jeong-Ju Yoo, Yeon Seok Seo, Su Jong Yu, Hyung Joon Yim, Young Kul Jung, Jisu Moon, Hye Won Lee, Mi Na Kim, Beom Kyung Kim, Jun Yong Park, Do Young Kim, Sang Hoon Ahn, Sang Gyune Kim, Seung Up Kim
Scientific Reports.2025;[Epub] CrossRef
Comparative Renal Safety of Besifovir Dipivoxil Maleate and Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients: Insights From a Nationwide Cohort Study
Hyun Bin Choi, Jae Young Kim, Jeong-Ju Yoo, Sang Gyune Kim, Young-Seok Kim
Journal of Korean Medical Science.2025;[Epub] CrossRef
Statin use is associated with better post‐operative prognosis among patients with hepatitis B virus‐related hepatocellular carcinoma
Byungyoon Yun, Sang Hoon Ahn, Juyeon Oh, Jin‐Ha Yoon, Beom Kyung Kim
European Journal of Clinical Investigation.2023;[Epub] CrossRef
Comparison of decline in renal function between patients with chronic hepatitis B with or without antiviral therapy
Jae Seung Lee, Chan‐Young Jung, Jung Il Lee, Sang Hoon Ahn, Beom Seok Kim, Seung Up Kim
Alimentary Pharmacology & Therapeutics.2023; 58(1): 99. CrossRef
Tenofovir versus entecavir on the prognosis of hepatitis B virus-related hepatocellular carcinoma: a systematic review and meta-analysis
Hui Liu, Cheng-Long Han, Bao-Wen Tian, Zi-Niu Ding, Ya-Fei Yang, Yun-Long Ma, Chun-Cheng Yang, Guang-Xiao Meng, Jun-Shuai Xue, Dong-Xu Wang, Zhao-Ru Dong, Zhi-Qiang Chen, Jian-Guo Hong, Tao Li
Expert Review of Gastroenterology & Hepatology.2023; 17(6): 623. CrossRef
Prediction model of hepatitis B virus-related hepatocellular carcinoma in patients receiving antiviral therapy
Beom Kyung Kim, Sang Hoon Ahn
Journal of the Formosan Medical Association.2023; 122(12): 1238. CrossRef
Identification and Characterization of Besifovir-Resistant Hepatitis B Virus Isolated from a Chronic Hepatitis B Patient
Jong Chul Kim, Hye Young Lee, Ah Ram Lee, Mehrangiz Dezhbord, Da Rae Lee, Seong Ho Kim, Juhee Won, Soree Park, Na Yeon Kim, Jae Jin Shin, Sang Gyune Kim, Young Seok Kim, Jeong-Ju Yoo, Kyun-Hwan Kim
Biomedicines.2022; 10(2): 282. CrossRef
KASL clinical practice guidelines for management of chronic hepatitis B

Clinical and Molecular Hepatology.2022; 28(2): 276. CrossRef
Susceptibility of Drug Resistant Hepatitis B Virus Mutants to Besifovir
Juhee Won, Ah Ram Lee, Mehrangiz Dezhbord, Da Rae Lee, Seong Ho Kim, Jong Chul Kim, Soree Park, Nayeon Kim, Byengjune Jae, Kyun-Hwan Kim
Biomedicines.2022; 10(7): 1637. CrossRef
Besifovir dipivoxil maleate: a novel antiviral agent with low toxicity and high genetic barriers for chronic hepatitis B
Jeong Eun Song, Jun Yong Park
Expert Opinion on Pharmacotherapy.2021; 22(18): 2427. CrossRef
Entecavir versus tenofovir in patients with chronic hepatitis B: Enemies or partners in the prevention of hepatocellular carcinoma
Sung Won Lee, Jonggi Choi, Seung Up Kim, Young-Suk Lim
Clinical and Molecular Hepatology.2021; 27(3): 402. CrossRef

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271 Download
17 Web of Science
Crossref

Viral hepatitis

Efficacy and safety of entecavir versus lamivudine over 5 years of treatment: A randomized controlled trial in Korean patients with hepatitis B e antigen-negative chronic hepatitis B: Kwan Sik Lee, Young-Oh Kweon, Soon-Ho Um, Byung-Ho Kim, Young Suk Lim, Seung Woon Paik, Jeong Heo, Heon-Ju Lee, Dong Joon Kim, Tae Hun Kim, Young-Sok Lee, Kwan Soo Byun, Daeghon Kim, Myung Seok Lee, Kyungha Yu, Dong Jin Suh; Clin Mol Hepatol 2017;23(4):331-339.
Published online September 26, 2017; DOI: https://doi.org/10.3350/cmh.2016.0040

Abstract
PDF

Background/Aims
Long-term data on antiviral therapy in Korean patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (CHB) are limited. This study evaluated the efficacy and safety of entecavir (ETV) and lamivudine (LAM) over 240 weeks.
Methods
Treatment-naive patients with HBeAg-negative CHB were randomized to receive ETV 0.5 mg/day or LAM 100 mg/day during the 96 week double-blind phase, followed by open-label treatment through week 240. The primary endpoint was the proportion of patients with virologic response (VR; hepatitis B virus [HBV] DNA<300 copies/mL) at week 24. Secondary objectives included alanine aminotransferase (ALT) normalization and emergence of ETV resistance (week 96), VR and log reduction in HBV DNA levels (week 240), and safety evaluation.
Results
In total, 120 patients (>16 years old) were included (ETV, n=56; LAM, n=64). Baseline characteristics were comparable between the two groups. A significantly higher proportion of ETV-treated patients achieved VR compared to LAM at week 24 (92.9% vs. 67.2%, P=0.0006), week 96 (94.6% vs. 48.4%, P<0.0001), and week 240 (95.0% vs. 47.6%, P<0.0001). At week 96, ALT normalization was observed in 87.5% and 51.6% of ETV and LAM patients, respectively (P<0.0001). Virologic breakthrough occurred in one patient (1.8%) receiving ETV and 26 patients (42.6%) receiving LAM (P<0.0001) up to week 96. Emergence of resistance to ETV was not detected. The incidence of serious adverse events was low and unrelated to the study medications.
Conclusions
Long-term ETV treatment was superior to LAM, with a significantly higher proportion of patients achieving VR. Both treatments were well tolerated.

Citations

Citations to this article as recorded by

Viral oncogenesis in cancer: from mechanisms to therapeutics
Qing Xiao, Yi Liu, Tingting Li, Chaoyu Wang, Sanxiu He, Liuyue Zhai, Zailin Yang, Xiaomei Zhang, Yongzhong Wu, Yao Liu
Signal Transduction and Targeted Therapy.2025;[Epub] CrossRef
Cost–effectiveness of switching from tenofovir disoproxil fumarate to tenofovir alafenamide versus entecavir for chronic hepatitis B patients in Greece
Emmanouil Sinakos, Nandita Kachru, Christos Tsoulas, Sushanth Jeyakumar, Nathaniel J Smith, Alon Yehoshua, Evangelos Cholongitas
Journal of Comparative Effectiveness Research.2024;[Epub] CrossRef
Entecavir: A Review and Considerations for Its Application in Oncology
Tânia Lourenço, Nuno Vale
Pharmaceuticals.2023; 16(11): 1603. CrossRef
No Difference in Incidence of Hepatocellular Carcinoma in Patients With Chronic Hepatitis B Virus Infection Treated With Entecavir vs Tenofovir
Hyunwoo Oh, Eileen L. Yoon, Dae Won Jun, Sang Bong Ahn, Hyo-Young Lee, Jae Yoon Jeong, Hyoung Su Kim, Soung Won Jeong, Sung Eun Kim, Jae-Jun Shim, Joo Hyun Sohn, Yong Kyun Cho
Clinical Gastroenterology and Hepatology.2020; 18(12): 2793. CrossRef
Adverse events of nucleos(t)ide analogues for chronic hepatitis B: a systematic review
Raquel Scherer de Fraga, Victor Van Vaisberg, Luiz Cláudio Alfaia Mendes, Flair José Carrilho, Suzane Kioko Ono
Journal of Gastroenterology.2020; 55(5): 496. CrossRef
Entecavir and tenofovir on renal function in patients with hepatitis B virus‐related hepatocellular carcinoma
Mi Young Jeon, Jae Seung Lee, Hye Won Lee, Beom Kyung Kim, Jun Yong Park, Do Young Kim, Kwang‐Hyub Han, Sang Hoon Ahn, Seung Up Kim
Journal of Viral Hepatitis.2020; 27(9): 932. CrossRef
Low-level viremia and cirrhotic complications in patients with chronic hepatitis B according to adherence to entecavir
Seung Bum Lee, Joonho Jeong, Jae Ho Park, Seok Won Jung, In Du Jeong, Sung-Jo Bang, Jung Woo Shin, Bo Ryung Park, Eun Ji Park, Neung Hwa Park
Clinical and Molecular Hepatology.2020; 26(3): 364. CrossRef
A comparative network meta-analysis of standard of care treatments in treatment-naïve chronic hepatitis B patients
Urbano Sbarigia, Talitha Vincken, Peter Wigfield, Mahmoud Hashim, Bart Heeg, Maarten Postma
Journal of Comparative Effectiveness Research.2020; 9(15): 1051. CrossRef
Screening for Hepatitis B Virus Infection in Nonpregnant Adolescents and Adults
Roger Chou, Ian Blazina, Christina Bougatsos, Rebecca Holmes, Shelley Selph, Sara Grusing, Janice Jou
JAMA.2020; 324(23): 2423. CrossRef
External validation of the modified PAGE‐B score in Asian chronic hepatitis B patients receiving antiviral therapy
Hye Won Lee, Seung Up Kim, Jun Yong Park, Do Young Kim, Sang Hoon Ahn, Kwang‐Hyub Han, Beom Kyung Kim
Liver International.2019; 39(9): 1624. CrossRef
Antiviral treatment for treatment-naïve chronic hepatitis B: systematic review and network meta-analysis of randomized controlled trials
William W. L. Wong, Petros Pechivanoglou, Josephine Wong, Joanna M. Bielecki, Alex Haines, Aysegul Erman, Yasmin Saeed, Arcturus Phoon, Mina Tadrous, Mona Younis, Noha Z. Rayad, Valeria Rac, Harry L. A. Janssen, Murray D. Krahn
Systematic Reviews.2019;[Epub] CrossRef

12,200 View
236 Download
15 Web of Science
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Liver fibrosis, cirrhosis, and portal hypertension

Clinical features and outcomes of gastric variceal bleeding: retrospective Korean multicenter data: Moon Young Kim, Soon Ho Um, Soon Koo Baik, Yeon Seok Seo, Soo Young Park, Jung Il Lee, Jin Woo Lee, Gab Jin Cheon, Joo Hyun Sohn, Tae Yeob Kim, Young Suk Lim, Tae Hyo Kim, Tae Hee Lee, Sung Jae Park, Seung Ha Park, Jin Dong Kim, Sang Young Han, Chang Soo Choi, Eun Young Cho, Dong Joon Kim, Jae Seok Hwang, Byoung Kuk Jang, June Sung Lee, Sang Gyune Kim, Young Seok Kim, So Young Kwon, Won Hyeok Choe, Chang Hyeong Lee, Byung Seok Kim, Jae Young Jang, Soung Won Jeong, Byung Ho Kim, Jae Jun Shim, Yong Kyun Cho, Moon Soo Koh, Hyun Woong Lee; Korean J Hepatol 2013;19(1):36-44.
Published online March 25, 2013; DOI: https://doi.org/10.3350/cmh.2013.19.1.36

Abstract
PDF

Background/Aims

While gastric variceal bleeding (GVB) is not as prevalent as esophageal variceal bleeding, it is reportedly more serious, with high failure rates of the initial hemostasis (>30%), and has a worse prognosis than esophageal variceal bleeding. However, there is limited information regarding hemostasis and the prognosis for GVB. The aim of this study was to determine retrospectively the clinical outcomes of GVB in a multicenter study in Korea.

Methods

The data of 1,308 episodes of GVB (males:females=1062:246, age=55.0±11.0 years, mean±SD) were collected from 24 referral hospital centers in South Korea between March 2003 and December 2008. The rates of initial hemostasis failure, rebleeding, and mortality within 5 days and 6 weeks of the index bleed were evaluated.

Results

The initial hemostasis failed in 6.1% of the patients, and this was associated with the Child-Pugh score [odds ratio (OR)=1.619; P<0.001] and the treatment modality: endoscopic variceal ligation, endoscopic variceal obturation, and balloon-occluded retrograde transvenous obliteration vs. endoscopic sclerotherapy, transjugular intrahepatic portosystemic shunt, and balloon tamponade (OR=0.221, P<0.001). Rebleeding developed in 11.5% of the patients, and was significantly associated with Child-Pugh score (OR=1.159, P<0.001) and treatment modality (OR=0.619, P=0.026). The GVB-associated mortality was 10.3%; mortality in these cases was associated with Child-Pugh score (OR=1.795, P<0.001) and the treatment modality for the initial hemostasis (OR=0.467, P=0.001).

Conclusions

The clinical outcome for GVB was better for the present cohort than in previous reports. Initial hemostasis failure, rebleeding, and mortality due to GVB were universally associated with the severity of liver cirrhosis.

Citations

Citations to this article as recorded by

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