Clinical and Molecular Hepatology

"Antiviral"

Special Issue

2025 KASL clinical practice guidelines for management of hepatitis C: Eun Sun Jang, Nae Yun Heo, Jae Yoon Jeong, Jung Gil Park, Do Seon Song, Eun Ju Cho, Chang Hun Lee, Jae Seung Lee, Jae Hyun Yoon, Seul Ki Han, Young Kul Jung, on behalf of the Korean Association for the Study of the Liver (KASL); Clin Mol Hepatol 2026;32(1):1-52.
Published online October 23, 2025; DOI: https://doi.org/10.3350/cmh.2025.0777

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Correspondence

Redefining MTCT prevention strategies toward HBV elimination: Correspondence to editorial on “Factors associated with hepatitis B mother-to-child transmission in a national prevention program”: Moran Ki, Jong-Hyun Kim; Clin Mol Hepatol 2026;32(2):e224-e226.
Published online July 28, 2025; DOI: https://doi.org/10.3350/cmh.2025.0805

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Editorials

Breaking the chain of perinatal hepatitis B transmission: Editorial on “Factors associated with hepatitis B mother-to-child transmission in a national prevention program”: Shang-Chin Huang, Jia-Horng Kao; Clin Mol Hepatol 2026;32(2):946-948.
Published online July 28, 2025; DOI: https://doi.org/10.3350/cmh.2025.0801

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Clinical implications of residual changes following HCV clearance: Editorial on “Distinct inflammatory imprint in non-cirrhotic and cirrhotic patients before and after direct-acting antiviral therapy”: So-Young Kim, Eui-Cheol Shin; Clin Mol Hepatol 2026;32(2):935-938.
Published online July 14, 2025; DOI: https://doi.org/10.3350/cmh.2025.0728

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Reply to Correspondence

Reply to correspondence on “Impacts of metabolic syndrome diseases on long-term outcomes of chronic hepatitis B patients treated with nucleos(t)ide analogues”: Heejoon Jang, Won Kim; Clin Mol Hepatol 2026;32(2):e254-e256.
Published online June 9, 2025; DOI: https://doi.org/10.3350/cmh.2025.0533

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Original Article

Distinct inflammatory imprint in non-cirrhotic and cirrhotic patients before and after direct-acting antiviral therapy: Moana Witte, Carlos Oltmanns, Jan Tauwaldt, Hagen Schmaus, Jasmin Mischke, Gordon Grabert, Mara Bretthauer, Lennart M. Roesner, Thomas Werfel, Katja Deterding, Benjamin Maasoumy, Heiner Wedemeyer, Tim Kacprowski, Anke R.M. Kraft, Markus Cornberg; Clin Mol Hepatol 2025;31(4):1269-1284.
Published online June 4, 2025; DOI: https://doi.org/10.3350/cmh.2025.0292

Background/Aims
Hepatitis C virus (HCV) infection remains a global health challenge, leading to chronic liver disease, cirrhosis, and hepatocellular carcinoma (HCC). Despite the high efficacy of direct-acting antiviral therapy in achieving sustained virologic response (SVR), concerns persist regarding long-term immune alterations and residual risks, particularly in cirrhotic patients.
Methods
This study investigates 75 soluble immune mediator (SIM) profiles in 102 chronic HCV patients, stratified by cirrhosis status, at therapy initiation, end of treatment, and long-term follow-up (median 96 weeks). Findings were compared with 51 matched healthy controls and validated in an independent cohort of 47 cirrhotic patients, 17 of whom developed HCC.
Results
We observed significant SIM alterations at baseline, with cirrhotic patients displaying a more profoundly dysregulated inflammatory milieu. Despite an overall decline in inflammatory markers following SVR, persistent alterations were evident, particularly in cirrhotic patients. Notably, those with liver stiffness exceeding 14 kPa exhibited sustained inflammatory dysregulation, correlating with liver elastography values. Key SIM such as interleukin (IL)-6, IL-8, urokinase plasminogen activator, and hepatocellular growth factor remained elevated and were associated with HCC development. Network analysis highlighted their roles in liver fibrosis, regeneration, and carcinogenesis.
Conclusions
These findings underscore the importance of early antiviral intervention to prevent cirrhosis-related sequelae. Future studies should explore the mechanistic pathways linking chronic inflammation, fibrosis, and oncogenesis to identify predictive biomarkers and novel therapeutic targets. Addressing persistent immune alterations post-HCV clearance may improve long-term outcomes, particularly in patients with advanced liver disease.

Citations

Citations to this article as recorded by

Gut microbiota–immunity cascade in hepatocellular carcinoma: mechanisms and therapeutic opportunities
Jihao Yang, Yishuang Dai, Jia Li
Oncology Reviews.2026;[Epub] CrossRef
Hepatitis C elimination: is it time to redefine the goals?
Yasser Fouad, Ming-Lung Yu, Saeed Hamid, Robert G. Gish, Mohammed Eslam
Nature Reviews Gastroenterology & Hepatology.2026;[Epub] CrossRef
HBV Dominance Is Associated With a Distinct Inflammatory Milieu in HBV/HCV Coinfection
Carlos Oltmanns, Moana Witte, Anika Wranke, Katja Deterding, Heiner Wedemeyer, Christine S. Falk, Anke R. M. Kraft, Steffen B. Wiegand, Markus Cornberg
Journal of Viral Hepatitis.2025;[Epub] CrossRef
IFNL4-rs12979860 CC genotype predisposes to accelerated terminal exhaustion and senescence in HIV/HCV-chronic infection
Sonia Arca-Lafuente, Violeta Lara-Aguilar, Manuel Llamas-Adán, Sergio Grande-García, Andrés Deza de la Casa, Luz Martín-Carbonero, Pablo Ryan, Ignacio de los Santos, Mariano Matarranz, Mª Ángeles Jiménez-Sousa, Amanda Fernández-Rodríguez, Verónica Briz
Journal of Translational Medicine.2025;[Epub] CrossRef

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Crossref

Correspondences

Correspondence to editorial 1 on “Impacts of metabolic syndrome diseases on long-term outcomes of chronic hepatitis B patients treated with nucleos(t)ide analogues”: Rui Huang, Mindie H. Nguyen; Clin Mol Hepatol 2026;32(1):e83-e84.
Published online May 8, 2025; DOI: https://doi.org/10.3350/cmh.2025.0479

Citations

Citations to this article as recorded by

Advancing metabolic risk profiling in chronic hepatitis B: Reply to correspondence on “Metabolic health in antiviral era of chronic hepatitis B”
Shang-Chin Huang, Jia-Horng Kao
Clinical and Molecular Hepatology.2026; 32(1): e117. CrossRef

3,247 View
13 Download
Crossref

Correspondence to editorial 2 on “Impacts of metabolic syndrome diseases on long-term outcomes of chronic hepatitis B patients treated with nucleos(t)ide analogues”: Rui Huang, Mindie H. Nguyen; Clin Mol Hepatol 2026;32(1):e85-e86.
Published online May 8, 2025; DOI: https://doi.org/10.3350/cmh.2025.0478

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Editorial

Type 2 diabetes as a key metabolic risk factor for adverse outcomes in nucleos(t)ide analogue-treated chronic hepatitis B: Editorial on “Impacts of metabolic syndrome diseases on long-term outcomes of chronic hepatitis B patients treated with nucleos(t)ide analogues”: Heejoon Jang, Won Kim; Clin Mol Hepatol 2026;32(1):426-428.
Published online April 28, 2025; DOI: https://doi.org/10.3350/cmh.2025.0430

Citations

Citations to this article as recorded by

Correspondence to editorial 2 on “Impacts of metabolic syndrome diseases on long-term outcomes of chronic hepatitis B patients treated with nucleos(t)ide analogues”
Rui Huang, Mindie H. Nguyen
Clinical and Molecular Hepatology.2026; 32(1): e85. CrossRef

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52 Download
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Correspondence

Revisiting unmet needs in clinical research on direct-acting antiviral therapy for HCC patients: Correspondence to letter to the editor on “Direct-acting antiviral therapy for patients with HCV-related hepatocellular carcinoma: A nationwide cohort study”: Teng-Yu Lee, Pei-Chien Tsai, Shou-Wu Lee, Ming- Lung Yu; Clin Mol Hepatol 2026;32(1):e99-e102.
Published online April 4, 2025; DOI: https://doi.org/10.3350/cmh.2025.0362

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Letter to the Editor

Letter to the editor on “Direct-acting antiviral therapy for patients with HCV-related hepatocellular carcinoma: a nationwide cohort study”: Qiong Wang, Zhongqing Qian, Xiaodi Yang, Deyan Chen, Xiaojing Wang, Fuliang Chen; Clin Mol Hepatol 2026;32(1):e7-e9.
Published online March 24, 2025; DOI: https://doi.org/10.3350/cmh.2025.0291

Citations

Citations to this article as recorded by

Revisiting unmet needs in clinical research on direct-acting antiviral therapy for HCC patients: Correspondence to letter to the editor on “Direct-acting antiviral therapy for patients with HCV-related hepatocellular carcinoma: A nationwide cohort study”
Teng-Yu Lee, Pei-Chien Tsai, Shou-Wu Lee, Ming- Lung Yu
Clinical and Molecular Hepatology.2026; 32(1): e99. CrossRef

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48 Download
Crossref

Reply to Correspondence

Should direct-acting antiviral be considered for all patients with HCV-related hepatocellular carcinoma?: Reply to correspondence on “Direct-acting antiviral therapy for patients with HCV-related hepatocellular carcinoma: A nationwide cohort study”: Yan Ling Ong, Apichat Kaewdech, Yu Jun Wong; Clin Mol Hepatol 2026;32(1):e109-e111.
Published online March 13, 2025; DOI: https://doi.org/10.3350/cmh.2025.0257

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Correspondence

Emerging evidence supports direct-acting antiviral therapy for HCC patients beyond the early stage: Correspondence to editorial on “Direct-acting antiviral therapy for patients with HCV-related hepatocellular carcinoma: A nationwide cohort study”: Teng-Yu Lee, Pei-Chien Tsai, Shou-Wu Lee, Ming-Lung Yu; Clin Mol Hepatol 2026;32(1):e68-e71.
Published online March 4, 2025; DOI: https://doi.org/10.3350/cmh.2025.0235

Citations

Citations to this article as recorded by

Revisiting unmet needs in clinical research on direct-acting antiviral therapy for HCC patients: Correspondence to letter to the editor on “Direct-acting antiviral therapy for patients with HCV-related hepatocellular carcinoma: A nationwide cohort study”
Teng-Yu Lee, Pei-Chien Tsai, Shou-Wu Lee, Ming- Lung Yu
Clinical and Molecular Hepatology.2026; 32(1): e99. CrossRef
Should direct-acting antiviral be considered for all patients with HCV-related hepatocellular carcinoma?: Reply to correspondence on “Direct-acting antiviral therapy for patients with HCV-related hepatocellular carcinoma: A nationwide cohort study”
Yan Ling Ong, Apichat Kaewdech, Yu Jun Wong
Clinical and Molecular Hepatology.2026; 32(1): e109. CrossRef

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1 Web of Science
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Reply to Correspondence

Viral hepatitis

Reply to correspondence on “Adverse impact of metabolic dysfunction on fibrosis regression following direct-acting antiviral therapy: A multicenter study for chronic hepatitis C”: Chen-Hua Liu, Yu-Ping Chang; Clin Mol Hepatol 2025;31(2):e232-e233.
Published online February 26, 2025; DOI: https://doi.org/10.3350/cmh.2025.0203

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25 Download

Correspondence

Viral hepatitis

Correspondence to editorial on “Adverse impact of metabolic dysfunction on fibrosis regression following direct-acting antiviral therapy: A multicenter study for chronic hepatitis C”: Tom Ryu, Young Chang, Seung Up Kim, Jae Young Jang; Clin Mol Hepatol 2025;31(2):e203-e205.
Published online February 24, 2025; DOI: https://doi.org/10.3350/cmh.2025.0179

Citations

Citations to this article as recorded by

Reply to correspondence on “Adverse impact of metabolic dysfunction on fibrosis regression following direct-acting antiviral therapy: A multicenter study for chronic hepatitis C”
Chen-Hua Liu, Yu-Ping Chang
Clinical and Molecular Hepatology.2025; 31(2): e232. CrossRef

5,244 View
27 Download
1 Web of Science
Crossref

Original Article

Direct-acting antiviral therapy for patients with hepatitis C virus-related hepatocellular carcinoma: A nationwide cohort study: Shou-Wu Lee, Sheng-Shun Yang, Pei-Chien Tsai, Chung-Feng Huang, Chi-Yi Chen, Chao-Hung Hung, Chien-Hung Chen, Chi-Ming Tai, Pin-Nan Cheng, Hsing-Tao Kuo, Kuo-Chih Tseng, Lein-Ray Mo, Ching-Chu Lo, Yi-Hsiang Huang, Han-Chieh Lin, Pei-Lun Lee, Ming-Jong Bair, Te-Sheng Chang, Chun-Yen Lin, Szu-Jen Wang, Tsai-Yuan Hsieh, Tzeng-Hue Yang, Cheng-Yuan Peng, Chi-Chieh Yang, Lee-Won Chong, Chien-Wei Huang, Chih-Wen Lin, Cheng-Hsin Chu, Ming-Chang Tsai, Jia-Horng Kao, Chun-Jen Liu, Wan-Long Chuang, Teng-Yu Lee, Ming-Lung Yu, on behalf of TACR investigators; Clin Mol Hepatol 2025;31(3):899-913.
Published online February 5, 2025; DOI: https://doi.org/10.3350/cmh.2024.1015

Background/Aims
The survival benefit of direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) infection in patients with hepatocellular carcinoma (HCC), particularly in Barcelona Clinic Liver Cancer (BCLC) stages B/C, remains largely uncertain. We aimed to explore the impact of DAA therapy on overall survival (OS) in HCC patients using a nationwide cohort study.
Methods
We utilized the nationwide Taiwan Association for the Study of the Liver (TASL) HCV Registry (TACR) database to include all adults receiving a DAA therapy for HCV, excluding those with other viral infections, liver transplantation, non-HCC malignancies, and terminal-staged HCC. We respectively analyzed the adjusted odds ratio (aOR) for sustained virological response (SVR) and adjusted hazard ratio (aHR) for OS.
Results
Between December 2013 and December 2020, 2,205 (9.3%) patients with HCC and 21,569 (90.7%) patients without HCC were include. The SVR rates were 96.6% in the HCC group and 98.8% in the non-HCC group (P<0.001), with HCC being an independent risk factor affecting SVR (aOR 0.41; 95% CI 0.31–0.54; P<0.001). In the whole patient cohort, SVR was independently associated with improved OS (aHR 0.46; 95% CI 0.35–0.60; P<0.001). Among patients with baseline HCC, SVR remained an independent factor related to OS (aHR 0.41; 95% CI 0.28–0.59; P<0.001). The impact of SVR on OS persisted significantly across BCLC stages 0/A and stages B/C.
Conclusions
High SVR rates among HCC patients underscore the importance of DAA therapy in enhancing OS, reaffirming its efficacy across various HCC stages.

Citations

Citations to this article as recorded by

Revisiting unmet needs in clinical research on direct-acting antiviral therapy for HCC patients: Correspondence to letter to the editor on “Direct-acting antiviral therapy for patients with HCV-related hepatocellular carcinoma: A nationwide cohort study”
Teng-Yu Lee, Pei-Chien Tsai, Shou-Wu Lee, Ming- Lung Yu
Clinical and Molecular Hepatology.2026; 32(1): e99. CrossRef
Emerging evidence supports direct-acting antiviral therapy for HCC patients beyond the early stage: Correspondence to editorial on “Direct-acting antiviral therapy for patients with HCV-related hepatocellular carcinoma: A nationwide cohort study”
Teng-Yu Lee, Pei-Chien Tsai, Shou-Wu Lee, Ming-Lung Yu
Clinical and Molecular Hepatology.2026; 32(1): e68. CrossRef
Survival impact of hepatitis C virus eradication in patients with or without active hepatocellular carcinoma: A nationwide cohort study
Teng-Yu Lee, Sheng-Shun Yang, Pei-Chien Tsai, Chung-Feng Huang, Chi-Yi Chen, Chao-Hung Hung, Chien-Hung Chen, Chi-Ming Tai, Pin-Nan Cheng, Hsing-Tao Kuo, Kuo-Chih Tseng, Lein-Ray Mo, Ching-Chu Lo, Yi-Hsiang Huang, Han-Chieh Lin, Pei-Lun Lee, Ming-Jong Bai
European Journal of Cancer.2026; 232: 116109. CrossRef
Letter to the editor on “Direct-acting antiviral therapy for patients with HCV-related hepatocellular carcinoma: a nationwide cohort study”
Qiong Wang, Zhongqing Qian, Xiaodi Yang, Deyan Chen, Xiaojing Wang, Fuliang Chen
Clinical and Molecular Hepatology.2026; 32(1): e7. CrossRef
Setting the Record Straight: Utility and Outcomes in Patients With HCV Related HCC
María Fernanda Guerra‐Veloz, Sital Shah, Beatrice Emmanouil, Mia Olsen, Renita George, Sarah Selemani, Paul J. Ross, Ivana Carey, Neha Mehta, Mark Gillyon‐Powell, Kosh Agarwal
Journal of Viral Hepatitis.2026;[Epub] CrossRef
Letter: Methodological Considerations in Interpreting Polygenic Risk Scores for Hepatocellular Carcinoma After SVR. Authors' Reply
Yu‐Sheng Lin, Yun‐Yu Chen, Teng‐Yu Lee
Alimentary Pharmacology & Therapeutics.2026;[Epub] CrossRef
Editorial: Residual HCC Risk After Hepatitis C Cure—Can Polygenic Risk Scores Refine Surveillance? Authors' Reply
Yu‐Sheng Lin, Hwai‐I Yang, Teng‐Yu Lee
Alimentary Pharmacology & Therapeutics.2026;[Epub] CrossRef
Letter: Beyond Association: Operationalizing PRS‐5 for Hepatocellular Carcinoma Surveillance. Authors' Reply
Yu‐Sheng Lin, Ying‐Cheng Lin, Teng‐Yu Lee
Alimentary Pharmacology & Therapeutics.2026;[Epub] CrossRef
HIV, Viral Hepatitis, and Schistosomiasis Association with Liver Cancer: A Systematic Review
Khumbuzile Canham, Pragalathan Naidoo, Sibusiso Senzani, Sayed Shakeel Kader, Zilungile L. Mkhize-Kwitshana
Microorganisms.2025; 13(12): 2753. CrossRef

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Review

Viral hepatitis

Update on the treatment navigation for functional cure of chronic hepatitis B: Expert consensus 2.0: Di Wu, Jia-Horng Kao, Teerha Piratvisuth, Xiaojing Wang, Patrick T.F. Kennedy, Motoyuki Otsuka, Sang Hoon Ahn, Yasuhito Tanaka, Guiqiang Wang, Zhenghong Yuan, Wenhui Li, Young-Suk Lim, Junqi Niu, Fengmin Lu, Wenhong Zhang, Zhiliang Gao, Apichat Kaewdech, Meifang Han, Weiming Yan, Hong Ren, Peng Hu, Sainan Shu, Paul Yien Kwo, Fu-sheng Wang, Man-Fung Yuen, Qin Ning; Clin Mol Hepatol 2025;31(Suppl):S134-S164.
Published online January 22, 2025; DOI: https://doi.org/10.3350/cmh.2024.0780

Abstract
PDF

As new evidence emerges, treatment strategies toward the functional cure of chronic hepatitis B are evolving. In 2019, a panel of national hepatologists published a Consensus Statement on the functional cure of chronic hepatitis B. Currently, an international group of hepatologists has been assembled to evaluate research since the publication of the original consensus, and to collaboratively develop the updated statements. The 2.0 Consensus was aimed to update the original consensus with the latest available studies, and provide a comprehensive overview of the current relevant scientific literatures regarding functional cure of hepatitis B, with a particular focus on issues that are not yet fully clarified. These cover the definition of functional cure of hepatitis B, its mechanisms and barriers, the effective strategies and treatment roadmap to achieve this endpoint, in particular new surrogate biomarkers used to measure efficacy or to predict response, and the appropriate approach to pursuing a functional cure in special populations, the development of emerging antivirals and immunomodulators with potential for curing hepatitis B. The statements are primarily intended to offer international guidance for clinicians in their practice to enhance the functional cure rate of chronic hepatitis B.

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
Dynamics and Sensitivity of the Lifecycle of Hepatitis B Virus
Dmitry Grebennikov, Igor Sazonov, Rostislav Savinkov, Matvey Zakharov, Mark Sorokin, Yakov Mokin, Andreas Meyerhans, Gennady Bocharov
Pathogens.2026; 15(2): 172. CrossRef
ZNF638 represses the transcription of HBV closed circular DNA involving HUSH complex-mediated histone modifications of epigenetic silencing
Sifan Meng, Jiaqian Li, Yunlong Fang, Binwei Duan, Jing Wang, Yang Si, Feng Li, Qiong Wu, Shan Cheng, Wei Ding
Cell Communication and Signaling.2026;[Epub] CrossRef
Response to letters to editor "Next-Step Paradigms for Hepatitis B Functional Cure: Insights from the Anchor Combination Therapy Trial" and “Critical Appraisal of the Anchor RCT on Entecavir, Peginterferon Alfa-2b, and GM-CSF Combination Therapy”
Di Wu, Da Huang, Weiming Yan, Qin Ning
Hepatology International.2026;[Epub] CrossRef
Response to letter to editor—Machine learning prediction of rapid HBsAg seroclearance at week 24 in inactive carriers treated with pegylated interferon
Jianxia Dong, Sujun Zheng, Xinyue Chen
Hepatology International.2026;[Epub] CrossRef
Residual viral expression in siRNA-treated HBV-replicating cell and mouse models
Mingzhu Xu, Yuyan Qian, Ziyang Song, Haiyu Wang, Lei Yue, Jiangxia Liu, Yaming Li, Wenjing Zai, Zhenghong Yuan, Jieliang Chen
Antiviral Research.2025; 240: 106210. CrossRef
Anti-HBV treatment partially restores the dysfunction of innate immune cells and unconventional T cells during chronic HBV infection
Yiwen Shu, Sumeng Li, Yanqin Du, Xin Zheng
Frontiers in Immunology.2025;[Epub] CrossRef
Quantitatively Evaluate the Improvement of Functional Cure for the Quality of Life of Chronic Hepatitis B Cases: Evidence from a Cross-Sectional Study in China
Sihui Zhang, Zhiliang Gao, Hui Li, Yi Kang, Lei Fu, Xuebing Chen, Xiaoyuan Xu, Xinyue Chen, Hui Zhuang, Hui Zheng, Fuqiang Cui
Healthcare.2025; 13(20): 2590. CrossRef
Discontinuation of nucleos(t)ide analogues after NA-induced HBsAg seroclearance: a single-center 48-week retrospective study
Yong-Hong Wang, Ya-Chao Tao, Meng-Lan Wang, Cheng-Run Song, Jiang-Nan Peng, En-Qiang Chen
Journal of Virus Eradication.2025; 11(4): 100617. CrossRef
An RNA interference therapeutic potentially achieves functional cure of chronic hepatitis B virus infection
Ze-Ao Huang, Yang Yang, Shuo Yang, Guang-Shen Ji, Rui Fu, Zhi-Kang Tian, Yu-Cheng Wu, Geng-Shen Song
Nature Communications.2025;[Epub] CrossRef
A Study on Serum Protein Tracking in Patients with Low Levels of HBsAg Undergoing Treatment for Chronic Hepatitis B with a Combination of Tenofovir Disoproxil Fumarate and Pegylated Interferon
Yimin Chen, Min Deng, Mingkai Tong, Peixia Lin, Hua Xuan, Dahai Wei
Hepatitis Monthly.2025;[Epub] CrossRef
Machine learning model for HBsAg seroclearance after 48-week pegylated interferon therapy in inactive HBsAg carriers: a retrospective study
Jianxia Dong, Shan Ren, Jing Zhao, Pengxuan Wu, Haitian Yu, Yao Xie, Junliang Fu, Xiaorong Mao, Zhiliang Gao, Bingliang Lin, Qingfa Ruan, Yongfang Jiang, Xiulan Xue, Yueyong Zhu, Haidong Zhao, Haifang Cao, Xinyue Chen, Sujun Zheng
Virology Journal.2025;[Epub] CrossRef
Functional cure of chronic hepatitis B virus infection: current therapeutic regimens
Yi-Wei Shi, Rui Pu, Yi-Bo Ding, Wen-Bin Liu, Zi-Shuai Li, Jia-Yi Zhao, Yi-Fan Chen, Guang-Wen Cao
Hepatoma Research.2025;[Epub] CrossRef

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Original Articles

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; Clin Mol Hepatol 2025;31(3):810-822.
Published online January 17, 2025; DOI: https://doi.org/10.3350/cmh.2024.0819

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

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Viral hepatitis

Adverse impact of metabolic dysfunction on fibrosis regression following direct-acting antiviral therapy: A multicenter study for chronic hepatitis C: Tom Ryu, Young Chang, Soung Won Jeong, Jeong-Ju Yoo, Sae Hwan Lee, Sang Gyune Kim, Young Seok Kim, Hong Soo Kim, Seung Up Kim, Jae Young Jang; Clin Mol Hepatol 2025;31(2):548-562.
Published online January 9, 2025; DOI: https://doi.org/10.3350/cmh.2024.0904

Background/Aims
Direct-acting antivirals (DAAs) effectively eradicate hepatitis C virus. This study investigated whether metabolic dysfunction influences the likelihood of fibrosis regression after DAA treatment in patients with chronic hepatitis C (CHC).
Methods
This multicenter, retrospective study included 8,819 patients diagnosed with CHC who were treated with DAAs and achieved a sustained virological response (SVR) between January 2014 and December 2022. Fibrosis regression was defined as a 20% reduction in noninvasive surrogates for liver fibrosis, such as liver stiffness (LS) measured by vibration-controlled transient elastography (VCTE) and the fibrosis-4 (FIB-4) score. Hypercholesterolemia (h-TC) was defined as >200 mg/dL.
Results
The median age of the study population was 59.6 years, with a predominance of male patients (n=4,713, 57.3%). Genotypes 1, 2, and others were confirmed in 3,872 (46.2%), 3,487 (41.6%), and 1,024 (12.2%) patients, respectively. Diabetes mellitus (DM) was present in 1,442 (17.2%) patients and the median LS was 7.50 kPa (interquartile range, 5.30–12.50). Multivariate analysis revealed that the presence of DM and pre-DAA h-TC were independently associated with a decreased probability of fibrosis regression by VCTE. Additionally, pre-DAA h-TC was independently associated with a decreased probability of fibrosis regression by the FIB-4.
Conclusions
Metabolic dysfunction has an unfavorable influence on fibrosis regression in patients with CHC who achieve SVR after DAA treatment.

Citations

Citations to this article as recorded by

Longitudinal Changes in Lipid Profile After Sustained Virological Response in Patients with Chronic Hepatitis C Treated with Direct-Acting Antivirals
Oana Koppandi, Bogdan Miutescu, Iulia Ratiu, Alexandru Popa, Camelia Nica, Eyad Gadour, Bogdan Dan Totolici, Raluca Lupusoru, Ana Maria Ghiuchici, Eftimie Miutescu
Healthcare.2026; 14(4): 486. CrossRef
Editorial: Risk of Incident Type 2 Diabetes and Prediabetes in Patients With Direct Acting Antiviral‐Induced Cure of Hepatitis C Virus Infection—Authors' Reply
Yu‐Ping Chang, Jia‐Horng Kao, Chen‐Hua Liu
Alimentary Pharmacology & Therapeutics.2025; 61(9): 1553. CrossRef
Epidemiologic Characteristics of Chronic Hepatitis B and Coinfections with Hepatitis C Virus or Human Immunodeficiency Virus in South Korea: A Nationwide Claims-Based Study Using the Korean Health Insurance Review and Assessment Service Database
Hyunwoo Oh, Won Sohn, Na Ryung Choi, Hyo Young Lee, Yeonjae Kim, Seung Woo Nam, Jae Yoon Jeong
Pathogens.2025; 14(7): 715. CrossRef

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Review

Viral hepatitis

Prospect of emerging treatments for hepatitis B virus functional cure: Rex Wan-Hin Hui, Lung-Yi Mak, James Fung, Wai-Kay Seto, Man-Fung Yuen; Clin Mol Hepatol 2025;31(Suppl):S165-181.
Published online November 14, 2024; DOI: https://doi.org/10.3350/cmh.2024.0855

Abstract
PDF

Functional cure, defined as sustained hepatitis B surface antigen (HBsAg) seroclearance with unquantifiable hepatitis B virus (HBV) DNA at 24 weeks off treatment, is a favorable treatment endpoint in chronic hepatitis B (CHB). Nonetheless, functional cure is rarely attained with the current treatment modalities of nucleos(t)ide analogues (NUCs) and pegylated interferon alpha. Multiple novel virus-targeting agents and immunomodulators are under development for HBV with functional cure as the treatment goal. Among virus-targeting agents, antisense oligonucleotides and small-interfering RNAs are the most advanced in the developmental pipeline, and can induce potent and sustainable HBsAg suppression. The other virus-targeting agents have varying effects on HBsAg and HBV DNA, depending on the drug mechanism. In contrast, immunomodulators have modest effects on HBsAg and have limited roles in monotherapy. Multiple combination regimens incorporating RNA interference agents with immunomodulators have been studied through many ongoing clinical trials. These combination strategies demonstrate synergistic effects in inducing functional cure, and will likely be the future direction of development. Despite the promising results, research is warranted to optimize treatment protocols and to establish criteria for NUC withdrawal after novel therapies. Functional cure is now an attainable target in CHB, and the emerging novel therapeutics will revolutionize CHB management.

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Targeting the innate immune system in treating hepatitis B: prospects for functional cure
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Reply to: “ALT to qHBsAg ratio predicts HBsAg seroclearance in HBeAg-negative patients receiving Peg-IFNα based therapy”
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Journal of Hepatology.2025; 82(5): e228. CrossRef
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Editorial

Viral hepatitis

Momentum towards simplifying and expanding treatment for chronic hepatitis B: The body of evidence continues to grow: Editorial on “Antiviral therapy for chronic hepatitis B with mildly elevated aminotransferase: A rollover study from the TORCH-B trial”: Robert J. Wong; Clin Mol Hepatol 2025;31(2):603-605.
Published online October 29, 2024; DOI: https://doi.org/10.3350/cmh.2024.0929

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Expanding treatment eligibility for chronic hepatitis B: Balancing benefits, limitations, and healthcare access: Correspondence to editorial on “Antiviral therapy for chronic hepatitis B with mildly elevated aminotransferase: A rollover study from the TOR
Yao-Chun Hsu, Chi-Yi Chen, Jaw-Town Lin
Clinical and Molecular Hepatology.2025; 31(2): e169. CrossRef

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Letter to the Editor

Viral hepatitis

Chronic hepatitis B, extrahepatic malignancies and the use of antiviral drugs: Meng-Che Wu, Shih-Chi Yang, Shuo-Yan Gau; Clin Mol Hepatol 2025;31(1):e19-e20.
Published online October 17, 2024; DOI: https://doi.org/10.3350/cmh.2024.0906

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Original Article

Viral hepatitis

Antiviral therapy for chronic hepatitis B with mildly elevated aminotransferase: A rollover study from the TORCH-B trial: Yao-Chun Hsu, Chi-Yi Chen, Cheng-Hao Tseng, Chieh-Chang Chen, Teng-Yu Lee, Ming-Jong Bair, Jyh-Jou Chen, Yen-Tsung Huang, I-Wei Chang, Chi-Yang Chang, Chun-Ying Wu, Ming-Shiang Wu, Lein-Ray Mo, Jaw-Town Lin; Clin Mol Hepatol 2025;31(1):213-226.
Published online October 17, 2024; DOI: https://doi.org/10.3350/cmh.2024.0640

Background/Aims
Treatment indications for patients with chronic hepatitis B (CHB) remain contentious, particularly for patients with mild alanine aminotransferase (ALT) elevation. We aimed to evaluate treatment effects in this patient population.
Methods
This rollover study extended a placebo-controlled trial that enrolled non-cirrhotic patients with CHB and ALT levels below two times the upper limit of normal. Following 3 years of randomized intervention with either tenofovir disoproxil fumarate (TDF) or placebo, participants were rolled over to open-label TDF for 3 years. Liver biopsies were performed before and after the treatment to evaluate histopathological changes. Virological, biochemical, and serological outcomes were also assessed (NCT02463019).
Results
Of 146 enrolled patients (median age 47 years, 80.8% male), 123 completed the study with paired biopsies. Overall, the Ishak fibrosis score decreased in 74 (60.2%), remained unchanged in 32 (26.0%), and increased in 17 (13.8%) patients (p<0.0001). The Knodell necroinflammation score decreased in 58 (47.2%), remained unchanged in 29 (23.6%), and increased in 36 (29.3%) patients (p=0.0038). The proportion of patients with an Ishak score ≥ 3 significantly decreased from 26.8% (n=33) to 9.8% (n=12) (p=0.0002). Histological improvements were more pronounced in patients switching from placebo. Virological and biochemical outcomes also improved in placebo switchers and remained stable in patients who continued TDF. However, serum HBsAg levels did not change and no patient cleared HBsAg.
Conclusions
In CHB patients with minimally raised ALT, favorable histopathological, biochemical, and virological outcomes were observed following 3-year TDF treatment, for both treatment-naïve patients and those already on therapy.

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Correspondence

Correspondence to editorial on “Hepatocellular carcinoma prediction model performance decreases with long-term antiviral therapy in chronic hepatitis B patients”: Xiaoqian Xu, Hong You, Jidong Jia, Yuanyuan Kong; Clin Mol Hepatol 2024;30(4):994-996.
Published online July 23, 2024; DOI: https://doi.org/10.3350/cmh.2024.0552

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Prediction Model for Familial Aggregated HBV‐Associated Hepatocellular Carcinoma Based on Serum Biomarkers
Linmei Zhong, Guole Nie, Qiaoping Wu, Honglong Zhang, Haiping Wang, Jun Yan
Cancer Reports.2025;[Epub] CrossRef
Reply to correspondence on “Hepatocellular carcinoma prediction model performance decreases with long-term antiviral therapy in chronic hepatitis B patients”
Beom Kyung Kim
Clinical and Molecular Hepatology.2024; 30(4): 1044. CrossRef

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2 Web of Science
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Original Article

Viral hepatitis

Vibration-controlled transient elastography for significant fibrosis in treatment-naïve chronic hepatitis B patients: A systematic review and meta-analysis: Mi Na Kim, Jihyun An, Eun Hwa Kim, Hee Yeon Kim, Han Ah Lee, Jung Hwan Yu, Young-Joo Jin, Young Eun Chon, Seung Up Kim, Dae Won Jun, Ji Won Han, Miyoung Choi; Clin Mol Hepatol 2024;30(Suppl):S106-S116.
Published online July 23, 2024; DOI: https://doi.org/10.3350/cmh.2024.0371

Backgrounds/Aims
Accurate diagnosis of significant liver fibrosis in patients with chronic hepatitis B (CHB) is crucial when determining whether to initiate antiviral treatment (AVT). We conduct a meta-analysis to assess the diagnostic performance of vibration-controlled transient elastography (VCTE) for significant liver fibrosis in AVT-naïve CHB patients with serum alanine transaminase (ALT) levels within 5-fold the upper limit of normal (ULN).
Methods
The Ovid-Medline, EMBASE, Cochrane, and KoreaMed databases were searched to identify studies that compared the performance of VCTE and liver biopsy (reference standard) when diagnosing significant liver fibrosis (≥F2) in AVT-naïve CHB patients with ALT within 5-fold the ULN. A hierarchical summary receiver operating characteristic curve (HSROC) and bivariate model were performed to evaluate the diagnostic performance of VCTE in the meta-analysis.
Results
Eight studies (2,003 patients) were included. The summary sensitivity and specificity for diagnosis of significant liver fibrosis were 0.78 (95% confidence interval [CI], 0.66–0.86) and 0.72 (95% CI, 0.60–0.82), respectively. The HSROC for the diagnosis of significant liver fibrosis was 0.81 (95% CI, 0.72–0.86). The optimal cutoff value of VCTE for diagnosis of significant liver fibrosis was 7.7 kPa with a sensitivity of 0.64 (95% CI, 0.50–0.76) and specificity of 0.83 (95% CI, 0.72–0.90).
Conclusions
Our study demonstrated that VCTE has an acceptable diagnostic performance for significant liver fibrosis in AVT-naïve CHB patients with ALT within 5-fold the ULN.

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Chronic Hepatitis B Infection: Patient Guidance
Lung‐Yi Mak, Jimmy Che‐To Lai, Ken Liu, Rashid Lui, Sakkarin Chirapongsathorn, Kuo Chao Yew, Mara Teresa Panlilio, Cosmas Rinaldi Adithya Lesmana, Ruveena Bhavani Rajaram, Liang Shen, Desmond Cheung, Lung‐Fai Wong, Hye Won Lee, Madhumita Premkumar, Anand
Journal of Gastroenterology and Hepatology.2026; 41(1): 61. CrossRef
Unraveling Demographic Patterns in Hepatitis B Clinical and Laboratory Profiles: Insights From a Ghanaian Cohort: A Retrospective Study
Napoleon Bellua Sam, Saeed Folorunsho Majeed, Adams Dramani
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Head‐to‐Head Comparison of Long‐Term HCC Risk of Antivirals‐Treated Versus Untreated Low‐Level Viremia in HBV‐Compensated Cirrhosis
Nobuharu Tamaki, Daniel Q. Huang, Hyung Woong Lee, Soo Young Park, Yu Rim Lee, Dong Hyun Sinn, Tae Seop Lim, Hiroyuki Marusawa, Seng Gee Lim, Hironori Ochi, Masahiko Kondo, Yasushi Uchida, Haruhiko Kobashi, Koichiro Furuta, Masayuki Kurosaki, Beom Kyung K
Journal of Gastroenterology and Hepatology.2025; 40(6): 1595. CrossRef
Assessing Liver Fibrosis in Chronic Hepatitis B: Liver Biopsy or Non-Invasive Fibrosis Markers?
Deniz Borcak, Zuhal Yesilbag, Yusuf Emre Ozdemir, Adile Sevde Demir, Esra Salim Dogdas, Aysegul Inci Sezen, Esra Canbolat Unlu, Sevtap Senoglu, Hayat Kumbasar Karaosmanoglu, Kadriye Kart Yasar
Journal of Clinical Medicine.2025; 14(22): 8164. CrossRef
Vibration-Controlled Transient Elastography in Chronic Liver Disease: Current Research Insights
Ho Soo Chun
Clinical Ultrasound.2025; 10(2): 69. CrossRef
Recent Trends in Noninvasive Tests for Assessing Hepatic Fibrosis in Patients with Chronic Liver Disease
Jung Hwan Yu
The Korean Journal of Medicine.2024; 99(5): 232. CrossRef
Noninvasive Imaging Test to Assess Liver Fibrosis: Vibration-controlled Transient Elastography
Mi Na Kim
The Korean Journal of Gastroenterology.2024; 84(5): 201. CrossRef
Liver Fibrosis Assessment in Chronic Liver Diseases Using Elastography: A Comprehensive Review of Vibration-Controlled Transient Elastography and Shear Wave Elastography
Han Ah Lee
Clinical Ultrasound.2024; 9(2): 70. CrossRef

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Editorials

Viral hepatitis

Nucleos(t)ide analog therapy of chronic hepatitis B and extrahepatic cancer risk: Is tenofovir better than entecavir?: Editorial on “Extrahepatic malignancies and antiviral drugs for chronic hepatitis B: A nationwide cohort study”: Yewan Park, Dong Hyun Sinn; Clin Mol Hepatol 2024;30(4):718-720.
Published online July 8, 2024; DOI: https://doi.org/10.3350/cmh.2024.0519

4,406 View
77 Download

Viral hepatitis

Decreasing performance of HCC prediction models during antiviral therapy for hepatitis B: what else to keep in mind: Editorial on “Hepatocellular carcinoma prediction model performance decreases with long-term antiviral therapy in chronic hepatitis B patients”: Beom Kyung Kim; Clin Mol Hepatol 2024;30(4):656-658.
Published online July 8, 2024; DOI: https://doi.org/10.3350/cmh.2024.0499

Citations

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Prediction Model for Familial Aggregated HBV‐Associated Hepatocellular Carcinoma Based on Serum Biomarkers
Linmei Zhong, Guole Nie, Qiaoping Wu, Honglong Zhang, Haiping Wang, Jun Yan
Cancer Reports.2025;[Epub] CrossRef
Reply to correspondence on “Hepatocellular carcinoma prediction model performance decreases with long-term antiviral therapy in chronic hepatitis B patients”
Beom Kyung Kim
Clinical and Molecular Hepatology.2024; 30(4): 1044. CrossRef
Correspondence to editorial on “Hepatocellular carcinoma prediction model performance decreases with long-term antiviral therapy in chronic hepatitis B patients”
Xiaoqian Xu, Hong You, Jidong Jia, Yuanyuan Kong
Clinical and Molecular Hepatology.2024; 30(4): 994. CrossRef

4,826 View
51 Download
3 Web of Science
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Viral hepatitis

Core protein inhibitors: Opportunities and challenges at the forefront of hepatitis B cure: Editorial on “Phase 1 trial of the safety, pharmacokinetics, and antiviral activity of EDP-514 in untreated viremic chronic hepatitis B patients”: Hae Lim Lee, Jeong Won Jang; Clin Mol Hepatol 2024;30(4):692-694.
Published online May 14, 2024; DOI: https://doi.org/10.3350/cmh.2024.0346

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Structural optimization of phthalazine derivatives for anti-HBV activities to improve oral bioavailability
Yurong Yang, Fuling Xiao, Jianping Zuo, Li Yang, Youhong Hu, Wuhong Chen
Bioorganic & Medicinal Chemistry.2025; 128: 118259. CrossRef

4,714 View
74 Download
1 Web of Science
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Original Article

Viral hepatitis

Extrahepatic malignancies and antiviral drugs for chronic hepatitis B: A nationwide cohort study: Moon Haeng Hur, Dong Hyeon Lee, Jeong-Hoon Lee, Mi-Sook Kim, Jeayeon Park, Hyunjae Shin, Sung Won Chung, Hee Jin Cho, Min Kyung Park, Heejoon Jang, Yun Bin Lee, Su Jong Yu, Sang Hyub Lee, Yong Jin Jung, Yoon Jun Kim, Jung-Hwan Yoon; Clin Mol Hepatol 2024;30(3):500-514.
Published online May 10, 2024; DOI: https://doi.org/10.3350/cmh.2024.0055

Background/Aims
Chronic hepatitis B (CHB) is related to an increased risk of extrahepatic malignancy (EHM), and antiviral treatment is associated with an incidence of EHM comparable to controls. We compared the risks of EHM and intrahepatic malignancy (IHM) between entecavir (ETV) and tenofovir disoproxil fumarate (TDF) treatment.
Methods
Using data from the National Health Insurance Service of Korea, this nationwide cohort study included treatment-naïve CHB patients who initiated ETV (n=24,287) or TDF (n=29,199) therapy between 2012 and 2014. The primary outcome was the development of any primary EHM. Secondary outcomes included overall IHM development. E-value was calculated to assess the robustness of results to unmeasured confounders.
Results
The median follow-up duration was 5.9 years, and all baseline characteristics were well balanced after propensity score matching. EHM incidence rate differed significantly between within versus beyond 3 years in both groups (P<0.01, Davies test). During the first 3 years, EHM risk was comparable in the propensity score-matched cohort (5.88 versus 5.84/1,000 person-years; subdistribution hazard ratio [SHR]=1.01, 95% confidence interval [CI]=0.88–1.17, P=0.84). After year 3, however, TDF was associated with a significantly lower EHM incidence compared to ETV (4.92 versus 6.91/1,000 person-years; SHR=0.70, 95% CI=0.60–0.81, P<0.01; E-value for SHR=2.21). Regarding IHM, the superiority of TDF over ETV was maintained both within (17.58 versus 20.19/1,000 person-years; SHR=0.88, 95% CI=0.81–0.95, P<0.01) and after year 3 (11.45 versus 16.20/1,000 person-years; SHR=0.68, 95% CI=0.62–0.75, P<0.01; E-value for SHR=2.30).
Conclusions
TDF was associated with approximately 30% lower risks of both EHM and IHM than ETV in CHB patients after 3 years of antiviral therapy.

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Chronic hepatitis B, extrahepatic malignancies and the use of antiviral drugs
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Antiviral Therapy Reduces Dyslipidemia and Cardiovascular Risk in Chronic Hepatitis B: TDF as the Most Effective Agent
Hyuk Kim, Jae‐Young Kim, Hyun Bin Choi, Ji‐Soo Lee, Yoon E. Shin, Jeong‐Ju Yoo, Sang Gyune Kim, Young‐Seok Kim
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Cuihong Tian, Xiao Wang, Liang Tao, Wanyi Wei, Xuan Zhang, Haoxian Tang, Yequn Chen, Xuerui Tan
Open Heart.2025; 12(2): e003511. CrossRef
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Yewan Park, Dong Hyun Sinn
Clinical and Molecular Hepatology.2024; 30(4): 718. CrossRef
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Tong Sun, Hongbo Chi, Jing Wang, Yufen Zheng, Hongguo Zhu, Jingxian Zhao, Kai Zhou, Mengyuan Chen, Donglian Wang, Tao-Hsin Tung, Jiaqin Xu, Bo Shen
BMC Infectious Diseases.2024;[Epub] CrossRef

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Correspondence

Viral hepatitis

Optimizing off-treatment outcome predictions: The potential of time-varying HBcrAg and the need for more research: Ying-Nan Tsai, Jia-Ling Wu, Yao-Chun Hsu; Clin Mol Hepatol 2024;30(2):276-278.
Published online April 1, 2024; DOI: https://doi.org/10.3350/cmh.2024.0220

5,657 View
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Editorial

Viral hepatitis

Toward hepatitis C virus elimination using artificial intelligence: Moon Haeng Hur, Jeong-Hoon Lee; Clin Mol Hepatol 2024;30(2):147-149.
Published online February 23, 2024; DOI: https://doi.org/10.3350/cmh.2024.0135

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Hepatocellular carcinoma surveillance after sustained virological response in chronic hepatitis C: Editorial on “Non-invasive prediction of post-sustained virological response hepatocellular carcinoma in hepatitis C virus: A systematic review and meta-ana
Ho Soo Chun, Minjong Lee
Clinical and Molecular Hepatology.2025; 31(1): 261. CrossRef
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Kirolos Eskandar
iLIVER.2025; 4(4): 100205. CrossRef
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Ming-Ying Lu, Ming-Lung Yu
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Correspondences

Viral hepatitis

Letter: Cardiovascular risk of tenofovir disoproxil fumarate or tenofovir alafenamide fumarate in patients with chronic hepatitis B: More questions than an answer – author’s reply: Hyeyeon Hong, Jonggi Choi; Clin Mol Hepatol 2024;30(2):272-273.
Published online February 21, 2024; DOI: https://doi.org/10.3350/cmh.2024.0123

Citations

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Reply to correspondence on “Cardiovascular risk in chronic hepatitis B patients treated with tenofovir disoproxil fumarate or tenofovir alafenamide”
Pin-Nan Cheng, Ming-Lung Yu
Clinical and Molecular Hepatology.2024; 30(4): 1031. CrossRef

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Artificial intelligence, epidemiology, methodology, or others

Harnessing hepatitis B core-related antigen measurement to optimize posttreatment monitoring: Ying-Nan Tsai, Jia-Ling Wu, Yao-Chun Hsu; Clin Mol Hepatol 2024;30(2):293-296.
Published online February 19, 2024; DOI: https://doi.org/10.3350/cmh.2024.0101

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Original Articles

Viral hepatitis

Hepatitis B core-related antigen dynamics and risk of subsequent clinical relapses after nucleos(t)ide analog cessation: Ying-Nan Tsai, Jia-Ling Wu, Cheng-Hao Tseng, Tzu-Haw Chen, Yi-Ling Wu, Chieh-Chang Chen, Yu-Jen Fang, Tzeng-Huey Yang, Mindie H. Nguyen, Jaw-Town Lin, Yao-Chun Hsu; Clin Mol Hepatol 2024;30(1):98-108.
Published online December 14, 2023; DOI: https://doi.org/10.3350/cmh.2023.0194

Background/Aims
Finite nucleos(t)ide analog (NA) therapy has been proposed as an alternative treatment strategy for chronic hepatitis B (CHB), but biomarkers for post-treatment monitoring are limited. We investigated whether measuring hepatitis B core-related antigen (HBcrAg) after NA cessation may stratify the risk of subsequent clinical relapse (CR).
Methods
This retrospective multicenter analysis enrolled adults with CHB who were prospectively monitored after discontinuing entecavir or tenofovir with negative HBeAg and undetectable HBV DNA at the end of treatment (EOT). Patients with cirrhosis or malignancy were excluded. CR was defined as serum alanine aminotransferase > two times the upper limit of normal with recurrent viremia. We applied time-dependent Cox proportional hazard models to clarify the association between HBcrAg levels and subsequent CR.
Results
The cohort included 203 patients (median age, 49.8 years; 76.8% male; 60.6% entecavir) who had been treated for a median of 36.9 months (interquartile range [IQR], 36.5–40.1). During a median post-treatment follow-up of 31.7 months (IQR, 16.7–67.1), CR occurred in 104 patients with a 5-year cumulative incidence of 54.8% (95% confidence interval [CI], 47.1–62.4%). Time-varying HBcrAg level was a significant risk factor for subsequent CR (adjusted hazard ratio [aHR], 1.53 per log U/mL; 95% CI, 1.12–2.08) with adjustment for EOT HBsAg, EOT anti-HBe, EOT HBcrAg and time-varying HBsAg. During follow-up, HBcrAg <1,000 U/mL predicted a lower risk of CR (aHR, 0.41; 95% CI, 0.21–0.81).
Conclusions
Dynamic measurement of HBcrAg after NA cessation is predictive of subsequent CR and may be useful to guide post-treatment monitoring.

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Edo J. Dongelmans, Jordan J. Feld, André Boonstra, Sylvia M. Brakenhoff, David Wong, Colina Yim, Mark Claassen, Pieter Honkoop, Bettina E. Hansen, Robert A. de Man, Scott Fung, Thomas Berg, Florian van Bömmel, Harry L. A. Janssen, Milan J. Sonneveld
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Jiarui Zheng, Zilong Wang, Linxiang Huang, Zixuan Qiu, Yandi Xie, Suzhen Jiang, Bo Feng
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Hepatitis B core-related antigen as a promising serological marker for monitoring hepatitis B virus cure
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Rong Fan, Rui Deng, Qing Xie, Fang Wang, Xieer Liang, Hong Ma, Huiying Rao, Yanhang Gao, Chunxiu Zhong, Qing Guo, Sheng Shen, Ya Xu, Xingyu Lu, Hongbo Gao, Honglian Bai, Xiaoguang Dou, Jian Sun
Clinical Gastroenterology and Hepatology.2025;[Epub] CrossRef
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Yong-Hong Wang, Ya-Chao Tao, Meng-Lan Wang, Cheng-Run Song, Jiang-Nan Peng, En-Qiang Chen
Journal of Virus Eradication.2025; 11(4): 100617. CrossRef
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Yoshihiko Yano, Itsuko Sato, Takamitsu Imanishi, Ryutaro Yoshida, Takanori Matsuura, Yoshihide Ueda, Yuzo Kodama
Diagnostics.2024; 14(7): 728. CrossRef
Letter regarding “Hepatitis B core-related antigen dynamics and risk of subsequent clinical relapses after nucleos(t)ide analog cessation”
Yun-Fan Liaw
Clinical and Molecular Hepatology.2024; 30(2): 269. CrossRef
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Chen-Te Huang, Tai-Chung Tseng
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Ying-Nan Tsai, Jia-Ling Wu, Yao-Chun Hsu
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A critical review of diagnostic and prognostic markers of chronic hepatitis B infection
Shuaibu Abdullahi Hudu, Sa’adatu Haruna Shinkafi, Abdulgafar Olayiwola Jimoh
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Virological markers for clinical trials in chronic viral hepatitis
Jean-Michel Pawlotsky
JHEP Reports.2024; 6(11): 101214. CrossRef

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Crossref

Viral hepatitis

Artificial intelligence predicts direct-acting antivirals failure among hepatitis C virus patients: A nationwide hepatitis C virus registry program: Ming-Ying Lu, Chung-Feng Huang, Chao-Hung Hung, Chi‐Ming Tai, Lein-Ray Mo, Hsing-Tao Kuo, Kuo-Chih Tseng, Ching-Chu Lo, Ming-Jong Bair, Szu-Jen Wang, Jee-Fu Huang, Ming-Lun Yeh, Chun-Ting Chen, Ming-Chang Tsai, Chien-Wei Huang, Pei-Lun Lee, Tzeng-Hue Yang, Yi-Hsiang Huang, Lee-Won Chong, Chien-Lin Chen, Chi-Chieh Yang, Sheng‐Shun Yang, Pin-Nan Cheng, Tsai-Yuan Hsieh, Jui-Ting Hu, Wen-Chih Wu, Chien-Yu Cheng, Guei-Ying Chen, Guo-Xiong Zhou, Wei-Lun Tsai, Chien-Neng Kao, Chih-Lang Lin, Chia-Chi Wang, Ta-Ya Lin, Chih‐Lin Lin, Wei-Wen Su, Tzong-Hsi Lee, Te-Sheng Chang, Chun-Jen Liu, Chia-Yen Dai, Jia-Horng Kao, Han-Chieh Lin, Wan-Long Chuang, Cheng-Yuan Peng, Chun-Wei- Tsai, Chi-Yi Chen, Ming-Lung Yu, TACR Study Group; Clin Mol Hepatol 2024;30(1):64-79.
Published online November 21, 2023; DOI: https://doi.org/10.3350/cmh.2023.0287

Background/Aims
Despite the high efficacy of direct-acting antivirals (DAAs), approximately 1–3% of hepatitis C virus (HCV) patients fail to achieve a sustained virological response. We conducted a nationwide study to investigate risk factors associated with DAA treatment failure. Machine-learning algorithms have been applied to discriminate subjects who may fail to respond to DAA therapy.
Methods
We analyzed the Taiwan HCV Registry Program database to explore predictors of DAA failure in HCV patients. Fifty-five host and virological features were assessed using multivariate logistic regression, decision tree, random forest, eXtreme Gradient Boosting (XGBoost), and artificial neural network. The primary outcome was undetectable HCV RNA at 12 weeks after the end of treatment.
Results
The training (n=23,955) and validation (n=10,346) datasets had similar baseline demographics, with an overall DAA failure rate of 1.6% (n=538). Multivariate logistic regression analysis revealed that liver cirrhosis, hepatocellular carcinoma, poor DAA adherence, and higher hemoglobin A1c were significantly associated with virological failure. XGBoost outperformed the other algorithms and logistic regression models, with an area under the receiver operating characteristic curve of 1.000 in the training dataset and 0.803 in the validation dataset. The top five predictors of treatment failure were HCV RNA, body mass index, α-fetoprotein, platelets, and FIB-4 index. The accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the XGBoost model (cutoff value=0.5) were 99.5%, 69.7%, 99.9%, 97.4%, and 99.5%, respectively, for the entire dataset.
Conclusions
Machine learning algorithms effectively provide risk stratification for DAA failure and additional information on the factors associated with DAA failure.

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AI-Safe-C score: Assessing liver-related event risks in patients without cirrhosis after successful direct-acting antiviral treatment
Huapeng Lin, Terry Cheuk-Fung Yip, Hye Won Lee, Xiangjun Meng, Jimmy Che-To Lai, Sang Hoon Ahn, Wenjing Pang, Grace Lai-Hung Wong, Lingfeng Zeng, Vincent Wai-Sun Wong, Victor de Lédinghen, Seung Up Kim
Journal of Hepatology.2025; 82(3): 456. CrossRef
Real‐world efficacy and safety of universal 8‐week glecaprevir/pibrentasvir in patients with chronic hepatitis C with early chronic kidney disease or pre‐end‐stage renal disease: Insights from a nationwide hepatisis C virus registry in Taiwan
Szu‐Jen Wang, Chung‐Feng Huang, Te‐Sheng Chang, Ching‐Chu Lo, Chao‐Hung Hung, Chien‐Wei Huang, Lee‐Won Chong, Pin‐Nan Cheng, Ming‐Lun Yeh, Cheng‐Yuan Peng, Chien‐Yu Cheng, Jee‐Fu Huang, Ming‐Jong Bair, Chih‐Lang Lin, Chi‐Chieh Yang, Hsing‐Tao Kuo, Tsai‐Yu
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Mitochondrial mt12361A>G increased risk of metabolic dysfunction-associated steatotic liver disease among non-diabetes
Ming-Ying Lu, Yu-Ju Wei, Chih-Wen Wang, Po-Cheng Liang, Ming-Lun Yeh, Yi-Shan Tsai, Pei-Chien Tsai, Yu-Min Ko, Ching-Chih Lin, Kuan-Yu Chen, Yi-Hung Lin, Tyng-Yuan Jang, Ming-Yen Hsieh, Zu-Yau Lin, Chung-Feng Huang, Jee-Fu Huang, Chia-Yen Dai, Wan-Long Ch
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Explainable machine learning for the assessment of donor grafts in liver transplantation
Liang Zhixing, Ye Linsen, Jiang Peng, Dong Siyi, Yu Haoyuan, Li Kun, Li Siqi, Hu Yongwei, Zhang Mingshen, Liu Wei, Li Hua, Yi Shuhong, Chen Guihua, Xu Xiao, Zheng Shusen, Yang Yang
Hepatology Research.2025; 55(6): 908. CrossRef
Role of risk factors and their variable types in predicting noise-induced hearing loss using artificial intelligence algorithms
Zhengheng Zhang, Longteng Jiang, Meibian Zhang, Yuan Pan, Jinnan Zheng, Anqi Liu, Weijiang Hu, Xin Jin
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Artificial Intelligence and Machine Learning Applications in Liver Disease
Bhargav Vemulapalli, Meghana Ghattu, Kavya Atluri, James Lee, Vinod Rustgi
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Aya I. Abdelaziz, Eman Abdelsameea, Sara A. Wahdan, Doaa Elsherbiny, Zeinab Zakaria, Samar S. Azab
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Hepatitis C Virus: Epidemiological Challenges and Global Strategies for Elimination
Daniela Toma, Lucreția Anghel, Diana Patraș, Anamaria Ciubară
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Chung-Feng Huang, Po-Cheng Liang, Yu-Ju Wei, Chao-Chun Wu, Shi-Lun Wei, Li-Ju Lin, Pei-Chun Hsieh, Tsui-Hsia Hsu, Maggie Shu-Mei Hsu, Ya-Xin Luo, Hsi-Chieh Chen, Tsu-Yun Ho, Shao-Hsuan Lin, Chia-Ling Liu, Kuo-Pen Cheng, John W. Ward, Ming-Lung Yu
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Nargiz Imamova, Ayten Feteliyeva, Adil M. Allahverdiyev
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Kirolos Eskandar
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Chin-Wei Chang, Wei-Fan Hsu, Kuo-Chih Tseng, Chi-Yi Chen, Pin-Nan Cheng, Chao-Hung Hung, Ching-Chu Lo, Ming-Jong Bair, Chien-Hung Chen, Pei-Lun Lee, Chun-Yen Lin, Hsing-Tao Kuo, Chun-Ting Chen, Chi-Chieh Yang, Jee-Fu Huang, Chi-Ming Tai, Jui-Ting Hu, Chih
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Guilherme Silva Julian, Wen-Yi Shau, Hsu-Wen Chou, Sajita Setia
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Ming‐Ying Lu, Wan‐Long Chuang, Ming‐Lung Yu
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Khalid M. Al-Naamani, Heba Omar, Said A. Al Busafi, Halima H. Al Shuaili, Zakariya Al-Naamani, Murtadha Al-Khabori, Elias A. Said, Abdullah H. AlKalbani, B. R. Kamath, Bashar Emad, Shahina Daar, Lolo Alhajri, Alya AlKalbani, Zainab AlFarsi, Haifa Alzuhaib
Journal of Clinical Medicine.2024; 13(23): 7411. CrossRef

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Viral hepatitis

Cardiovascular risk in chronic hepatitis B patients treated with tenofovir disoproxil fumarate or tenofovir alafenamide: Hyeyeon Hong, Won-Mook Choi, Danbi Lee, Ju Hyun Shim, Kang Mo Kim, Young-Suk Lim, Han Chu Lee, Jonggi Choi; Clin Mol Hepatol 2024;30(1):49-63.
Published online November 20, 2023; DOI: https://doi.org/10.3350/cmh.2023.0328

Background/Aims
Tenofovir disoproxil fumarate (TDF) is known to have a lipid-lowering effect. This is in contrast to tenofovir alafenamide (TAF), which has a lipid-neutral effect. Therefore, concerns have been raised as to whether these differences affect long-term cardiovascular risk. Here, we aimed to evaluate the long-term risk of cardiovascular events in chronic hepatitis B (CHB) patients treated with TAF or TDF.
Methods
We retrospectively analyzed 4,124 treatment-naïve CHB patients treated with TDF (n=3,186) or TAF (n=938) between 2012 and 2022. The primary outcome was a composite endpoint of major adverse cardiovascular events (MACE), including myocardial infarction, ischemic stroke, and hospitalization for unstable angina or heart failure. Serial changes in lipid profiles between two treatments were also explored.
Results
The median age of the patients was 50.6 years, and 60.6% of the patients were male. At baseline, 486 (11.8%) and 637 (15.4%) of the patients had dyslipidemia and fatty liver, respectively. A total of 42 MACE occurred, with an annual incidence of 0.2%/100 person-years (PYs). At 1, 3, and 5 years, the cumulative risk of MACE was 0.4%, 0.8%, and 1.2% in patients treated with TDF, and 0.2%, 0.7%, and 0.7% in patients treated with TAF, respectively (p=0.538). No significant differences in the risk of MACE were observed between TDF and TAF. A multivariable analysis found that current smoker and a history of cardiovascular events were risk factors associated with an increased risk of MACE.
Conclusions
Patients treated with TAF had comparable risks of cardiovascular outcomes, defined as MACE, as patients treated with TDF.

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Efficacy and Safety of Tenofovir Alafenamide (TAF) and Tenofovir Disoproxil Fumarate (TDF) Followed by TAF in Chronic Hepatitis B Patients of East Asian Ethnicity Following 5 Years of Treatment
Grace Lai‐Hung Wong, Edward Gane, Calvin Q. Pan, Scott Fung, Mang M. Ma, Namiki Izumi, Shalimar, Seng Gee Lim, Wan‐Long Chuang, Rajiv Mehta, Young‐Suk Lim, Leland J. Yee, John F. Flaherty, Frida Abramov, Hongyuan Wang, Maria Buti
Alimentary Pharmacology & Therapeutics.2026; 63(1): 132. CrossRef
Atherosclerotic Cardiovascular Risk in Patients with Chronic Hepatitis B: Tenofovir Disoproxil Fumarate Vs. Tenofovir Alafenamide: A Korean Nationwide Study
Jiwon Yang, Jihye Lim, Ye‐jee Kim, Hwa Jung Kim, Jonggi Choi
Journal of Medical Virology.2026;[Epub] CrossRef
Association between statin use and hepatic decompensation in patients with primary biliary cholangitis: A target trial emulation study
Jonggi Choi, Junqing Xu, Vy H. Nguyen, Eric Przybyszewski, Daniel S. Pratt, Jiunn Song, Allison Carroll, Megan Michta, Erik Almazan, Tracey G. Simon, Raymond T. Chung
Hepatology.2026;[Epub] CrossRef
Evaluating fracture risk with TDF in elderly patients with hepatitis B: A Korean perspective
Yoon E. Shin, Jae Young Kim, Jeong Ju Yoo, Sang Gyune Kim, Young Seok Kim
Journal of Hepatology.2025; 82(6): e301. CrossRef
Tenofovir Disoproxil Fumarate Versus Entecavir: Effects on Lipid Profiles and Cardiovascular Outcomes in People Living With Chronic Hepatitis B
Log Young Kim, Jae Young Kim, Jeong‐Ju Yoo, Sang Gyune Kim, Young‐Seok Kim
Journal of Medical Virology.2025;[Epub] CrossRef
Safety of tenofovir alafenamide in the context of hyperlipidemia and cardiovascular diseases: a nationwide analysis
Jae-Young Kim, Hyuk Kim, Jeong-Ju Yoo, Sang Gyune Kim, Young-Seok Kim
Hepatology International.2025; 19(4): 959. CrossRef
Impact of Tenofovir Alafenamide on Lipid Profiles in Chronic Hepatitis B Patients: Systematic Review and Meta‐Analysis
Ping‐Yu Hsu, Hui‐Chen Su, Mi‐Chia Ma, Chien‐An Chen, Sin‐Yi Yu, Yi‐Ming Hua
Journal of Medical Virology.2025;[Epub] CrossRef
Effect of switching from prior Nucleos(t)ide Analogue(s) to Tenofovir alafenamide on lipid profile and cardiovascular risk in patients with Chronic Hepatitis B
Witchayaporn Praguylertluck, Apichat Kaewdech, Naichaya Chamroonkul, Teerha Piratvisuth, Pimsiri Sripongpun, Tyng-Yuan Jang
PLOS One.2025; 20(5): e0324897. CrossRef
Metabolic effects and cardiovascular disease risks of TDF or TAF in patients with chronic hepatitis B: a systematic review and meta-analysis
Yuan-Hai Zhou, Nan Cai, Yu-Xin Chen, Yong-Lu Su, Peng Hu
Frontiers in Pharmacology.2025;[Epub] CrossRef
Tenofovir alafenamide-related hyperlipidemia and cardiovascular risk
Ankur Jindal, Manoj Kumar
Hepatology International.2025; 19(4): 701. CrossRef
Comparison of bone mineral density changes between denosumab and bisphosphonates in tenofovir-exposed chronic hepatitis B patients with osteoporosis
Yunmi Ko, Byeong Geun Song, Hyunjae Shin, Youngsu Park, Jeayeon Park, Min Kyung Park, Yun Bin Lee, Su Jong Yu, Dong Hyun Sinn, Yoon Jun Kim, Jung-Hwan Yoon, Seung Shin Park, Moon Haeng Hur, Jeong-Hoon Lee
Osteoporosis International.2025; 36(8): 1391. CrossRef
Blood pressure and metabolic outcomes after efavirenz‐ or dolutegravir‐based therapy started in acute HIV infection
Phillip Chan, Sarah Moreland, Carlo Sacdalan, Donn J. Colby, Ferron Ocampo, Pathariya Promsena, Somchai Sriplienchan, Jarawee Wattana, Jintana Intasan, Nittaya Phanuphak, Sandhya Vasan, Robert Paul, Lydie Trautmann, Serena Spudich, Eugène Kroon
HIV Medicine.2025; 26(10): 1619. CrossRef
Pharmacovigilance analysis of metabolic and nutritional adverse reactions associated with entecavir and tenofovir using the FDA adverse event reporting system database
Haomin Zhu, Baolong Ding, Zhuying Jing, Hongting Yao, Yue Li, Lihong Gao, Yulu Zhu, Xin Li
International Journal of Clinical Pharmacy.2025; 47(5): 1510. CrossRef
Antiviral Therapy Reduces Dyslipidemia and Cardiovascular Risk in Chronic Hepatitis B: TDF as the Most Effective Agent
Hyuk Kim, Jae‐Young Kim, Hyun Bin Choi, Ji‐Soo Lee, Yoon E. Shin, Jeong‐Ju Yoo, Sang Gyune Kim, Young‐Seok Kim
Journal of Medical Virology.2025;[Epub] CrossRef
Hepatocellular Carcinoma Risk in Chronic Hepatitis B Patients Treated With Tenofovir Alafenamide or Tenofovir Disoproxil Fumarate
Jiwon Yang, Jihye Lim, Ye‐Jee Kim, Hwa Jung Kim, Jonggi Choi
Liver International.2025;[Epub] CrossRef
Letter: Cardiovascular risk of tenofovir disoproxil fumarate or tenofovir alafenamide fumarate in patients with chronic hepatitis B: More questions than an answer – author’s reply
Hyeyeon Hong, Jonggi Choi
Clinical and Molecular Hepatology.2024; 30(2): 272. CrossRef
Cardiovascular risk of tenofovir disoproxil fumarate or tenofovir alafenamide in patients with chronic hepatitis B: More questions than an answer
Pin-Nan Cheng, Ming-Lung Yu
Clinical and Molecular Hepatology.2024; 30(2): 144. CrossRef
Lipid safety of tenofovir alafenamide during 96-week treatment in treatment-naive chronic hepatitis B patients
Wenjuan Zhao, Yi Liu, Mengdi Zhang, Zixin Cui, Zhan Qu, Yiyang Li, Meijuan Wan, Wen Wang, Yunru Chen, Lei Shi, Jianzhou Li, Feng Ye
Frontiers in Medicine.2024;[Epub] CrossRef
Reply to correspondence on “Cardiovascular risk in chronic hepatitis B patients treated with tenofovir disoproxil fumarate or tenofovir alafenamide”
Pin-Nan Cheng, Ming-Lung Yu
Clinical and Molecular Hepatology.2024; 30(4): 1031. CrossRef
Effects of tenofovir alafenamide fumarate on serum lipid profiles in patients with chronic hepatitis B
Fei Cao, Tao Fan, Xue Jiang, Jian Wang, Yilin Liu, Li Zhu, Ye Xiong, Shaoqiu Zhang, Zhiyi Zhang, Yifan Pan, Yuanyuan Li, Chao Jiang, Juan Xia, Xiaomin Yan, Jie Li, Xingxiang Liu, Chuanwu Zhu, Rui Huang, Chao Wu
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Eight‐year efficacy and safety of tenofovir alafenamide for treatment of chronic hepatitis B virus infection: Final results from two randomised phase 3 trials
Maria Buti, Young‐Suk Lim, Henry Lik Yuen Chan, Kosh Agarwal, Patrick Marcellin, Maurizia R. Brunetto, Wan‐Long Chuang, Harry L. A. Janssen, Scott K. Fung, Namiki Izumi, Maciej S. Jablkowski, Dzhamal Abdurakhmanov, Frida Abramov, Hongyuan Wang, Irina Botr
Alimentary Pharmacology & Therapeutics.2024; 60(11-12): 1573. CrossRef

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Letter to the Editor

Viral hepatitis

Letter regarding “Treated chronic hepatitis B is a good prognostic factor of diffuse large B-cell lymphoma”: Chi Hsiao, Yung-Po Liaw; Clin Mol Hepatol 2024;30(1):109-110.
Published online October 11, 2023; DOI: https://doi.org/10.3350/cmh.2023.0373

4,525 View
56 Download

Snapshot

Viral hepatitis

HBeAg-positive grey-zone patients: Treatment beyond guideline recommendations?: Soon Kyu Lee, Jung Hyun Kwon; Clin Mol Hepatol 2023;29(3):825-827.
Published online May 31, 2023; DOI: https://doi.org/10.3350/cmh.2023.0185

Citations

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Liver histological study of patients with chronic hepatitis B virus infection in the grey zone
Weijia Lin, Rongrong Ding, Shuangshuang Sun, Wei Lu, Yanbin Wang, Xinlan Zhou, Dan Huang, Xiufen Li, Zhanqing Zhang, Liang Chen
BMC Infectious Diseases.2025;[Epub] CrossRef
Correspondence to editorial on “Optimal tacrolimus levels for reducing CKD risk and the impact of intrapatient variability on CKD and ESRD development following liver transplantation”
Soon Kyu Lee, Jong Young Choi
Clinical and Molecular Hepatology.2025; 31(2): e161. CrossRef
Distinguishing True Immune Tolerant Hepatitis B Patients: Insights From Long‐Term Clinical Outcomes
Jung Hyun Kwon, Sung Won Lee, Hee‐Yeon Kim, Do Seon Song, Soon Kyu Lee, Heechul Nam, Soon Woo Nam, Si Hyun Bae, Jong Young Choi, Seung Kew Yoon, Jeong Won Jang
Journal of Viral Hepatitis.2025;[Epub] CrossRef
Gray zone and the need for expansion in chronic hepatitis B: From theory to clinical practice
Thang Viet Luong, Ngoc Phan Hong Nguyen, Tri Van Nguyen, Duong Hung Tran, Thien Dinh Nguyen, Hai Nguyen Ngoc Dang
World Journal of Hepatology.2025;[Epub] CrossRef
Vibration-controlled transient elastography for significant fibrosis in treatment-naïve chronic hepatitis B patients: A systematic review and meta-analysis
Mi Na Kim, Jihyun An, Eun Hwa Kim, Hee Yeon Kim, Han Ah Lee, Jung Hwan Yu, Young-Joo Jin, Young Eun Chon, Seung Up Kim, Dae Won Jun, Ji Won Han, Miyoung Choi
Clinical and Molecular Hepatology.2024; 30(Suppl): S106. CrossRef

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Original Articles

Viral hepatitis

Treated chronic hepatitis B is a good prognostic factor of diffuse large B-cell lymphoma: Jeayeon Park, Sung Won Chung, Yun Bin Lee, Hyunjae Shin, Moon Haeng Hur, Heejin Cho, Min Kyung Park, Jeonghwan Youk, Ji Yun Lee, Jeong-Ok Lee, Su Jong Yu, Yoon Jun Kim, Jung-Hwan Yoon, Tae Min Kim, Jeong-Hoon Lee; Clin Mol Hepatol 2023;29(3):794-809.
Published online May 17, 2023; DOI: https://doi.org/10.3350/cmh.2023.0057

Background/Aims
Chronic hepatitis B (CHB) is a risk factor for non-Hodgkin lymphoma (NHL). Our recent study suggested that antiviral treatment may reduce the incidence of NHL in CHB patients. This study compared the prognoses of hepatitis B virus (HBV)-associated diffuse large B-cell lymphoma (DLBCL) patients receiving antiviral treatment and HBV-unassociated DLBCL patients.
Methods
This study comprised 928 DLBCL patients who were treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) at two referral centers in Korea. All patients with CHB received antiviral treatment. Time-to-progression (TTP) and overall survival (OS) were the primary and secondary endpoints, respectively.
Results
Among the 928 patients in this study, 82 were hepatitis B surface antigen (HBsAg)-positive (the CHB group) and 846 were HBsAg-negative (the non-CHB group). The median follow-up time was 50.5 months (interquartile range [IQR]=25.6–69.7 months). Multivariable analyses showed longer TTP in the CHB group than the non-CHB group both before inverse probability of treatment weighting (IPTW; adjusted hazard ratio [aHR]=0.49, 95% confidence interval [CI]=0.29–0.82, p=0.007) and after IPTW (aHR=0.42, 95% CI=0.26–0.70, p<0.001). The CHB group also had a longer OS than the non-CHB group both before IPTW (HR=0.55, 95% CI=0.33–0.92, log-rank p=0.02) and after IPTW (HR=0.53, 95% CI=0.32–0.99, log-rank p=0.02). Although liver-related deaths did not occur in the non-CHB group, two deaths occurred in the CHB group due to hepatocellular carcinoma and acute liver failure, respectively.
Conclusions
Our findings indicate that HBV-associated DLBCL patients receiving antiviral treatment have significantly longer TTP and OS after R-CHOP treatment than HBV-unassociated DLBCL patients.

Citations

Citations to this article as recorded by

Chronic hepatitis b coinfection and survival in pediatric T-ALL: A propensity-matched analysis
Yutong Zhang, Ruihong Wu, Yuan Zhang, Yufei Zhao, Xiaodan Zhong, Xianmei Jin, Chao Zhang, Jian Chang
iScience.2026; 29(1): 114319. CrossRef
Letter regarding “Treated chronic hepatitis B is a good prognostic factor of diffuse large B-cell lymphoma”
Chi Hsiao, Yung-Po Liaw
Clinical and Molecular Hepatology.2023; 30(1): 109. CrossRef

8,566 View
186 Download
3 Web of Science
Crossref

Viral hepatitis

Hepatocellular carcinoma prediction model performance decreases with long-term antiviral therapy in chronic hepatitis B patients: Xiaoning Wu, Xiaoqian Xu, Jialing Zhou, Yameng Sun, Huiguo Ding, Wen Xie, Guofeng Chen, Anlin Ma, HongXin Piao, Bingqiong Wang, Shuyan Chen, Tongtong Meng, Xiaojuan Ou, Hwai-I Yang, Jidong Jia, Yuanyuan Kong, Hong You; Clin Mol Hepatol 2023;29(3):747-762.
Published online May 10, 2023; DOI: https://doi.org/10.3350/cmh.2023.0121

Background/Aims
Existing hepatocellular carcinoma (HCC) prediction models are derived mainly from pretreatment or early on-treatment parameters. We reassessed the dynamic changes in the performance of 17 HCC models in patients with chronic hepatitis B (CHB) during long-term antiviral therapy (AVT).
Methods
Among 987 CHB patients administered long-term entecavir therapy, 660 patients had 8 years of follow-up data. Model scores were calculated using on-treatment values at 2.5, 3, 3.5, 4, 4.5, and 5 years of AVT to predict threeyear HCC occurrence. Model performance was assessed with the area under the receiver operating curve (AUROC). The original model cutoffs to distinguish different levels of HCC risk were evaluated by the log-rank test.
Results
The AUROCs of the 17 HCC models varied from 0.51 to 0.78 when using on-treatment scores from years 2.5 to 5. Models with a cirrhosis variable showed numerically higher AUROCs (pooled at 0.65–0.73 for treated, untreated, or mixed treatment models) than models without (treated or mixed models: 0.61–0.68; untreated models: 0.51–0.59). Stratification into low, intermediate, and high-risk levels using the original cutoff values could no longer reflect the true HCC incidence using scores after 3.5 years of AVT for models without cirrhosis and after 4 years of AVT for models with cirrhosis.
Conclusions
The performance of existing HCC prediction models, especially models without the cirrhosis variable, decreased in CHB patients on long-term AVT. The optimization of existing models or the development of novel models for better HCC prediction during long-term AVT is warranted.

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Viral hepatitis

Safety considerations for withdrawal of nucleos(t)ide analogues in patients with chronic hepatitis B: First, do no harm: Yao-Chun Hsu, Cheng-Hao Tseng, Jia-Horng Kao; Clin Mol Hepatol 2023;29(4):869-890.
Published online March 14, 2023; DOI: https://doi.org/10.3350/cmh.2022.0420

Abstract
PDF

Nucleos(t)ide analogues (NA) are widely used to treat hepatitis B virus (HBV) infection, but they cannot eradicate the virus and treatment duration can be lifelong if the endpoint is set at seroclearance of the hepatitis B surface antigen (HBsAg). As an alternative strategy, finite NA therapy without the prerequisite of HBsAg seroclearance has been proposed to allow treatment cessation in patients with sustained undetectable HBV viremia for two to three years. However, reactivation of viral replication almost always follows NA withdrawal. Whereas HBV reactivation might facilitate HBsAg seroclearance in some, it could lead to serious acute flare-ups in a certain proportion of patients. Occurrence and consequences of NA withdrawal flares are complicated with various factors involving the virus, host, and treatment. Accurate risk prediction for severe flares following NA cessation is essential to ensure patient safety. The risks of life-threatening flares in patients who discontinued NA according to the stopping rules of current guidelines or local reimbursement policies have recently been quantitatively estimated in large-scale studies, which also provided empirical evidence to help identify vulnerable patients at risk of devastating outcomes. Moreover, risk predictors were further explored and validated to hopefully aid in patient selection and management. In this narrative review with a focus on patient safety, we summarize and discuss current literature on the incidence of severe flares following NA cessation, risk stratification for candidate selection, rules of posttreatment monitoring, and indications for treatment resumption. We also share our thoughts on the limitations of existing knowledge and suggestions for future research.

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Editorial

Viral hepatitis

The imitator of immune-tolerant chronic hepatitis B: A killer in disguise: Moon Haeng Hur, Jeong-Hoon Lee; Clin Mol Hepatol 2023;29(2):363-366.
Published online March 9, 2023; DOI: https://doi.org/10.3350/cmh.2023.0079

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Review

Viral hepatitis

Acute hepatitis C virus infection: clinical update and remaining challenges: Chen-Hua Liu, Jia-Horng Kao; Clin Mol Hepatol 2023;29(3):623-642.
Published online February 20, 2023; DOI: https://doi.org/10.3350/cmh.2022.0349

Abstract
PDF

Acute hepatitis C virus (HCV) infection is a global health concern with substantial geographical variation in the incidence rate. People who have received unsafe medical procedures, used injection drugs, and lived with human immunodeficiency virus are reported to be most susceptible to acute HCV infection. The diagnosis of acute HCV infection is particularly challenging in immunocompromised, reinfected, and superinfected patients due to difficulty in detecting anti-HCV antibody seroconversion and HCV ribonucleic acid from a previously negative antibody response. With an excellent treatment effect on chronic HCV infection, recently, clinical trials investigating the benefit of direct-acting antivirals (DAAs) treatment for acute HCV infection have been conducted. Based on the results of cost-effectiveness analysis, DAAs should be initiated early in acute HCV infection prior to spontaneous viral clearance. Compared to the standard 8–12 week-course of DAAs for chronic HCV infection, DAAs treatment duration may be shortened to 6–8 weeks in acute HCV infection without compromising the efficacy. Standard DAA regimens provide comparable efficacy in treating HCV-reinfected patients and DAA-naïve ones. For cases contracting acute HCV infection from HCV-viremic liver transplant, a 12-week course of pangenotypic DAAs is suggested. While for cases contracting acute HCV infection from HCV-viremic non-liver solid organ transplants, a short course of prophylactic or pre-emptive DAAs is suggested. Currently, prophylactic HCV vaccines are unavailable. In addition to treatment scale-up for acute HCV infection, practice of universal precaution, harm reduction, safe sex, and vigilant surveillance after viral clearance remain critical in reducing HCV transmission.

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Editorial

Viral hepatitis

Moving toward hepatitis B virus functional cure - the impact of on-treatment kinetics of serum viral markers: Lilian Yan Liang, Vincent Wai-Sun Wong, Grace Lai-Hung Wong, Terry Cheuk-Fung Yip; Clin Mol Hepatol 2023;29(1):113-117.
Published online October 31, 2022; DOI: https://doi.org/10.3350/cmh.2022.0333

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Review

Viral hepatitis

Toward a complete cure for chronic hepatitis B: Novel therapeutic targets for hepatitis B virus: Sun Woong Kim, Jun Sik Yoon, Minjong Lee, Yuri Cho; Clin Mol Hepatol 2022;28(1):17-30.
Published online July 20, 2021; DOI: https://doi.org/10.3350/cmh.2021.0093

Abstract
PDF

Hepatitis B virus (HBV) affects approximately 250 million patients worldwide, resulting in the progression to cirrhosis and hepatocellular carcinoma, which are serious public health problems. Although universal vaccination programs exist, they are only prophylactic and not curative. In the HBV life cycle, HBV forms covalently closed circular DNA (cccDNA), which is the viral minichromosome, in the nuclei of human hepatocytes and makes it difficult to achieve a complete cure with the current nucleos(t)ide analogs and interferon therapies. Current antiviral therapies rarely eliminate cccDNA; therefore, lifelong antiviral treatment is necessary. Recent trials for antiviral treatment of chronic hepatitis B have been focused on establishing a functional cure, defined by either the loss of hepatitis B surface antigen, undetectable serum HBV DNA levels, and/or seroconversion to hepatitis B surface antibody. Novel therapeutic targets and molecules are in the pipeline for early clinical trials aiming to cure HBV infection. The ideal strategy for achieving a long-lasting functional or complete cure might be using combination therapies targeting different steps of the HBV life cycle and immunomodulators. This review summarizes the current knowledge about novel treatments and combination treatments for a complete HBV cure.

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Original Articles

Viral hepatitis

Sofosbuvir/velpatasvir plus ribavirin for Child-Pugh B and Child-Pugh C hepatitis C virus-related cirrhosis: Chen-Hua Liu, Chi-Yi Chen, Wei-Wen Su, Chun-Jen Liu, Ching-Chu Lo, Ke-Jhang Huang, Jyh-Jou Chen, Kuo-Chih Tseng, Chi-Yang Chang, Cheng-Yuan Peng, Yu-Lueng Shih, Chia-Sheng Huang, Wei-Yu Kao, Sheng-Shun Yang, Ming-Chang Tsai, Jo-Hsuan Wu, Po-Yueh Chen, Pei-Yuan Su, Jow-Jyh Hwang, Yu-Jen Fang, Pei-Lun Lee, Chi-Wei Tseng, Fu-Jen Lee, Hsueh-Chou Lai, Tsai-Yuan Hsieh, Chun-Chao Chang, Chung-Hsin Chang, Yi-Jie Huang, Jia-Horng Kao; Clin Mol Hepatol 2021;27(4):575-588.
Published online July 13, 2021; DOI: https://doi.org/10.3350/cmh.2021.0155

Background/Aims
Real-world studies assessing the effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) plus ribavirin (RBV) for Child-Pugh B/C hepatitis C virus (HCV)-related cirrhosis are limited.
Methods
We included 107 patients with Child-Pugh B/C HCV-related cirrhosis receiving SOF/VEL plus RBV for 12 weeks in Taiwan. The sustained virologic response rates at off-treatment week 12 (SVR₁₂) for the evaluable population (EP), modified EP, and per-protocol population (PP) were assessed. Thesafety profiles were reported.
Results
The SVR₁₂ rates in the EP, modified EP and PP were 89.7% (95% confidence interval [CI], 82.5–94.2%), 94.1% (95% CI, 87.8–97.3%), and 100% (95% CI, 96.2–100%). Number of patients who failed to achieve SVR₁₂ were attributed to virologic failures. The SVR₁₂ rates were comparable regardless of patient characteristics. One patient discontinued treatment because of adverse events (AEs). Twenty-four patients had serious AEs and six died, but none were related to SOF/VEL or RBV. Among the 96 patients achieving SVR₁₂, 84.4% and 64.6% had improved Child-Pugh and model for endstage liver disease (MELD) scores. Multivariate analysis revealed that a baseline MELD score ≥15 was associated with an improved MELD score of ≥3 (odds ratio, 4.13; 95% CI, 1.16–14.71; P=0.02). Patients with chronic kidney disease (CKD) stage 1 had more significant estimated glomerular filtration rate declines than patients with CKD stage 2 (-0.42 mL/min/1.73 m²/month; P=0.01) or stage 3 (-0.56 mL/min/1.73 m²/month; P<0.001).
Conclusions
SOF/VEL plus RBV for 12 weeks is efficacious and well-tolerated for Child-Pugh B/C HCV-related cirrhosis.

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Viral hepatitis

The impact of unrestricted access to direct-acting antiviral among incarcerated hepatitis C virus-infected patients: Yu Jun Wong, Prem Harichander Thurairajah, Rahul Kumar, Kwong Ming Fock, Ngai Moh Law, Sin-Yoong Chong, Fria Gloriba Manejero, Tiing-Leong Ang, Eng Kiong Teo, Jessica Tan; Clin Mol Hepatol 2021;27(3):474-485.
Published online February 19, 2021; DOI: https://doi.org/10.3350/cmh.2021.0015

Background/Aims
Despite the disproportionally high prevalence rates of hepatitis C virus (HCV) amongst the incarcerated population, eradication remains challenging due to logistic and financial barriers. Although treatment prioritization based on disease severity is commonly practiced, the efficacy of such approach remained uncertain. We aimed to compare the impact of unrestricted access to direct-acting antiviral (DAA) among incarcerated HCV-infected patients in Singapore.
Methods
In this retrospective study, we reviewed all incarcerated HCV-infected patients treated in our hospital during the restricted DAA era (2013–2018) and unrestricted DAA access era (2019). Study outcomes included the rate of sustained virological response (SVR), treatment completion and treatment default. Subgroup analysis was performed based on the presence of liver cirrhosis, HCV genotype and HCV treatment types.
Results
A total of 1,001 HCV patients was followed-up for 1,489 person-year. They were predominantly male (93%) with genotype-3 HCV infection (71%), and 38% were cirrhotic. The overall SVR during the restricted DAA access era and unrestricted DAA access era were 92.1% and 99.1%, respectively. Unrestricted access to DAA exponentially improved the treatment access among HCV-infected patients by 460%, resulting in a higher SVR rate (99% vs. 92%, P=0.003), higher treatment completion rate (99% vs. 93%, P<0.001) and lower treatment default rate (1% vs. 9%, P<0.001).
Conclusion
In this large cohort of incarcerated HCV-infected patients, we demonstrated that unrestricted access to DAA is an impactful strategy to allow rapid treatment up-scale in HCV micro-elimination.

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Editorial

Viral hepatitis

Drug-drug interactions with direct-acting antivirals — less is more: Grace Lai-Hung Wong; Clin Mol Hepatol 2021;27(1):81-82.
Published online December 3, 2020; DOI: https://doi.org/10.3350/cmh.2020.0278

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The Korean Journal of Internal Medicine.2022; 37(6): 1167. CrossRef

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Review

Viral hepatitis

Current and future strategies for the treatment of chronic hepatitis C: Omar Alshuwaykh, Paul Y. Kwo; Clin Mol Hepatol 2021;27(2):246-256.
Published online December 3, 2020; DOI: https://doi.org/10.3350/cmh.2020.0230

Abstract
PDF

Chronic hepatitis C infection is a major cause of liver disease and hepatocellular carcinoma worldwide. While hepatitis C has been treated for decades with some success, the introduction of direct acting antiviral agents has revolutionized the treatment of hepatitis C with finite, highly effective, well-tolerated therapy and there are few populations that cannot be successfully treated now or are complicated to manage. The World Health Organization has released elimination targets in an effort to eliminate viral hepatitis and reduce dramatically the morbidity and mortality caused by both viral hepatitis. While hepatitis C is straightforward to treat, it remains problematic to eliminate on a global scale. Diagnosis of hepatitis C remains the major gap in the cascade of care and numerous screening strategies will be required to reduce this gap. While historically, treatment of hepatitis C has been centralized, decentralized approaches will be required to diagnose, evaluate, and link to care the large population of individuals worldwide with hepatitis C across low-, middle-, and high-income countries. With the introduction of multiple pangenotypic treatment options and reduced cost for these therapies, assessment and treatment for those with hepatitis C has been simplified and made more accessible worldwide. There are multiple populations for whom care models are being developed and refined, including those when inject drugs, those who are incarcerated, those who present with sexually transmitted disease including the men who have sex with men population, amongst many others. While a vaccine for hepatitis C remains elusive these efforts continue. Multiple successful elimination efforts have been reported.

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Original Article

Negligible risks of hepatocellular carcinoma during biomarker-defined immune-tolerant phase for patients with chronic hepatitis B: Mi Young Jeon, Beom Kyung Kim, Jae Seung Lee, Hye Won Lee, Jun Yong Park, Do Young Kim, Sang Hoon Ahn, Kwang-Hyub Han, Seung Up Kim; Clin Mol Hepatol 2021;27(2):295-304.
Published online December 3, 2020; DOI: https://doi.org/10.3350/cmh.2020.0216

Background/Aims
The immune-tolerant (IT) phase of chronic hepatitis B (CHB) patients is not generally indicative of antiviral therapy (AVT). We assessed and compared the risk of hepatocellular carcinoma (HCC) during the IT-phase stringently defined by a low fibrosis-4 (FIB-4) index, compared to that in patients undergoing AVT.
Methods
Among 125 untreated patients that were hepatitis B e-antigen positive, hepatitis B virus-DNA >20,000 IU/mL, with normal alanine aminotransferase level from 2012 to 2018, those with a FIB-4 index of <1.45 were classified into the IT-group. The cumulative probability of HCC was estimated using Kaplan-Meier analysis. All patients were assessed until HCC development (intention-to-treat [ITT] analysis), whereas those suspected of experiencing CHB phase switch were assessed using the per-protocol (PP) and censored at the time of phase switch.
Results
The cumulative probability of HCC at 1-, 3-, and 5-years among the IT-group was zero, compared to AVT-treated patients with FIB-4 indices <1.45 during the same period: 0.2%, 0.6%, and 1.4%, respectively (P=0.264 for ITT and P=0.533 for PP). Among the initially screened 125 untreated patients, those with a FIB-4 index of ≥1.45 had a higher risk of HCC compared to the IT-group (P=0.005). Furthermore, among AVT-treated patients, those with a FIB-4 index of ≥1.45 had a higher risk of HCC compared to their counterpart (P<0.001).
Conclusions
The risk of HCC was negligible in the IT-group stringently defined by a low FIB-4 index. However, given that a higher HCC risk exists among untreated patients with higher FIB-4, appropriate criteria for AVT should be established.

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