Clinical and Molecular Hepatology

"Hepatitis B virus"

Review Article

Treatment Strategies for Patients with HBV Infection Coexisting with HCV or MASLD: Chieh Liu, Yi-Fen Shih, Chun-Jen Liu; Received October 28, 2025 Accepted January 2, 2026 Published online January 9, 2026; DOI: https://doi.org/10.3350/cmh.2025.1227 [Accepted]

Abstract
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Hepatitis B virus (HBV) remains a major cause of chronic liver diseases, especially in the Asia-Pacific region. In recent decades, coinfection with hepatitis C virus (HCV) and coexistence with metabolic dysfunction-associated steatotic liver disease (MASLD) have emerged as significant clinical concerns among HBV-infected subjects. Although global HBV vaccination programs and curative therapies for HCV have led to a marked decline in HBV/HCV coinfection, MASLD is rapidly becoming the predominant comorbidity due to the global surge in metabolic risk factors. HBV/HCV coinfection typically results in more severe liver damage, with unique challenges in antiviral treatment and risk of HBV reactivation post-HCV clearance. In contrast, HBV/MASLD overlap demonstrates complex metabolic-viral interactions that may influence viral replication, hepatitis B surface antigen seroclearance, fibrosis progression, and risk of hepatocellular carcinoma. This review critically compares the epidemiology, clinical outcomes, and management strategies of HBV patients with concurrent HCV or MASLD, while addressing current research gaps and proposing directions for future investigations.

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Original Articles

Dissecting antibody-mediated NK cell effects reveals a cytotoxic CX3CR1⁺KLRC2⁻CD16^hisubset linked to HBV outcomes: Libo Tang, Yuhao Wang, Zihan Jin, Yurong Gu, Zhaofeng Zeng, Linnan Song, Xuan Yi, Lingtao Zhang, Yujing Zhang, Weiying He, Liping Wang, Weixin He, Jianru Sun, Xiaoqin Lan, Xiangyong Li, Shihong Zhong, Yongyin Li; Received August 18, 2025 Accepted December 15, 2025 Published online December 19, 2025; DOI: https://doi.org/10.3350/cmh.2025.0842 [Accepted]

Abstract
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Background/Aims
Natural killer (NK) cell function is generally considered dampened in chronic hepatitis B virus (HBV) infection; however, the NK cell pool exhibits phenotypic and functional heterogeneity, and the antibody-mediated effect of NK cells remains less characterized. This study evaluated the dynamic changes in antibody-mediated NK cell responses and the involvement of distinct NK subsets across disease stages and during antiviral treatment.
Methods
A T-cell receptor-like antibody specific for the HBV core 18–27 peptide (cTCRL-Ab) was used to determine the antibody-mediated effect of NK cells, and an array of NK cell surface markers were analyzed in cross-sectional and longitudinal cohorts of patients with chronic HBV infection. Single-cell RNA sequencing (scRNA-seq) was performed to identify the heterogeneity of NK subsets.
Results
The cTCRL-Ab enabled the detection of NK cell cytolytic activity and IFNγ production. Notably, cTCRL-Ab-mediated NK cell responses were compromised in chronically HBV-infected patients, particularly in those receiving pegylated interferon-α (Peg-IFNα), which was associated with the downregulation of CD16 expression. Correspondingly, Peg-IFNα inhibited cTCRL-Ab-mediated NK cell function by reducing CD16 expression in vitro. scRNA-seq revealed that CD16 downregulation occurred mainly within a dysfunctional CD16^hi NK subset exhibiting exhaustion properties. In contrast, an activated CD16^hiNK subpopulation (CX3CR1⁺KLRC2⁻CD16^hi) with high cytotoxicity was enriched in patients who experienced favorable treatment responses. Furthermore, the intrahepatic CX3CR1+KLRC2-CD16^hisubset tended to exhibit functional restoration in HBsAg loss individuals.
Conclusions
Our data contribute to the understanding of antibody-mediated responses of NK cells in chronic HBV infection, and highlight a previously unappreciated functional CX3CR1+KLRC2-CD16^hiNK subset as a potential therapeutic target.

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ACSS2-mediated acetyl-CoA accumulation promotes mitophagy and tumor growth via increased H3K27ac in HBV-related HCC: Shan Li, Jie Hu, Yihan Yan, Xinrui Liu, Xiao Dong, Huijun Liang, Xin Tang, Junji Tao, Rong Zhang, Yuan Hu, Ailong Huang, Kai Wang, Ni Tang; Received July 13, 2025 Accepted December 13, 2025 Published online December 19, 2025; DOI: https://doi.org/10.3350/cmh.2025.0754 [Accepted]

Abstract
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Background/Aims
Acetyl coenzyme A (acetyl-CoA) is one of the most essential metabolites in cell metabolism but its function and concentration in hepatocellular carcinoma (HCC) remains elusive and controversial.
Methods
A comprehensive analysis of acetyl-CoA levels and ACSS2 expression across a range of samples, including patient specimens from both HBV positive and HBV negative HCC individuals, HBV-transgenic mouse HCC models, and multiple cell lines. Furthermore, to evaluate the functional significance of ACSS2 in HBV-related HCC, we implemented both genetic and pharmacological inhibition strategies targeting ACSS2. Molecular mechanism and mitophagy assessment were revealed by CUT &Tag, RNA sequencing, bioinformatic analyses, transmission electron microscopy (TEM) and JC-1 staining.
Results
Our study revealed a distinct metabolic signature of HBV-related HCC, marked by elevated acetyl-CoA, which was driven by acetyl-CoA synthetase 2 (ACSS2). ACSS2 was upregulated by the carbohydrate response element-binding protein (ChREBP) in HBV-related HCC. Furthermore, ACSS2 improved tumor cell proliferation, an effect that was dependent on its enzymatic activity. Mechanistically, ACSS2-induced acetyl-CoA accumulation activated voltage-dependent anion channels 1 (VDAC1) transcription through increased H3K27ac occupancy, which subsequently promoted mitophagy and HBV-related HCC tumorigenesis. Notably, targeting ACSS2 by depletion or inhibition with a catalytic inhibitor significantly suppressed tumor growth.
Conclusions
These findings not only illustrate the interplay between metabolic reprogramming, epigenetic modification, and tumorigenesis in the context of HBV infection, but also highlight ACSS2 as a novel metabolic vulnerability in HBV-related HCC. Therefore, targeting ACSS2 could be a novel strategy against HBV-associated HCC.

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Review

Targeting the innate immune system in treating hepatitis B: prospects for functional cure: Karen Cheuk-Ying Ho, Rex Wan-Hin Hui, Wai-Kay Seto, Man-Fung Yuen, Lung-Yi Mak; Clin Mol Hepatol 2026;32(1):184-199.
Published online November 11, 2025; DOI: https://doi.org/10.3350/cmh.2025.0935

Abstract
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Chronic hepatitis B (CHB) infection remains a significant global public health concern. Functional cure, defined as hepatitis B surface antigen seroclearance with unquantifiable HBV DNA at 24 weeks off treatment, is a desirable endpoint in the treatment of CHB, yet challenging to achieve. Given the limitations of current therapies including nucleos(t)ide analogues and pegylated interferon alpha, novel agents targeting functional cure are emerging. As hepatitis B virus (HBV) is a non-cytolytic virus, liver damage stems from the host immune response towards HBV-infected cells. The innate immune response during the initial phase of HBV infection is crucial in establishing an adequate level of immunity against the virus. However, HBV adopts various mechanisms to evade the host’s innate immunity, partly contributing to the chronicity of infection. This article provides a comprehensive review on how the HBV life cycle interacts with the host’s innate immune system. The latest evidence of novel agents targeting the innate immunity will also be covered. Retinoic acid inducible gene I agonists, toll-like receptor agonists, and interferons are therapies that target the HBV evasion strategies against host’s innate immunity. While small interfering RNAs and antisense oligonucleotides are originally designed for antigen knockdown and reinvigoration of the adaptive immune response, they have also shown additional impacts on the innate immunity. With ongoing research and innovation in combination strategies, advancement in the management of CHB is anticipated in the future.

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Correspondence

Correspondence to editorial on “Factors associated with hepatitis B mother-to-child transmission in a national prevention program”: Redefining MTCT prevention strategies toward HBV elimination: Moran Ki, Jong-Hyun Kim; Received July 21, 2025 Accepted July 24, 2025 Published online July 28, 2025; DOI: https://doi.org/10.3350/cmh.2025.0805 [Accepted]

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Research Letter

Contemporary trends in extrahepatic mortality of chronic liver disease in the United States from 2014 to 2023: Donghee Kim, Pojsakorn Danpanichkul, Karn Wijarnpreecha, Aijaz Ahmed; Clin Mol Hepatol 2026;32(1):e24-e28.
Published online July 28, 2025; DOI: https://doi.org/10.3350/cmh.2025.0802

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Review

Global strategies and actions to eliminate hepatitis B virus infection: Chih-Lin Lin, Jia-Horng Kao; Clin Mol Hepatol 2025;31(4):1197-1212.
Published online July 28, 2025; DOI: https://doi.org/10.3350/cmh.2025.0492

Abstract
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Through the implementation of hepatitis B vaccination and effective antiviral treatment over the past four decades, the hepatitis B surface antigen (HBsAg) seroprevalence of the vaccinated generation dramatically decline. The incidence of hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) also decreases. However, the elimination of HBV is still a challenge to achieve. Novel HBV biomarkers, including quantitative HBsAg, hepatitis B virus core-related antigen and HBV RNA are promising in predicting clinical phases, risks of disease progression and HBV functional cure. Current antiviral therapies, nucleoside/nucleotide and pegylated alpha-interferon, effectively decrease HCC incidence in chronic hepatitis B (CHB) patients and minimize the recurrence of HCC in patients receiving curative therapy. Novel agents under development to achieve HBV cure include direct-acting antivirals that target various stages of the HBV lifecycle and host targeting agents that enhance HBV-specific immunity. The action plans for eliminating hepatitis B in the future are universal HBV screening, early and simplified treatment as well as precision lifelong management for CHB patients. This narrative review will summarize and discuss global strategies and initiatives aimed at eliminating HBV infection.

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Aspirin Use and Risk of HCC and Gastrointestinal Bleeding in Patients With HBV‐Related Cirrhosis: A Landmark Analysis
Mi Na Kim, Geun U. Park, Seng Chan You, Jae Seung Lee, Hye Won Lee, Beom Kyung Kim, Seung Up Kim, Jun Yong Park, Do Young Kim, Sang Hoon Ahn
Journal of Gastroenterology and Hepatology.2025; 40(11): 2750. CrossRef

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Original Article

Factors associated with hepatitis B mother-to-child transmission in a national prevention program: Moran Ki, Byung-Woo Kim, Dahye Baik, Jong-Hyun Kim; Clin Mol Hepatol 2025;31(4):1298-1315.
Published online June 24, 2025; DOI: https://doi.org/10.3350/cmh.2025.0214

Background/Aims
Hepatitis B virus (HBV) mother-to-child transmission (MTCT) remains a global health concern, with over 90% of perinatal infections leading to chronic HBV. To evaluate long-term trends in MTCT rates and associated factors within Korea’s national program.
Methods
Population-based cohort study using linked data from the Perinatal Hepatitis B Prevention Program (PHBPP) and National Health Insurance Service in Korea. The study included HBsAg-positive mother-infant pairs with post-vaccination serologic results from 2002 to 2021.
Results
Among the 154,478 mother-infant pairs, the overall MTCT rate after prophylaxis was 2.3%. Antiviral use lowered MTCT rates (0.9% vs. 2.4%) particularly in HBeAg-positivity (1.0% vs. 5.9%; adjusted odds ratio [aOR] 0.21; 95% confidence interval [CI] 0.14–0.32). Lower MTCT rates were observed for cesarean section vs. vaginal delivery (1.9% vs. 2.6%; aOR 0.78; 95% CI 0.73–0.84) and breastfeeding vs. formula feeding (1.8% vs. 2.8%; aOR 0.65; 95% CI 0.56–0.76). Annual MTCT rates decreased from 3.6% (2002–2005) to 1.3% (2018–2021). Antivirals reduced MTCT rates; initiation at 14–27 weeks (0.39%), or 28–32 weeks (0.44%) vs. ≥33 weeks (1.47%); postpartum continuation (0.55%) vs. antepartum discontinuation (1.44%); use ≥61 days (0.51%) vs. 1–60 days (1.67%). Lower MTCT risk was associated with maternal (old age, high income) and infant (female sex, preterm birth) factors.
Conclusions
This comprehensive analysis of the PHBPP in Korea demonstrates that the use of antivirals, breastfeeding, and cesarean section, combined with conventional immunoprophylaxis, has significantly reduced MTCT rates. These results are crucial for global HBV elimination and can help to guide HBV MTCT prevention strategies.

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Reply to Correspondence

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; Clin Mol Hepatol 2026;32(1):e117-e118.
Published online May 13, 2025; DOI: https://doi.org/10.3350/cmh.2025.0500

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Editorials

Metabolic health in antiviral era of 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”: Shang-Chin Huang, Jia-Horng Kao; Clin Mol Hepatol 2026;32(1):423-425.
Published online April 11, 2025; DOI: https://doi.org/10.3350/cmh.2025.0369

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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
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
Clinical and Molecular Hepatology.2026; 32(1): e83. CrossRef

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Viral manipulation of host cell glutamine metabolism and glutamine rewiring in hepatic diseases: Editorial on “Glutamate dehydrogenase 1-dependent α-ketoglutarate promotes hepatitis B virus transcription by modulating histone methylations on the covalently closed circular DNA minichromosome”: Mehrangiz Dezhbord, Kyun-Hwan Kim; Clin Mol Hepatol 2026;32(1):385-389.
Published online April 11, 2025; DOI: https://doi.org/10.3350/cmh.2025.0366

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Regulation of hepatitis B virus cccDNA by metabolic pathways: Editorial on “GDH1-dependent α-ketoglutarate promotes HBV transcription by modulating histone methylations on the cccDNA minichromosome”: Hyeong-Jin Cho, Sung-Gyoo Park; Clin Mol Hepatol 2026;32(1):381-384.
Published online March 12, 2025; DOI: https://doi.org/10.3350/cmh.2025.0255

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Establishment and evaluation of an immortalized dzo kidney cell line
Wenkai Liu, Cong Xu, Jiamin Wang, Na Sun, Zhongren Ma, Jin Zhao, Jianguo Chen, You Li, Zilin Qiao
Scientific Reports.2025;[Epub] CrossRef

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Viral hepatitis

Reconsidering treatment indications for chronic hepatitis B: Insights from the TORCH-B roll-over study: Editorial on “Antiviral therapy for chronic hepatitis B with mildly elevated aminotransferase: A rollover study from the TORCH-B trial”: Chih-Wen Wang, Ming-Lung Yu; Clin Mol Hepatol 2025;31(2):606-609.
Published online December 3, 2024; DOI: https://doi.org/10.3350/cmh.2024.1078

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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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Reviews

Viral hepatitis

Mechanisms of hepatocellular carcinoma and cirrhosis development in concurrent steatotic liver disease and chronic hepatitis B: Saisai Zhang, Lung-Yi Mak, Man-Fung Yuen, Wai-Kay Seto; Clin Mol Hepatol 2025;31(Suppl):S182-S195.
Published online November 21, 2024; DOI: https://doi.org/10.3350/cmh.2024.0837

Abstract
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Chronic hepatitis B (CHB) poses a major global public health challenge and is a leading cause of cirrhosis and liver cancer. Hepatic steatosis is common in individuals with CHB compared to the non-CHB population and is particularly prevalent in hepatitis B virus (HBV)-endemic regions, affecting about one-third of CHB patients. The interaction between hepatic steatosis and CHB-related disease progression is complex and still under debate. Evidence demonstrates that co-existing steatosis may worsen liver fibrosis while paradoxically increasing the likelihood of achieving better HBV control. In particular, despite the association of steatotic liver disease (SLD) with lower HBV viral loads and higher rates of HBsAg seroclearance, the coexistence of CHB and SLD can potentially accelerate liver disease progression. Factors such as fat deposition, lipotoxicity, oxidative stress, and chronic inflammation in SLD may foster a pro-fibrotic and pro-carcinogenic environment, accelerating the disease progression. Additionally, loss of global DNA methylation, changes in the immune microenvironment, and genetic susceptibility further contribute to the development of CHB-related cirrhosis and hepatocellular carcinoma (HCC). This review examines the mechanisms driving liver disease progression and the heightened risk of cirrhosis and HCC in patients with concurrent CHB and steatotic liver disease, underscoring the importance of prioritizing antiviral therapy for CHB in addition to addressing SLD.

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Sisi Yang, Zhenxuan Ma
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Mai Abd El-Meguid, Ghada M. Salum, Basma E. Fotouh, Naglaa Zayed, Shereen Abdel Alem, Ayman Yosry, Reham M. Dawood
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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
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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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Large-scale profile study on hepatitis B surface antigen levels in chronic hepatitis B: implications for drug development targeting functional cure
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Clinical and Molecular Hepatology.2026; 32(1): e55. CrossRef
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Targeting the innate immune system in treating hepatitis B: prospects for functional cure
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Rex Wan-Hin Hui, Lung-Yi Mak, Man-Fung Yuen
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Expanding treatment indications in chronic hepatitis B: Should we treat all patients?
Rex Wan-Hin Hui, Lung-Yi Mak, James Fung, Wai-Kay Seto, Man-Fung Yuen
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Correspondence

Hepatic neoplasm

Correspondence to editorial on “Genetically-modified, redirected T cells target hepatitis B surface antigen-positive hepatocytes and hepatocellular carcinoma lesions in a clinical setting”: Shunda Du, Karin Wisskirchen, Ke Zhang, Ulrike Protzer; Clin Mol Hepatol 2025;31(1):e44-e47.
Published online October 21, 2024; DOI: https://doi.org/10.3350/cmh.2024.0781

Citations

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Reply to correspondence on “Genetically-modified, redirected T cells target hepatitis B surface antigen-positive hepatocytes and hepatocellular carcinoma lesions in a clinical setting”
Antonio Bertoletti, Anthony T Tan
Clinical and Molecular Hepatology.2025; 31(1): e113. CrossRef

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57 Download
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Reply to Correspondence

Hepatic neoplasm

Reply to correspondence on “Genetically-modified, redirected T cells target hepatitis B surface antigen-positive hepatocytes and hepatocellular carcinoma lesions in a clinical setting”: Antonio Bertoletti, Anthony T Tan; Clin Mol Hepatol 2025;31(1):e113-e116.
Published online October 11, 2024; DOI: https://doi.org/10.3350/cmh.2024.0867

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Letter to the Editor

Viral hepatitis

Presence of liver fibrosis in chronic hepatitis B patients with varying serum hepatitis B virus DNA levels: Letter to the editor on “Non-linear association between liver fibrosis scores and viral load in patients with chronic hepatitis B”: Jian Wang, Shaoqiu Zhang, Chuanwu Zhu, Yuanwang Qiu, Chao Wu, Rui Huang; Clin Mol Hepatol 2025;31(1):e27-e30.
Published online August 7, 2024; DOI: https://doi.org/10.3350/cmh.2024.0602

Citations

Citations to this article as recorded by

Correspondence to letter to the editor on “Non-linear association between liver fibrosis scores and viral load in patients with chronic hepatitis B”
Gi-Ae Kim, Seung Won Choi, Young-Suk Lim
Clinical and Molecular Hepatology.2025; 31(1): e108. CrossRef

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Correspondence

Viral hepatitis

Correspondence to letter to the editor on “Non-linear association between liver fibrosis scores and viral load in patients with chronic hepatitis B”: Gi-Ae Kim, Seung Won Choi, Young-Suk Lim; Clin Mol Hepatol 2025;31(1):e108-e109.
Published online August 5, 2024; DOI: https://doi.org/10.3350/cmh.2024.0619

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Reply to Correspondence

Viral hepatitis

Reply to correspondence 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):1044-1046.
Published online July 29, 2024; DOI: https://doi.org/10.3350/cmh.2024.0584

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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

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Original Article

Viral hepatitis

Non-linear association between liver fibrosis scores and viral load in patients with chronic hepatitis B: Gi-Ae Kim, Seung Won Choi, Seungbong Han, Young-Suk Lim; Clin Mol Hepatol 2024;30(4):793-806.
Published online July 19, 2024; DOI: https://doi.org/10.3350/cmh.2024.0252

Background/Aims
Serum hepatitis B virus (HBV) DNA levels and non-invasive liver fibrosis scores are significantly associated with hepatocellular carcinoma (HCC) risk in chronic hepatitis B (CHB) patients. Nonetheless, the relationship between HBV DNA levels and liver fibrosis scores is unclear.
Methods
A historical cohort comprising 6,949 non-cirrhotic Korean CHB patients without significant alanine aminotransferase elevation was investigated. The association of HBV DNA levels with the aspartate aminotransferase to platelet ratio index (APRI) and fibrosis (FIB)-4 score at baseline was analyzed using general linear models.
Results
In HBeAg-negative patients (n=4,868), HBV DNA levels correlated linearly with both APRI and FIB-4 scores. In contrast, in HBeAg-positive patients (n=2,081), HBV DNA levels correlated inversely with both APRI and FIB-4 scores. Across the entire cohort, a significant non-linear parabolic relationship was identified between HBV DNA levels and fibrosis scores, independent of age and other covariates. Notably, moderate viral loads (6–7 log10 IU/mL) corresponded to the highest APRI and FIB-4 scores (p<0.001). Over a median 10-year follow-up, 435 patients (6.3%) developed HCC. Higher APRI scores ≥0.5 and FIB-4 scores ≥1.45 were significantly associated with elevated HCC risk (p<0.001 for both). HBV DNA level remained a significant predictive factor for HCC development, even after adjusting for APRI or FIB-4 scores.
Conclusions
HBV viral load is significantly correlated with APRI and FIB-4 scores, and is also associated with HCC risk independent of those scores in CHB patients. These findings suggest that HBV DNA level is associated with hepatocarcinogenesis through both direct and indirect pathways.

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Clinical and Molecular Hepatology.2025; 31(1): e27. CrossRef
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Min Wang, Yun Li, Yuan Cao, Meng-Meng Yang, Fu-Jing Liu, Jie Jiao, Sheng-Yuan Wang, Bin Song, Lu Wang, Yi-Qi Wu, Hong-Jun Kang
Annals of Medicine.2025;[Epub] CrossRef
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
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Journal of Hepatology.2025; 83(2): 502. CrossRef
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Ke-Jie He, Guoyu Gong
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Shan Ren, Sujun Zheng, Xinyang Zhang, Junliang Fu, Rongshan Fan, Qingfa Ruan, Wenqi Huang, Haibing Gao, Xiulan Xue, Fang Yang, Yao Xie, Minghui Li, Xinyue Chen
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Tamer A. Addissouky, Ibrahim El Tantawy El Sayed, Ayman E. El Agroudy, Yuliang Wang
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Viral Load–Based Prediction of Hepatocellular Carcinoma Risk in Noncirrhotic Patients With Chronic Hepatitis B
Gi-Ae Kim, Young-Suk Lim
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Hiba Sami, Mohd Asaad, Sohail Ansari, Syed Haider Mehdi Husaini, Mohammad Azam Khan, Parvez Anwar Khan, Nazish Fatima, Haris Manzoor Khan
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Reply to Correspondence

Viral hepatitis

Reply to correspondence on “Novel role of MHC class II transactivator in hepatitis B virus replication and viral counteraction”: Cho-Rong Lee, Sung-Gyoo Park; Clin Mol Hepatol 2024;30(4):1053-1054.
Published online July 17, 2024; DOI: https://doi.org/10.3350/cmh.2024.0572

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Reply to correspondence on “Novel role of MHC class II transactivator in hepatitis B virus replication and viral counteraction”
Cho-Rong Lee, Sung-Gyoo Park
Clinical and Molecular Hepatology.2024; 30(4): 1053. CrossRef

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Editorial

Viral hepatitis

Class II transactivator restricts viral replication, extending its effect to HBV: Editorial on “Novel role of MHC class II transactivator in hepatitis B virus replication and viral counteraction”: Cho-Rong Lee, Sung-Gyoo Park; Clin Mol Hepatol 2024;30(4):724-727.
Published online July 3, 2024; DOI: https://doi.org/10.3350/cmh.2024.0465

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Next-generation T cell immunotherapy: overcoming exhaustion, senescence, and suppression
Guangmei Li, Dengju Li, Xiaojian Zhu
Frontiers in Immunology.2025;[Epub] CrossRef
Correspondence on editorial regarding “Novel role of MHC class II transactivator in hepatitis B virus replication and viral counteraction”
Mehrangiz Dezhbord, Kyun-Hwan Kim
Clinical and Molecular Hepatology.2024; 30(4): 1028. CrossRef

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Original Article

Hepatic neoplasm

Genetically-modified, redirected T cells target hepatitis B surface antigen-positive hepatocytes and hepatocellular carcinoma lesions in a clinical setting: Xueshuai Wan, Karin Wisskirchen, Tao Jin, Lu Yang, Xiaorui Wang, Xiang’an Wu, Fang Liu, Yu Wu, Christy Ma, Yong Pang, Qi Li, Ke Zhang, Ulrike Protzer, Shunda Du; Clin Mol Hepatol 2024;30(4):735-755.
Published online May 29, 2024; DOI: https://doi.org/10.3350/cmh.2024.0058

Background/Aims
Hepatitis B virus (HBV)-DNA integration in HBV-related hepatocellular carcinoma (HBV-HCC) can be targeted by HBV-specific T cells. SCG101 is an autologous, HBV-specific T-cell product expressing a T-cell receptor (TCR) after lentiviral transduction recognizing the envelope-derived peptide (S_20-28) on HLA-A2. We here validated its safety and efficacy preclinically and applied it to an HBV-related HCC patient (NCT05339321).
Methods
Good Manufacturing Practice-grade manufactured cells were assessed for off-target reactivity and functionality against hepatoma cells. Subsequently, a patient with advanced HBV-HCC (Child-Pugh class A, Barcelona Clinic Liver Cancer stage B, Eastern Cooperative Oncology Group performance status 0, hepatitis B e antigen-, serum hepatitis B surface antigen [HBsAg]+, HBsAg+ hepatocytes 10%) received 7.9×10⁷ cells/kg after lymphodepletion. Safety, T-cell persistence, and antiviral and antitumor efficacy were evaluated.
Results
SCG101, produced at high numbers in a closed-bag system, showed HBV-specific functionality against HBV-HCC cells in vitro and in vivo. Clinically, treatment was well tolerated, and all adverse events, including transient hepatic damage, were reversible. On day 3, ALT levels increased to 1,404 U/L, and concurrently, serum HBsAg started decreasing by 3.84 log¹⁰ and remained <1 IU/mL for over six months. HBsAg-expressing hepatocytes in liver biopsies were undetectable after 73 days. The patient achieved a partial response according to modified RECIST with a >70% reduction in target lesion size. Transferred T cells expanded, developed a stem cell-like memory phenotype, and were still detectable after six months in the patient’s blood.
Conclusions
SCG101 T-cell therapy showed encouraging efficacy and safety in preclinical models and in a patient with primary HBV-HCC and concomitant chronic hepatitis B with the capability to eliminate HBsAg⁺ cells and achieve sustained tumor control after single dosing.

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Clinical results of an HBV-specific T-cell receptor-T-cell therapy (SCG101) in patients with HBV-related hepatocellular carcinoma treated in an investigator-initiated, interventional trial
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Gut.2026; 75(1): 147. CrossRef
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Tao Zhang, Cong Ren, Zhanyu Yang, Ning Zhang, Haowen Tang
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Elmar Jaeckel, Scott L. Friedman, Michael Hudecek, Ulrike Protzer
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Corey Smith, Rajiv Khanna, Graeme N. Forrest
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Antonio Bertoletti, Anthony T Tan
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Editorials

Steatotic liver disease

Metabolic dysfunction-associated fatty liver disease is a ubiquitous latent cofactor in viral- and alcoholic-related hepatocellular carcinoma: Editorial on “Global prevalence of metabolic dysfunction-associated fatty liver disease-related hepatocellular carcinoma: A systematic review and meta-analysis”

Toru Nakamura, Masahito Nakano, Tsubasa Tsutsumi, Keisuke Amano, Takumi Kawaguchi

Clin Mol Hepatol 2024;30(4):705-708.
Published online May 20, 2024

DOI: https://doi.org/10.3350/cmh.2024.0372

PDF

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Ho Soo Chun, Minjong Lee
Clinical and Molecular Hepatology.2025; 31(1): 261.     CrossRef
Temporal Trends in Cardiovascular Mortality in Underlying Viral Hepatitis: A Retrospective Analysis of Gender, Racial/Ethnic, and Regional Disparities
Wania Sultan, Haider Ashfaq, Hamza Ashraf, Ahmad Khan, Ayman Omair Hashmi, Muhammad Omar Larik, Maheen Zahid, Yasir Majeed, Pratik Bhattarai, Ashujot K. Dang, Ahmed Ali Aziz, Hafiz Muhammad Sharjeel Arshad
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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

PDF

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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

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Original Articles

Viral hepatitis

Novel role of MHC class II transactivator in hepatitis B virus replication and viral counteraction

Mehrangiz Dezhbord, Seong Ho Kim, Soree Park, Da Rae Lee, Nayeon Kim, Juhee Won, Ah Ram Lee, Dong-Sik Kim, Kyun-Hwan Kim

Clin Mol Hepatol 2024;30(3):539-560.
Published online May 14, 2024

DOI: https://doi.org/10.3350/cmh.2024.0060

Abstract

PDF
Supplementary Material

Background/Aims
The major histocompatibility class II (MHC II) transactivator, known as CIITA, is induced by Interferon gamma (IFN-γ) and plays a well-established role in regulating the expression of class II MHC molecules in antigen-presenting cells.
Methods
Primary human hepatocytes (PHH) were isolated via therapeutic hepatectomy from two donors. The hepatocellular carcinoma (HCC) cell lines HepG2 and Huh7 were used for the mechanistic study, and HBV infection was performed in HepG2-NTCP cells. HBV DNA replication intermediates and secreted antigen levels were measured using Southern blotting and ELISA, respectively.
Results
We identified a non-canonical function of CIITA in the inhibition of hepatitis B virus (HBV) replication in both HCC cells and patient-derived PHH. Notably, in vivo experiments demonstrated that HBV DNA and secreted antigen levels were significantly decreased in mice injected with the CIITA construct. Mechanistically, CIITA inhibited HBV transcription and replication by suppressing the activity of HBV-specific enhancers/promoters. Indeed, CIITA exerts antiviral activity in hepatocytes through ERK1/2-mediated down-regulation of the expression of hepatocyte nuclear factor 1α (HNF1α) and HNF4α, which are essential factors for virus replication. In addition, silencing of CIITA significantly abolished the IFN-γ-mediated anti-HBV activity, suggesting that CIITA mediates the anti-HBV activity of IFN-γ to some extent. HBV X protein (HBx) counteracts the antiviral activity of CIITA via direct binding and impairing its function.
Conclusions
Our findings reveal a novel antiviral mechanism of CIITA that involves the modulation of the ERK pathway to restrict HBV transcription. Additionally, our results suggest the possibility of a new immune avoidance mechanism involving HBx.

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Xiaobing Lu, Ziling Qin, Zhe Hu, Hao Huang, Jie Su, Xiaoru Zhang, Meisheng Yi, Kuntong Jia
Fish & Shellfish Immunology.2025; 162: 110336.     CrossRef
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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
Bioinformatics and system biology approach to discover the common pathogenetic processes between COVID-19 and chronic hepatitis B
Xiao Ma, Tengda Huang, Yujia Song, Hongyuan Pan, Ao Du, Xinyi Zhou, Yong Zeng, Kefei Yuan, Xiaosheng Tan
PLOS One.2025; 20(5): e0323708.     CrossRef
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Enis Kostallari, Robert F. Schwabe, Adrien Guillot
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Gender-specific alteration of steroid metabolism and its impact on viral replication in a mouse model of hepatitis B virus infection
Eun-Sook Park, Juhee Won, Sung Hyun Ahn, Ah Ram Lee, Donghyo Lee, Ju-Yeon Moon, Man Ho Choi, Kyun-Hwan Kim
Animal Cells and Systems.2024; 28(1): 466.     CrossRef
Class II transactivator restricts viral replication, extending its effect to HBV: Editorial on “Novel role of MHC class II transactivator in hepatitis B virus replication and viral counteraction”
Cho-Rong Lee, Sung-Gyoo Park
Clinical and Molecular Hepatology.2024; 30(4): 724.     CrossRef
Chronic Hepatitis B Genotype C Mouse Model with Persistent Covalently Closed Circular DNA
Deok-Hwa Seo, Wonhee Hur, Juhee Won, Ji-Won Han, Seung-Kew Yoon, Songmee Bae, Kyun-Hwan Kim, Pil-Soo Sung
Viruses.2024; 16(12): 1890.     CrossRef

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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

Abstract

PDF
Supplementary Material

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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Clinical and Molecular Hepatology.2024; 30(4): 718.     CrossRef
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Viral hepatitis

Phase 1 trial of the safety, pharmacokinetics, and antiviral activity of EDP-514 in untreated viremic chronic hepatitis B patients

Man-Fung Yuen, Wan-Long Chuang, Cheng-Yuan Peng, Wen-Juei Jeng, Wei-Wen Su, Ting-Tsung Chang, Chi-Yi Chen, Yao-Chun Hsu, Guy De La Rosa, Alaa Ahmad, Ed Luo, Annie L. Conery

Clin Mol Hepatol 2024;30(3):375-387.
Published online March 26, 2024

DOI: https://doi.org/10.3350/cmh.2023.0535

Abstract

PDF
Supplementary Material

Background/Aims
Oral EDP-514 is a potent core protein inhibitor of hepatitis B virus (HBV) replication, which produced a >4-log viral load reduction in HBV-infected chimeric mice with human liver cells. This study evaluated the safety, pharmacokinetics, and antiviral activity of three doses of EDP-514 in treatment-naive viremic patients with HBeAgpositive or -negative chronic HBV infection.
Methods
Patients with HBsAg detectable at screening and at least 6 months previously were eligible. HBeAg-positive and -negative patients had a serum/plasma HBV DNA level ≥20,000 and ≥2,000 IU/mL, respectively. Twenty-five patients were randomized to EDP-514 200 (n=6), 400 (n=6) or 800 mg (n=7) or placebo (n=6) once daily for 28 days.
Results
A dose-related increase in EDP-514 exposure (AUC_last and C_max) was observed across doses. At Day 28, mean reductions in HBV DNA were –2.9, –3.3, –3.5 and –0.2 log₁₀ IU/mL with EDP-514 200 mg, 400 mg, 800 mg, and placebo groups, respectively. The corresponding mean change from baseline for HBV RNA levels was –2.9, –2.4, –2.0, and –0.02 log₁₀ U/mL. No virologic failures were observed. No clinically meaningful changes from baseline were observed for HBsAg, HBeAg or HBcrAg. Nine patients reported treatment emergent adverse events of mild or moderate severity with no discontinuations, serious AEs or deaths.
Conclusions
In treatment-naïve viremic patients, oral EDP-514 was generally safe and well-tolerated, displayed PK profile supportive of once-daily dosing, and markedly reduced HBV DNA and HBV RNA.

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Functional cure with new antiviral therapy for hepatitis B virus: a systematic review and meta-analysis
Jing Chen, Dong Ji, Jidong Jia, Hui Zhuang, Xinxin Zhang, Fu-Sheng Wang, Wenhong Zhang, Xiaoguang Dou, Tawesak Tanwandee, Shiv Kumar Sarin, Rakhi Maiwall, Manoj Kumar, George Boon-Bee Goh, Hasmik Ghazinyan, Anuchit Chutaputti, Pei-Jer Chen, Hong You, Ming
Hepatology International.2025; 19(4): 773.     CrossRef
Mise à jour concernant le traitement des hépatites virales
Marie Ongaro, Francesco Negro
Schweizer Gastroenterologie.2025; 6(2): 46.     CrossRef
Advances in the computational development of hepatitis B virus capsid assembly modulators
Ke Liu, Shaoqing Du, Weiqiao Deng, Zongjin Qu, Xueping Hu
Drug Discovery Today.2025; 30(10): 104458.     CrossRef
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
Clinical and Molecular Hepatology.2024; 30(4): 692.     CrossRef

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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

Abstract

PDF
Supplementary Material

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.

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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

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Review

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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Robert Gish, Kosh Agarwal, Anadi Mahajan, Supriya Desai, Saifuddin Kharawala, Rob Elston, Joyeta Das, Stuart Kendrick, Vera Gielen
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Hyuk Kim, Jae-Young Kim, Yoon E. Shin, Hye-Jin Yoo, Jeong-Ju Yoo, Sang Gyune Kim, Young-Seok Kim
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Editorial: The Relevance of Hepatic Flares and Quantitative Hepatitis B Surface Antigen After Stopping HBV Polymerase Inhibitors—Authors' Reply
Ying‐Nan Tsai, Jia‐Ling Wu, Yao‐Chun Hsu
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Association Between Elevation of Serum Alanine Aminotransferase and HBsAg Seroclearance After Nucleos(t)ide Analog Withdrawal
Ying‐Nan Tsai, Jia‐Ling Wu, Cheng‐Hao Tseng, Shang‐Chen Tseng, Chih‐Lung Hung, Mindie H. Nguyen, Jaw‐Town Lin, Yao‐Chun Hsu
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Letter: No Biochemical Relapse Is Associated With the Highest Off‐Therapy HBsAg Loss Rate—Authors' Reply
Ying‐Nan Tsai, Yao‐Chun Hsu
Alimentary Pharmacology & Therapeutics.2025; 61(8): 1424.     CrossRef
Incidences of Virological and Clinical Relapses After Cessation of Tenofovir Alafenamide, Tenofovir Disoproxil Fumarate, or Entecavir in Patients With HBeAg‐Negative Chronic Hepatitis B
Cheng‐Hao Tseng, Teng‐Yu Lee, Chi‐Yi Chen, Chung‐Feng Huang, Po‐Yueh Chen, Tyng‐Yuan Jang, Tzeng‐Huey Yang, Chia‐Ching Wu, Yao‐Chun Hsu
Journal of Gastroenterology and Hepatology.2025; 40(5): 1245.     CrossRef
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Clinical and Molecular Hepatology.2025; 31(2): e169.     CrossRef
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Jihye Lim, Hyundam Gu, Hyunji Sang, Su Jin Jeong, Ha Il Kim
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Hyuk Kim, Jae Young Kim, Hye-Jin Yoo, Log Young Kim, Jeong-Ju Yoo, Sang Gyune Kim, Young-Seok Kim
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Chih-Lin Lin, Jia-Horng Kao
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Letter: Estimating the incidence of HBsAg seroclearance after cessation of tenofovir and entecavir ‐ potential influence of censored observation
Ying‐Nan Tsai, Jia‐Ling Wu, Yao‐Chun Hsu
Alimentary Pharmacology & Therapeutics.2024; 59(1): 136.     CrossRef
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
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Enhancing off-nucleos(t)ide analogue outcome predictions in chronic hepatitis B with time-varying hepatitis B core-related antigen
Chen-Te Huang, Tai-Chung Tseng
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Yao-Chun Hsu
Clinical Liver Disease.2024;[Epub]     CrossRef
Current perspectives of viral hepatitis
Daisuke Usuda, Yuki Kaneoka, Rikuo Ono, Masashi Kato, Yuto Sugawara, Runa Shimizu, Tomotari Inami, Eri Nakajima, Shiho Tsuge, Riki Sakurai, Kenji Kawai, Shun Matsubara, Risa Tanaka, Makoto Suzuki, Shintaro Shimozawa, Yuta Hotchi, Ippei Osugi, Risa Katou,
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Marina Manea, Ion Mărunțelu, Ileana Constantinescu
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Jie Wang, He Jiang, Guoqi Zhang, Xiahong Dai, Hainv Gao, Lanjuan Li
Journal of Medical Virology.2024;[Epub]     CrossRef
Severe hepatitis B flares with hepatic decompensation after withdrawal of nucleos(t)ide analogues: A population‐based cohort study
Yao‐Chun Hsu, Yi‐Hsian Lin, Teng‐Yu Lee, Mindie H. Nguyen, Cheng‐Hao Tseng, Hsiu J. Ho, Feng‐Yu Kao, Jaw‐Town Lin, Chen‐Yi Wu, Chun‐Ying Wu
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Editorial: Mitigating the risk of severe hepatitis flare following nucleoside analogue discontinuation—Insights from a real‐world study. Authors' reply
Yao‐Chun Hsu, Chun‐Ying Wu
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Yao‐Chun Hsu, Mindie H. Nguyen, Chun‐Ying Wu
Alimentary Pharmacology & Therapeutics.2023; 58(7): 733.     CrossRef

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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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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
Clinical and Molecular Hepatology.2024; 30(3): 500.     CrossRef
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
Clinical and Molecular Hepatology.2023; 29(3): 794.     CrossRef

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Review

Chronic hepatitis B with concurrent metabolic dysfunction-associated fatty liver disease: Challenges and perspectives

Shang-Chin Huang, Chun-Jen Liu

Clin Mol Hepatol 2023;29(2):320-331.
Published online February 1, 2023

DOI: https://doi.org/10.3350/cmh.2022.0422

Abstract

PDF

The prevalence of metabolic dysfunction-associated fatty liver disease (MAFLD) has increased among the general population and chronic hepatitis B (CHB) patients worldwide. Although fatty liver disease is a well-known risk factor for adverse liver outcomes like cirrhosis and hepatocellular carcinoma, its interactions with the hepatitis B virus (HBV) and clinical impacts seem complex. The presence of hepatic steatosis may suppress HBV viral activity, potentially leading to attenuated liver injury. In contrast, the associated co-morbidities like diabetes mellitus or obesity may increase the risk of developing adverse liver outcomes. These findings implicate that components of MAFLD may have diverse effects on the clinical manifestations of CHB. To this end, a clinical strategy is proposed for managing patients with concurrent CHB and MAFLD. This review article discusses the updated evidence regarding disease prevalence, interactions between steatosis and HBV, clinical impacts, and management strategies, aiming at optimizing holistic health care in the CHB population.

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Frontiers in Immunology.2026;[Epub]     CrossRef
Pre-Existing and New-Onset Metabolic Dysfunctions Increase Cirrhosis and Its Complication Risks in Chronic Hepatitis B
Shang-Chin Huang, Tung-Hung Su, Tai-Chung Tseng, Sih-Han Liao, Shih-Jer Hsu, Chun-Ming Hong, Ting-Yuan Lan, Chen-Hua Liu, Hung-Chih Yang, Chun-Jen Liu, Jia-Horng Kao
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Ammara A Majeed, Amna S Butt
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Di Shen, Xintian Cai, Junli Hu, Shuaiwei Song, Qing Zhu, Huimin Ma, Yingying Zhang, Rui Ma, Pan Zhou, Wenbo Yang, Jing Hong, Delian Zhang, Nanfang Li
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Shang-Chin Huang, Tung-Hung Su
Journal of Hepatology.2025; 83(1): e34.     CrossRef
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Toru Nakamura, Atsutaka Masuda, Dan Nakano, Keisuke Amano, Tomoya Sano, Masahito Nakano, Takumi Kawaguchi
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Chih-Jan Ko
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Saisai Zhang, Lung-Yi Mak, Man-Fung Yuen, Wai-Kay Seto
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Cao-Ngoc Huynh
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Arnulfo E Morales-Galicia, Mariana M Ramírez-Mejía, Guadalupe Ponciano-Rodriguez, Nahum Méndez-Sánchez
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Letter to the Editor

Viral hepatitis

Letter regarding “Long-term prognosis and the need for histologic assessment of chronic hepatitis B in the serological immune-tolerant phase”

Chia-Ming Chu, Yun-Fan Liaw

Clin Mol Hepatol 2023;29(2):510-512.
Published online January 30, 2023

DOI: https://doi.org/10.3350/cmh.2023.0018

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Correspondence on Letter regarding “Long-term prognosis and the need for histologic assessment of chronic hepatitis B in the serological immune tolerant phase”
Jeong-Ju Yoo, Sang Gyune Kim
Clinical and Molecular Hepatology.2023; 29(2): 513.     CrossRef

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Original Article

Viral hepatitis

Long-term prognosis and the need for histologic assessment of chronic hepatitis B in the serological immune-tolerant phase

Jeong-Ju Yoo, Soo Young Park, Ji Eun Moon, Yu Rim Lee, Han Ah Lee, Jieun Lee, Young Seok Kim, Yeon Seok Seo, Sang Gyune Kim

Clin Mol Hepatol 2023;29(2):482-495.
Published online January 5, 2023

DOI: https://doi.org/10.3350/cmh.2022.0322

Abstract

PDF
Supplementary Material

Background/Aims
The histologic status of the immune-tolerant (IT) phase of chronic hepatitis B relative to long-term outcomes is unclear. This study aimed to discover how the serological criteria currently in use correspond to histologic criteria in determining the IT phase and indication for liver biopsy.
Methods
Patients in the serological IT phase determined by positive hepatitis B e antigen, hepatitis B virus (HBV) DNA ≥106 IU/mL, and normal or minimally elevated alanine aminotransferase (ALT) ≤60 IU/L, who underwent liver biopsy at three different hospitals were included. The distribution of the histologic IT phase, defined as fibrosis of stage 1 or less and inflammation of grade 1 or less, was compared with that of the serological IT phase. The risk factors for the incidence of liver-related events, such as hepatocellular carcinoma, liver cirrhosis, liver transplantation, and death, were also analyzed.
Results
Eighty-two (31.7%) out of 259 clinically suspected IT phase patients belonged to the histologic IT phase. Age over 35, high AST, and low albumin were useful for ruling out the histologic IT phase. Risk factors predicting liver-related events were age and significant fibrosis stage. There was no significant difference in the proportion of histologic IT phase and clinical prognosis between normal ALT and mildly elevated ALT groups. However, even in patients with normal ALT, age was an important factor in predicting the presence of the histologic IT phase.
Conclusions
A significant number of patients who belonged to the serological IT phase were not in the histologic IT phase. Patients over 35 years and those with high AST, low albumin, and low HBV DNA levels were more likely to experience poor long-term clinical outcomes. Therefore, additional histologic assessment should be considered.

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Editorials

Viral hepatitis

New biomarkers of hepatitis B virus (HBV) infection: HBV RNA and HBV core-related antigen, new kids on the block?

Young-Suk Lim

Clin Mol Hepatol 2023;29(1):118-119.
Published online November 29, 2022

DOI: https://doi.org/10.3350/cmh.2022.0413

PDF

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Napoleon Bellua Sam, Saeed Folorunsho Majeed, Adams Dramani
Health Science Reports.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
Hepatitis B Virus RNA Predicts Hepatocellular Carcinoma Despite Viral Suppression
Takashi Kumada, Hidenori Toyoda, Satoshi Yasuda, Yuichi Koshiyama, Takanori Ito, Tomoyuki Akita, Junko Tanaka
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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
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8 Web of Science

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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

PDF

Citations

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Risk of Hepatocellular Carcinoma Decreases After Antiviral Therapy–Induced HBsAg Seroclearance
Han Ah. Lee, Hyun Woong Lee, Yeon Seok Seo, Dong Hyun Sinn, Sang Hoon Ahn, Beom Kyung Kim, Seung Up Kim
Journal of Gastroenterology and Hepatology.2025; 40(7): 1675.     CrossRef
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Jimmy Che-To Lai, Vicki Wing-Ki Hui, Grace Lai-Hung Wong, Vincent Wai-Sun Wong, Terry Cheuk-Fung Yip
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Rapid monophasic HBsAg decline during nucleic-acid polymer–based therapy predicts functional cure
Leeor Hershkovich, Louis Shekhtman, Michel Bazinet, Victor Pântea, Gheorge Placinta, Scott J. Cotler, Andrew Vaillant, Harel Dahari
Hepatology Communications.2023;[Epub]     CrossRef
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Lung-Yi Mak, Wai-Kay Seto, Man-Fung Yuen
Clinical and Molecular Hepatology.2023; 29(1): 191.     CrossRef
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Daniel G. Sausen, Oren Shechter, William Bietsch, Zhenzhen Shi, Samantha M. Miller, Elisa S. Gallo, Harel Dahari, Ronen Borenstein
International Journal of Molecular Sciences.2022; 23(24): 15973.     CrossRef

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Original Article

Decreased vitamin D-binding protein level portends poor outcome in acute-on-chronic liver failure caused by hepatitis B virus

Daxian Wu, Qunfang Rao, Zhongyang Xie, Xiaoqing Zhu, Yuanmei Che, Jian Wu, Hainv Gao, Jingyu Zhang, Zhouhua Hou, Xiaoyu Cheng, Zeyu Sun

Clin Mol Hepatol 2022;28(4):912-925.
Published online July 28, 2022

DOI: https://doi.org/10.3350/cmh.2022.0121

Abstract

PDF
Supplementary Material

Background/Aims
Acute-on-chronic liver failure (ACLF) is a catastrophic illness. Few studies investigated the prognostic value of vitamin D-binding protein (VDBP) for hepatitis B virus (HBV)-related ACLF (HBV-ACLF) resulted in conflicting results.
Methods
Two prospective HBV-ACLF cohorts (n=287 and n=119) were enrolled to assess and validate the prognostic performance of VDBP.
Results
VDBP levels in the non-survivors were significantly lower than in the survivors (P<0.001). Multivariate Cox regression demonstrated that VDBP was an independent prognostic factor for HBV-ACLF. The VDBP level at admission gradually decreased as the number of failed organs increased (P<0.001), and it was closely related to coagulation failure. The areas under the receiver operating characteristic curve (AUCs) of the Child-Pugh-VDBP and chronic liver failuresequential organ failure assessment (CLIF–SOFA)-VDBP scores were significantly higher than those of Child-Pugh (P<0.001) and CLIF-SOFA (P=0.0013). The AUCs of model for end-stage liver disease (MELD)-VDBP were significantly higher than those of MELD (P= 0.0384) only in the case of cirrhotic HBV-ACLF patients. Similar results were validated using an external multicenter HBV-ACLF cohort. By longitudinal observation, the VDBP levels gradually increased in survivors (P=0.026) and gradually decreased in non-survivors (P<0.001). Additionally, the VDBP levels were found to be significantly decreased in the deterioration group (P=0.012) and tended to be decreased in the fluctuation group (P=0.055). In contrast, they showed a significant increase in the improvement group (P=0.036).
Conclusions
The VDBP was a promising prognostic biomarker for HBV-ACLF. Sequential measurement of circulating VDBP shows value for the monitoring of ACLF progression.

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Review

RNA interference as a novel treatment strategy for chronic hepatitis B infection

Rex Wan-Hin Hui, Lung-Yi Mak, Wai-Kay Seto, Man-Fung Yuen

Clin Mol Hepatol 2022;28(3):408-424.
Published online February 17, 2022

DOI: https://doi.org/10.3350/cmh.2022.0012

Abstract

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Chronic hepatitis B (CHB) is a major cause of liver-related morbidity and mortality. Functional cure of CHB, defined as sustainable hepatitis B surface antigen (HBsAg) seroclearance, is associated with improved clinical outcomes. However, functional cure is rarely attainable by current treatment modalities. RNA interference (RNAi) by small-interfering RNA (siRNA) and anti-sense oligonucleotide (ASO) has been studied as a novel treatment strategy for CHB. RNAi targets post-transcriptional messenger RNAs and pregenomic RNAs to reduce hepatitis B virus (HBV) antigen production and viral replication. By reducing viral antigens, host immune reconstitution against HBV may also be attained. Phase I/II trials on siRNAs have demonstrated them to be safe and well-tolerated. siRNA is effective when given in monthly doses with different total number of doses according to different trial design, and can lead to sustainable dose-dependent mean HBsAg reduction by 2–2.5 log. Incidences of HBsAg seroclearance after siRNA therapy have also been reported. ASOs have also been studied in early phase trials, and a phase Ib study using frequent dosing regimen within 4 weeks could achieve similar HBsAg reduction of 2 log from baseline. Given the established efficacy and safety of nucleos(t) ide analogues (NAs), future RNAi regimens will likely include NA backbone. While the current evidence on RNAi appears promising, it remains undetermined whether the potent HBsAg reduction by RNAi can result in a high rate of HBsAg seroclearance with durability. Data on RNAi from phase IIb/III trials are keenly anticipated.

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Viral hepatitis

History and future of hepatitis B virus control in South Korea

Do Young Kim

Clin Mol Hepatol 2021;27(4):620-622.
Published online September 23, 2021

DOI: https://doi.org/10.3350/cmh.2021.0277

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Okjoo Lee, Jong Man Kim, Sang Jin Kim, Jinsoo Rhu, Gyu‐Seong Choi, Jae‐Won Joh
World Journal of Surgery.2022; 46(6): 1474.     CrossRef

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Original Article

Liver Transplantation

Cost-effectiveness and long-term outcomes of liver transplantation using hepatitis B core antibody-positive grafts with hepatitis B immunoglobulin prophylaxis in Korea

Kyeong Deok Kim, Ji Eun Lee, Jong Man Kim, Okjoo Lee, Na Young Hwang, Jinsoo Rhu, Gyu-Seong Choi, Kyunga Kim, Jae-Won Joh

Clin Mol Hepatol 2021;27(4):603-615.
Published online September 8, 2021

DOI: https://doi.org/10.3350/cmh.2021.0137

Abstract

PDF
Supplementary Material

Background/Aims
Hepatitis B core antibody (anti-HBc)-positive donors are used as an extended donor pool, and current guidelines recommend the usage of nucleos(t)ide analogues (NAs) as prophylaxis for preventing de novo hepatitis B virus infection (DNH). We analyzed the long-term outcomes of a large cohort of liver transplantation (LT) patients receiving anti-HBc-positive grafts and evaluated the risk of DNH when hepatitis B immunoglobulin (HBIG) monotherapy was used as prophylaxis. We also compared the cost-effectiveness of HBIG and NAs.
Methods
We retrospectively reviewed 457 patients with anti-HBc-positive grafts and 898 patients with anti-HBc-negative grafts who underwent LT between January 2001 and December 2018. We compared recipient characteristics according to the anti-HBc status of the donor, and compared the costs of using NAs for the rest of the patient’s life and using HBIG to maintain hepatitis B surface antibody titers above 200 IU/L.
Results
The 1-, 5-, and 10-year patient survival rates were 87.7%, 73.5%, and 67.7%, respectively, in patients with anti-HBc-positive grafts, and 88.5%, 77.4%, and 70.3%, respectively, in patients with anti-HBc-negative grafts (P=0.113). Among 457 recipients with anti-HBc-positive grafts, 117 (25.6%) were non-HBV recipients. The overall incidence of DNH was 0.9%. When using HBIG under insurance coverage, the cumulative cost was lower compared with using NA continuously without insurance coverage in Korea.
Conclusions
Anti-HBc-positive grafts alone do not affect patient survival or graft survival. HBIG monoprophylaxis has good outcomes for preventing DNH, and the patient’s long-term cost burden is low in Korea because of the national insurance system in this cohort.

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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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Editorial

Viral hepatitis

Another oral antiviral treatment, but still far away from hepatitis B virus cure

Tai-Chung Tseng

Clin Mol Hepatol 2021;27(2):281-282.
Published online March 10, 2021

DOI: https://doi.org/10.3350/cmh.2021.0072

PDF

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ALT Is Not Associated With Achieving Subcirrhotic Liver Stiffness and HCC During Entecavir Therapy in HBV-Related Cirrhosis
Mi Na Kim, Jae Seung Lee, Hye Won Lee, Beom Kyung Kim, Jun Yong Park, Do Young Kim, Sang Hoon Ahn, Se Young Jang, Won Young Tak, Young-Oh Kweon, Soo Young Park, Seung Up Kim
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Review

Viral hepatitis

Three heads are better than two: Hepatitis B core-related antigen as a new predictor of hepatitis B virus-related hepatocellular carcinoma

Jer-Wei Wu, Jia-Horng Kao, Tai-Chung Tseng

Clin Mol Hepatol 2021;27(4):524-534.
Published online February 23, 2021

DOI: https://doi.org/10.3350/cmh.2021.0012

Abstract

PDF

Patients with chronic hepatitis B virus (HBV) infection are at risk of developing hepatocellular carcinoma (HCC), and serum markers reflecting viral replication are potential predictors for HCC development. Besides the levels of serum HBV DNA and hepatitis B surface antigen (HBsAg), hepatitis B core-related antigen (HBcrAg) quantification is an emerging serological marker for viral replication. Unlike HBV DNA and HBsAg, HBcrAg is a covalently closed circular DNA-derived protein marker, consisting of hepatitis B e antigen (HBeAg), p22cr, and hepatitis B core antigen. In treatment-naïve HBV patients, higher HBcrAg levels are shown to be associated with an increased risk of HCC in several studies. More importantly, HBcrAg may complement HBV DNA level to predict HCC development. For example, an Asian treatmentnaïve cohort study’s data showed that HBcrAg level of 4 log U/mL was effective to stratify HCC risk in HBeAg-negative patients with intermediate viral loads, who may not need antiviral therapy because of the low to moderate risk of HCC. In patients receiving prolonged nucleos(t)ide analogue with profound viral suppression, most data indicated that HBV DNA and HBsAg levels no longer serve as HCC predictors. However, several studies suggested on-treatment HBcrAg levels may remain as an HCC predictor. In summary, HBcrAg level can be a useful biomarker for treatment-naïve patients, but its value in on-treatment patients needs validation. The next challenge is how to combine HBcrAg with the other viral markers to construct a better HCC prediction model, optimizing the management of HBV patients.

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Letter to the Editor

Viral hepatitis

A dilemma that probably would never resolve

Ravi Thanage, Shubham Jain, Sanjay Chandnani, Pravin Rathi

Clin Mol Hepatol 2021;27(1):219-220.
Published online December 3, 2020

DOI: https://doi.org/10.3350/cmh.2020.0274

PDF

6,408 View

79 Download

Original Article

Persistence of intrahepatic hepatitis B virus DNA integration in patients developing hepatocellular carcinoma after hepatitis B surface antigen seroclearance

Jeong Won Jang, Jin Seoub Kim, Hye Seon Kim, Kwon Yong Tak, Heechul Nam, Pil Soo Sung, Si Hyun Bae, Jong Young Choi, Seung Kew Yoon, Lewis R. Roberts

Clin Mol Hepatol 2021;27(1):207-218.
Published online December 3, 2020

DOI: https://doi.org/10.3350/cmh.2020.0115

Abstract

PDF
Supplementary Material

Background/Aims
The role of hepatitis B virus (HBV) integration into the host genome in hepatocarcinogenesis following hepatitis B surface antigen (HBsAg) seroclearance remains unknown. Our study aimed to investigate and characterize HBV integration events in chronic hepatitis B (CHB) patients who developed hepatocellular carcinoma (HCC) after HBsAg seroclearance.

Methods
Using probe-based HBV capturing followed by next-generation sequencing technology, HBV integration was examined in 10 samples (seven tumors and three non-tumor tissues) from seven chronic carriers who developed HCC after HBsAg loss. Genomic locations and patterns of HBV integration were investigated.

Results
HBV integration was observed in six patients (85.7%) and eight (80.0%) of 10 tested samples. HBV integration breakpoints were detected in all of the non-tumor (3/3, 100%) and five of the seven (71.4%) tumor samples, with an average number of breakpoints of 4.00 and 2.43, respectively. Despite the lower total number of tumoral integration breakpoints, HBV integration sites in the tumors were more enriched within the genic area. In contrast, non-tumor tissues more often showed intergenic integration. Regarding functions of the affected genes, tumoral genes with HBV integration were mostly associated with carcinogenesis. At enrollment, patients who did not remain under regular HCC surveillance after HBsAg seroclearance had a large HCC, while those on regular surveillance had a small HCC.

Conclusions
The biological functions of HBV integration are almost comparable between HBsAg-positive and HBsAgserocleared HCCs, with continuing pro-oncogenic effects of HBV integration. Thus, ongoing HCC surveillance and clinical management should continue even after HBsAg seroclearance in patients with CHB.

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Review

Viral hepatitis

Comparison of clinical practice guidelines for the management of chronic hepatitis B: When to start, when to change, and when to stop

Hyung Joon Yim, Ji Hoon Kim, Jun Yong Park, Eileen L. Yoon, Hana Park, Jung Hyun Kwon, Dong Hyun Sinn, Sae Hwan Lee, Jeong-Hoon Lee, Hyun Woong Lee

Clin Mol Hepatol 2020;26(4):411-429.
Published online August 28, 2020

DOI: https://doi.org/10.3350/cmh.2020.0049

Abstract

PDF

Clinical practice guidelines are important for guiding the management of specific diseases by medical practitioners, trainees, and nurses. In some cases, the guidelines are utilized as a reference for health policymakers in controlling diseases with a large public impact. With this in mind, practice guidelines for the management of chronic hepatitis B (CHB) have been developed in the United States, Europe, and Asian-Pacific regions to suggest the best-fit recommendations for each social and medical circumstance. Recently, the Korean Association for the Study of the Liver published a revised version of its clinical practice guidelines for the management of CHB. The guidelines included updated information based on newly available antiviral agents, the most recent opinion on the initiation and cessation of treatment, and updates for the management of drug resistance, partial virological response, and side effects. Additionally, CHB management in specific situations was comprehensively revised. This review compares the similarities and differences among the various practice guidelines to identify unmet needs and improve future recommendations.

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Seunghwan Shin, Seung Up Kim, Jun Yong Park, Do Young Kim, Sang Hoon Ahn, Beom Kyung Kim
Diagnostics.2022; 12(2): 441.     CrossRef
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Journal of Korean Medical Science.2022;[Epub]     CrossRef
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Fátima Higuera-de la Tijera, Alfredo Servín-Caamaño, Luis Servín-Abad
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Original Articles

Viral hepatitis

The dilemma of differentiating between acute hepatitis B and chronic hepatitis B with acute exacerbation: Is quantitative serology the answer?

Sujata Lall, Pragya Agarwala, Guresh Kumar, Manoj Kumar Sharma, Ekta Gupta

Clin Mol Hepatol 2020;26(2):187-195.
Published online April 7, 2020

DOI: https://doi.org/10.3350/cmh.2019.0060

Abstract

PDF

Background/Aims
Acute exacerbations of chronic hepatitis B (CHB-AEs) are common in endemic areas and are often presumed to be acute hepatitis B (AHB) due to their similarities in clinical and serological pictures, presenting a major diagnostic dilemma. This study aimed to identify laboratory markers for differentiating between the two groups, and to establish the cut-off value for significant markers.

Methods
A retrospective analysis of records was conducted for patients who presented with clinical features of acute hepatitis along with hepatitis B surface antigen (HBsAg) and IgM antibody to hepatitis B core antigen (IgM anti-HBc) positivity from May 2015 to May 2017. A total of 172 patients were enrolled and grouped as AHB (n=89) and CHB-AE (n=83) based on their history of hepatitis B virus infection and duration of HBsAg persistence. Virological and biochemical parameters were analyzed and compared. Cut-off values, sensitivity, and specificity of the variables were calculated.

Results
The median value of signal by cut-off (S/Co) ratio for IgM anti-HBc was significantly higher in AHB group (30.44) compared to CHB-AE group (8.63) with a sensitivity and specificity of 97% and 84%, respectively, at a cut-off of 20.5 (P<0.01). The mean international normalized ratio (INR) was significantly greater in CHB-AE (1.88±1.24) group compared to AHB group (1.62±0.17) with a sensitivity and specificity of 57.9% and 45.1%, respectively, at a cut-off value of 1.27.

Conclusions
A value of 20.5 S/Co of IgM anti-HBc and 1.27 INR could be helpful in differentiating between AHB and CHB-AE. (Clin Mol Hepatol 2020;26:187-195)

Citations

Citations to this article as recorded by

Detection of hepatitis B virus surface antigen, IgM and IgG antibodies to hepatitis B virus core antigen in the clinical classification and epidemiological surveillance of HBV infection
Robério Amorim de Almeida Pondé
Molecular Biology Reports.2025;[Epub]     CrossRef
EASL Clinical Practice Guidelines on the management of hepatitis B virus infection
Markus Cornberg, Lisa Sandmann, Jerzy Jaroszewicz, Patrick Kennedy, Pietro Lampertico, Maud Lemoine, Sabela Lens, Barbara Testoni, Grace Lai-Hung Wong, Francesco Paolo Russo
Journal of Hepatology.2025; 83(2): 502.     CrossRef
The Role of HBx Mutations in Chronic Hepatitis B with Acute Exacerbation
Xiaobei Chen, Jinzhi Shi, Ping Zhou, Yunyun Tian, Yajing Zheng, Tingting Liu, Yan Li, Fan Zhu
Viruses.2025; 17(9): 1223.     CrossRef
Clinical Significance and Remaining Issues of Anti-HBc Antibody and HBV Core-Related Antigen
Yoshihiko Yano, Itsuko Sato, Takamitsu Imanishi, Ryutaro Yoshida, Takanori Matsuura, Yoshihide Ueda, Yuzo Kodama
Diagnostics.2024; 14(7): 728.     CrossRef
Newer Diagnostic Virological Markers for Hepatitis B Virus Infection
Jasmine Samal, Reshu Agarwal, Ekta Gupta, Sheetalnath Rooge, Akshita Gupta
Euroasian journal of hepato-gastroenterology.2024; 14(2): 214.     CrossRef
Clinical Utility of Quantitative HBV Core Antibodies for Solving Diagnostic Dilemmas
Ivana Lazarevic, Ana Banko, Danijela Miljanovic, Maja Cupic
Viruses.2023; 15(2): 373.     CrossRef
Unusual serological profile in hepatitis B virus (HBV) infection associated with a probable clinical case of acute exacerbation of pre-existing chronic HBV infection
Robério Amorim de Almeida Pondé
Molecular Biology Reports.2023; 50(8): 6435.     CrossRef
A dilemma that probably would never resolve
Ravi Thanage, Shubham Jain, Sanjay Chandnani, Pravin Rathi
Clinical and Molecular Hepatology.2021; 27(1): 219.     CrossRef
The Prognostic Role of On-Treatment Liver Stiffness for Hepatocellular Carcinoma Development in Patients with Chronic Hepatitis B
Hye Won Lee, Hyun Woong Lee, Jae Seung Lee, Yun Ho Roh, Hyein Lee, Seung Up Kim, Jun Yong Park, Do Young Kim, Sang Hoon Ahn, Beom Kyung Kim
Journal of Hepatocellular Carcinoma.2021; Volume 8: 467.     CrossRef
Treatment efficacy by hepatic arterial infusion chemotherapy vs. sorafenib after liver-directed concurrent chemoradiotherapy for advanced hepatocellular carcinoma
Sojung Han, Hye Jin Choi, Seung-Hoon Beom, Hye Rim Kim, Hyein Lee, Jae Seung Lee, Hye Won Lee, Jun Yong Park, Seung Up Kim, Do Young Kim, Sang Hoon Ahn, Kwang-Hyub Han, Jinsil Seong, Jong Yun Won, Beom Kyung Kim
Journal of Cancer Research and Clinical Oncology.2021; 147(10): 3123.     CrossRef
External validation of CAGE‐B and SAGE‐B scores for Asian chronic hepatitis B patients with well‐controlled viremia by antivirals
Jung Hyun Ji, Soo Young Park, Won Jeong Son, Hye Jung Shin, Hyein Lee, Hye Won Lee, Jae Seung Lee, Seung Up Kim, Jun Yong Park, Do Young Kim, Sang Hoon Ahn, Beom Kyung Kim
Journal of Viral Hepatitis.2021; 28(6): 951.     CrossRef
Effect of tenofovir alafenamide vs. tenofovir disoproxil fumarate on hepatocellular carcinoma risk in chronic hepatitis B
Hye Won Lee, Young Youn Cho, Hyein Lee, Jae Seung Lee, Seung Up Kim, Jun Yong Park, Do Young Kim, Sang Hoon Ahn, Beom Kyung Kim, Soo Young Park
Journal of Viral Hepatitis.2021; 28(11): 1570.     CrossRef
Impact of tenofovir alafenamide vs. entecavir on hepatocellular carcinoma risk in patients with chronic hepatitis B
Hye Won Lee, Young Youn Cho, Hyein Lee, Jae Seung Lee, Seung Up Kim, Jun Yong Park, Do Young Kim, Sang Hoon Ahn, Beom Kyung Kim, Soo Young Park
Hepatology International.2021; 15(5): 1083.     CrossRef
Novel Liver Stiffness-Based Nomogram for Predicting Hepatocellular Carcinoma Risk in Patients with Chronic Hepatitis B Virus Infection Initiating Antiviral Therapy
Jae Seung Lee, Hyun Woong Lee, Tae Seop Lim, Hye Jung Shin, Hye Won Lee, Seung Up Kim, Jun Yong Park, Do Young Kim, Sang Hoon Ahn, Beom Kyung Kim
Cancers.2021; 13(23): 5892.     CrossRef
Should physicians go out of the way to differentiate between acute hepatitis B and acute exacerbation of chronic hepatitis B?
Hyun Woong Lee
Clinical and Molecular Hepatology.2020; 26(2): 180.     CrossRef
A challenge in distinguishing between acute hepatitis B and acute exacerbation of chronic hepatitis B
Yang-Hyun Baek
Clinical and Molecular Hepatology.2020; 26(2): 233.     CrossRef

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Viral hepatitis

Association between hepatic steatosis and the development of hepatocellular carcinoma in patients with chronic hepatitis B

Yun Bin Lee, Yeonjung Ha, Young Eun Chon, Mi Na Kim, Joo Ho Lee, Hana Park, Kwang-il Kim, Soo-Hwan Kim, Kyu Sung Rim, Seong Gyu Hwang

Clin Mol Hepatol 2019;25(1):52-64.
Published online October 23, 2018

DOI: https://doi.org/10.3350/cmh.2018.0040

Abstract

PDF

Background/Aims
Nonalcoholic fatty liver disease (NAFLD) is becoming a worldwide epidemic, and is frequently found in patients with chronic hepatitis B (CHB). We investigated the impact of histologically proven hepatic steatosis on the risk for hepatocellular carcinoma (HCC) in CHB patients without excessive alcohol intake.
Methods
Consecutive CHB patients who underwent liver biopsy from January 2007 to December 2015 were included. The association between hepatic steatosis (≥ 5%) and subsequent HCC risk was analyzed. Inverse probability weighting (IPW) using the propensity score was applied to adjust for differences in patient characteristics, including metabolic factors.
Results
Fatty liver was histologically proven in 70 patients (21.8%) among a total of 321 patients. During the median (interquartile range) follow-up of 5.3 (2.9–8.3) years, 17 of 321 patients (5.3%) developed HCC: 8 of 70 patients (11.4%) with fatty liver and 9 of 251 patients (3.6%) without fatty liver. The five-year cumulative incidences of HCC among patients without and with fatty liver were 1.9% and 8.2%, respectively (P=0.004). Coexisting fatty liver was associated with a higher risk for HCC (adjusted hazards ratio [HR], 3.005; 95% confidence interval [CI], 1.122–8.051; P=0.03). After balancing with IPW, HCC incidences were not significantly different between the groups (P=0.19), and the association between fatty liver and HCC was not significant (adjusted HR, 1.709; 95% CI, 0.404–7.228; P=0.47).
Conclusions
Superimposed NAFLD was associated with a higher HCC risk in CHB patients. However, the association between steatosis per se and HCC risk was not evident after adjustment for metabolic factors.

Citations

Citations to this article as recorded by

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Gastroenterology Report.2025;[Epub]     CrossRef
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Chih-Jan Ko
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Editorial

Viral hepatitis

Assessment of fibrotic burden among chronic hepatitis B virus-infected patients with normal transaminase level

Mi Young Jeon, Beom Kyung Kim, Seung Up Kim

Clin Mol Hepatol 2018;24(4):367-369.
Published online September 19, 2018

DOI: https://doi.org/10.3350/cmh.2018.1008

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