Clinical and Molecular Hepatology

"Antiviral therapy"

Editorial

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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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; 23(5): 376. CrossRef
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
Clinical and Molecular Hepatology.2026; 32(2): 935. 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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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

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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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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
Comparable Predictive Performance of Non‐VCTE–Based Machine Learning Model for HBV‐Infected Hepatocellular Carcinoma Risk
Hahn Yi, Hye Won Lee, Jae Il Shin, Hyung Woong Lee, Tae Seop Lim, Beom Kyung Kim, Namkug Kim
Journal of Gastroenterology and Hepatology.2026;[Epub] 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

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.

Citations

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BEAT‐B Study (Behavior, Aspirations, and Treatment Needs): A Mixed‐Methods Study of Patient Values, Preferences, and Barriers to Care Among People Living With Chronic Hepatitis B in South and Southeast Asia
Manya Prasad, Tushar Prabhakar, Priyanka Shenoy, Priyanka Aggarwal, Tawesak Tanwandee, K. C. Sudhamshu, M. Golam Azam, Zaigham Abbas, G. Vaishnavi, Vivekanandan Shanmugam, Bharat Bhushan Rewari, Shiv Kumar Sarin
Journal of Gastroenterology and Hepatology.2026; 41(9): 2903. CrossRef

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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

Citations

Citations to this article as recorded by

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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Editorials

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

Citations to this article as recorded by

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

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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

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Correspondence

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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Reviews

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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Conghui Zhang, Qingfeng Ma, Wei Wang, Hui Song, Xue Wang, Fengxia Xu, Chengliang Zhu, Xinghui Liu, Seth Agyei Domfeh
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Tao Cheng, Guoyong Li, Huiming Ning, Liang Hao
The Journal of Arthroplasty.2023; 38(2): 300. CrossRef
The emerging age-pattern changes of patients with hepatocellular carcinoma in Korea
Yuri Cho, Bo Hyun Kim, Joong-Won Park
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Lung-Yi Mak, Wai-Kay Seto, Man-Fung Yuen
Clinical and Molecular Hepatology.2023; 29(1): 191. CrossRef
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
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Overview of the development of HBV small molecule inhibitors
Huihui Yang, Weiwei Yao, Jinfei Yang
European Journal of Medicinal Chemistry.2023; 249: 115128. CrossRef
The progress of molecules and strategies for the treatment of HBV infection
Youlu Pan, Heye Xia, Yanwen He, Shenxin Zeng, Zhengrong Shen, Wenhai Huang
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Viral hepatitis

Management of viral hepatitis in liver transplant recipients: Soung Won Jeong, YoungRok Choi, Jin-Wook Kim; Clin Mol Hepatol 2014;20(4):338-344.
Published online December 24, 2014; DOI: https://doi.org/10.3350/cmh.2014.20.4.338

Abstract
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Recurrence of viral hepatitis after liver transplantation (LT) can progress to graft failure and lead to a decrease in long-term survival. Recently, there have been remarkable improvement in the treatment of chronic hepatitis B (CHB) using potent antiviral agents. Combination of hepatitis B immunoglobulin and potent antiviral therapy has brought marked advances in the management of CHB for liver transplant recipients. Post-transplant antiviral therapy for hepatitis C virus infection is generally reserved for patients showing progressive disease. Acheiving a sustained virological response in patients with LT greatly ameliorates graft and overall survival, however this only occurs in 30% of transplant recipient using pegylated interferon and ribavirin (RBV). Direct acting antivirals such as protease inhibitors, polymerase or other non-structural proteins inhibitors are anticipated to establish the new standard of care for transplant recipients. In liver transplant recipients, hepatitis E virus infection is an uncommon disease. However, it can lead to chronic hepatitis and cirrhosis and may require retransplantation. Recently, 3-month course of RBV monotherapy has been reported as an effective treatment. This review focuses on the recent management and therapeutic approaches of viral hepatitis in liver transplant recipient.

Citations

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