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Original Article

Molecular determinants of outcome to gemcitabine, cisplatin, and nab-paclitaxel in patients with advanced biliary tract cancer
Daeseong Kim, Nam Suk Sim, Seonjeong Woo, Min Hwan Kim, Choong-kun Lee, Seung Soo Hong, Sung Hyun Kim, Ho Kyoung Hwang, Chang Moo Kang, Woo Jung Lee, Jung Hyun Jo, Taek Chung, Sohyun Hwang, Beodeul Kang, Jung Sun Kim, Chang-Il Kwon, Sangwoo Kim, Hong Jae Chon, Chang Gon Kim, Young Nyun Park, Hye Jin Choi
Received September 9, 2025  Accepted December 24, 2025  Published online December 26, 2025  
DOI: https://doi.org/10.3350/cmh.2025.1019    [Accepted]
Background & Aims
Biliary tract cancer (BTC) is a rare malignancy with poor prognosis. We investigated genomic determinants of clinical benefit from gemcitabine, cisplatin, and nab-paclitaxel (GAP) versus gemcitabine and cisplatin (GC) in advanced BTC.
Methods
Clinical and genomic data using TruSight Oncology 500 were analyzed from patients treated with GAP (N=198) or GC (N=89) as first-line therapy.
Results
With a median follow-up of 33.0 months, GAP modestly improved progression-free survival (PFS) (hazard ratio [HR]=0.764, 95% confidence interval [CI]=0.591–0.989) without significant overall survival (OS) difference compared to GC. Genomic profiling revealed frequent alterations in TP53 (35.2%), KRAS (16.4%), SMAD4 (10.5%), and TNFRSF14 (10.5%), involving RTK/RAS (44.3%), TP53 (41.8%), and PI3K (20.2%) pathways. Single-gene mutations did not predict treatment benefit. However, pathway-level analysis identified PI3K pathway activation as significantly associated with inferior PFS (HR=2.148, 95% CI=1.478–3.124) and OS (HR=2.096, 95% CI=1.413–3.109) in patients receiving GAP, an effect not observed with GC. Importantly, GAP conferred clinical benefit only in patients without PI3K pathway activation, while no survival advantage was seen in those with such alterations (Pinteraction=0.023 for PFS, Pinteraction=0.003 for OS). Similar results were obtained in the independent validation cohort treated with GAP (N=103) or GC (N=64) for BTC.
Conclusion
Genomic profiling using next-generation sequencing identified PI3K pathway activation as key molecular determinant that differentiates patient outcomes between GAP and GC treatments in advanced BTC.
  • 649 View
  • 80 Download

Research Letter

Optimized MASH treatment eligibility cutoffs for MRE-measured liver stiffness and proton density fat fraction
Nana Owusu, Kyle Kalutkiewicz, Jiahui Li, Alina M. Allen, Rohit Loomba, Richard L. Ehman, Meng Yin
Clin Mol Hepatol 2026;32(1):e47-e51.
Published online December 8, 2025
DOI: https://doi.org/10.3350/cmh.2025.1267
  • 569 View
  • 58 Download

Special Issue

2025 KASL clinical practice guidelines for management of hepatitis C
Eun Sun Jang, Nae Yun Heo, Jae Yoon Jeong, Jung Gil Park, Do Seon Song, Eun Ju Cho, Chang Hun Lee, Jae Seung Lee, Jae Hyun Yoon, Seul Ki Han, Young Kul Jung, on behalf of the Korean Association for the Study of the Liver (KASL)
Clin Mol Hepatol 2026;32(1):1-52.
Published online October 23, 2025
DOI: https://doi.org/10.3350/cmh.2025.0777
  • 1,367 View
  • 170 Download

Correspondence

Correspondence to editorial on “Human cytomegalovirus reactivation in cirrhosis patients with acute decompensation”
Changze Hong, Jinjun Chen
Received August 9, 2025  Accepted August 21, 2025  Published online August 25, 2025  
DOI: https://doi.org/10.3350/cmh.2025.0899    [Accepted]
  • 2,802 View
  • 7 Download

Reviews

Tumor-based biomarkers and circulating tumor DNA for precision medicine in advanced hepatocellular carcinoma
Sabrina Sidali, Claudia Campani, Jihyun An, Ju Hyun Shim, Jean-Charles Nault
Clin Mol Hepatol 2026;32(1):69-90.
Published online August 20, 2025
DOI: https://doi.org/10.3350/cmh.2025.0746
Hepatocellular carcinoma (HCC) is the most common primary liver cancer and remains a major cause of cancer-related mortality worldwide. Systemic therapies, including targeted therapies and immune checkpoint inhibitors, have revolutionized the management of advanced HCC. Although the prognosis of patients with advanced HCC remains poor, significant progress has been made with recent advances in drug development, particularly with the introduction of effective treatments such as atezolizumab plus bevacizumab or durvalumab plus tremelimumab. Indeed, treatment response varies significantly among patients, highlighting the need for robust biomarkers. In addition, the development of molecular driver-targeted therapies remains an active research focus as most genetic alterations observed in HCC are currently undruggable. Meeting these goals will require additional efforts to obtain histological material in clinical trials, in order to enable robust translational research. This review explores the current landscape of biomarkers of response to systemic treatments in HCC, including molecular, immune-based markers as well as circulating tumor DNA and highlights potential paths of improvement.

Citations

Citations to this article as recorded by  Crossref logo
  • Prognostic value of tumor microenvironment-based molecular subtypes in hepatocellular carcinoma patients undergoing surgery for spinal metastases: refining conventional scoring systems
    Bing Liang, Annan Hu, Jian Zhou, Juan Li, Jian Dong
    Clinical and Experimental Medicine.2025;[Epub]     CrossRef
  • 3,369 View
  • 137 Download
  • Crossref
Prospects of late-stage development agents in the treatment of metabolic dysfunction-associated steatohepatitis
Brian Lee, Ussama Ghumman, Lisa D. Pedicone, Andres Gomez Aldana, Eric Lawitz
Clin Mol Hepatol 2025;31(4):1167-1196.
Published online August 4, 2025
DOI: https://doi.org/10.3350/cmh.2025.0337
Metabolic dysfunction-associated steatotic liver disease (MASLD) is a spectrum of pathology involving fatty liver disease that may progress to fibrosis, cirrhosis, hepatocellular carcinoma, and liver failure. The prevalence of MASLD and metabolic dysfunction-associated steatohepatitis (MASH) continues to increase, mirroring the rise in global prevalence of related comorbidities such as obesity and type 2 diabetes mellitus. Due to the alarming rise of these comorbidities, a greater proportion of the population is at risk for developing MASLD and MASH. As such, there has been a significant effort to develop effective therapies for MASLD and MASH. Recently, the U.S. Food and Drug Administration approved resmetirom, a selective thyroid hormone receptor-beta agonist, as the first treatment for patients with MASH. In India, the Drug Controller General of India approved saroglitazar, a dual peroxisome proliferator-activated receptor (PPAR) α/γ agonist, for the treatment of MASLD. Currently, we have various drug classes, including liver-specific therapies, in Phase 3 development with even more agents earlier in the pipeline. This review will discuss prospective therapies in later stages of development such as thyroid hormone receptor-beta agonists, PPAR agonists, glucagon-like peptide-1 receptor agonists, fibroblast growth factor 21 agonists, and fatty acid synthase inhibitors.

Citations

Citations to this article as recorded by  Crossref logo
  • Combination therapies for metabolic dysfunction-associated steatohepatitis: challenges and opportunities
    Xiao-Dong Zhou, Qiong-Yue Fan, Christopher D Byrne, Giovanni Targher, Mark D Muthiah, Daniel Q Huang, Qin-Fen Chen, Mazen Noureddin, Wenhao Li, Vlad Ratziu, Rohit Loomba, Sven M Francque, Arun J Sanyal, Ming-Hua Zheng
    Gut.2025; : gutjnl-2025-337431.     CrossRef
  • 5,433 View
  • 226 Download
  • 1 Web of Science
  • Crossref

Correspondence

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
Clin Mol Hepatol 2026;32(1):e55-e57.
Published online April 15, 2025
DOI: https://doi.org/10.3350/cmh.2025.0379
  • 3,860 View
  • 31 Download

Reviews

Emerging therapies and real-world application of metabolic dysfunction-associated steatotic liver disease treatment
Hee Yeon Kim, Mary E. Rinella
Clin Mol Hepatol 2025;31(3):753-770.
Published online April 2, 2025
DOI: https://doi.org/10.3350/cmh.2025.0083
Metabolic dysfunction-associated steatotic liver disease, formerly referred to as non-alcoholic fatty liver disease, is the most common liver disease in Western countries and has emerged as the leading indication for liver transplantation. Metabolic dysfunction-associated steatohepatitis (MASH), a more advanced stage, carries a high risk of progression to liver fibrosis, cirrhosis, liver failure, and hepatocellular carcinoma. Until recently, lifestyle intervention remained the mainstay of MASH management, with no pharmacological treatments specifically approved. However, advances in understanding its pathophysiological mechanisms have fueled numerous clinical trials, culminating in the Food and Drug Administration’s (FDA) approval of resmetirom as the first treatment for MASH in 2024. Additionally, many investigational drugs are nearing FDA approval or progressing through late-stage clinical trials. This review examines the current therapeutic landscape, highlights strategies for identifying patients suitable for liver-directed therapies in real-world settings, and discusses the challenges that remain.

Citations

Citations to this article as recorded by  Crossref logo
  • Quzhou-sourced Fructus Aurantii ameliorates MASLD by modulating glycolysis-dependent M1 polarization in hepatic macrophages
    Junbin Yan, Yunmeng Nie, Menglu Ding, Mi Zhou, Tingyuan Li, Sumei Xu, Shuo Zhang
    Phytomedicine.2026; 150: 157572.     CrossRef
  • Stimuli-responsive nanomedicines for hepatic diseases: mechanism, design, recent advances, and clinical translation
    Leyi Wang, Xue Zhang, Yinggang Li, Min Zhao, Gang Xu, Zhenyu Duan, Qiyong Gong, Kui Luo
    Journal of Controlled Release.2026; 390: 114522.     CrossRef
  • Convergent Metabolic Pathways in MASH Therapeutics: An AMPK‐Centric Analysis
    Seungchan Choi, Jin‐Seok Jung, Yie‐sung Seo, Sungmin Song, Jeehye Ham, Hannah Chung, Yousef Ramadan, Kangchan Choi
    Journal of Cellular and Molecular Medicine.2026;[Epub]     CrossRef
  • Steatotic Liver Disease in Older Adults: Clinical Implications and Unmet Needs
    Daniel Clayton-Chubb, William W. Kemp, Ammar Majeed, Peter W. Lange, Jessica A. Fitzpatrick, Karl Vaz, John S. Lubel, Alexander D. Hodge, Joanne Ryan, John J. McNeil, Alice J. Owen, Robyn L. Woods, Stuart K. Roberts
    Nutrients.2025; 17(13): 2189.     CrossRef
  • Tirzepatide in metabolic dysfunction-associated steatotic liver disease and steatohepatitis: a novel star on the horizon?
    Amedeo Lonardo, Ralf Weiskirchen
    Exploration of Drug Science.2025;[Epub]     CrossRef
  • Timosaponin AIII from Anemarrhena asphodeloides binds and inhibits S100A8-mediated neutrophil infiltration and NET formation ameliorates MASH
    Yunfan Bai, Jingxin Ju, Ruishi Xie, Jing Li, Xinyi Zhao, Xiaoxue Fang, Ming Zhu, Xintian Lan, Haoming Luo
    International Immunopharmacology.2025; 166: 115539.     CrossRef
  • Full Active Nanoplatform Restores ROS Homeostasis for Synergistic Therapy of Fatty Liver Disease via Dual Endogenous–Exogenous Pathways
    Ziyi Lin, Peng Xu, Yuehai Xu, Yixin Zheng, Huimin Li, Zixin Chen, Zhe Wang, Shaochen Song, Yuhao Liu, Zhao Yang, Ju Cui, Heyun Shen
    ACS Applied Materials & Interfaces.2025;[Epub]     CrossRef
  • From mechanisms to management: Early detection and improved treatment of MASLD and its related hepatocellular carcinoma
    Dingwu Li, Xiang Zhang
    Hepatology Communications.2025;[Epub]     CrossRef
  • Editorial: Combination Therapies for MASH: A Step Forward or More Complexity?
    Xiao‐Dong Zhou, Yusuf Yilmaz, Mazen Noureddin, Hung N. Luu, Ming‐Hua Zheng
    Alimentary Pharmacology & Therapeutics.2025;[Epub]     CrossRef
  • Combination therapies for metabolic dysfunction-associated steatohepatitis: challenges and opportunities
    Xiao-Dong Zhou, Qiong-Yue Fan, Christopher D Byrne, Giovanni Targher, Mark D Muthiah, Daniel Q Huang, Qin-Fen Chen, Mazen Noureddin, Wenhao Li, Vlad Ratziu, Rohit Loomba, Sven M Francque, Arun J Sanyal, Ming-Hua Zheng
    Gut.2025; : gutjnl-2025-337431.     CrossRef
  • 11,473 View
  • 307 Download
  • 8 Web of Science
  • Crossref

Autoimmune liver disease

Hard-to-treat autoimmune hepatitis and primary biliary cholangitis: The dawn of a new era of pharmacological treatment
Atsumasa Komori, Yuki Kugiyama
Clin Mol Hepatol 2025;31(1):90-104.
Published online November 11, 2024
DOI: https://doi.org/10.3350/cmh.2024.0821
Patients with hard-to-treat autoimmune hepatitis (AIH) or primary biliary cholangitis (PBC) are defined a posteriori as those who do not show a sufficient response or are intolerant to pharmacological treatments, thus not achieving biochemical surrogate endpoints that are associated with long-term liver-related-event-free survival. The absence of a recently harmonized definition of ‘complete biochemical response within 6 months (CBR≤6M)’, which is defined as the normalization of serum transaminase and IgG levels below the upper limit of normal at ≤6 months after treatment initiation, is regarded as hard-to-treat AIH. The implementation of CBR≤6M, in turn, has been facilitating clinical trials, e.g., between azathioprine and mycophenolate mofetil, to reconsider appropriate first-line steroid sparing agents, leading to a reduction in the number of hard-to-treat AIH cases. Regarding PBC, one of the disseminated definitions of hard-to-treat patients is the absence of POISE criteria, which are evaluated at 12 months with serum alkaline phosphatase and bilirubin levels, after the introduction of ursodeoxycholic acid. Hard-to-treat PBC not meeting the POISE criteria has very recently been the target population for the U.S. FDA-approved second-line drugs, elafibranor and seladelpar. In future pharmacological treatment of AIH and PBC, the primary
objective
for AIH is likely to focus on lowering the number of hard-to-treat patients with personalized steroid sparing treatment regimens. A challenging goal in PBC treatment is the further optimization of treatment surrogate endpoints, even to the stricter alkaline phosphatase normalization, with which an indication of second- or later-line drugs might be expanded, but could ultimately lengthen patients’ long-term survival.

Citations

Citations to this article as recorded by  Crossref logo
  • Clinical Characteristics and Long‐Term Prognosis of Primary Biliary Cholangitis in Japan: Results of the 2nd‐Generation Nationwide Survey
    Yuki Kugiyama, Masanori Abe, Tadashi Namisaki, Hitoshi Yoshiji, Kazumichi Abe, Hiromasa Ohira, Ryosaku Shirahashi, Keiji Yokoyama, Atsushi Fukunaga, Kazuhito Kawata, Masahiro Umemura, Akira Honda, Tadashi Ikegami, Shiho Miyase, Toshiaki Nakano, Atsumasa K
    Hepatology Research.2026; 56(1): 50.     CrossRef
  • 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 covalentl
    Mehrangiz Dezhbord, Kyun-Hwan Kim
    Clinical and Molecular Hepatology.2026; 32(1): 385.     CrossRef
  • Pruritus in Chronic Cholestatic Liver Diseases, Especially in Primary Biliary Cholangitis: A Narrative Review
    Tatsuo Kanda, Reina Sasaki-Tanaka, Naruhiro Kimura, Hiroyuki Abe, Tomoaki Yoshida, Kazunao Hayashi, Akira Sakamaki, Takeshi Yokoo, Hiroteru Kamimura, Atsunori Tsuchiya, Kenya Kamimura, Shuji Terai
    International Journal of Molecular Sciences.2025; 26(5): 1883.     CrossRef
  • The Treatment of Primary Biliary Cholangitis: Time for Personalized Medicine
    Xinyi Men, Yansheng Liu, Han Zhao, Bingrui Xie, Changcun Guo, Patrick S. C. Leung, Suraj Timilsina, M. Eric Gershwin, Yulong Shang, Ying Han
    Clinical Reviews in Allergy & Immunology.2025;[Epub]     CrossRef
  • Autoimmune Hepatitis: Histopathological Spectrum and Diagnostic Implications
    Mina Komuta, Kenichi Harada
    Kanzo.2025; 66(11): 473.     CrossRef
  • Autoimmune Hepatitis: Histopathological Diversity and Its Clinical Implications
    Mina Komuta, Kenichi Harada
    Hepatology Research.2025;[Epub]     CrossRef
  • 7,612 View
  • 262 Download
  • 6 Web of Science
  • Crossref

Reply to Correspondence

COVID-19

Reply to correspondence on “Long-term gastrointestinal and hepatobiliary outcomes of COVID-19: A multinational population-based cohort study from South Korea, Japan, and the UK”
Yang-Hyun Baek
Clin Mol Hepatol 2025;31(1):e123-e124.
Published online November 6, 2024
DOI: https://doi.org/10.3350/cmh.2024.0966
  • 5,303 View
  • 24 Download

Original Articles

Viral hepatitis

Vibration-controlled transient elastography for significant fibrosis in treatment-naïve chronic hepatitis B patients: A systematic review and meta-analysis
Mi Na Kim, Jihyun An, Eun Hwa Kim, Hee Yeon Kim, Han Ah Lee, Jung Hwan Yu, Young-Joo Jin, Young Eun Chon, Seung Up Kim, Dae Won Jun, Ji Won Han, Miyoung Choi
Clin Mol Hepatol 2024;30(Suppl):S106-S116.
Published online July 23, 2024
DOI: https://doi.org/10.3350/cmh.2024.0371
Backgrounds/Aims
Accurate diagnosis of significant liver fibrosis in patients with chronic hepatitis B (CHB) is crucial when determining whether to initiate antiviral treatment (AVT). We conduct a meta-analysis to assess the diagnostic performance of vibration-controlled transient elastography (VCTE) for significant liver fibrosis in AVT-naïve CHB patients with serum alanine transaminase (ALT) levels within 5-fold the upper limit of normal (ULN).
Methods
The Ovid-Medline, EMBASE, Cochrane, and KoreaMed databases were searched to identify studies that compared the performance of VCTE and liver biopsy (reference standard) when diagnosing significant liver fibrosis (≥F2) in AVT-naïve CHB patients with ALT within 5-fold the ULN. A hierarchical summary receiver operating characteristic curve (HSROC) and bivariate model were performed to evaluate the diagnostic performance of VCTE in the meta-analysis.
Results
Eight studies (2,003 patients) were included. The summary sensitivity and specificity for diagnosis of significant liver fibrosis were 0.78 (95% confidence interval [CI], 0.66–0.86) and 0.72 (95% CI, 0.60–0.82), respectively. The HSROC for the diagnosis of significant liver fibrosis was 0.81 (95% CI, 0.72–0.86). The optimal cutoff value of VCTE for diagnosis of significant liver fibrosis was 7.7 kPa with a sensitivity of 0.64 (95% CI, 0.50–0.76) and specificity of 0.83 (95% CI, 0.72–0.90).
Conclusions
Our study demonstrated that VCTE has an acceptable diagnostic performance for significant liver fibrosis in AVT-naïve CHB patients with ALT within 5-fold the ULN.

Citations

Citations to this article as recorded by  Crossref logo
  • Unraveling Demographic Patterns in Hepatitis B Clinical and Laboratory Profiles: Insights From a Ghanaian Cohort: A Retrospective Study
    Napoleon Bellua Sam, Saeed Folorunsho Majeed, Adams Dramani
    Health Science Reports.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
    Journal of Gastroenterology and Hepatology.2025; 40(6): 1595.     CrossRef
  • Assessing Liver Fibrosis in Chronic Hepatitis B: Liver Biopsy or Non-Invasive Fibrosis Markers?
    Deniz Borcak, Zuhal Yesilbag, Yusuf Emre Ozdemir, Adile Sevde Demir, Esra Salim Dogdas, Aysegul Inci Sezen, Esra Canbolat Unlu, Sevtap Senoglu, Hayat Kumbasar Karaosmanoglu, Kadriye Kart Yasar
    Journal of Clinical Medicine.2025; 14(22): 8164.     CrossRef
  • Chronic Hepatitis B Infection: Patient Guidance
    Lung‐Yi Mak, Jimmy Che‐To Lai, Ken Liu, Rashid Lui, Sakkarin Chirapongsathorn, Kuo Chao Yew, Mara Teresa Panlilio, Cosmas Rinaldi Adithya Lesmana, Ruveena Bhavani Rajaram, Liang Shen, Desmond Cheung, Lung‐Fai Wong, Hye Won Lee, Madhumita Premkumar, Anand 
    Journal of Gastroenterology and Hepatology.2025;[Epub]     CrossRef
  • Vibration-Controlled Transient Elastography in Chronic Liver Disease: Current Research Insights
    Ho Soo Chun
    Clinical Ultrasound.2025; 10(2): 69.     CrossRef
  • Recent Trends in Noninvasive Tests for Assessing Hepatic Fibrosis in Patients with Chronic Liver Disease
    Jung Hwan Yu
    The Korean Journal of Medicine.2024; 99(5): 232.     CrossRef
  • Noninvasive Imaging Test to Assess Liver Fibrosis: Vibration-controlled Transient Elastography
    Mi Na Kim
    The Korean Journal of Gastroenterology.2024; 84(5): 201.     CrossRef
  • Liver Fibrosis Assessment in Chronic Liver Diseases Using Elastography: A Comprehensive Review of Vibration-Controlled Transient Elastography and Shear Wave Elastography
    Han Ah Lee
    Clinical Ultrasound.2024; 9(2): 70.     CrossRef
  • 5,959 View
  • 131 Download
  • 6 Web of Science
  • Crossref

Viral hepatitis

Extrahepatic malignancies and antiviral drugs for chronic hepatitis B: A nationwide cohort study
Moon Haeng Hur, Dong Hyeon Lee, Jeong-Hoon Lee, Mi-Sook Kim, Jeayeon Park, Hyunjae Shin, Sung Won Chung, Hee Jin Cho, Min Kyung Park, Heejoon Jang, Yun Bin Lee, Su Jong Yu, Sang Hyub Lee, Yong Jin Jung, Yoon Jun Kim, Jung-Hwan Yoon
Clin Mol Hepatol 2024;30(3):500-514.
Published online May 10, 2024
DOI: https://doi.org/10.3350/cmh.2024.0055
Background/Aims
Chronic hepatitis B (CHB) is related to an increased risk of extrahepatic malignancy (EHM), and antiviral treatment is associated with an incidence of EHM comparable to controls. We compared the risks of EHM and intrahepatic malignancy (IHM) between entecavir (ETV) and tenofovir disoproxil fumarate (TDF) treatment.
Methods
Using data from the National Health Insurance Service of Korea, this nationwide cohort study included treatment-naïve CHB patients who initiated ETV (n=24,287) or TDF (n=29,199) therapy between 2012 and 2014. The primary outcome was the development of any primary EHM. Secondary outcomes included overall IHM development. E-value was calculated to assess the robustness of results to unmeasured confounders.
Results
The median follow-up duration was 5.9 years, and all baseline characteristics were well balanced after propensity score matching. EHM incidence rate differed significantly between within versus beyond 3 years in both groups (P<0.01, Davies test). During the first 3 years, EHM risk was comparable in the propensity score-matched cohort (5.88 versus 5.84/1,000 person-years; subdistribution hazard ratio [SHR]=1.01, 95% confidence interval [CI]=0.88–1.17, P=0.84). After year 3, however, TDF was associated with a significantly lower EHM incidence compared to ETV (4.92 versus 6.91/1,000 person-years; SHR=0.70, 95% CI=0.60–0.81, P<0.01; E-value for SHR=2.21). Regarding IHM, the superiority of TDF over ETV was maintained both within (17.58 versus 20.19/1,000 person-years; SHR=0.88, 95% CI=0.81–0.95, P<0.01) and after year 3 (11.45 versus 16.20/1,000 person-years; SHR=0.68, 95% CI=0.62–0.75, P<0.01; E-value for SHR=2.30).
Conclusions
TDF was associated with approximately 30% lower risks of both EHM and IHM than ETV in CHB patients after 3 years of antiviral therapy.

Citations

Citations to this article as recorded by  Crossref logo
  • Chronic hepatitis B, extrahepatic malignancies and the use of antiviral drugs
    Meng-Che Wu, Shih-Chi Yang, Shuo-Yan Gau
    Clinical and Molecular Hepatology.2025; 31(1): e19.     CrossRef
  • The critical role of ferroptosis in virus-associated hematologic malignancies and its potential value in antiviral-antitumor therapy
    Miao Miao, Yuelei Chen, Xuehan Wang, Shengyang Li, Rong Hu
    Virulence.2025;[Epub]     CrossRef
  • Antiviral Therapy Reduces Dyslipidemia and Cardiovascular Risk in Chronic Hepatitis B: TDF as the Most Effective Agent
    Hyuk Kim, Jae‐Young Kim, Hyun Bin Choi, Ji‐Soo Lee, Yoon E. Shin, Jeong‐Ju Yoo, Sang Gyune Kim, Young‐Seok Kim
    Journal of Medical Virology.2025;[Epub]     CrossRef
  • Characteristics and outcomes in atorvastatin therapy for chronic subdural hematoma: a national, observational real-world study in China, 2019–2024
    Tao Liu, Zhihao Zhao, Jiao Wang, Xiaoying Chen, Jinhao Huang, Weiwei Jiang, Yunhu Yu, Xide Zhu, Kaijie Wang, Kun Lin, Hu Qin, Baixiang Peng, Guohe Zhang, Zhiyong Liu, Weiliang Chen, Jun Shen, Baozhi Chen, Shengjie Li, Mingqi Liu, Wanqiang Su, Wanhai Ding,
    The Lancet Regional Health - Western Pacific.2025; 63: 101688.     CrossRef
  • Association between atherogenic index of plasma and incident aortic disease: a population-based prospective analysis
    Cuihong Tian, Xiao Wang, Liang Tao, Wanyi Wei, Xuan Zhang, Haoxian Tang, Yequn Chen, Xuerui Tan
    Open Heart.2025; 12(2): e003511.     CrossRef
  • Nucleos(t)ide analog therapy of chronic hepatitis B and extrahepatic cancer risk: Is tenofovir better than entecavir?: Editorial on “Extrahepatic malignancies and antiviral drugs for chronic hepatitis B: A nationwide cohort study”
    Yewan Park, Dong Hyun Sinn
    Clinical and Molecular Hepatology.2024; 30(4): 718.     CrossRef
  • Effect of SARS-CoV-2 infection on liver function in patients with hepatitis B
    Tong Sun, Hongbo Chi, Jing Wang, Yufen Zheng, Hongguo Zhu, Jingxian Zhao, Kai Zhou, Mengyuan Chen, Donglian Wang, Tao-Hsin Tung, Jiaqin Xu, Bo Shen
    BMC Infectious Diseases.2024;[Epub]     CrossRef
  • 7,578 View
  • 224 Download
  • 6 Web of Science
  • Crossref

Correspondence

Viral hepatitis

Optimizing off-treatment outcome predictions: The potential of time-varying HBcrAg and the need for more research
Ying-Nan Tsai, Jia-Ling Wu, Yao-Chun Hsu
Clin Mol Hepatol 2024;30(2):276-278.
Published online April 1, 2024
DOI: https://doi.org/10.3350/cmh.2024.0220
  • 5,268 View
  • 47 Download

Review

Viral hepatitis

Comprehensive approach to controlling chronic hepatitis B in China
Shan Shan, Xinyan Zhao, Jidong Jia
Clin Mol Hepatol 2024;30(2):135-143.
Published online January 5, 2024
DOI: https://doi.org/10.3350/cmh.2023.0412
Hepatitis B virus (HBV) infection was highly endemic in China, where the prevalence of HBsAg was 9.7% in 1992. Comprehensive strategies, including universal infant hepatitis B vaccination with emphasis on timely birth-dose and 3-dose coverage, dramatically reduced the mother-to-infant transmission and early childhood acquisition of HBV, resulting in estimated HBsAg prevalence rates of 5.6% and 0.1% in the general population and among children aged <5 years in 2022, respectively. Clinical guidelines on the prevention and treatment of chronic hepatitis B have been periodically updated based on emerging evidence from clinical research. The continuously improved reimbursement policy and the massively reduced price of antiviral drugs through government negotiation and central procurement have increased treatment accessibility and affordability. However, due to the low rates of diagnosis and treatment, China still faces a large challenge in achieving the 2030 goal of lowering HBV-related mortality by 65%. A public health approach involving concerted efforts from the government, medical community, industry, and society as a whole would be necessary to increase the uptake of HBV tests and treatment to achieve the global goal of eliminating viral hepatitis as a public health threat by 2030.

Citations

Citations to this article as recorded by  Crossref logo
  • Global inequality in the burden of hepatitis B from 1990 to 2021: Findings from the global burden of disease study 2021: Letter to the editor on “Comprehensive approach to controlling chronic hepatitis B in China”
    Chunlong Liu, Jiangtao Yu
    Clinical and Molecular Hepatology.2025; 31(2): e134.     CrossRef
  • Unraveling Demographic Patterns in Hepatitis B Clinical and Laboratory Profiles: Insights From a Ghanaian Cohort: A Retrospective Study
    Napoleon Bellua Sam, Saeed Folorunsho Majeed, Adams Dramani
    Health Science Reports.2025;[Epub]     CrossRef
  • Effect of Nucleos(t)ide Analogues Withdrawal on Survival Outcomes in Patients With Hepatitis B Virus‐Related Acute‐on‐Chronic Liver Failure
    Yanxue Lin, Xueping Yu, Huimin Lin, Jiajia Han, Yan Yan, Xiaoting Zhao, Yijie Lin, Zixuan Huang, Yinyin Zheng, Yahong Gao, Wenjin Yuan, Meifang Zhou, Jiming Zhang, Dawu Zeng
    Alimentary Pharmacology & Therapeutics.2025; 62(5): 504.     CrossRef
  • Construction and validation of a nomogram prediction model for antiviral efficacy based on clinical characteristics and intestinal microflora distribution in patients with chronic hepatitis B
    Hongjie Wu, Mingqiang Yue, Tianbao Wang, Xiaoxia Wei, Yanping Wang, Changyun Si
    Frontiers in Medicine.2025;[Epub]     CrossRef
  • 48-week prognostic analysis of very low-level viremia in patients with hepatitis B cirrhosis: a single-center retrospective study
    Yinong Feng, Zehong Wang, Shaoyuan Shi, Li Zhou, Yongli Hua, Xuanxuan Wang, Jianzhong Ma
    Frontiers in Medicine.2025;[Epub]     CrossRef
  • Chinese medicine monomers for hepatocellular carcinoma: New ideas related to autophagy
    Shi-Hao Zheng, Tian-Yu Xue, Qiu-Yue Wang, Yong-An Ye, Peng Zhang
    World Journal of Gastroenterology.2025;[Epub]     CrossRef
  • Trends in the disease burden of early-onset cancers in China from 1990 to 2021: a systematic analysis of the 2021 Global Burden of Disease study
    Jicun Zhu, Tiandong Li, Jiajun Chen, Wenhua Xue, Shuhong Liang, Chen Xie, Xiting Han, Weiwei Hao, Yixin He, Gaoxing Qiao, Xiaoran Duan, Lifeng Li, Jie Zhao
    BMC Cancer.2025;[Epub]     CrossRef
  • Global Disease and Economic Burden of Noncommunicable Diseases Attributable to Hepatitis B Infection: A Health Economic Evaluation Study
    Xu Wang, Ningjun Ren, Hanting Liu, Jinzhao Xie, Yusheng Jie, Chun Hao, Stuart Gilmour, Jinghua Li, Jing Gu, Lei Zhang
    Journal of Medical Virology.2025;[Epub]     CrossRef
  • Characterization of inflammatory protein expression patterns and their association with viral DNA load in hepatitis B virus infection via Olink proteomics analysis
    Xiangjuan Li
    American Journal of Translational Research.2025; 17(6): 4701.     CrossRef
  • Epidemiological trends and projections to 2035 of hepatitis B burden in China, 1990–2021
    Xinyue Qi, Yongzheng Hu, Wei Jiang, Pengpeng Ye,
    PLOS One.2025; 20(9): e0330633.     CrossRef
  • Burden of liver cancer in adolescents and young adults aged 15-49 years in China: a comprehensive analysis based on the Global Burden of Disease study (1990-2021)
    Yi-Xin Zou, Zhuo-Ying Li, Xiao-Hui Zhou, Dan-Ni Yang, Jia-Yi Tuo, Qiu-Ming Shen, Yu-Ting Tan, Hong-Lan Li, Yong-Bing Xiang
    Hepatoma Research.2025;[Epub]     CrossRef
  • Pretreatment viral quasispecies characteristics and evolutionary phases correlate with HBsAg seroconversion in peginterferon-alfa-2a-treated children with HBeAg-positive chronic hepatitis B
    Juncheng Yang, Guifeng Yang, Haitang He, Hai Liu, Qunfang Fu, Xiaoting Wu, Ran Meng, Zhuoyue Li, Qian Zhao, Kangxian Luo, Zhihua Liu
    Antiviral Research.2025; 244: 106291.     CrossRef
  • Parental perceptions and willingness to pay for childhood vaccination experiences in China: a multi-city comprehensive evaluation study
    Bei Liu, Ninghua Huang, Yaqiong Liu, Xiyu Zhang, Bing Wu, Bing Cao, Tao Sun, Yudong Miao, Fuqiang Cui
    Vaccine.2025; 67: 127826.     CrossRef
  • Global burden, trends and inequalities of hepatitis B among women of childbearing age, 1990–2021
    Hong Zhang, Haitao Wang
    Annals of Medicine.2025;[Epub]     CrossRef
  • Global, regional, and national burden and trends of liver cancer due to hepatitis B in young adults from 1990 to 2021 and forecast to 2030: insights from the Global Burden of Disease Study 2021
    Jinbo Li, Yaling Li, Bihong Ke, Xiaosheng Zhang, Weigang Wang, Yandi Li, Jia Lian, Tian Yao, Keke Wang, Suping Wang, Yongliang Feng
    Internal and Emergency Medicine.2025;[Epub]     CrossRef
  • Predictors of low-level viremia in chronic hepatitis B and the efficacy of pegylated interferon-alpha: a real-world study
    Wenyuan Zhang, Jia Chen, Wenjin Sun, Nana Xie, Fangbing Tian, Wencong Zhang, Qiurong Ruan, Jianxin Song
    Virology Journal.2025;[Epub]     CrossRef
  • Effectiveness of the National Immunisation Programme and the catch-up vaccination on the incidence of hepatitis B in China: an interrupted time series analysis from 2005 to 2019
    Bo-Wen Ming, Jinlun Zhang, Li Li, Xiaohan Xu, Chen Shi, Juanjuan Zhang, Chun-Quan Ou
    BMJ Global Health.2025; 10(11): e019080.     CrossRef
  • Efficacy Analysis and Influencing Factors of HBsAg Response in Chronic Hepatitis B Patients Treated with Nucleoside Analogues and Pegylated Interferon Sequential Therapy with High HBsAg Levels
    Jingdan Chen, Shangkun Lai, Mijia Zheng
    Hepatitis Monthly.2025;[Epub]     CrossRef
  • Serial Liver Stiffness Measurement and Serum Biomarkers Are Not Strong Predictors of the Regression of Fibrosis among Chronic Hepatitis B Patients Receiving Antiviral Therapy Based on Triple Liver Biopsies
    Jiayi Zhang, Shuyan Chen, Jialing Zhou, Bingqiong Wang, Xiaoning Wu, Xiaoqian Xu, Xinyu Zhao, Yuanyuan Kong, Xiaojuan Ou, Yameng Sun, Hong You
    Gut and Liver.2025; 19(6): 889.     CrossRef
  • Molecular mechanism of RBM15-mediated m6A modification in hepatitis B virus replication
    Min Ni, Bingbing Li, Lingli Wang, Shengju Ma, Kun Ma
    Virology Journal.2025;[Epub]     CrossRef
  • Economic evaluation of hepatocellular carcinoma surveillance in chronic hepatitis B patients with virological remission
    Kailu Fang, Shuwen Li, Yushi Lin, Yu Zhang, Jie Wu
    BMC Public Health.2024;[Epub]     CrossRef
  • Associations between chronic hepatitis B infection and inflammatory bowel diseases in East Asian populations
    Haiyan Ye, Deqin Wei, Yike Huang
    Future Virology.2024; 19(16-18): 563.     CrossRef
  • 11,006 View
  • 293 Download
  • 25 Web of Science
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Original Articles

Viral hepatitis

Hepatitis B core-related antigen dynamics and risk of subsequent clinical relapses after nucleos(t)ide analog cessation
Ying-Nan Tsai, Jia-Ling Wu, Cheng-Hao Tseng, Tzu-Haw Chen, Yi-Ling Wu, Chieh-Chang Chen, Yu-Jen Fang, Tzeng-Huey Yang, Mindie H. Nguyen, Jaw-Town Lin, Yao-Chun Hsu
Clin Mol Hepatol 2024;30(1):98-108.
Published online December 14, 2023
DOI: https://doi.org/10.3350/cmh.2023.0194
Background/Aims
Finite nucleos(t)ide analog (NA) therapy has been proposed as an alternative treatment strategy for chronic hepatitis B (CHB), but biomarkers for post-treatment monitoring are limited. We investigated whether measuring hepatitis B core-related antigen (HBcrAg) after NA cessation may stratify the risk of subsequent clinical relapse (CR).
Methods
This retrospective multicenter analysis enrolled adults with CHB who were prospectively monitored after discontinuing entecavir or tenofovir with negative HBeAg and undetectable HBV DNA at the end of treatment (EOT). Patients with cirrhosis or malignancy were excluded. CR was defined as serum alanine aminotransferase > two times the upper limit of normal with recurrent viremia. We applied time-dependent Cox proportional hazard models to clarify the association between HBcrAg levels and subsequent CR.
Results
The cohort included 203 patients (median age, 49.8 years; 76.8% male; 60.6% entecavir) who had been treated for a median of 36.9 months (interquartile range [IQR], 36.5–40.1). During a median post-treatment follow-up of 31.7 months (IQR, 16.7–67.1), CR occurred in 104 patients with a 5-year cumulative incidence of 54.8% (95% confidence interval [CI], 47.1–62.4%). Time-varying HBcrAg level was a significant risk factor for subsequent CR (adjusted hazard ratio [aHR], 1.53 per log U/mL; 95% CI, 1.12–2.08) with adjustment for EOT HBsAg, EOT anti-HBe, EOT HBcrAg and time-varying HBsAg. During follow-up, HBcrAg <1,000 U/mL predicted a lower risk of CR (aHR, 0.41; 95% CI, 0.21–0.81).
Conclusions
Dynamic measurement of HBcrAg after NA cessation is predictive of subsequent CR and may be useful to guide post-treatment monitoring.

Citations

Citations to this article as recorded by  Crossref logo
  • Similar hepatic outcome by SGLT2i vs. DPP4i for at-risk cohort with CHB & T2DM: A nationwide target trial emulation study
    Byungyoon Yun, Juyeon Oh, Heejoo Park, Jian Lee, Beom Kyung Kim, Jin-Ha Yoon
    Annals of Hepatology.2026; 31(1): 102175.     CrossRef
  • Mitochondrial metabolic remodeling predicts therapeutic response to PegIFN-α in chronic hepatitis B
    Yingying Zhang, Xiu Han, Chengyu Xu, Yahui Song, Jinghan Zhu, Ruoran Zhou, Yiling Chen, Mingming Liu, Junchi Xu, Xiangwei Wu, Qingzhen Han, Zutao Chen
    Frontiers in Cellular and Infection Microbiology.2026;[Epub]     CrossRef
  • Early HBcrAg and Anti‐HBc Levels Identify Patients at High Risk for Severe Flares After Nucleos(t)ide Analogue Cessation—A Pooled Analysis of Two Clinical Trials
    Edo J. Dongelmans, Jordan J. Feld, André Boonstra, Sylvia M. Brakenhoff, David Wong, Colina Yim, Mark Claassen, Pieter Honkoop, Bettina E. Hansen, Robert A. de Man, Scott Fung, Thomas Berg, Florian van Bömmel, Harry L. A. Janssen, Milan J. Sonneveld
    Alimentary Pharmacology & Therapeutics.2025; 61(3): 570.     CrossRef
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    Jiarui Zheng, Zilong Wang, Linxiang Huang, Zixuan Qiu, Yandi Xie, Suzhen Jiang, Bo Feng
    Virus Research.2025; 351: 199507.     CrossRef
  • Hepatitis B core-related antigen as a promising serological marker for monitoring hepatitis B virus cure
    Yue Qiu, Qiao Tang, Xiao-Qing Liu, Yun-Ling Xue, Yi Zeng, Peng Hu
    World Journal of Hepatology.2025;[Epub]     CrossRef
  • Comparative Hepatic Outcomes of SGLT2i or DPP4i Compared to GLP‐1RA in CHB and T2DM Patients
    Byungyoon Yun, Juyeon Oh, Heejoo Park, Jian Lee, Beom Kyung Kim, Jin‐Ha Yoon
    Liver International.2025;[Epub]     CrossRef
  • Novel HBV Biomarkers-Guided NAs Withdrawal Strategy Promotes HBsAg Clearance in Asian CHB Patients: A Randomized Controlled Trial
    Rong Fan, Rui Deng, Qing Xie, Fang Wang, Xieer Liang, Hong Ma, Huiying Rao, Yanhang Gao, Chunxiu Zhong, Qing Guo, Sheng Shen, Ya Xu, Xingyu Lu, Hongbo Gao, Honglian Bai, Xiaoguang Dou, Jian Sun
    Clinical Gastroenterology and Hepatology.2025;[Epub]     CrossRef
  • Discontinuation of nucleos(t)ide analogues after NA-induced HBsAg seroclearance: a single-center 48-week retrospective study
    Yong-Hong Wang, Ya-Chao Tao, Meng-Lan Wang, Cheng-Run Song, Jiang-Nan Peng, En-Qiang Chen
    Journal of Virus Eradication.2025; 11(4): 100617.     CrossRef
  • 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
  • Letter regarding “Hepatitis B core-related antigen dynamics and risk of subsequent clinical relapses after nucleos(t)ide analog cessation”
    Yun-Fan Liaw
    Clinical and Molecular Hepatology.2024; 30(2): 269.     CrossRef
  • 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
    Clinical and Molecular Hepatology.2024; 30(2): 154.     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
    Clinical and Molecular Hepatology.2024; 30(2): 276.     CrossRef
  • Harnessing hepatitis B core-related antigen measurement to optimize posttreatment monitoring
    Ying-Nan Tsai, Jia-Ling Wu, Yao-Chun Hsu
    Clinical and Molecular Hepatology.2024; 30(2): 293.     CrossRef
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    Shuaibu Abdullahi Hudu, Sa’adatu Haruna Shinkafi, Abdulgafar Olayiwola Jimoh
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    Jean-Michel Pawlotsky
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  • Crossref

Hepatic neoplasm

Loco-regional therapies competing with radiofrequency ablation in potential indications for hepatocellular carcinoma: a network meta-analysis
Ha Il Kim, Jihyun An, Seungbong Han, Ju Hyun Shim
Clin Mol Hepatol 2023;29(4):1013-1028.
Published online July 5, 2023
DOI: https://doi.org/10.3350/cmh.2023.0131
Background/Aims
There is no clear consensus on the relative ranking of interventional and radiation techniques with indications similar to those of radiofrequency ablation (RFA) for the treatment of early hepatocellular carcinoma (HCC). We used a network meta-analysis to compare the efficacy of non-surgical treatments for early HCC.
Methods
We searched databases for randomized trials assessing the efficacy of loco-regional treatments for HCCs ≤5 cm with no extrahepatic spread or portal invasion. The primary outcome was the pooled hazard ratio (HR) for overall survival (OS), and secondary outcomes included overall and local progression-free survival (PFS). A frequentist network meta-analysis was performed, and the relative ranking of therapies was assessed with P-scores.
Results
Nineteen studies comparing 11 different strategies in 2,793 patients were included. Chemoembolization plus RFA improved OS better than RFA alone (HR 0.52, 95% confidence interval [CI] 0.33–0.82; P-score=0.951). Cryoablation, microwave ablation, laser ablation, and proton beam therapy had similar effects on OS compared with RFA. For overall PFS, but not local PFS, only chemoembolization plus RFA performed significantly better than RFA (HR 0.61, 95% CI 0.42–0.88; P-score=0.964). Injection of percutaneous ethanol or acetic acid was significantly less effective than RFA for all measured outcomes, while no differences in progression outcomes were identified for other therapies included in the network.
Conclusions
Our results suggest that chemoembolization combined with RFA is the best option for local treatment of early HCC. Cases with potential contraindications for RFA may benefit from a tailored approach using thermal or radiation modalities.

Citations

Citations to this article as recorded by  Crossref logo
  • Digital pathology-based prognostic model for hepatocellular carcinoma: Integrating pathomics signatures with clinical parameters for recurrence prediction and biological interpretation
    Qi Wang, Yuxi Huang, Yu Zhang, Yu Zhu, Peng Hu, Yongfu Xu, Zhen-yu Jiang, Long Liu, Shao-wei Li
    Computer Methods and Programs in Biomedicine.2026; 275: 109180.     CrossRef
  • A network meta-analysis of different interventional treatment strategies for unresectable hepatocellular carcinoma
    Xing-Yan Le, Jun-Bang Feng, Xiao-Li Yu, Sui-Li Li, Xiaocai Zhang, Jiaqing Li, Chuan-Ming Li
    BMC Gastroenterology.2025;[Epub]     CrossRef
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    B Yun, J Oh, S H Ahn, B K Kim, J-H Yoon
    Occupational Medicine.2025; 75(2): 113.     CrossRef
  • The Emerging Landscape for Combating Resistance Associated with Energy‐Based Therapies via Nanomedicine
    Qitao Hu, Huali Zuo, Jessica C. Hsu, Cheng Zeng, Zhou Tian, Zhouyi Sun, Weibo Cai, Zhe Tang, Weiyu Chen
    Advanced Materials.2024;[Epub]     CrossRef
  • Efficacy and Safety of CT-guided Percutaneous Cryoablation for Hepatocellular Carcinoma at High-risk Sites
    Weihao Zhang, Yan Wang, Xiaohui Zhao, Wei Gao, Changfu Liu, Tongguo Si, Xueling Yang, Wenge Xing, Haipeng Yu
    Academic Radiology.2024; 31(11): 4434.     CrossRef
  • Chemoembolization combined with radiofrequency ablation is the best option for the local treatment of early hepatocellular carcinoma?
    Hyo-Cheol Kim
    Clinical and Molecular Hepatology.2023; 29(4): 984.     CrossRef
  • 8,800 View
  • 183 Download
  • 6 Web of Science
  • Crossref

Snapshot

Viral hepatitis

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

Citations

Citations to this article as recorded by  Crossref logo
  • Liver histological study of patients with chronic hepatitis B virus infection in the grey zone
    Weijia Lin, Rongrong Ding, Shuangshuang Sun, Wei Lu, Yanbin Wang, Xinlan Zhou, Dan Huang, Xiufen Li, Zhanqing Zhang, Liang Chen
    BMC Infectious Diseases.2025;[Epub]     CrossRef
  • Correspondence to editorial on “Optimal tacrolimus levels for reducing CKD risk and the impact of intrapatient variability on CKD and ESRD development following liver transplantation”
    Soon Kyu Lee, Jong Young Choi
    Clinical and Molecular Hepatology.2025; 31(2): e161.     CrossRef
  • Distinguishing True Immune Tolerant Hepatitis B Patients: Insights From Long‐Term Clinical Outcomes
    Jung Hyun Kwon, Sung Won Lee, Hee‐Yeon Kim, Do Seon Song, Soon Kyu Lee, Heechul Nam, Soon Woo Nam, Si Hyun Bae, Jong Young Choi, Seung Kew Yoon, Jeong Won Jang
    Journal of Viral Hepatitis.2025;[Epub]     CrossRef
  • Gray zone and the need for expansion in chronic hepatitis B: From theory to clinical practice
    Thang Viet Luong, Ngoc Phan Hong Nguyen, Tri Van Nguyen, Duong Hung Tran, Thien Dinh Nguyen, Hai Nguyen Ngoc Dang
    World Journal of Hepatology.2025;[Epub]     CrossRef
  • Vibration-controlled transient elastography for significant fibrosis in treatment-naïve chronic hepatitis B patients: A systematic review and meta-analysis
    Mi Na Kim, Jihyun An, Eun Hwa Kim, Hee Yeon Kim, Han Ah Lee, Jung Hwan Yu, Young-Joo Jin, Young Eun Chon, Seung Up Kim, Dae Won Jun, Ji Won Han, Miyoung Choi
    Clinical and Molecular Hepatology.2024; 30(Suppl): S106.     CrossRef
  • 9,913 View
  • 113 Download
  • 5 Web of Science
  • Crossref

Original Article

Viral hepatitis

Hepatocellular carcinoma prediction model performance decreases with long-term antiviral therapy in chronic hepatitis B patients
Xiaoning Wu, Xiaoqian Xu, Jialing Zhou, Yameng Sun, Huiguo Ding, Wen Xie, Guofeng Chen, Anlin Ma, HongXin Piao, Bingqiong Wang, Shuyan Chen, Tongtong Meng, Xiaojuan Ou, Hwai-I Yang, Jidong Jia, Yuanyuan Kong, Hong You
Clin Mol Hepatol 2023;29(3):747-762.
Published online May 10, 2023
DOI: https://doi.org/10.3350/cmh.2023.0121
Background/Aims
Existing hepatocellular carcinoma (HCC) prediction models are derived mainly from pretreatment or early on-treatment parameters. We reassessed the dynamic changes in the performance of 17 HCC models in patients with chronic hepatitis B (CHB) during long-term antiviral therapy (AVT).
Methods
Among 987 CHB patients administered long-term entecavir therapy, 660 patients had 8 years of follow-up data. Model scores were calculated using on-treatment values at 2.5, 3, 3.5, 4, 4.5, and 5 years of AVT to predict threeyear HCC occurrence. Model performance was assessed with the area under the receiver operating curve (AUROC). The original model cutoffs to distinguish different levels of HCC risk were evaluated by the log-rank test.
Results
The AUROCs of the 17 HCC models varied from 0.51 to 0.78 when using on-treatment scores from years 2.5 to 5. Models with a cirrhosis variable showed numerically higher AUROCs (pooled at 0.65–0.73 for treated, untreated, or mixed treatment models) than models without (treated or mixed models: 0.61–0.68; untreated models: 0.51–0.59). Stratification into low, intermediate, and high-risk levels using the original cutoff values could no longer reflect the true HCC incidence using scores after 3.5 years of AVT for models without cirrhosis and after 4 years of AVT for models with cirrhosis.
Conclusions
The performance of existing HCC prediction models, especially models without the cirrhosis variable, decreased in CHB patients on long-term AVT. The optimization of existing models or the development of novel models for better HCC prediction during long-term AVT is warranted.

Citations

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  • Racing toward the future of chronic hepatitis B management: Achieving functional cure and enhancing hepatocellular carcinoma surveillance through precision medicine
    Yaru Shi, Rong Fan
    Interdisciplinary Medicine.2025;[Epub]     CrossRef
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    Carla Osiowy, Fernando Alvarez, Carla S. Coffin, Curtis L. Cooper, Scott K. Fung, Hin Hin Ko, Sébastien Poulin, Jennifer van Gennip
    Canadian Liver Journal.2025; 8(2): 402.     CrossRef
  • The management of chronic hepatitis B: 2025 Guidelines update from the Canadian Association for the Study of the Liver and Association of Medical Microbiology and Infectious Disease Canada
    Carla Osiowy, Fernando Alvarez, Carla S Coffin, Curtis L Cooper, Scott K Fung, Hin Hin Ko, Sébastien Poulin, Jennifer van Gennip
    Canadian Liver Journal.2025; 8(2): 368.     CrossRef
  • 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
  • LEAST as a novel prediction model of hepatocellular carcinoma development in patients with chronic hepatitis B: a multi-center study
    Jingjing Song, Jie Li, Zhigang Ren, Wen Xie, Jinhua Shao, Xiaoxiao Zhang, Yang Zhou, Fajuan Rui, Xiaoqing Wu, Qiuling Wang, Zuxiong Huang, Chao Sun, Yuemin Nan
    BMC Medicine.2025;[Epub]     CrossRef
  • Validation of the Texas Hepatocellular Carcinoma Risk Index Predictive Model for Hepatocellular Carcinoma in Asian Cohort
    Jeong-Ju Yoo, Young-Gi Song, Ji Eun Moon, Young Seok Kim, Sang Gyune Kim
    Clinical Gastroenterology and Hepatology.2024; 22(9): 1953.     CrossRef
  • Risk predictive model for the development of hepatocellular carcinoma before initiating long‐term antiviral therapy in patients with chronic hepatitis B virus infection
    Junjie Chen, Tienan Feng, Qi Xu, Xiaoqi Yu, Yue Han, Demin Yu, Qiming Gong, Yuan Xue, Xinxin Zhang
    Journal of Medical Virology.2024;[Epub]     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
  • 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 pati
    Beom Kyung Kim
    Clinical and Molecular Hepatology.2024; 30(4): 656.     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
  • 7,312 View
  • 175 Download
  • 9 Web of Science
  • Crossref

Guideline

Autoimmune liver disease

KASL clinical practice guidelines for management of autoimmune hepatitis 2022
The Korean Association for the Study of the Liver (KASL)
Clin Mol Hepatol 2023;29(3):542-592.
Published online May 3, 2023
DOI: https://doi.org/10.3350/cmh.2023.0087

Citations

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  • Risk of Extrahepatic Malignancies in Patients With Autoimmune Hepatitis: A Nationwide Cohort Study
    Sung Won Chung, Ye-Jee Kim, Jihye Lim, Jonggi Choi, Danbi Lee, Ju Hyun Shim, Kang Mo Kim, Young-Suk Lim, Han Chu Lee, Sehee Kim, Won-Mook Choi
    American Journal of Gastroenterology.2025; 120(10): 2302.     CrossRef
  • Transient elastography for assessing liver fibrosis in autoimmune liver diseases: Excellent performance but limited details: Editorial on “Diagnostic accuracy of vibration-controlled transient elastography for staging liver fibrosis in autoimmune liver di
    Kyung-Ah Kim
    Clinical and Molecular Hepatology.2025; 31(1): 275.     CrossRef
  • Hard-to-treat autoimmune hepatitis and primary biliary cholangitis: The dawn of a new era of pharmacological treatment
    Atsumasa Komori, Yuki Kugiyama
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  • Comment on “Characteristics and Outcomes of Hepatocellular Carcinoma in Patients with Autoimmune Hepatitis”
    Bilal Ahmad, Ayesha Arshad, Niqab Muhammad
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    Anna Usachova, Lyudmila Onyshchuk
    The Ukrainian Scientific Medical Youth Journal.2025; 154(2): 35.     CrossRef
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    Jihye Lim, Ye-Jee Kim, Sehee Kim, Ju Hyun Shim, Ashraf Elbahrawy
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  • Incidence and risk factors of hepatocellular carcinoma in patients with autoimmune hepatitis in Asia
    Jiwon Yang, Sun Young Yim, Kunhee Kim, Hye Won Lee, Jonggi Choi
    JHEP Reports.2025; 7(10): 101524.     CrossRef
  • Difficult to treat and refractory autoimmune hepatitis: Recent advances in pharmacological management
    Sayan Malakar, Umair Shamsul Hoda, Suprabhat Giri, Arghya Samanta, Akash Roy, Rajat Gupta, S Rakesh Kumar, Mayank Agarwal, Anubhav Pawar, Sumit Rungta, Uday C Ghoshal
    World Journal of Hepatology.2025;[Epub]     CrossRef
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    Rongyu Zhu, Haixin Zhang, Fuli Zhang
    Frontiers in Immunology.2025;[Epub]     CrossRef
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    Atsushi Tanaka, Sombat Treeprasertsuk, Ming-Ling Chang, Soek-Siam Tan, Cumali Efe, Sook-Hyang Jeong, Xiong Ma, Martin Weltman, Hiroyuki Isayama, Jidong Jia
    Hepatology International.2025;[Epub]     CrossRef
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    Brian J. Wentworth, Kwang Il Seo
    Kosin Medical Journal.2025; 40(4): 249.     CrossRef
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    Atsumasa Komori
    Clinical and Molecular Hepatology.2024; 30(2): 157.     CrossRef
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    Jihye Lim, Hwa Jung Kim
    Orphanet Journal of Rare Diseases.2024;[Epub]     CrossRef
  • The Impact of Histologic Portal T-Cell Density on the Clinical Outcomes in Hepatic Graft-versus-Host Disease and Autoimmune Liver Diseases
    Soon Kyu Lee, Sung-Soo Park, Silvia Park, Sung-Eun Lee, Byung-Sik Cho, Ki-Seong Eom, Yoo-Jin Kim, Hee-Je Kim, Chang-Ki Min, Seok-Goo Cho, Jong Wook Lee, Seok Lee, Younghoon Kim, Ji Won Han, Hyun Yang, Si Hyun Bae, Jeong Won Jang, Jong Young Choi, Seung Ke
    Diagnostics.2024; 14(16): 1745.     CrossRef
  • Diagnostic accuracy of vibration-controlled transient elastography for staging liver fibrosis in autoimmune liver diseases: A systematic review and meta-analysis
    Jihyun An, Young Eun Chon, Gunho Kim, Mi Na Kim, Hee Yeon Kim, Han Ah Lee, Jung Hwan Yu, Miyoung Choi, Dae Won Jun, Seung Up Kim, Ji Won Han, Young-Joo Jin
    Clinical and Molecular Hepatology.2024; 30(Suppl): S134.     CrossRef
  • Analysis of Azathioprine Metabolites in Autoimmune Hepatitis Patient Blood—Method Development and Validation
    Andrea Guba, Patrícia Kováts, Zoltán A. Mezei, Mária Papp, Éva Csősz, Gergő Kalló
    International Journal of Molecular Sciences.2024; 25(20): 11233.     CrossRef
  • AUTOIMMUNE HEPATITIS AND THE COMPLEXITY OF ITS MANAGEMENT: A CLINICAL CASE
    V. N. Zhdan, O. A. Kyrian, M. Yu. Babanina, I. V. Ivanytskyi, M. V. Tkachenko, V. G. Lebid
    Bulletin of Problems Biology and Medicine.2023; 1(2): 179.     CrossRef
  • Comparison of four histological scoring systems for autoimmune hepatitis to improve diagnostic sensitivity
    Soomin Ahn, Sook-Hyang Jeong, Eun Ju Cho, Kyoungbun Lee, Gilhyang Kim, Haeryoung Kim
    Clinical and Molecular Hepatology.2023; 30(1): 37.     CrossRef
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Editorials

Hepatic neoplasm

What should be done to reduce the discrepancy between guidelines and real-life practice for hepatocellular carcinoma in Korea?
Min Kyung Park, Yoon Jun Kim
Clin Mol Hepatol 2023;29(2):332-334.
Published online March 16, 2023
DOI: https://doi.org/10.3350/cmh.2023.0080

Citations

Citations to this article as recorded by  Crossref logo
  • Limited Generalizability of Retrospective Single-Center Cohort Study in Comparison to Multicenter Cohort Study on Prognosis of Hepatocellular Carcinoma
    Ye Rim Kim, Sung Won Chung, Min-Ju Kim, Won-Mook Choi, Jonggi Choi, Danbi Lee, Han Chu Lee, Ju Hyun Shim
    Journal of Hepatocellular Carcinoma.2024; Volume 11: 1235.     CrossRef
  • 6,572 View
  • 66 Download
  • 1 Web of Science
  • Crossref

Hepatic neoplasm

The clinical management of hepatocellular carcinoma in China: Progress and challenges
Shan Shan, Jidong Jia
Clin Mol Hepatol 2023;29(2):339-341.
Published online March 16, 2023
DOI: https://doi.org/10.3350/cmh.2023.0077

Citations

Citations to this article as recorded by  Crossref logo
  • A case study of a patient with platelet transfusion refractoriness (PTR) combined with human leucocyte antigen (HLA) antibody positivity during hepatic arterial infusion chemotherapy in conjunction with the ‘atezolizumab plus bevacizumab’ regimen
    Yawen Xie, Yanxia Huang, Shuyue Liu
    Nursing in Critical Care.2025;[Epub]     CrossRef
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  • Dual-Functional Micelles for Codelivery of Sorafenib and Dehydrodiisoeugenol in Treatment of Hepatocellular Carcinoma
    Su-Yu Yang, Shu-Tong Li, Tian-Hua Li, De-Jin Ma, Jun-Jie Yu, Yang Liu, Yang Yu, Xue-Tao Li, Juan Zang, Zi-Min Yuan, Liang Kong
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    Pharmaceuticals.2025; 18(4): 448.     CrossRef
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    Xin Jin, Xigan He, Runze Huang, Qinyu Liu, Lei Wang, Xuanci Bai, Yibin Wu, Yixiu Wang, Ziting Jiang, Yi Shi, Gautam Sethi, Lu Wang, Weiping Zhu
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  • Refining Prognosis and Treatment Strategies Beyond the Barcelona Clinic Liver Cancer Stage in Hepatocellular Carcinoma with Lung Metastases: A Multicenter Cohort Study
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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

Citations

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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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  • 107 Download
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Reviews

Hepatic neoplasm

Hepatic arterial infusion chemotherapy for advanced hepatocellular carcinoma in the era of chemo-diversity
Hideki Iwamoto, Shigeo Shimose, Tomotake Shirono, Takashi Niizeki, Takumi Kawaguchi
Clin Mol Hepatol 2023;29(3):593-604.
Published online February 13, 2023
DOI: https://doi.org/10.3350/cmh.2022.0391
Recently, treatments for unresectable hepatocellular carcinoma (HCC) have undergone remarkable development. Various systemic chemotherapy drugs have been approved and are recommended by clinical guidelines worldwide. Although systemic treatments are effective and contribute to prolonged patient survival, their effects are unsatisfactory for some specific tumor conditions, such as macrovascular invasion. Hepatic arterial infusion chemotherapy (HAIC) is a traditional treatment for advanced HCC. As yet, there is no worldwide consensus recommending HAIC because no high-quality clinical trials have demonstrated its survival benefit. However, clinical evidence is gradually accumulating that shows its survival benefit, and it is recognized as an effective locoregional treatment for advanced HCC. Several HAIC regimens have been reported, including cisplatin monotherapy, cisplatin plus 5-fluorouracil (low-dose FP), lipiodol-suspended FP, and an oxaliplatin-based regimen. We have entered an era of chemo-diversity in the treatment of advanced HCC. This review aimed to clarify the relevance of HAIC in the era of chemo-diversity. We propose a multidisciplinary therapeutic strategy combining locoregional HAIC treatment with sequential drug therapy, with the aim of becoming cancer-free through conversion therapy.

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Viral hepatitis

The role of different viral biomarkers on the management of chronic hepatitis B
Lung-Yi Mak, Rex Wan-Hin Hui, James Fung, Wai Kay Seto, Man-Fung Yuen
Clin Mol Hepatol 2023;29(2):263-276.
Published online January 19, 2023
DOI: https://doi.org/10.3350/cmh.2022.0448
Chronic hepatitis B infection is a major public health challenge. With the advancement in technology, various components of the viral cycle can now be measured in the blood to assess viral activity. In this review article, we summarize the relevant data of how antiviral therapies impact viral biomarkers, and discuss their potential implications. Viral nucleic acids including hepatitis B virus (HBV) double-stranded deoxy-ribonucleic acid (DNA) and to a lesser extent, pre-genomic RNA, are readily suppressed by nucleos(t)ide analogues (NUCs). The primary role of these markers include risk prediction for hepatocellular carcinoma (HCC) and risk stratification for partial cure, defined as off-therapy virological control, or functional cure, defined as hepatitis B surface antigen (HBsAg) seroclearance plus undetectable serum HBV DNA for ≥6 months. Viral translational products including hepatitis e antigen, quantitative HBsAg and hepatitis B core-related antigen can be reduced by NUCs and pegylated interferon a. They are important in defining disease phase, delineating treatment endpoints, and predicting clinical outcomes including HCC risk and partial/ functional cure. As the primary outcome of phase III trials in chronic hepatitis B is set as HBsAg seroclearance, appropriate viral biomarkers can potentially inform the efficacy of novel compounds. Early viral biomarker response can help with prioritization of subjects into clinical trials. However, standardization and validation studies would be crucial before viral biomarkers can be broadly implemented in clinical use.

Citations

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    Rex Wan-Hin Hui, Trevor Kwan-Hung Wu, Karen Cheuk-Ying Ho, Ryan Hin-Man Leung, Matthew Shing-Hin Chung, Danny Ka-Ho Wong, James Fung, Wai-Kay Seto, Lung Yi Mak, Man-Fung Yuen
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    Journal of Viral Hepatitis.2025;[Epub]     CrossRef
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    Beom Kyung Kim
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    Armando Andres Roca Suarez, Fabien Zoulim
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Hepatic neoplasm

Clinical practice guideline and real-life practice in hepatocellular carcinoma: A Korean perspective
Myung Ji Goh, Dong Hyun Sinn, Jong Man Kim, Min Woo Lee, Dong Ho Hyun, Jeong Il Yu, Jung Yong Hong, Moon Seok Choi
Clin Mol Hepatol 2023;29(2):197-205.
Published online January 5, 2023
DOI: https://doi.org/10.3350/cmh.2022.0404
Hepatocellular carcinoma (HCC) is a major cause of death in many countries, including South Korea. To provide useful and sensible advice for clinical management of patients with HCC, the Korean Liver Cancer Association and National Cancer Center Korea Practice Guideline Revision Committee have recently revised the practice guidelines for HCC management. However, there are some differences between practice guidelines and real-life clinical practice. In this review, we describe some key recommendations of the 2022 version of practice guidelines and the real-life clinical situation in South Korea, together with discussion about efforts needed to reduce the difference between guidelines and real-life clinical practice.

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Hepatic neoplasm

Clinical practice guidelines and real-life practice in hepatocellular carcinoma: A Chinese perspective
Diyang Xie, Jieyi Shi, Jian Zhou, Jia Fan, Qiang Gao
Clin Mol Hepatol 2023;29(2):206-216.
Published online December 22, 2022
DOI: https://doi.org/10.3350/cmh.2022.0402
Liver cancer is the fourth most prevalent and the second most lethal cancer in China. Hepatitis B virus (HBV) infection represents a major risk factor for hepatocellular carcinoma (HCC). Liver ultrasonography plus alpha-fetoprotein every 6 months continues to be the predominant surveillance modality. The age-Male-ALBI-Platelets score was recommended in the recent 2022 Chinese guidelines to predict HCC occurrence. The Chinese liver cancer (CNLC) staging system proposed in the 2017 guidelines continues to be the standard model for staging with modifications in the treatment allocations. Considering the aggressive nature of HBV-associated HCC, multimodal and high-intensity strategies like the addition of immunotherapy-based systemic treatment to local therapies, including resection, ablation, and intra-arterial therapies, have been adopted in real-life practices in China. The latest Chinese guidelines recommend atezolizumab plus bevacizumab, suntilimab plus a bevacizumab analog, lenvatinib, sorafenib, donafenib, and FOLFOX (folinic acid, fluorouracil, and oxaliplatin) chemotherapy as first-line treatment without priority. Regorafenib, apatinib, camrelizumab, and tislelizumab have been added as second-line systemic therapies for patients who progressed on sorafenib. Systemic therapies adopted in real-life practice are sophisticated with various combination modalities and different sequences.

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Steatotic liver disease

Pharmacological advances in the treatment of nonalcoholic fatty liver diseases : focused on global results of randomized controlled trials
Jihyun An, Joo Hyun Sohn
Clin Mol Hepatol 2023;29(Suppl):S268-S275.
Published online December 20, 2022
DOI: https://doi.org/10.3350/cmh.2022.0437
Nonalcoholic fatty liver disease (NAFLD) is the most common cause of liver disease globally, and its prevalence is rapidly increasing. Nonalcoholic steatohepatitis (NASH), a progressive form of NAFLD, is characterized by hepatocellular injury, inflammation, and fibrosis. Patients with NASH or severe fibrosis should be treated according to international NAFLD guidelines. Currently, regulatory agencies have not approved any pharmaceutical treatment for NAFLD. Vitamin E and pioglitazone are efficacious for NASH resolution; however, their benefits must be weighed against the reported risks. In a phase 2 trial, a glucagon-like peptide-1 agonist commonly used for diabetes and obesity was found to improve liver histology in patients with NASH. Furthermore, therapeutic agents targeting NASH pathogenesis, including bile acid signaling, insulin resistance, and lipid metabolism, are in various phases of clinical development. In this article, we review the benefits and drawbacks of current pharmacotherapy and the efficacy of upcoming treatments for NASH.

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Steatotic liver disease

Surveillance of the progression and assessment of treatment endpoints for nonalcoholic steatohepatitis
Yi-wen Shi, Jian-Gao Fan
Clin Mol Hepatol 2023;29(Suppl):S228-S243.
Published online December 14, 2022
DOI: https://doi.org/10.3350/cmh.2022.0401
Nonalcoholic steatohepatitis (NASH) is an aggressive form of nonalcoholic fatty liver disease (NAFLD) characterized by steatosis-associated inflammation and liver injury. Without effective treatment or management, NASH can have life-threatening outcomes. Evaluation and identification of NASH patients at risk for adverse outcomes are therefore important. Key issues in screening NASH patients are the assessment of advanced fibrosis, differentiation of NASH from simple steatosis, and monitoring of dynamic changes during follow-up and treatment. Currently, NASH staging and evaluation of the effectiveness for drugs still rely on pathological diagnosis, despite sample error issues and the subjectivity associated with liver biopsy. Optimizing the pathological assessment of liver biopsy samples and developing noninvasive surrogate methods for accessible, accurate, and safe evaluation are therefore critical. Although noninvasive methods including elastography, serum soluble biomarkers, and combined models have been implemented in the last decade, noninvasive diagnostic measurements are not widely applied in clinical practice. More work remains to be done in establishing cost-effective strategies both for screening for at-risk NASH patients and identifying changes in disease severity. In this review, we summarize the current state of noninvasive methods for detecting steatosis, steatohepatitis, and fibrosis in patients with NASH, and discuss noninvasive assessments for screening at-risk patients with a focus on the characteristics that should be monitored at follow-up.

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Correspondence

Viral hepatitis

Correspondence on Editorial regarding “HBV pgRNA and HBcrAg reductions at week 4 predict favourable HBsAg response upon long-term nucleos(t)ide analogue in CHB”
Lung-Yi Mak, Wai-Kay Seto, Man-Fung Yuen
Clin Mol Hepatol 2023;29(1):191-193.
Published online November 22, 2022
DOI: https://doi.org/10.3350/cmh.2022.0410
  • 5,924 View
  • 76 Download

Original Article

Viral hepatitis

Hepatitis B virus pre-genomic RNA and hepatitis B core-related antigen reductions at week 4 predict favourable hepatitis B surface antigen response upon long-term nucleos(t)ide analogue in chronic hepatitis B
Lung-Yi Mak, Danny Wong, Alison Kuchta, Martina Hilfiker, Aaron Hamilton, Ning Chow, XianHua Mao, Wai Kay Seto, Man-Fung Yuen
Clin Mol Hepatol 2023;29(1):146-162.
Published online August 19, 2022
DOI: https://doi.org/10.3350/cmh.2022.0172
Background/Aims
We investigated the dynamics of serum HBV pre-genomic RNA (pgRNA) and hepatitis B core-related antigen (HBcrAg) in patients receiving nucleos(t)ide analogues (NAs) and their predictability for favourable suppression of serum hepatitis B surface antigen (HBsAg).
Methods
Serum viral biomarkers were measured at baseline, weeks 4, 12, 24, 36, and 48 of treatment. Patients were followed up thereafter and serum HBsAg level was measured at end of follow-up (EOFU). Favourable HBsAg response (FHR) was defined as ≤100 IU/mL or HBsAg seroclearance upon EOFU.
Results
Twenty-eight hepatitis B e antigen (HBeAg)-positive and 36 HBeAg-negative patients (median, 38.2 years old; 71.9% male) were recruited with median follow-up duration of 17.1 years (interquartile range, 12.8–18.2). For the entire cohort, 22/64 (34.4%) achieved FHR. For HBeAg-positive patients, serum HBV pgRNA decline at week 4 was significantly greater for patients with FHR compared to non-FHR (5.49 vs. 4.32 log copies/mL, respectively; P=0.016). The area under the receiver-operating-characteristic curve (AUROC) for week 4 HBV pgRNA reduction to predict FHR in HBeAg-positive patients was 0.825 (95% confidence interval [CI], 0.661–0.989). For HBeAg-negative patients, instead of increase in serum HBcrAg in non-FHR patients, FHR patients had median reduction in HBcrAg at week 4 (increment of 1.75 vs. reduction of 2.98 log U/mL; P=0.023). The AUROC for week 4 change of HBcrAg to predict FHR in HBeAg-negative patients was 0.789 (95% CI, 0.596–0.982).
Conclusions
Early on-treatment changes of serum HBV pgRNA and HBcrAg at 4 weeks predict HBsAg seroclearance or ≤100 IU/mL in NA-treated CHB patients upon long-term FU.

Citations

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    Yue Qiu, Qiao Tang, Xiao-Qing Liu, Yun-Ling Xue, Yi Zeng, Peng Hu
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    Lung-Yi Mak, Mark Anderson, Michael Stec, Matthew Shing-Hin Chung, Danny Ka-Ho Wong, Rex Wan-Hin Hui, Wai-Kay Seto, Gavin Cloherty, Man-Fung Yuen
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    Florian van Bömmel, Elisabetta Degasperi, Alena van Bömmel, Floriana Facchetti, Dana Sambarino, Danilo Deichsel, Jessica Brehm, Rodrigue Kamga Wouambo, Melanie Maier, Maria Pfefferkorn, Thomas Berg, Pietro Lampertico
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    Yaru Shi, Rong Fan
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    Yun-Fan Liaw
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  • Correspondence on Editorial regarding “HBV pgRNA and HBcrAg reductions at week 4 predict favourable HBsAg response upon long-term nucleos(t)ide analogue in CHB”
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    Lung-Yi Mak, Rex Wan-Hin Hui, James Fung, Wai Kay Seto, Man-Fung Yuen
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  • Crossref

Review

Therapeutic mechanisms and beneficial effects of non-antidiabetic drugs in chronic liver diseases
Han Ah Lee, Young Chang, Pil Soo Sung, Eileen L. Yoon, Hye Won Lee, Jeong-Ju Yoo, Young-Sun Lee, Jihyun An, Do Seon Song, Young Youn Cho, Seung Up Kim, Yoon Jun Kim
Clin Mol Hepatol 2022;28(3):425-472.
Published online July 1, 2022
DOI: https://doi.org/10.3350/cmh.2022.0186
The global burden of chronic liver disease (CLD) is substantial. Due to the limited indication of and accessibility to antiviral therapy in viral hepatitis and lack of effective pharmacological treatment in nonalcoholic fatty liver disease, the beneficial effects of antidiabetics and non–antidiabetics in clinical practice have been continuously investigated in patients with CLD. In this narrative review, we focused on non-antidiabetic drugs, including ursodeoxycholic acid, silymarin, dimethyl4,4’-dimethoxy-5,6,5’,6’-dimethylenedixoybiphenyl-2,2’-dicarboxylate, L-ornithine L-aspartate, branched chain amino acids, statin, probiotics, vitamin E, and aspirin, and summarized their beneficial effects in CLD. Based on the antioxidant, anti-inflammatory properties, and regulatory functions in glucose or lipid metabolism, several non–antidiabetic drugs have shown beneficial effects in improving liver histology, aminotransferase level, and metabolic parameters and reducing risks of hepatocellular carcinoma and mortality, without significant safety concerns, in patients with CLD. Although the effect as the centerpiece management in patients with CLD is not robust, the use of these non-antidiabetic drugs might be potentially beneficial as an adjuvant or combined treatment strategy.

Citations

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  • CYP4A14-PPARα axis serves as a therapeutic target for ursodeoxycholic acid in ameliorating high-fat diet-induced MASLD
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Guidelines

Viral hepatitis

KASL clinical practice guidelines for management of chronic hepatitis B
The Korean Association for the Study of the Liver (KASL)
Clin Mol Hepatol 2022;28(2):276-331.
Published online April 1, 2022
DOI: https://doi.org/10.3350/cmh.2022.0084

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Steatotic liver disease

KASL clinical practice guidelines: Management of nonalcoholic fatty liver disease
Seong Hee Kang, Hye Won Lee, Jeong-Ju Yoo, Yuri Cho, Seung Up Kim, Tae Hee Lee, Byoung Kuk Jang, Sang Gyune Kim, Sang Bong Ahn, Haeryoung Kim, Dae Won Jun, Joon-Il Choi, Do Seon Song, Won Kim, Soung Won Jeong, Moon Young Kim, Hong Koh, Sujin Jeong, Jin-Woo Lee, Yong Kyun Cho, on behalf of The Korean Association for the Study of the Liver (KASL)
Clin Mol Hepatol 2021;27(3):363-401.
Published online June 22, 2021
DOI: https://doi.org/10.3350/cmh.2021.0178

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Review

Autoimmune liver disease

Recent updates on the management of autoimmune hepatitis
Atsumasa Komori
Clin Mol Hepatol 2021;27(1):58-69.
Published online December 10, 2020
DOI: https://doi.org/10.3350/cmh.2020.0189
Autoimmune hepatitis (AIH) is an immunoinflammatory chronic liver disease with dynamic and rather heterogeneous disease manifestations. A trend of increasing prevalence of AIH has been observed worldwide, along with a relative increase in the percentage of male patients. AIH is characterized and diagnosed based on serum biochemistry and liver histology: elevated aminotransferases and serum immunoglobulin G (IgG), the presence of serum anti-nuclear antibody or anti-smooth muscle antibody, and interface lympho-plasmacytic hepatitis. Clinical manifestations differ among disease subtypes with distinct time-frames, i.e., AIH with a chronic insidious onset, and acute-onset AIH (the diagnosis of which is often challenging due to the lack of typical serum findings). The absence of disease-specific biomarkers or histological findings may expand the disease phenotype into drug-induced AIH-like liver injury. Corticosteroids and azathioprine are recommended first-line treatments for AIH. The complete normalization of aminotransferases and serum IgG is an essential treatment response to ensure long-term overall survival. An incomplete response or intolerance to these drugs is considered an indication for second-line treatment, especially with mycophenolate mofetil. Life-long maintenance treatment is required for the majority of patients, but the few who achieve prolonged and stringent biochemical remission with lower alanine aminotransferase and IgG within the normal range may be able to discontinue the medications. In the future, the quality of life of AIH patients should be managed by personalized medicine, including the appropriate selection and dosing of first-line therapy and perhaps alternating with potential therapeutics, and the prediction of the success of treatment withdrawal.

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Original Article

Hepatic neoplasm

Substantial risk of recurrence even after 5 recurrence-free years in early-stage hepatocellular carcinoma patients
Jihye Kim, Wonseok Kang, Dong Hyun Sinn, Geum-Youn Gwak, Yong-Han Paik, Moon Seok Choi, Joon Hyeok Lee, Kwang Cheol Koh, Seung Woon Paik
Clin Mol Hepatol 2020;26(4):516-528.
Published online September 11, 2020
DOI: https://doi.org/10.3350/cmh.2020.0016
Background/Aims
Although hepatocellular carcinoma (HCC) is notorious for its high recurrence rate, some patients do not experience recurrence for more than 5 years after resection or radiofrequency ablation for early-stage HCC. For those with five recurrence-free period, the risk of HCC recurrence within the next 5 years remains unknown.
Methods
A total of 1,451 consecutive patients (median, 55 years old; males, 79.0%; hepatitis B virus-related, 79.3%) with good liver function (Child-Pugh class A) diagnosed with early-stage HCC by Barcelona Clinic Liver Cancer Staging and received radiofrequency ablation or resection as an initial treatment between 2005 and 2010 were analyzed.
Results
During a median follow-up period of 8.1 years, 961 patients (66.2%) experienced HCC recurrence. The cumulative recurrence rates increased to 39.7%, 60.3%, and 71.0% at 2, 5, and 10 years, respectively, and did not reach a plateau. Five years after HCC diagnosis, 487 patients were alive without experiencing a recurrence. Among them, during a median of 3.9 additional years of follow-up (range, 0.1–9.0 years), 127 patients (26.1%) experienced recurrence. The next 5-year cumulative recurrence rate (5–10 years from initial diagnosis) was 27.0%. Male sex, higher fibrosis-4 scores, and alpha-fetoprotein levels at 5 years were associated with later HCC recurrence among patients who did not experience recurrence for more than 5 years.
Conclusions
The HCC recurrence rate following 5 recurrence-free years after HCC treatment was high, indicating that HCC patients warrant continued HCC surveillance, even after 5 recurrence-free years.

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Reviews

Steatotic liver disease

Beneficial effect of anti-diabetic drugs for nonalcoholic fatty liver disease
Kyung-Soo Kim, Byung-Wan Lee
Clin Mol Hepatol 2020;26(4):430-443.
Published online August 14, 2020
DOI: https://doi.org/10.3350/cmh.2020.0137
Nonalcoholic fatty liver disease (NAFLD) is the most common liver disorder and is associated with various metabolic diseases, including type 2 diabetes mellitus. There are no approved drugs for NAFLD, and the only approved treatment option is weight reduction. As insulin resistance plays an important role in the development of NAFLD, many anti-diabetic drugs have been evaluated for the treatment of NAFLD. Improvement of liver enzymes has been demonstrated by many anti-diabetic drugs, but histological assessment still remains insufficient. Pioglitazone could become the first-line therapy for T2DM patients with NAFLD, based on evidence of histological improvement in patients with biopsy-proven nonalcoholic steatohepatitis (NASH). Liraglutide, another promising alternative, is not yet recommended in patients with NAFLD/NASH due to limited evidence. Therefore, well-designed randomized controlled trials should be performed in the near future to demonstrate if and how anti-diabetic drugs can play a role in the treatment of NAFLD.

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Viral hepatitis

Unmet needs of chronic hepatitis C in the era of direct-acting antiviral therapy
Chung-Feng Huang, Ming-Lung Yu
Clin Mol Hepatol 2020;26(3):251-260.
Published online March 19, 2020
DOI: https://doi.org/10.3350/cmh.2020.0018
The treatment of chronic hepatitis C (CHC) has been revolutionized in an era of all-oral direct-acting antivirals (DAAs) since 2014. Satisfactory treatment efficacy and tolerability can be provided by novel DAAs. Nevertheless, there are still some unmet needs and emerging issues in the treatment of CHC in the DAA era. Certain hard-to-cure populations are prone to have inferior treatment responses, including patients with severe liver decompensation, active hepatocellular carcinoma (HCC), and hepatitis C virus (HCV) genotype 3 (HCV-3) infection and those who experience multiple DAA treatment failures. Hepatitis B virus (HBV) reactivation during and after DAA treatment has raised concern regarding the use of prophylactic antivirals against HBV throughout DAA treatment. However, the standard strategy for the use of prophylactic antivirals is not uniform across regional guidelines. In the post-sustained virological response (SVR) period, HCC still occurs in a substantial proportion of patients. Due to the relatively short follow-up period, the net benefit of the achievement of an SVR by DAAs in the reduction of extrahepatic manifestations has not yet been determined. Attention must also be paid to HCV reinfection, particularly in high-risk populations. The most critical and unmet need for HCV elimination is the large gap in the HCV care cascade at the population level. To accomplish the World Health Organization (WHO)’s goal for HCV elimination by 2030, the expansion of access to HCV care requires a continuous effort to overcome practical and political challenges.

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Viral hepatitis

KASL clinical practice guidelines for management of chronic hepatitis B
Korean Association for the Study of the Liver (KASL)
Clin Mol Hepatol 2019;25(2):93-159.
Published online June 12, 2019
DOI: https://doi.org/10.3350/cmh.2019.1002

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Viral hepatitis

Upcoming direct acting antivirals for hepatitis C patients with a prior treatment failure
Tommaso Lorenzo Parigi, Maria Corina Plaz Torres, Alessio Aghemo
Clin Mol Hepatol 2019;25(4):360-365.
Published online May 2, 2019
DOI: https://doi.org/10.3350/cmh.2019.0022
Despite the high efficacy of direct acting antivirals (DAAs) not all patients successfully clear hepatitis C virus infection, in fact, approximately 1–3% fail to reach a sustained virological response 12 weeks after end of treatment. DAA failures are characterized by advanced liver disease, specific genotypes/subtypes and resistance associated substitutions to the DAA class they have been treated with. Current European Association for the Study of the Liver guidelines recommend three therapeutic options for such patients. The first is a 12 week course of sofosbuvir (SOF), velpatasvir (VEL) and voxilaprevir (VOX), which has shown to be effective in 90–99% of patients and was granted A1 level recommendation. The second option, reserved for patients who have predictors of failure consists in 12 weeks regimen with glecaprevir (GLE) and pibrentasvir (PIB), effective in 90–97%. Finally, although not supported by published data, for especially difficult to treat patients there should theoretically be a benefit in prolonged combinations of SOF+GLE/PIB or SOF/VEL/VOX±ribavirin. This review presents the latest evidence from both clinical trials and real-life on such therapeutic strategies.

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    Grace Lai-Hung Wong
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Editorial

Viral hepatitis

How does hepatic steatosis affect the outcome of patients with chronic hepatitis B?
Jung Hwan Yu, Jin-Woo Lee
Clin Mol Hepatol 2019;25(3):280-282.
Published online January 21, 2019
DOI: https://doi.org/10.3350/cmh.2018.0104

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    Chun-Jen Liu, Wai Kay Seto, Ming-Lung Yu
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  • Association of Physical Activity with the Risk of Hepatocellular Carcinoma in Patients with Chronic Hepatitis B
    Ho Soo Chun, Sojeong Park, Minjong Lee, Yuri Cho, Ha Sung Kim, A Reum Choe, Hwi Young Kim, Kwon Yoo, Tae Hun Kim
    Cancers.2021; 13(14): 3424.     CrossRef
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Review

Viral hepatitis

2017 KASL clinical practice guidelines management of hepatitis C: Treatment of chronic hepatitis C
The Korean Association for the Study of the Liver (KASL)
Clin Mol Hepatol 2018;24(3):169-229.
Published online August 10, 2018
DOI: https://doi.org/10.3350/cmh.2018.1004

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Original Articles

Hepatic neoplasm

Clinical features and outcomes of patients with hepatocellular carcinoma complicated with bile duct invasion
Jihyun An, Kwang Sun Lee, Kang Mo Kim, Do Hyun Park, Sang Soo Lee, Danbi Lee, Ju Hyun Shim, Young-Suk Lim, Han Chu Lee, Young-Hwa Chung, Yung Sang Lee
Clin Mol Hepatol 2017;23(2):160-169.
Published online May 16, 2017
DOI: https://doi.org/10.3350/cmh.2016.0088
Background/Aims
Little is known about the treatment or outcomes of hepatocellular carcinoma (HCC) complicated with bile duct invasion.
Methods
A total of 247 consecutive HCC patients with bile duct invasion at initial diagnosis were retrospectively included.
Results
The majority of patients had Barcelona Clinic Liver Cancer (BCLC) stage C HCC (66.8%). Portal vein tumor thrombosis was present in 166 (67.2%) patients. Median survival was 4.1 months. Various modalities of treatment were initially employed including surgical resection (10.9%), repeated transarterial chemoembolization (TACE) (42.5%), and conservative management (42.9%). Among the patients with obstructive jaundice (n=88), successful biliary drainage was associated with better overall survival rate. Among the patients with BCLC stage C, overall survival differed depending on the initial treatment for HCC; surgical resection, TACE, systemic chemotherapy, and conservative management showed overall survival rates of 11.5, 6.0 ,2.4, and 1.6 months, respectively. After adjusting for confounders, surgical resection and repeated TACE were significant prognostic factors for HCC patients with bile duct invasion (hazard ratios 0.47 and 0.39, Ps <0.001, respectively).
Conclusions
The survival of HCC patients with bile duct invasion at initial diagnosis is generally poor. However, aggressive treatments for HCC such as resection or biliary drainage may be beneficial therapeutic options for patients with preserved liver function.

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Hepatic neoplasm

Preemptive antiviral therapy with entecavir can reduce acute deterioration of hepatic function following transarterial chemoembolization
Sun Hong Yoo, Jeong Won Jang, Jung Hyun Kwon, Seung Min Jung, Bohyun Jang, Jong Young Choi
Clin Mol Hepatol 2016;22(4):458-465.
Published online December 25, 2016
DOI: https://doi.org/10.3350/cmh.2016.0054
Background/Aims
Hepatic damage during transarterial chemoembolization (TACE) is a critical complication in patients with hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC). Apart from its role in preventing HBV reactivation, there is some evidence for the benefits of preemptive antiviral therapy in TACE. This study evaluated the effect of preemptive antiviral therapy on acute hepatic deterioration following TACE.
Methods
This retrospective observational study included a prospectively collected cohort of 108 patients with HBV-related HCC who underwent TACE between January 2007 and January 2013. Acute hepatic deterioration following TACE was evaluated. Treatment-related hepatic decompensation was defined as newly developed encephalopathy, ascites, variceal bleeding, elevation of the bilirubin level, prolongation of prothrombin time, or elevation of the Child-Pugh score by ≥2 within 2 weeks following TACE. Univariate and multivariate analyses were conducted to identify factors influencing treatment-related decompensation. Preemptive antiviral therapy involves directing prophylaxis only toward high-risk chronic hepatitis B patients in an attempt to prevent the progression of liver disease. We regarded at least 6 months as a significant duration of preemptive antiviral treatment before diagnosis of HCC.
Results
Of the 108 patients, 30 (27.8%) patients received preemptive antiviral therapy. Treatment-related decompensation was observed in 25 (23.1%) patients during the follow-up period. Treatment-related decompensation following TACE was observed more frequently in the nonpreemptive group than in the preemptive group (29.5% vs. 6.7%, P=0.008). In the multivariate analysis, higher serum total bilirubin (Hazard ratio [HR] =3.425, P=0.013), hypoalbuminemia (HR=3.990, P=0.015), and absence of antiviral therapy (HR=7.597, P=0.006) were significantly associated with treatment-related hepatic decompensation.
Conclusions
Our findings suggest that preemptive antiviral therapy significantly reduces the risk of acute hepatic deterioration. Preventing hepatic deterioration during TACE by applying such a preemptive approach may facilitate the continuation of anticancer therapy and thus improve long-term outcomes.

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Reviews

Liver fibrosis, cirrhosis, and portal hypertension

Acute kidney injury in liver cirrhosis: new definition and application
Florence Wong
Clin Mol Hepatol 2016;22(4):415-422.
Published online December 14, 2016
DOI: https://doi.org/10.3350/cmh.2016.0056
The traditional diagnostic criteria of renal dysfunction in cirrhosis are a 50% increase in serum creatinine (SCr) with a final value above 1.5 mg/dL. This means that patients with milder degrees of renal dysfunction are not being diagnosed, and therefore not offered timely treatment. The International Ascites Club in 2015 adapted the term acute kidney injury (AKI) to represent acute renal dysfunction in cirrhosis, and defined it by an increase in SCr of 0.3 mg/dL (26.4 µmoL/L) in <48 hours, or a 50% increase in SCr from a baseline within ≤3 months. The severity of AKI is described by stages, with stage 1 represented by these minimal changes, while stages 2 and 3 AKI by 2-fold and 3-fold increases in SCr respectively. Hepatorenal syndrome (HRS), renamed AKI-HRS, is defined by stage 2 or 3 AKI that fulfils all other diagnostic criteria of HRS. Various studies in the past few years have indicated that these new diagnostic criteria are valid in the prediction of prognosis for patients with cirrhosis and AKI. The future in AKI diagnosis may include further refinements such as inclusion of biomarkers that can identify susceptibility for AKI, differentiating the various prototypes of AKI, or track its progression.

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Steatotic liver disease

Non-alcoholic fatty liver diseases: update on the challenge of diagnosis and treatment
Hyunwoo Oh, Dae Won Jun, Waqar K Saeed, Mindie H Nguyen
Clin Mol Hepatol 2016;22(3):327-335.
Published online September 25, 2016
DOI: https://doi.org/10.3350/cmh.2016.0049
The prevalence of non-alcoholic fatty liver disease (NAFLD) is estimated to be 25-30% of the population, and is the most common cause of elevated liver enzymes in Korea. NAFLD is a “hot potato” for pharmaceutical companies. Many clinical trials are underway to develop a first-in-class drug to treat NAFLD. However, there are several challenging issues regarding the diagnosis of NAFLD. Currently, liver biopsy is the gold standard method for the diagnosis of NAFLD and steatohepatitis. Ideally, globally recognized standards for histological diagnosis and methods to optimize observer agreement on biopsy interpretation should be developed. Liver biopsy is the best method rather than a perfect one. Recently, multi-parametric magnetic resonance imagery can estimate the amount of intrahepatic fat successfully and is widely used in clinical trials. But no diagnostic method can discriminate between steatohepatitis and simple steatosis. The other unresolved issue in regard to NAFLD is the absence of satisfactory treatment options. Vitamin E and obeticholic acid have shown protective effects in randomized controlled trials, but this drug has not been approved for use in Korea. This study will provide a description of diagnostic methods and treatments that are currently recommended for NAFLD.

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Original Articles

Viral hepatitis

Hepatitis B surface antigen titer is a good indicator of durable viral response after entecavir off-treatment for chronic hepatitis B
Han Ah Lee, Yeon Seok Seo, Seung Woon Park, Sang Jung Park, Tae Hyung Kim, Sang Jun Suh, Young Kul Jung, Ji Hoon Kim, Hyunggin An, Hyung Joon Yim, Jong Eun Yeon, Kwan Soo Byun, Soon Ho Um
Clin Mol Hepatol 2016;22(3):382-389.
Published online September 25, 2016
DOI: https://doi.org/10.3350/cmh.2016.0047
Background/Aims
Clear indicators for stopping antiviral therapy in chronic hepatitis B (CHB) patients are not yet available. Since the level of hepatitis B surface antigen (HBsAg) is correlated with covalently closed circular DNA, the HBsAg titer might be a good indicator of the off-treatment response. This study aimed to determine the relationship between the HBsAg titer and the entecavir (ETV) off-treatment response.
Methods
This study analyzed 44 consecutive CHB patients (age, 44.6±11.4 years, mean±SD; men, 63.6%; positive hepatitis B envelope antigen (HBeAg) at baseline, 56.8%; HBV DNA level, 6.8±1.3 log10 IU/mL) treated with ETV for a sufficient duration and in whom treatment was discontinued after HBsAg levels were measured. A virological relapse was defined as an increase in serum HBV DNA level of >2000 IU/mL, and a clinical relapse was defined as a virological relapse with a biochemical flare, defined as an increase in the serum alanine aminotransferase level of >2 × upper limit of normal.
Results
After stopping ETV, virological relapse and clinical relapse were observed in 32 and 24 patients, respectively, during 20.8±19.9 months of follow-up. The cumulative incidence rates of virological relapse were 36.2% and 66.2%, respectively, at 6 and 12 months, and those of clinical relapse were 14.3% and 42.3%. The off-treatment HBsAg level was an independent factor associated with clinical relapse (hazard ratio, 2.251; 95% confidence interval, 1.076–4.706; P=0.031). When patients were grouped according to off-treatment HBsAg levels, clinical relapse did not occur in patients with an off-treatment HBsAg level of ≤2 log10 IU/mL (n=5), while the incidence rates of clinical relapse at 12 months after off-treatment were 28.4% and 55.7% in patients with off-treatment HBsAg levels of >2 and ≤3 log10 IU/mL (n=11) and >3 log10 IU/mL (n=28), respectively.
Conclusions
The off-treatment HBsAg level is closely related to clinical relapse after treatment cessation. A serum HBsAg level of <2 log10 IU/mL is an excellent predictor of a sustained off-treatment response in CHB patients who have received ETV for a sufficient duration.

Citations

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    Ben Kang, Dae Yong Yi, Byung-Ho Choe
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    Florian van Bömmel, Thomas Berg
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  • An expert consensus for the management of chronic hepatitis B in Asian Americans
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Hepatic neoplasm

Obesity and hepatocellular carcinoma in patients receiving entecavir for chronic hepatitis B
Jaemin Lee, Sun Hong Yoo, Won Sohn, Hyung Woo Kim, Yong Sun Choi, Jung Ho Won, Jin Young Heo, Sang Jong Park, Young Min Park
Clin Mol Hepatol 2016;22(3):339-349.
Published online September 25, 2016
DOI: https://doi.org/10.3350/cmh.2016.0021
Background/Aims
This study aimed to clarify the effect of obesity on the development of hepatocellular carcinoma (HCC) in chronic hepatitis B (CHB) patients receiving antiviral treatment.
Methods
This study applied a retrospective analysis to a historical cohort in Bundang Jesaeng Hospital. In total, 102 CHB patients were treated with entecavir as an initial treatment for CHB and checked for obesity using a body composition analyzer. Hepatic steatosis was measured semiquantitatively using Hamaguchi’s scoring system in ultrasonography. Risk factors for the development of HCC were analyzed, including obesity-related factors (body mass index [BMI], waist circumference [WC], waist-to-hip ratio [WHR], visceral fat area [VFA], and hepatic steatosis).
Results
The median follow-up duration of the patients was 45.2 months (interquartile range: 36.0-58.3 months). The cumulative incidence rates of HCC at 1 year, 3 years, and 5 years were 0%, 5.3%, and 9.0%, respectively. Univariable analysis revealed that the risk factors for HCC development were a platelet count of <120,000 /mm2 (hazard ratio [HR]=5.21, P=0.031), HBeAg negativity (HR=5.61, P=0.039), and liver cirrhosis (HR=10.26, P=0.031). Multivariable analysis showed that the significant risk factor for HCC development was liver cirrhosis (HR=9.07, P=0.042). However, none of the obesity-related risk factors were significantly associated with HCC: BMI ≥25 kg/m2 (HR=0.90, P=0.894), WC ≥90 cm (HR=1.10, P=0.912), WHR ≥0.9 (HR=1.94, P=0.386), VFA ≥100 cm2 (HR=1.69, P=0.495), and hepatic steatosis (HR=0.57, P=0.602).
Conclusions
HCC development is associated with liver cirrhosis but not obesity-related factors in CHB patients receiving entecavir.

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Editorial

Viral hepatitis

Is the tenofovir based therapy almighty for previous treatment failure in chronic hepatitis B?
Hyung Joon Yim
Clin Mol Hepatol 2016;22(2):238-240.
Published online June 25, 2016
DOI: https://doi.org/10.3350/cmh.2016.0103

Citations

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  • Validation of PAGE‐B model in Asian chronic hepatitis B patients receiving entecavir or tenofovir
    Mi Na Kim, Seong Gyu Hwang, Kyu Sung Rim, Beom Kyung Kim, Jun Yong Park, Do Young Kim, Sang Hoon Ahn, Kwang‐Hyub Han, Seung Up Kim
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Reviews

Viral hepatitis

KASL clinical practice guidelines: Management of Hepatitis C
The Korean Association for the Study of the Liver (KASL)
Clin Mol Hepatol 2014;20(2):89-136.
Published online June 30, 2014
DOI: https://doi.org/10.3350/cmh.2014.20.2.89

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Viral hepatitis

Options for the management of antiviral resistance during hepatitis B therapy: reflections on battles over a decade
Hyung Joon Yim, Seong Gyu Hwang
Clin Mol Hepatol 2013;19(3):195-209.
Published online September 30, 2013
DOI: https://doi.org/10.3350/cmh.2013.19.3.195

Although much advancement has been achieved in the treatment of chronic hepatitis B, antiviral resistance is still a challenging issue. Previous generation antiviral agents have already developed resistance in a number of patients, and it is still being used especially in resource limited countries. Once antiviral resistance occurs, it predisposes to subsequent resistance, resulting in multidrug resistance. Therefore, prevention of initial antiviral resistance is the most important strategy, and appropriate choice and modification of therapy would be the cornerstone in avoiding treatment failures. Until now, management of antiviral resistance has been evolving from sequential therapy to combination therapy. In the era of tenofovir, the paradigm shifts again, and we have to decide when to switch and when to combine on the basis of newly emerging clinical data. We expect future eradication of chronic hepatitis B virus infection by proper prevention and optimal management of antiviral resistance.

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