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Special Issue

KASL clinical practice guidelines for liver cirrhosis: Ascites and related complications 2026
Do Seon Song, Jeong-Ju Yoo, Jeong Eun Song, Seong Hee Kang, Seung Kak Shin, Seul Ki Han, Sung Won Chung, Gi-Ae Kim, Moon Haeng Hur, Han Ah Lee, Yeonjung Ha, Young Chang, Jae Hyun Yoon, Jae Seung Lee, Sang Gyune Kim, Young Kul Jung, Moon Young Kim
Received March 4, 2026  Accepted April 26, 2026  Published online April 28, 2026  
DOI: https://doi.org/10.3350/cmh.2026.0281    [Accepted]
  • 553 View
  • 73 Download

Correspondences

Incorporating chronic kidney disease into the cost-effectiveness of MASLD treatment
Eileen L. Yoon, Jeong-Yeon Cho, Mimi Kim, Huiyul Park, Hye-Lin Kim, Dae Won Jun
Received January 20, 2026  Accepted January 24, 2026  Published online February 2, 2026  
DOI: https://doi.org/10.3350/cmh.2026.0099    [Accepted]
  • 753 View
  • 47 Download
Key challenges in cost-effectiveness analyses of emerging MASLD therapies: adherence, adverse events, cardiometabolic benefits, and age-related uncertainty
Eileen L. Yoon, Jeong-Yeon Cho, Mimi Kim, Huiyul Park, Hye-Lin Kim, Dae Won Jun
Received January 13, 2026  Accepted January 17, 2026  Published online January 27, 2026  
DOI: https://doi.org/10.3350/cmh.2026.0059    [Accepted]
  • 625 View
  • 34 Download

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
Clin Mol Hepatol 2026;32(2):721-736.
Published online December 26, 2025
DOI: https://doi.org/10.3350/cmh.2025.1019
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.
Conclusions
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.

Citations

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  • Systematic review and first meta-analysis of the efficacy and safety of gemcitabine-cisplatin combined with paclitaxel in patients with advanced biliary tract cancer
    Gang Zhu, Shenglan Li, Yan Zhang, Guoying Feng, Guangnian Zhang, Huanli Cheng, Bo Jiang, Benjian Gao, Xiaoli Yang, Bo Li
    European Journal of Clinical Pharmacology.2026;[Epub]     CrossRef
  • CBC3T-3: a novel patient-derived cisplatin-resistant distal cholangiocarcinoma cell line harboring multiple TP53 missense mutations
    Jiahui Xi, Mingzhen Bai, Ruyang Zhong, Chongfei Huang, Ruoshui An, Long Gao, Haidong Ma, Liang Tian, Jinyu Zhao, Ningzu Jiang, Xiang He, Leiqing Wang, Zihe Dong, Ping Yue, Yanyan Lin, Zhongtian Bai, Wenbo Meng
    Human Cell.2026;[Epub]     CrossRef
  • 2,191 View
  • 174 Download
  • 1 Web of Science
  • Crossref

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
  • 1,324 View
  • 80 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
  • 4,310 View
  • 292 Download

Correspondence

Correspondence to editorial on “Human cytomegalovirus reactivation in cirrhosis patients with acute decompensation”
Changze Hong, Jinjun Chen
Clin Mol Hepatol 2026;32(2):e227-e230.
Published online August 25, 2025
DOI: https://doi.org/10.3350/cmh.2025.0899
  • 3,370 View
  • 14 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
  • A novel signature of palmitoylation for predicting prognosis and therapeutic response of hepatocellular carcinoma
    Yun Li, Zhongquan Yi, Linhua Liu, Danping Huang
    Discover Oncology.2026;[Epub]     CrossRef
  • Tislelizumab-induced hyperosmolar diabetic ketoacidosis complicated with rhabdomyolysis in hepatocellular carcinoma patients: case report
    Longjun Chen, Xiaojuan Zeng, Tianping Li
    Frontiers in Oncology.2026;[Epub]     CrossRef
  • Functional Interpretation of Recurrent Genetic Variants in Hepatocellular Carcinoma: Molecular Consequences and Clinical Relevance
    Yuntao Ye, Zhulin Xu, Jiang Wang, Chunyu Chen, Yuan Peng, Bo Li, Shaoqiu Chen
    Human Mutation.2026;[Epub]     CrossRef
  • 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
  • 6,560 View
  • 223 Download
  • 4 Web of Science
  • 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.2026; 75(4): 815.     CrossRef
  • Peroxisome proliferator‑activated receptor α regulates acesulfame‑K‑induced NAFLD via hepatic PLCβ: Foe and friend
    Peng-Yao Lin, Jia-Rong Xie, Tian-Chen Qian, Shi-Song Wang, Si-Yi Yu, Wen-Bo Shi, Ying Wang, Lu-Ze Cen, Qing-Jing Zhu, Yi-Yang Zheng, Hui Gao, Rong Fang, Zhao-Xia Xia, Ai-Ming Liu, Lei Xu
    International Journal of Molecular Medicine.2026; 57(4): 1.     CrossRef
  • Reply to correspondence on “Glucagon-like peptide 1 receptor agonist and reduced liver and non-liver complications in adults with type 2 diabetes and metabolic dysfunction-associated steatotic liver disease: a target trial emulation study”
    Xingyu Yao
    Clinical and Molecular Hepatology.2026; 32(2): e267.     CrossRef
  • Predictors of Discordance Between Controlled Attenuation Parameter and Magnetic Resonance-Proton Density Fat Fraction in Hepatic Steatosis
    Dong Yun Kim, Hyung-Jin Rhee, Beom Kyung Kim
    Clinical and Translational Gastroenterology.2026;[Epub]     CrossRef
  • 7,411 View
  • 255 Download
  • 3 Web of Science
  • Crossref

Correspondences

Correspondence to editorial on “Glucagon-like peptide 1 receptor agonist and reduced liver and non-liver complications in adults with type 2 diabetes and metabolic dysfunction-associated steatotic liver disease: a target trial emulation study”
Xianhua Mao, Mindie H. Nguyen
Clin Mol Hepatol 2026;32(2):e219-e220.
Published online July 8, 2025
DOI: https://doi.org/10.3350/cmh.2025.0705
  • 2,861 View
  • 36 Download
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
  • 4,515 View
  • 44 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
  • 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.2026; 63(6): 903.     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.2026; 75(4): 815.     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
  • Clinical Utility of a 50% and 30% Decline in Magnetic Resonance Imaging-Proton Density Fat Fraction in Predicting Fibrosis Improvement in Metabolic Dysfunction-associated Steatohepatitis
    Rohit Loomba, Peter Chen-Yang Nikhil Daniel, Youxin Wang, Ricki Bettencourt, Egbert Madamba, Harris Siddiqi, Lisa Richards, Mildred D. Gottwald, Shibao Feng, Maya Margalit, Daniel Q. Huang
    Clinical Gastroenterology and Hepatology.2026;[Epub]     CrossRef
  • The role and possible mechanism of intestinal fungi in the progression of chronic liver diseases
    Yirui Hu, Ye Yang, Shuyan Wang, Huikuan Chu
    npj Biofilms and Microbiomes.2026;[Epub]     CrossRef
  • Artificial Intelligence, Real Results: AI Successfully Risk-Stratifies Patients with MASLD
    Cristian R. Perez, Mohamed A. Elfeki
    Digestive Diseases and Sciences.2026;[Epub]     CrossRef
  • p53: from understanding its structure to advances in therapeutic targeting
    Wenhua Wang, Xia Liu, Hengqi Liu, Hassan Abolhassani, Han Yan, Huilai Zhang, Xianhuo Wang
    Signal Transduction and Targeted Therapy.2026;[Epub]     CrossRef
  • Dyslipidemia in liver cirrhosis: Pathophysiology and emerging therapeutic approaches
    Jenyfer M Fuentes-Mendoza, Marcio J Concepción-Zavaleta, Jeny J Mendoza-Godoy, Luis A Concepción-Urteaga, Carlos O Martínez-Gutiérrez, José Paz-Ibarra
    World Journal of Hepatology.2026;[Epub]     CrossRef
  • Metabolic Dysfunction‐Associated Steatotic Liver Disease and Obesity: Pathogenesis, Diagnostics, Risk Stratification, and Therapeutic Approach
    Beom Kyung Kim
    The Kaohsiung Journal of Medical Sciences.2026;[Epub]     CrossRef
  • Metabolic Pathways Linking Atherosclerotic Cardiovascular Disease With Metabolic Dysfunction-Associated Steatotic Liver Disease
    Koral S. E. Richard, Sumati Rohilla, Reethika Gade, Fabio Arias, Oren Rom
    Current Atherosclerosis Reports.2026;[Epub]     CrossRef
  • Metabolism-modulating nanoparticles for remodeling adipose-liver crosstalk to reverse liver fibrosis
    Ling-Feng Zhang, Su-Qing Liang, Qing-Wen Huang, Jia-Wen Ru, Ze-Quan Ding, Chun-Yu Zhang, Yi Wang, Tian-Jiao Zhou, Lei Xing, Xian Wu Cheng, Yu-Kyoung Oh, Hu-Lin Jiang
    Journal of Controlled Release.2026; 395: 115026.     CrossRef
  • The Evolution of MASLD Management: From Revised Nomenclature to Disease-Modifying Therapies
    Karolina Kornatowska, Szymon Kopciał, Mateusz Wiekiera, Adrianna Wiekiera, Paweł Budzik, Mateusz Tyniec, Kamal Morshed
    Gastroenterology Insights.2026; 17(2): 33.     CrossRef
  • Health inequity and the risk of MAFLD/MASLD
    Ziyan Pan, Abdulla Al Hassani, Khalid M. AlNaamani, Yasser Fouad, Munira Y. Altarrah, Mohammed Eslam
    Clinical Nutrition ESPEN.2026; 74: 103355.     CrossRef
  • Predictors of Discordance Between Controlled Attenuation Parameter and Magnetic Resonance-Proton Density Fat Fraction in Hepatic Steatosis
    Dong Yun Kim, Hyung-Jin Rhee, Beom Kyung Kim
    Clinical and Translational Gastroenterology.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
  • 14,045 View
  • 334 Download
  • 15 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
  • Autoimmune Hepatitis: Histopathological Diversity and Its Clinical Implications
    Mina Komuta, Kenichi Harada
    Hepatology Research.2026; 56(2): 139.     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
  • PBC-AIH Overlap Syndrome: Diagnostic Challenges, Clinical Recognition of the “Grey Zone” and Treatment Updates
    红静 王
    Advances in Clinical Medicine.2026; 16(04): 2281.     CrossRef
  • Autoimmune Hepatitis: Emerging Frontiers in Research and Clinical Management
    Armando Curto, Irene Scami, Giulia Gliottone, Rocco G. Iamello, Erica N. Lynch, Andrea Galli
    Gastrointestinal Disorders.2026; 8(2): 20.     CrossRef
  • Unraveling immunological heterogeneity in recalcitrant AIH-PBC/PSC overlap syndromes: from molecular crosstalk to precision therapeutics
    Zefeng Zhang
    Frontiers in Immunology.2026;[Epub]     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
  • 9,499 View
  • 284 Download
  • 7 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
  • 5,925 View
  • 25 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
  • Chronic Hepatitis B Infection: Patient Guidance
    Lung‐Yi Mak, Jimmy Che‐To Lai, Ken Liu, Rashid Lui, Sakkarin Chirapongsathorn, Kuo Chao Yew, Mara Teresa Panlilio, Cosmas Rinaldi Adithya Lesmana, Ruveena Bhavani Rajaram, Liang Shen, Desmond Cheung, Lung‐Fai Wong, Hye Won Lee, Madhumita Premkumar, Anand 
    Journal of Gastroenterology and Hepatology.2026; 41(1): 61.     CrossRef
  • Unraveling Demographic Patterns in Hepatitis B Clinical and Laboratory Profiles: Insights From a Ghanaian Cohort: A Retrospective Study
    Napoleon Bellua Sam, Saeed Folorunsho Majeed, Adams Dramani
    Health Science Reports.2025;[Epub]     CrossRef
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    Nobuharu Tamaki, Daniel Q. Huang, Hyung Woong Lee, Soo Young Park, Yu Rim Lee, Dong Hyun Sinn, Tae Seop Lim, Hiroyuki Marusawa, Seng Gee Lim, Hironori Ochi, Masahiko Kondo, Yasushi Uchida, Haruhiko Kobashi, Koichiro Furuta, Masayuki Kurosaki, Beom Kyung K
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    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
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    Jung Hwan Yu
    The Korean Journal of Medicine.2024; 99(5): 232.     CrossRef
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    Mi Na Kim
    The Korean Journal of Gastroenterology.2024; 84(5): 201.     CrossRef
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    Han Ah Lee
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Viral hepatitis

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

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Correspondence

Viral hepatitis

Optimizing off-treatment outcome predictions: The potential of time-varying HBcrAg and the need for more research
Ying-Nan Tsai, Jia-Ling Wu, Yao-Chun Hsu
Clin Mol Hepatol 2024;30(2):276-278.
Published online April 1, 2024
DOI: https://doi.org/10.3350/cmh.2024.0220
  • 5,844 View
  • 49 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.

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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

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  • 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
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    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
  • Risk factors and predicted model for clinical relapse after antiviral therapy cessation in chronic hepatitis B patients: a retrospective real-world data analysis
    Xiaoli Zhang, Meiyan Mao, Yunxia Zhang, Xiuxi Li
    BioMedical Engineering OnLine.2026;[Epub]     CrossRef
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    Edo J. Dongelmans, Jordan J. Feld, André Boonstra, Sylvia M. Brakenhoff, David Wong, Colina Yim, Mark Claassen, Pieter Honkoop, Bettina E. Hansen, Robert A. de Man, Scott Fung, Thomas Berg, Florian van Bömmel, Harry L. A. Janssen, Milan J. Sonneveld
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    Yue Qiu, Qiao Tang, Xiao-Qing Liu, Yun-Ling Xue, Yi Zeng, Peng Hu
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    Byungyoon Yun, Juyeon Oh, Heejoo Park, Jian Lee, Beom Kyung Kim, Jin‐Ha Yoon
    Liver International.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
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    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
  • A critical review of diagnostic and prognostic markers of chronic hepatitis B infection
    Shuaibu Abdullahi Hudu, Sa’adatu Haruna Shinkafi, Abdulgafar Olayiwola Jimoh
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    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

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  • 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
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Snapshot

Viral hepatitis

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

Citations

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    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
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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.

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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

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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

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  • 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
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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

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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

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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
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  • Treated chronic hepatitis B is a good prognostic factor of diffuse large B-cell lymphoma
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    Clinical and Molecular Hepatology.2023; 29(3): 794.     CrossRef
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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.

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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
  • 6,375 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.

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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.

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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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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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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.

Citations

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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 Article

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.

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