Clinical and Molecular Hepatology

"Hepatitis B, Chronic"

Letter to the Editor

Viral hepatitis

Functional cure of chronic hepatitis B encounters resmetirom: Nai-Bin Yang, Wai-Kay Seto, Ming-Hua Zheng; Clin Mol Hepatol 2024;30(3):580-581.
Published online April 30, 2024; DOI: https://doi.org/10.3350/cmh.2024.0301

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Correspondence

Viral hepatitis

Correspondence on Letter regarding “Is liver biopsy essential to identifying the immune tolerant phase of chronic hepatitis B?”: Joo Hyun Oh, Dong Hyun Sinn; Clin Mol Hepatol 2023;29(3):820-820.
Published online May 19, 2023; DOI: https://doi.org/10.3350/cmh.2023.0135

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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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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
La prise en charge de l'hépatite B chronique: mise à jour 2025 des lignes directrices de l'Association canadienne pour l'étude du foie et de l'Association pour la microbiologie médicale et l'infectiologie 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): 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
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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
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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

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Editorials

Viral hepatitis

Is liver biopsy essential to identifying the immune tolerant phase of chronic hepatitis B?: Joo Hyun Oh, Dong Hyun Sinn; Clin Mol Hepatol 2023;29(2):367-370.
Published online March 20, 2023; DOI: https://doi.org/10.3350/cmh.2023.0054; Correction in: Clin Mol Hepatol 2023;29(3):828

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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
Letter regarding “Is liver biopsy essential to identifying the immune tolerant phase of chronic hepatitis B?”
Halil Haldun Emiroglu
Clinical and Molecular Hepatology.2023; 29(3): 812. CrossRef
The Relationship between Mean Platelet Volume and Neutrophil–Lymphocyte Ratio and Liver Fibrosis in Patients with Chronic Hepatitis B
Mehmet Onder Ekmen, Metin Uzman
Medicina.2023; 59(7): 1287. CrossRef

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Viral hepatitis

Risk of hepatocellular carcinoma in untreated patients with chronic hepatitis B: Independent of HBeAg status?: Ho Soo Chun, Minjong Lee; Clin Mol Hepatol 2021;27(3):448-450.
Published online June 23, 2021; DOI: https://doi.org/10.3350/cmh.2021.0130

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Association of HBV serological markers with host antiviral immune response relevant hepatic inflammatory damage in chronic HBV infection
Bei Jiang, Leijie Wang, Huan Liu, Lin Wang, Rui Su, Liang Xu, Guochao Wei, Jia Li, Fengmin Lu, Xiangmei Chen
Journal of Medical Virology.2024;[Epub] CrossRef

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131 Download
2 Web of Science
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Viral hepatitis

Another oral antiviral treatment, but still far away from hepatitis B virus cure: Tai-Chung Tseng; Clin Mol Hepatol 2021;27(2):281-282.
Published online March 10, 2021; DOI: https://doi.org/10.3350/cmh.2021.0072

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Mi Na Kim, Jae Seung Lee, Hye Won Lee, Beom Kyung Kim, Jun Yong Park, Do Young Kim, Sang Hoon Ahn, Se Young Jang, Won Young Tak, Young-Oh Kweon, Soo Young Park, Seung Up Kim
Clinical Gastroenterology and Hepatology.2023; 21(9): 2278. CrossRef
Comparison of decline in renal function between patients with chronic hepatitis B with or without antiviral therapy
Jae Seung Lee, Chan‐Young Jung, Jung Il Lee, Sang Hoon Ahn, Beom Seok Kim, Seung Up Kim
Alimentary Pharmacology & Therapeutics.2023; 58(1): 99. CrossRef
A machine learning model for predicting hepatocellular carcinoma risk in patients with chronic hepatitis B
Hye Won Lee, Hwiyoung Kim, Taeyun Park, Soo Young Park, Young Eun Chon, Yeon Seok Seo, Jae Seung Lee, Jun Yong park, Do Young Kim, Sang Hoon Ahn, Beom Kyung Kim, Seung Up Kim
Liver International.2023; 43(8): 1813. CrossRef
Identification and Characterization of Besifovir-Resistant Hepatitis B Virus Isolated from a Chronic Hepatitis B Patient
Jong Chul Kim, Hye Young Lee, Ah Ram Lee, Mehrangiz Dezhbord, Da Rae Lee, Seong Ho Kim, Juhee Won, Soree Park, Na Yeon Kim, Jae Jin Shin, Sang Gyune Kim, Young Seok Kim, Jeong-Ju Yoo, Kyun-Hwan Kim
Biomedicines.2022; 10(2): 282. CrossRef
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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Original Articles

Hepatic neoplasm

Serum fibrosis index-based risk score predicts hepatocellular carcinoma in untreated patients with chronic hepatitis B: Lilian Yan Liang, Hye Won Lee, Vincent Wai-Sun Wong, Terry Cheuk-Fung Yip, Yee-Kit Tse, Vicki Wing-Ki Hui, Grace Chung-Yan Lui, Henry Lik-Yuen Chan, Grace Lai-Hung Wong; Clin Mol Hepatol 2021;27(3):499-509.
Published online February 26, 2021; DOI: https://doi.org/10.3350/cmh.2020.0333

Background/Aims
Serum fibrosis scores comprised of common laboratory tests have high utility to assess severity of liver fibrosis. We aimed to derive and validate a hepatocellular carcinoma (HCC) risk score based on serum fibrosis scores to predict HCC in treatment-naïve chronic hepatitis B (CHB) patients.
Methods
Fifteen thousand one hundred eighty-seven treatment-naïve adult CHB patients were identified to form the training cohort in this retrospective study. Individual fibrosis score was included to construct a new HCC prediction score. The score was externally validated in an independent treatment-naïve Korean CHB cohort.
Results
180/15,187 patients (1.2%) in training cohort and 47/4,286 patients (1.1%) in validation cohort developed HCC during a mean follow-up of 52 and 50 months, respectively. The newly developed HCC risk score, Liang score, is composed of gender, age, hepatitis B virus DNA, fibrosis-4 (FIB-4) index, and ranges from 0 to 22. Area under the time-dependent receiver operating characteristic curve of Liang score was 0.79 (95% confidence interval, 0.70–0.89). A cutoff value of nine provided an extremely high negative predictive value of 99.9% and high sensitivity of 90.0% at 5 years in the validation cohort. Patients with Liang score ≤9 had HCC incidence <0.2% per year in both training and validation cohorts, in whom HCC surveillance might be exempted.
Conclusion
A novel HCC risk score, Liang score, based on FIB-4 index, is applicable and accurate to identify treatment-naïve CHB patients with very low risk of HCC to be exempted from HCC surveillance.

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JNCI: Journal of the National Cancer Institute.2025; 117(4): 761. CrossRef
Development and Validation of a Machine Learning-Based Model Used for Predicting Hepatocellular Carcinoma Risk in Patients with Hepatitis B-Related Cirrhosis: A Retrospective Study
Yixin Hou, Jianguo Yan, Ke Shi, Xiaoli Liu, Fangyuan Gao, Tong Wu, Peipei Meng, Min Zhang, Yuyong Jiang, Xianbo Wang
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Byungyoon Yun, Juyeon Oh, Sang Hoon Ahn, Jin-Ha Yoon, Beom Kyung Kim
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Ho Soo Chun, Minjong Lee
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Viral hepatitis

Continuing besifovir dipivoxil maleate versus switching from tenofovir disoproxil fumarate for treatment of chronic hepatitis B: Results of 192-week phase 3 trial: Do Seon Song, Won Kim, Sang Hoon Ahn, Hyung Joon Yim, Jae Young Jang, Young Oh Kweon, Yong Kyun Cho, Yoon Jun Kim, Gun Young Hong, Dong Joon Kim, Young Kul Jung, Joo Hyun Sohn, Jin-Woo Lee, Sung Jae Park, Byung Seok Lee, Ju Hyun Kim, Hong Soo Kim, Seung Kew Yoon, Moon Young Kim, Kwan Sik Lee, Young Suk Lim, Wan Sik Lee, Jin Mo Yang, Kyun-Hwan Kim, Kwang-Hyub Han, Soon Ho Um; Clin Mol Hepatol 2021;27(2):346-359.
Published online January 25, 2021; DOI: https://doi.org/10.3350/cmh.2020.0307

Background/Aims
Besifovir dipivoxil maleate (BSV), an acyclic nucleotide phosphonate, shows potent antiviral activity against hepatitis B virus. Our previous 48-week trial revealed that BSV has comparable antiviral efficacy to tenofovir disoproxil fumarate (TDF) and better safety profiles in terms of improved renal and bone safety. This extension study evaluated the prolonged efficacy and safety of BSV in treatment-naive chronic hepatitis B patients.
Methods
Patients continued to participate in an open-label BSV study after an initial 48-week double-blind comparison of BSV and TDF treatment. The antiviral efficacy and drug safety was evaluated up to 192 weeks in two groups: patients continuing BSV treatment (BSV-BSV) and patients switching from TDF to BSV after 48 weeks (TDF-BSV).
Results
Among 197 patients receiving randomized treatments, 170 (86%) entered the open-label phase and 152 (77%) entered the 192-week extension study. Virological response rates over 192 weeks were 92.50% and 93.06% in the BSV-BSV and TDF-BSV groups, respectively (P=0.90). Hepatitis B envelop antigen seroconversion and alanine aminotransferase normalization rates were similar between the groups (P=0.75 and P=0.36, respectively). There were no drug-resistant mutations to BSV. Bone mineral density and renal function were well preserved in the BSV-BSV group, whereas these initially worsened then recovered after switching therapy in the TDF-BSV group.
Conclusions
BSV maintained potent antiviral efficacy after 192 weeks and showed no evidence of drug resistance. BSV was safe, well tolerated, and effective in patients who switched from TDF to BSV. Trial Registration Number: NCT01937806 (date: 10 Sep 2013).

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Comparison of hepatocellular carcinoma incidence after long-term treatment with besifovir vs. tenofovir AF
Hyuk Kim, Jae-Young Kim, Yoon E. Shin, Hye-Jin Yoo, Jeong-Ju Yoo, Sang Gyune Kim, Young-Seok Kim
Scientific Reports.2025;[Epub] CrossRef
Switching to besifovir in patients with chronic hepatitis B receiving tenofovir disoproxil fumarate: A randomized trial
Hyung Joon Yim, Yeon Seok Seo, Ji Hoon Kim, Won Kim, Young Kul Jung, Jae Young Jang, Sae Hwan Lee, Yun Soo Kim, Chang Wook Kim, Hyoung Su Kim, Jae-Jun Shim, Eun-Young Cho, In Hee Kim, Byung Seok Lee, Jeong-Hoon Lee, Byung Seok Kim, Jeong Won Jang, Hyun Wo
Clinical and Molecular Hepatology.2025; 31(3): 810. CrossRef
Correspondence to Editorial on “Switching to Besifovir in Patients with Chronic Hepatitis B Receiving Tenofovir Disoproxil Fumarate: A Randomized Trial”
Hyung Joon Yim, Seong Hee Kang, Young Kul Jung, Jin Mo Yang
Clinical and Molecular Hepatology.2025;[Epub] CrossRef
Besifovir dipivoxil maleate versus other antivirals in reducing hepatocellular carcinoma in chronic hepatitis B
Jae Seung Lee, Sung Won Lee, Hae Lim Lee, Jeong-Ju Yoo, Yeon Seok Seo, Su Jong Yu, Hyung Joon Yim, Young Kul Jung, Jisu Moon, Hye Won Lee, Mi Na Kim, Beom Kyung Kim, Jun Yong Park, Do Young Kim, Sang Hoon Ahn, Sang Gyune Kim, Seung Up Kim
Scientific Reports.2025;[Epub] CrossRef
Comparative Renal Safety of Besifovir Dipivoxil Maleate and Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients: Insights From a Nationwide Cohort Study
Hyun Bin Choi, Jae Young Kim, Jeong-Ju Yoo, Sang Gyune Kim, Young-Seok Kim
Journal of Korean Medical Science.2025;[Epub] CrossRef
Statin use is associated with better post‐operative prognosis among patients with hepatitis B virus‐related hepatocellular carcinoma
Byungyoon Yun, Sang Hoon Ahn, Juyeon Oh, Jin‐Ha Yoon, Beom Kyung Kim
European Journal of Clinical Investigation.2023;[Epub] CrossRef
Comparison of decline in renal function between patients with chronic hepatitis B with or without antiviral therapy
Jae Seung Lee, Chan‐Young Jung, Jung Il Lee, Sang Hoon Ahn, Beom Seok Kim, Seung Up Kim
Alimentary Pharmacology & Therapeutics.2023; 58(1): 99. CrossRef
Tenofovir versus entecavir on the prognosis of hepatitis B virus-related hepatocellular carcinoma: a systematic review and meta-analysis
Hui Liu, Cheng-Long Han, Bao-Wen Tian, Zi-Niu Ding, Ya-Fei Yang, Yun-Long Ma, Chun-Cheng Yang, Guang-Xiao Meng, Jun-Shuai Xue, Dong-Xu Wang, Zhao-Ru Dong, Zhi-Qiang Chen, Jian-Guo Hong, Tao Li
Expert Review of Gastroenterology & Hepatology.2023; 17(6): 623. CrossRef
Prediction model of hepatitis B virus-related hepatocellular carcinoma in patients receiving antiviral therapy
Beom Kyung Kim, Sang Hoon Ahn
Journal of the Formosan Medical Association.2023; 122(12): 1238. CrossRef
Identification and Characterization of Besifovir-Resistant Hepatitis B Virus Isolated from a Chronic Hepatitis B Patient
Jong Chul Kim, Hye Young Lee, Ah Ram Lee, Mehrangiz Dezhbord, Da Rae Lee, Seong Ho Kim, Juhee Won, Soree Park, Na Yeon Kim, Jae Jin Shin, Sang Gyune Kim, Young Seok Kim, Jeong-Ju Yoo, Kyun-Hwan Kim
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KASL clinical practice guidelines for management of chronic hepatitis B

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Susceptibility of Drug Resistant Hepatitis B Virus Mutants to Besifovir
Juhee Won, Ah Ram Lee, Mehrangiz Dezhbord, Da Rae Lee, Seong Ho Kim, Jong Chul Kim, Soree Park, Nayeon Kim, Byengjune Jae, Kyun-Hwan Kim
Biomedicines.2022; 10(7): 1637. CrossRef
Besifovir dipivoxil maleate: a novel antiviral agent with low toxicity and high genetic barriers for chronic hepatitis B
Jeong Eun Song, Jun Yong Park
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Entecavir versus tenofovir in patients with chronic hepatitis B: Enemies or partners in the prevention of hepatocellular carcinoma
Sung Won Lee, Jonggi Choi, Seung Up Kim, Young-Suk Lim
Clinical and Molecular Hepatology.2021; 27(3): 402. CrossRef

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Review

Viral hepatitis

Comparison of clinical practice guidelines for the management of chronic hepatitis B: When to start, when to change, and when to stop: Hyung Joon Yim, Ji Hoon Kim, Jun Yong Park, Eileen L. Yoon, Hana Park, Jung Hyun Kwon, Dong Hyun Sinn, Sae Hwan Lee, Jeong-Hoon Lee, Hyun Woong Lee; Clin Mol Hepatol 2020;26(4):411-429.
Published online August 28, 2020; DOI: https://doi.org/10.3350/cmh.2020.0049

Abstract
PDF

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

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Original Articles

Artificial intelligence, epidemiology, methodology, or others

Trends in the prevalence of chronic liver disease in the Korean adult population, 1998–2017: Seung Ha Park, Lindsay D. Plank, Ki Tae Suk, Yong Eun Park, Jin Lee, Joon Hyuk Choi, Nae Yun Heo, Jongha Park, Tae Oh Kim, Young Soo Moon, Hyun Kuk Kim, Hang Jea Jang, Ha Young Park, Dong Joon Kim; Clin Mol Hepatol 2020;26(2):209-215.
Published online November 4, 2019; DOI: https://doi.org/10.3350/cmh.2019.0065

Abstract
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Data on the trends in the prevalence of chronic liver disease (CLD) in Korea are scarce. This study aimed to evaluate whether the CLD prevalence changed between 1998–2001 and 2016–2017. Data were extracted from the Korea National Health and Nutrition Examination Survey (1998–2001 to 2016–2017; n=25,893). Non-alcoholic fatty liver disease (NAFLD) was defined as a hepatic steatosis index >36 in the absence of any other evidence of CLD. The definition of alcoholrelated liver disease (ALD) was excessive alcohol consumption (≥210 g/week for men and ≥140 g/week for women) and an ALD/NAFLD index >0. The prevalence of NAFLD increased from 18.6% (95% confidence interval [CI], 17.8–19.5%) in 1998–2001 to 21.5% (95% CI, 20.6–22.6%) in 2016–2017. During the same time period, increases were observed in the prevalence of obesity (27.0 vs. 35.1%), central obesity (29.4 vs. 36.0%), diabetes (7.5 vs. 10.6%), and excessive drinking (7.3 vs. 10.5%). ALD prevalence also increased from 3.8% (95% CI, 3.4–4.2%) to 7.0% (95% CI, 6.4–7.6%). In contrast, chronic hepatitis B decreased from 5.1% (95% CI, 4.6–5.5%) to 3.4% (95% CI, 3.0–3.8%). The prevalence of chronic hepatitis C was approximately 0.3% in 2016–2017. The prevalence of NAFLD and ALD increase among Korean adults. Our results suggest potential targets for interventions to reduce the future burden of CLD.

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Viral hepatitis

Hepatitis B screening rates and reactivation in solid organ malignancy patients undergoing chemotherapy in Southern Thailand: Ratchapong Laiwatthanapaisan, Pimsiri Sripongpun, Naichaya Chamroonkul, Arunee Dechaphunkul, Chirawadee Sathitruangsak, Siwat Sakdejayont, Chanon Kongkamol, Teerha Piratvisuth; Clin Mol Hepatol 2019;25(4):366-373.
Published online July 17, 2019; DOI: https://doi.org/10.3350/cmh.2018.0111

Abstract
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Background/Aims
Hepatitis B virus reactivation (HBVr) following chemotherapy (CMT) is well-known among hematologic malignancies, and screening recommendations are established. However, HBVr data in solid organ malignancy (SOM) patients are limited. This study aims to determine hepatitis B surface antigen (HBsAg) screening rates, HBV prevalence, and the rate of significant hepatitis caused by HBVr in SOM patients undergoing CMT.
Methods
Based on the Oncology unit’s registration database from 2009–2013, we retrospectively reviewed records of all SOM patients ≥18 years undergoing CMT at Songklanagarind Hospital who were followed until death or ≥6 months after CMT sessions. Exclusion criteria included patients without baseline liver function tests (LFTs) and who underwent CMT before the study period. We obtained and analyzed baseline clinical characteristics, HBsAg screening, and LFT data during follow-up.
Results
Of 3,231 cases in the database, 810 were eligible. The overall HBsAg screening rate in the 5-year period was 27.7%. Screening rates were low from 2009–2012 (7.8–21%) and increased in 2013 to 82.9%. The prevalence of HBV among screened patients was 7.1%. Of those, 75% underwent prophylactic antiviral therapy. During the 6-month follow-up period, there were three cases of significant hepatitis caused by HBVr (4.2% of all significant hepatitis cases); all were in the unscreened group.
Conclusions
The prevalence of HBV in SOM patients undergoing CMT in our study was similar to the estimated prevalence in general Thai population, but the screening rate was quite low. Cases of HBVr causing significant hepatitis occurred in the unscreened group; therefore, HBV screening and treatment in SOM patients should be considered in HBV-endemic areas.

Citations

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Review

Acute liver injury and Acute liver failure

The fibrogenic process and the unleashing of acute-on-chronic liver failure: Guillermo Nahúm López-Sánchez, Mayra Dóminguez-Pérez, Misael Uribe, Natalia Nuño-Lámbarri; Clin Mol Hepatol 2020;26(1):7-15.
Published online June 14, 2019; DOI: https://doi.org/10.3350/cmh.2019.0011

Abstract
PDF

Acute-on-chronic liver failure (ACLF) is a life-threatening condition characterized by a rapid deterioration of previously well-compensated chronic liver diseases. One of the main obstacles in ACLF is the lack of knowledge of the pathogenesis and specific broad-spectrum treatments. An excessive systemic inflammatory response has been proposed to explain the pathogenesis of ACLF; this hypothesis involves stellate cells, which are implicated in many liver homeostatic functions that include vitamin A storage, regulation of sinusoidal blood flow, local inflammation, maintenance of the hepatocyte phenotype and extracellular matrix remodeling. However, when there is damage to the liver, these cells are the main target of the inflammatory stimulus, as a result, the secretion of the extracellular matrix is altered. Activated hepatic stellate cells raise the survival of neutrophils by the stimulation of granulocytes colonies and macrophages, which exacerbates liver inflammation and promotes damage to hepatocytes. Elevation of pathogen-associated molecular patterns is related to liver damage by different pathophysiological mechanisms of decompensation, showing ballooning degeneration and cell death with a predominance of cholestatic infection. Moreover, patients with ACLF present a marked elevation of C-reactive protein together with an elevation of the leukocyte count. Chronic liver disease is a complex pathological state with a heterogeneous pathophysiology in which genetic factors of the host and external triggers interact and culminate in hepatic insufficiency. The better understanding of such interactions should lead to a better comprehension of the disease and to the discovery of new treatment targets that will make acute decompensations preventable and even decrease mortality.

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Hepatic mir-122-3p, mir-140-5p and mir-148b-5p expressions are correlated with cytokeratin-18 serum levels in MAFLD
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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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Original Articles

Viral hepatitis

Influence of hepatic steatosis on the outcomes of patients with chronic hepatitis B treated with entecavir and tenofovir: David Sooik Kim, Mi Young Jeon, Hye Won Lee, Beom Kyung Kim, Jun Yong Park, Do Young Kim, Sang Hoon Ahn, Kwang-Hyub Han, Seung Up Kim; Clin Mol Hepatol 2019;25(3):283-293.
Published online November 13, 2018; DOI: https://doi.org/10.3350/cmh.2018.0054

Background/Aims
The influence of hepatic steatosis (HS) on chronic hepatitis B (CHB) is unclear. We evaluated the influence of the degree of HS, assessed using the controlled attenuation parameter (CAP) of transient elastography (TE), on treatment outcomes in CHB patients initiated on antiviral therapy.
Methods
A total of 334 patients who were initiated on entecavir or tenofovir between 2007 and 2016 with available TE results were recruited.
Results
Of the total study population, 146 (43.7%) patients had HS (CAP > 238 dB/m). Three-hundred-three patients (90.7%) achieved complete virological response (CVR) (hepatitis B virus DNA<12 IU/L), and 25 patients (7.5%) developed hepatocellular carcinoma (HCC). Among hepatitis B e antigen (HBeAg)-positive patients (n=172, 51.5%), 37 (21.5%) experienced HBeAg loss. On univariate analysis, CAP value was not associated with the probability of HCC development (P=0.380). However, lower CAP value was independently associated with higher probability of HBeAg loss among HBeAg-positive patients (hazard ratio [HR]=0.991, P=0.026) and with CVR achievement in the entire study population (HR=0.996, P=0.004). The cumulative incidence of HBeAg loss among HBeAg-positive patients was significantly higher in patients without HS than in those with HS (log-rank, P=0.022).
Conclusions
CAP values were not correlated with HCC development in patients initiated on entecavir and tenofovir. However, CAP values were negatively correlated with the probability of HBeAg loss among HBeAg-positive patients and with CVR achievement.

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Viral hepatitis

Hepatitis B surface antigen levels at 6 months after treatment can predict the efficacy of lamivudine-adefovir combination therapy in patients with lamivudine-resistant chronic hepatitis B: Jeong Han Kim, Hee Won Moon, Soon Young Ko, Won Hyeok Choe, So Young Kwon; Clin Mol Hepatol 2014;20(3):274-282.
Published online September 25, 2014; DOI: https://doi.org/10.3350/cmh.2014.20.3.274

Abstract
PDF

Background/Aims

Quantitation of hepatitis B surface antigen (HBsAg) is an increasingly popular method to determine the treatment response in chronic hepatitis B (CHB) patients. The clinical value of HBsAg level measurement during rescue therapy for lamivudine (LMV)-resistant CHB patients have not been evaluated to date. Therefore, this study investigated the correlation between HBsAg level and treatment response in LMV-resistant CHB patients treated with adefovir (ADV) add-on therapy.

Methods

LMV-resistant CHB patients treated with LMV-ADV combination therapy for over 2 years were included. HBsAg levels were measured at 6 month intervals until 1 year, and annually thereafter. Treatment response was assessed by determining the virological response (VR, undetectable HBV DNA levels) during treatment.

Results

Fifty patients were included, of which 40 showed a VR. HBsAg levels were not different significantly at baseline (4.0 vs. 3.6 Log10 IU/mL, P=0.072). However, the HBsAg level decreased after 6 months of treatment in patients with a VR and became different significantly between the groups thereafter (3.9 vs. 3.3 at 6 months, P=0.002; 3.8 vs. 3.2 at 1 year, P=0.004; 3.9 vs. 3.2 at 2 years, P=0.008; 3.7 vs. 3.1 at 3 years, P =0.020).

Conclusions

The HBsAg level at 6 months after treatment can help predict treatment response.

Citations

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Hussam Murad, Haythum O Tayeb, Mahmoud Mosli, Misbahuddin Rafeeq, Mohammed Basheikh
International Journal of General Medicine.2021; Volume 14: 8753. CrossRef
The efficacy of tenofovir-based therapy in patients showing suboptimal response to entecavir-adefovir combination therapy
Jeong Han Kim, Sung Hyun Ahn, Soon Young Ko, Won Hyeok Choe, Kyun-Hwan Kim, So Young Kwon
Clinical and Molecular Hepatology.2016; 22(2): 241. CrossRef

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Review

Genetic epidemiological study on single nucleotide polymorphisms associated with hepatocellular carcinoma in patients with chronic HBV infection: Yoon Jun Kim , Hyo Suk Lee; Korean J Hepatol 2009;15(1):7-14.
Published online March 31, 2009; DOI: https://doi.org/10.3350/kjhep.2009.15.1.7

Abstract
PDF

Hepatocellular carcinoma (HCC) is associated with hepatitis B virus (HBV) as an etiologic agent in 80% of cases, and is the major cause of death among HBV carriers. Family history of HCC is a known risk factor for the development of HCC among chronically HBV infected patients, therefore, genetic factors are likely to modify the risk of HCC. However, the genetic factors that determine progression to HCC remain mostly to be recovered. It is estimated that there are millions of single nucleotide polymorphisms (SNPs) within human genome and they are likely to explain much of the genetic diversity of individuals. In this review, the natural history of HBV infection and host genetic factors related to HCC, study design and target gene selection for the detection of SNPs related to the occurrence of HCC were discussed. Also, several SNPs or haplotypes, which were reportedly associated with increased or reduced risk of HCC occurrence in patients with chronic HBV infection, were reviewed. Especially, recent studies in Korea, one of the HBV endemic areas, were discussed. Screening of these polymorphisms might be useful in clinical practice to stratify the lower or higher risk group for HCC and might modify the design of HCC surveillance programs in patients with chronic HBV infection, if further genetic susceptibilities are identified. The ongoing studies of the distributions and functions of the implicated allele polymorphisms will not only provide insight into the pathogenesis of HCC, but may also provide a novel rationale for new methods of diagnosis and therapeutic strategies. (Korean J Hepatol 2008;15:7-14)

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Influence of TP53 gene somatic mutations in Helicobacter pylori infected gastric tumor
Souvik Ghatak, Payel Chakraborty, Subbarayan Sarathbabu, Jeremy L. Pautu, John Zohmingthanga, C. Lalchhandama, Nachimuthu Senthil Kumar
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Yonggang Wei, Fei Liu, Bo Li, Xi Chen, Yu Ma, Lvnan Yan, Tianfu Wen, Mingqing Xu, Wentao Wang, Jiayin Yang
Digestive Diseases and Sciences.2011; 56(8): 2227. CrossRef
Inhibition of hepatitis B virus replication by RNA interference
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The Korean Journal of Hepatology.2009; 15(1): 1. CrossRef

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Case Report

A case report of treatment with pegylated interferon alpha for Lamivudine-resistant chronic hepatitis B virus infection: Won Haing Hur , Hyun Young Woo , Soung Won Jeong , Chan Ran You , Si Hyun Bae , Jong Young Choi , Seung Kew Yoon; Korean J Hepatol 2008;14(4):513-518.
Published online December 31, 2008; DOI: https://doi.org/10.3350/kjhep.2008.14.4.513

Abstract
PDF

The wide use of lamivudine in chronic hepatitis B has produced a monotonic increase in patients with lamivudine resistance. Therefore, treating lamivudine resistance in chronic hepatitis B is a major concern in clinical practice for the treatment of hepatitis B virus (HBV). There is conflicting evidence on the outcome of pegylated interferon alpha (PEG-IFN α) therapy against lamivudine-resistant HBV, which is due to mutations in the YMDD motif. We experienced a patient with chronic hepatitis B who was successfully treated with PEG-IFN α-2a after the development of virologic and biochemical breakthrough during lamivudine therapy. Virologic breakthrough was associated with the emergence of YMDD mutants 48 months after starting lamivudine therapy. Treatment with PEG-IFN α-2a for 12 months resulted in an undetectable serum level of HBV DNA and the resolution of hepatitis, and the virologic response was maintained over 16 months after cessation of PEG-IFN α-2a. (Korean J Hepatol 2008;14:513-518)

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A 28-year-old male patient with asymptomatic and multi-drug-resistant HBV infection: a case report
Syed Ayaz Kazmi, Abdul Rauf, Muhammad Zahid Latif, Beenish Shahid, Sundus Khawaja, Zeeshan Anjum
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Hepatology Elsewheres

The Korean Journal of Entecavir 1 mg therapy for Lamivudine-refractory chronic hepatitis B: Hyung Joon Kim; Korean J Hepatol 2008;14(3):411-416.
Published online September 30, 2008; DOI: https://doi.org/10.3350/kjhep.2008.14.3.411

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The Korean Journal of Adefovir plus Lamivudine combination therapy in Lamivudine-resistant chronic hepatitis B: So Young Kwon; Korean J Hepatol 2008;14(2):235-239.
Published online June 20, 2008; DOI: https://doi.org/10.3350/kjhep.2008.14.2.235

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Background/Aims
In lamivudine-resistant patients with chronic hepatitis B (CHB), we compared efficacy, predictive response factors and changes in viral mutants in two antiviral approaches with adefovir. Methods: A prospective cohort study on therapy with adefovir alone (29 patients) or combined with ongoing lamivudine (23 patients) was performed. Results: A virological response was achieved in 55% of patients treated with adefovir and in 83% of those treated with the combination (p>0.05). This response was directly related to the basal viral load (p<0.0001) and obtained in 10 patients with basal HBV-DNA<17,200 IU/ml using both strategies. In patients with a higher basal viral load, the virological response was more frequent when treated with the combination (p<0.05). Mutation at locus rt181 predicted HBV-DNA persistence during therapy. A virological rebound was observed in 18% of non-responders while on adefovir monotherapy. Conclusions: To achieve a complete virological response and reduce the risk of adefovir-resistant mutants in lamivudine- resistant patients, rescue therapy is preferable at early evidence of genotypic resistance. However, in subjects with a significant viral load, combination therapy is more effective. The presence of the rt181 mutation is associated with incomplete response.

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The Korean Journal of Normal range of serum ALT level in patients with chronic hepatitis: Yeon Seok Seo; Korean J Hepatol 2008;14(1):116-121.
Published online March 20, 2008; DOI: https://doi.org/10.3350/kjhep.2008.14.1.116

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The clinical significance of persistently normal ALT in chronic hepatitis B infection Lai M, Hyatt BJ, Nasser I, Curry M, Afdhal NH Background/Aims: Chronic hepatitis B virus (HBV) disease is caused by both necroinflammation and active viral replication. The role of ALT levels as a predictor of liver injury has recently been questioned. The aim of the study was to determine whether normal ALT is associated with liver injury in a cohort of HBV patients undergoing liver biopsy. Methods: This is a retrospective review of chronic HBV patients divided into 3 groups; (1) persistently normal ALT (PNALT); (2) ALT 1~1.5× ULN and (3) ALT > 1.5× ULN. Multiple clinical, biochemical, virological variables were evaluated. Results: One hundred and ninety-two patients met the inclusion criteria, 59 with PNALT, 26 with ALT 1~1.5× ULN, and 107 with ALT > 1.5× ULN. Increasing age, higher ALT, higher grade of inflammation on biopsy, and HBeAg positivity predicted fibrosis. 18% of patients with PNALT had stage 2+ fibrosis and 34% had grade 2 or 3 inflammation. Overall 37% of patients with PNALT had significant fibrosis or inflammation. Subgroup analysis showed the majority with fibrosis belonged to the high normal ALT group and that only a minority who were young and immune tolerant had significant findings on biopsy. Conclusions: There is significant fibrosis and inflammation in 37% of patients with PNALT and a liver biopsy should be considered in patients older than 40 with high normal ALT. [J Hepatol 2007;47:760-767

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Original Articles

Change of HBV DNA Level as a Predictor of HBeAg Loss after Lamivudine Treatment: Jae Kwon Jung, M.D., Chang Hyeong Lee, M.D., Eun Young Kim, M.D., Jin Tae Jung, M.D., Joon Hyuck Choi, M.D., Ji Min Han, M.D., Myoung In Jin, M.D., Ju Yeon Cho, M.D., Byung Seok Kim, M.D., Im Hee Shin, Ph.D.1; Korean J Hepatol 2007;13(4):513-520.
Published online December 20, 2007; DOI: https://doi.org/10.3350/kjhep.2007.13.4.513

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Backgroud/Aims: Lamivudine is an effective, safe therapeutic agent for the treatment of chronic hepatitis B. The aim of this study was to investigate whether early suppression of the viral load predicts HBeAg loss within 1 year during lamivudine therapy. Methods: This prospective study encompassed 74 patients (mean age: 37.1 years, male/female: 51/23) who were positive HBeAg, their AST or ALT levels were ≥2 times the upper limit of normal and their HBV DNA was ≥105 copies/mL. The patients received lamivudine 100 mg for 12 months with monitoring their HBV DNA, AST, ALT, HBeAg and anti-HBe, and all these tests were performed at pretreatment and 1, 3, 6, 9 and 12 months after treatment. The serum HBV DNA was measured by HBV branched DNA assay. Results: HBeAg loss was observed in 12 patients (16.2%), and 9 patients achieved anti-HBe seroconversion during up to 1 year of lamivudine therapy. The mean time to HBeAg loss was 5.6 months (range: 1-12 months). The posttreatment HBV DNA (<2,000 copies/mL) after 3 month (P=0.008) and 6 month (P=0.012)) were significant predictors of HBeAg loss after 1 year of lamivudine treatment on univariate analysis. Pretreatment HBV DNA, AST/ALT, gender, age and liver cirrhosis had no impact on HBeAg loss. The six-month posttreatment HBV DNA level <2,000 copies/mL was a significant predictor of HBeAg loss on multivariate analysis (P=0.008, odds ratio=0.108). Conclusion: We suggest that an HBV DNA level <2,000 copies/mL at 6 month after lamivudine therapy is the most important predictor of HBeAg loss during up to 1 year of lamivudine therapy. (Korean J Hepatol 2007;13:513-520)

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The Efficacy and Safety of Telbivudine in Korean Patients with Chronic Hepatitis B: Young-Myoung Moon, M.D.1, Seong-Gyu Hwang, M.D.2, Boo-Sung Kim, M.D.3, Kyu-Sung Rim, M.D.2, Mong Cho, M.D.4, Dong-Joon Kim, M.D.5, Joon-Yeol Han, M.D.6, Young-Seok Kim, M.D.3, Ho-Soon Choi, M.D.7, Sang-Hoon Ahn, M.D.8; Korean J Hepatol 2007;13(4):503-512.
Published online December 20, 2007; DOI: https://doi.org/10.3350/kjhep.2007.13.4.503

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Background/Aims
Telbivudine is an L-nucleoside analogue with potent antiviral activity against hepatitis B virus (HBV). Clinical trials have shown that telbivudine is more potent than lamivudine for suppressing virus. Methods: A total 101 Korean patients among 1,367 patients who participated in the phase III GLOBE trial were randomized in this study. All 101 HBeAg positive or HBeAg negative patients were assigned to treatment with 600 mg of telbivudine or 100 mg of lamivudine once daily. The primary efficacy endpoint (the "therapeutic response") was defined as suppression of the serum HBV DNA to less than 5 log10 copies/mL coupled with either normalization of the serum alanine aminotransferase level or loss of HBeAg. The secondary endpoints included the histologic response, serum HBV DNA reduction, serum alanine aminotransferase normalization and HBeAg loss for the HBeAg positive patients. This analysis includes the data collected at 52 weeks of treatment. Results: Fifty four of 101 patients were assigned to telbivudine treatment and 47 patients were assigned to lamivudine treatment. At week 52, significantly more patients who were treated with telbivudine than those treated with lamivudine had a therapeutic response (83% vs 62%, respectively, P=0.017), their mean serum HBV DNA levels were more reduced (6.6 vs 5.6 log10 copies/mL, respectively, P=0.027), and they more often achieved PCR-undetectable levels of serum HBV DNA (74% vs 34%, P<0.0001). No virologic resistance to telbivudine was detected (0% vs 18%, respectively, P=0.001). Telbivudine was well tolerated and it had a safety profile comparable to lamivudine. Conclusions: Patients treated with telbivudine achieved earlier and more profound viral suppression than those treated with lamivudine. (Korean J Hepatol 2007;13:503-512)

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Chao Wei Hsu, You Chen Chao, Chuan Mo Lee, Ting Tsung Chang, Yi Cheng Chen
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The Korean Journal of Hepatology.2007; 13(4): 447. CrossRef

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Effect of Initial Virologic Response to Adefovir on the Development of Resistance to Adefovir in Lamivudine-resistant Chronic Hepatitis B: In Hee Kim , Seong Hun Kim , Hyun Chul Kim , Kyoung Deok Shin , Sang Wook Kim , Seong Ok Lee , Soo Teik Lee , Dae Ghon Kim; Korean J Hepatol 2007;13(3):349-362.
Published online September 20, 2007; DOI: https://doi.org/10.3350/kjhep.2007.13.3.349

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Background/Aims: Adefovir dipivoxil (ADV) resistance in patients with lamivudine-resistant chronic hepatitis B is not well understood. This study examined the initial virologic response (IVR) to ADV, the rate of ADV resistance and the factors associated with ADV resistance. Methods: Eighty one lamivudine-resistant HBeAg-positive patients were enrolled in this study. IVR was defined as HBV DNA < 4 log10 copies/mL after 6 months of therapy. Results: IVR was observed in 37/81(45.7%) patients and it was associated with higher pretreatment ALT (P=0.002), and low pretreatment HBV DNA level (P=0.015). The HBV DNA levels were significantly higher in the non-IVR patients than the IVR patients at 12, 18 and 24 months (4.73 vs 2.59, 4.53 vs 2.31, 4.39 vs 2.40 log10 copies/mL, respectively; P<0.01). During the follow-up period, 17(21.0%) patients showed phenotypic resistance to ADV and 9 (11.1%) patients had ADV-resistant mutations. The cumulative probabilities of the phenotypic resistance to ADV at 12 and 24 months were 8.7% and 32.5%, respectively. The cumulative probabilities of the genotypic resistance to ADV at 12 and 24 months were 0% and 14.6%, respectively. Resistance to ADV was associated with a higher pretreatment HBV DNA (P=0.019), and non-IVR (P<0.001). Conclusions: The cumulative probabilities of the phenotypic and genotypic resistance to ADV at 24 months were 32.5% and 14.6%. The high pretreatment HBV DNA and non-IVR (HBV DNA ≥ 4 log10 copies/mL after 6 months of therapy) were associated with ADV resistance. (Korean J Hepatol 2007;13: 349-362)

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Initial Virological Response and Viral Mutation with Adefovir Dipivoxil Added to Ongoing Lamivudine Therapy in Lamivudine-Resistant Chronic Hepatitis B
Shuang Wu, Kenichi Fukai, Fumio Imazeki, Makoto Arai, Tatsuo Kanda, Yutaka Yonemitsu, Osamu Yokosuka
Digestive Diseases and Sciences.2011; 56(4): 1207. CrossRef

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Editorial

Clinical Significance and Natural History of "HBeAg Negativity" in Patients with Chronic HBV Infection: Young Sok Lee; Korean J Hepatol 2006;12(2):133-135.

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Review

Action Mechanism in Immunopathogenesis and Clearance of HBV: Se Jin Im , Young Chul Sung; Korean J Hepatol 2006;12(2):154-162.

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Hepatitis B virus (HBV) currently infects more than 400 million people worldwide and they are at risk of developing chronic liver disease, cirrhosis and hepatocellular carcinoma. The immune response to HBV- encoded antigens is responsible both for viral clearance and for disease pathogenesis during HBV infection. While the humoral antibody response to viral envelope antigens contributes to the clearance of circulating virus particles, the cellular immune responses to the envelope, nucleocapsid, and polymerase antigens were known to eliminate virus in infected hepatocytes through cytolytic as well as noncytolytic mechanisms. Liver injury could be initiated by an immune response against HBV, but mainly resulted from HBV non-specific lymphocytes and macrophages. There are growing evidences that T helper 1 memory T cells play a predominant role in suppressing viral replication mainly by IFN-γ through noncytolytic antiviral mechanism. Elucidation of the immunological and virological basis for HBV infection may yield effective immunotherapeutic and antiviral strategies to terminate chronic HBV infection. (Korean J Hepatol 2006;12: 154-162)

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Original Articles

Natural History of HBeAg Negative Chronic Hepatitis B Virus Infection; A Cohort Study: Chang Mo Moon, M.D., Do Young Kim, M.D., Ki Jun Song, Ph.D.1, Ja Kyung Kim, M.D., Hyun Woong Lee, M.D., Jung Min Lee, M.D., Ki Tae Yoon, M.D., Yong Han Paik, M.D., Dong Ki Kim, Ph.D.1, Kwang-Hyub Han, M.D., Chae Yoon Chon, M.D., Young Myoung Moon, M.D., and Sang Hoon Ahn, M.D.; Korean J Hepatol 2006;12(2):163-172.

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Background/Aims
The long-term virologic and biochemical changes in patients with HBeAg negative HBV infection, especially in Asia, remain unclear. To address this issue, we conducted a 3 year- retrospective, cohort study. Methods: A total of 157 patients with HBeAg negative HBV infection who were monitored without treatment were reviewed between January 1999 and March 2004. Those patients were followed up every 3 months with liver function tests and serologic tests. All patients were stratified into 3 groups; inactive carrier (IC), viremic carrier (VC) and chronic hepatitis (CH). Serum HBV DNA was measured by a hybridization assay (sensitivity: 1.4×105 genomes/mL, Digene Diagnostics, Silver Spring, USA). Results: The median age of enrolled patients was 42.7 years (M:F=2.3:1). By single time-point observations, the 3 year-cohort prevalence of HBeAg negative CH varied from 12.7 to 35.8% (median 20.7%) HBeAg negative CH was accumulated over time (P=0.002) and transition rates among three groups after 3 years of follow-up are as follows: IC to CH, 6.0%; IC to VC, 4.1%; VC to CH, 23.2%. VC seems to be a disease state in the middle of transition from IC to CH. Conclusions: We demonstrated the dynamic changing patterns of HBeAg negative CH with time, of which the change from IC or VC to CH was dominant. (Korean J Hepatol 2006;12:163-172)

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Correlation of HBV DNA Level and Viral Breakthrough During Lamivudine Therapy for Chronic Hepatitis B: Hee Seung Park , Dong Hyun Lee , Jeong Heo , Gwang Ha Kim , Dae Hwan Kang , Geun Am Song , Mong Cho; Korean J Hepatol 2006;12(2):173-183.

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Background/Aims: Lamivudine is an effective therapy in chronic hepatitis B patients, but the emergence of resistant hepatitis B virus (HBV) mutants is a major concern. This study was performed to investigate whether serum viral DNA levels during lamivudine therapy are related with viral breakthrough in patients with chronic HBV infection. Methods: This study consisting of 103 patients was performed retrospectively and prospectively. Follow-up duration was 24 months after lamivudine therapy. Serum HBV DNA levels were quantified by PCR-based assay every 6 months. Results: Cumulative rate of viral breakthrough was 0%, 19.4%, 36%, and 48.5% in 6, 12, 18, and 24 months respectively. The rate of viral breakthrough in 24 months increased as serum HBV DNA levels increased at 6 months. When serum HBV DNA levels were 2-3 log10, 3-4 log10, 4-5 log10, and 5 log10 copies/mL or more, the breakthrough rates were significantly higher than that of the HBV DNA level less than 2 log10 copies/mL. The relative risks were 1.10, 1.93, 2.69, 3.21 respectively (P<0.001). The viral breakthrough rate also increased as serum HBV DNA levels at 12 months increased. When the HBV DNA levels were 2-3 log10, 3-4 log10, 4-5 log10, and 5 log10 copies/ mL or more, the breakthrough rate were significantly higher than those of HBV DNA level less than 2 log10 copies/mL. The relative risks were 2.42, 4.35, 3.73, 2.61, respectively (P=0.002). Conclusions: The serum HBV DNA levels at 6 months and 12 months during lamivudine therapy can be closely correlated with the rate of viral breakthrough in 24 months. (Korean J Hepatol 2006;12:173-183)

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Comparison of Clinical Outcome Between Patients Continuing and Discontinuing Lamivudine Therapy in Acute Exacerbation After Viral breakthrough During Lamivudine Therapy in Chronic Hepatitis B: Jong Ryul Eun; Korean J Hepatol 2006;12(2):184-190.

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Backgrounds/Aims: Continuation of lamivudine therapy is controversial for patients with chronic hepatitis B when viral breakthrough occurs. Moreover, the effect of continuous lamivudine therapy is unknown in patients with acute exacerbation after viral breakthrough. We assessed clinical course of acute exacerbation after viral breakthrough in patients who continued and discontinued lamivudine therapy. Methods: Medical records of 109 patients with viral breakthrough during lamivudine therapy were reviewed. Of 40 patients with acute exacerbation (ALT level >5×ULN), adefovir dipivoxil was unavailable in 38 patients. These 38 patients (mean age 42.6 years; male/female, 34/6) were divided into continuation (n=21) and discontinuation (n=17) groups. Clinical courses of the 2 groups were compared. Results: During follow- up period (mean, 27 months; range, 6-60 months), ALT levels decreased to <2×ULN in 11 patients (52%) of continuation group and 9 patients (53%) of discontinuation group, varied from 2× to 5×ULN in 9 (43%) and 5 (29%), respectively, and increased to >5×ULN in 1 (5%) and 3 (18%), respectively, with no statistical significance (P=.417). Conclusions: When acute exacerbation of ALT levels occurs after viral breakthrough during lamivudine administration in patients with compensated chronic hepatitis B, continuation of lamivudine may have no advantage over discontinuation. (Korean J Hepatol 2006;12:184-190)

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Review

Resistance to Adefovir in Patients with Chronic Hepatitis B: Soo Hyung Ryu, M.D.,* Young-Hwa Chung, M.D.; Korean J Hepatol 2006;12(4):484-492.

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Adefovir dipivoxil (ADV) is effective in the treatment of chronic hepatitis patients with wild type and lamivudine-resistant hepatitis B virus. The occurrence of viral resistance to long-term adefovir therapy is rare, the cumulative rates of resistance were 0%, 3%, 11%, 18%, and 28% at 1, 2, 3, 4, and 5 years of therapy, respectively. The emergence of adefovir resistant mutant in patients with lamivudine resistance is more common than in treatment-naive patients. Two major mutations of adefovir resistance are rtN236T and rtA181V/T. Other mutations in the HBV polymerase (rtP237H, rtN238T/D, rtV84M, rtS85A, rtV214A, rtQ215S) reduce sensitivity to adefovir, but the significance of these mutations is unclear. The adefovir mutations slightly decrease adefovir susceptibility in vitro, suggesting mild clinical course after the occurrence of adefovir resistance. However, some patients show viral rebound and hepatic decompensation. Lamivudine, entecavir, and tenofovir are used currently for salvage therapy in patients with adefovir resistance. To reduce adefovir resistance, combination therapy with adefovir and lamivudine in patients with lamivudine resistance may be a treatment option. (Korean J Hepatol 2006;12:484-492)

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Original Articles

Clinical Significances of Serum Soluble Fas and Soluble Fas Ligand in Chronic Hepatitis B: Eun Jung Jun, M.D., Joon-Yeol Han, M.D., and Hee Sik Sun, M.D.1; Korean J Hepatol 2006;12(4):507-514.

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Background/Aims
Apoptosis via Fas/FasL system is thought to be involved in the development of hepatocyte death in viral hepatitis B. In chronic hepatitis C, sFas/sFasL system was reported to control liver injury induced by Fas/FasL mediated apoptosis. To determine the role of sFas/sFasL system in chronic hepatitis B, we analyzed serum sFas/sFasL in 58 HBV patients and 29 healthy controls. Methods: HBV patients were categorized into two groups; normal ALT (≤40 IU/L) and elevated ALT (>40 IU/ L). Serum sFas/sFasL levels in HBV patients were measured by ELISA and was compared with those in 29 healthy controls. Serum ALT levels, histological activity, and Fas/FasL expression of liver were compared. Results: Chronic hepatitis B patients with elevated ALT had significantly higher serum sFas levels than those in healthy controls (P<0.01). Serum sFasL levels, however, were significantly lower than those in healthy controls (P<0.01). Patients with moderate to marked degree of inflammation and fibrosis had significantly higher serum sFas levels than those in healthy controls (P<0.05). Serum sFasL levels had no correlation with the hepatic histological activity. Serum sFas/sFasL levels also had no significant correlation with the Fas/FasL expression of liver. Conclusions: Serum sFas/sFasL levels play a possible role in the pathogenesis of chronic hepatitis B. These results suggest that serum sFas levels might serve as a marker for estimating the degree of hepatic histological activity. (Korean J Hepatol 2006;12:507-514)

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Clinical Outcomes of Lamivudine Therapy in HBeAg Positive Chronic Hepatitis B with Minimally Elevated ALT: Dong Ha Han , Neung Hwa Park , Jung Woo Shin , Seok Won Jung , Young Tae Hwang , Hyun Soo Kim , In Du Jeong , Sung Jo Bang , Do Ha Kim; Korean J Hepatol 2007;13(2):146-156.

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Background/Aims
The aim of this study was to compare the efficacy of lamivudine therapy between chronic hepatitis B (CHB) patients, whose ALT levels less than 2 times the upper limit of normal (ULN) and patients whose ALT levels are more than 2 times ULN. Methods: We retrospectively analyzed 508 consecutive patients with HBeAg-positive CHB who were treated with lamivudine for 1 year or more. Forty-six patients (Group A) with pretreatment ALT levels less than 2 times ULN were retrospectively compared with 462 patients (Group B) whose ALT levels are more than 2 times ULN. Results: HBeAg seroconversion was achieved in 15 (32.6%) of group A and 162 (35.1%) of group B. The cumulative rates of HBeAg seroconversion in group A and B were 19% and 21% at 12 months; 35% and 31% at 24 months; and 38% and 39% at 36 months, respectively. HBV breakthrough was observed in 20 (43.5%) of group A and 192 (41.6%) of group B. The cumulative breakthrough rates of group A and B were 18% and 12% at 12 months; 33% and 29 % at 18 months; 45% and 42% at 24 months, respectively. Post-treatment relapse in group A and B occurred in 56% (5/9) and 41% (44/108), respectively. Therefore, the rates of the HBeAg seroconversion, breakthrough, and post-treatment relapse were not significantly different between these two groups. Conclusions: Lamivudine therapy in HBeAg-positive CHB patients whose ALT levels are minimally elevated is as effective as in treatment of the patients whose pretreated ALT levels are twice more than ULN. (Korean J Hepatol 2007;13:146-156)

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Predictors of Lamivudine Resistance in Patients with Chronic Hepatitis B Virus Infection: Jeong Heo , Mong Cho , Byung Mann Cho , Sun Mi Lee , Tae Oh Kim , Gwang Ha Kim , Dae Hwan Kang , Geun Am Song; Korean J Hepatol 2007;13(2):157-165.

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Background
/Aim: Drug resistance is a major concern during nucleos(t)ide analogues therapy in patients with chronic hepatitis B virus (HBV) infections. The aim of this study was to measure the risk of lamivudine resistance provided for each predictive factor in patients with chronic HBV infections. Methods: A total of 183 patients were analyzed among 315 patients with chronic HBV infections enrolled in a tertiary referral hospital between January 2001 and December 2003 on this retrospective cohort study. AST/ALT, HBeAg/anti-HBe, serum HBV DNA levels were tested for every 3 or 6 months. HBV DNA level was tested using Cobas Amplicor HBV Monitor test™. Viral breakthrough was defined as HBV DNA ≥ 5 log10 copies/mL on two consecutive visits in patients who, on treatment, achieved HBV DNA < 5 log10 copies/mL. The risk of viral breakthrough was measured using Cox proportional hazards model for variables: age, sex, BMI (kg/m2), baseline ALT, HBeAg positivity, baseline HBV DNA level, serum HBV DNA level at 6 month of lamivudine therapy. Results: The cumulative rates of viral breakthrough were 9.6%, 39.0%, 55.8% at 12, 24, 36 months, respectively. Serum HBV DNA level of 6 month of lamivudine therapy and presence of HBeAg were independent predictors for viral breakthrough. The relative risk was 1.43 (95% C.I. 1.09-1.89, P=0.010) for serum HBV DNA level at 6 months of lamivudine therapy and 1.77 (95% C.I. 1.06-2.95, P=0.029) for presence of HBeAg. Conclusions: Serum HBV DNA level at 6 months of therapy and HBeAg positivity were predictors of early lamivudine resistance in patients with chronic HBV infections. An alternate therapy should be considered when serum viral load is high at 6 months of lamivudine therapy. (Korean J Hepatol 2007;13:157- 165)

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