Clinical and Molecular Hepatology

"Antiviral agents"

Correspondences

Correspondence to editorial 1 on “Impacts of metabolic syndrome diseases on long-term outcomes of chronic hepatitis B patients treated with nucleos(t)ide analogues”: Rui Huang, Mindie H. Nguyen; Clin Mol Hepatol 2026;32(1):e83-e84.
Published online May 8, 2025; DOI: https://doi.org/10.3350/cmh.2025.0479

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Advancing metabolic risk profiling in chronic hepatitis B: Reply to correspondence on “Metabolic health in antiviral era of chronic hepatitis B”
Shang-Chin Huang, Jia-Horng Kao
Clinical and Molecular Hepatology.2026; 32(1): e117. CrossRef

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Correspondence to editorial 2 on “Impacts of metabolic syndrome diseases on long-term outcomes of chronic hepatitis B patients treated with nucleos(t)ide analogues”: Rui Huang, Mindie H. Nguyen; Clin Mol Hepatol 2026;32(1):e85-e86.
Published online May 8, 2025; DOI: https://doi.org/10.3350/cmh.2025.0478

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Editorial

Type 2 diabetes as a key metabolic risk factor for adverse outcomes in nucleos(t)ide analogue-treated chronic hepatitis B: Editorial on “Impacts of metabolic syndrome diseases on long-term outcomes of chronic hepatitis B patients treated with nucleos(t)ide analogues”: Heejoon Jang, Won Kim; Clin Mol Hepatol 2026;32(1):426-428.
Published online April 28, 2025; DOI: https://doi.org/10.3350/cmh.2025.0430

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Correspondence to editorial 2 on “Impacts of metabolic syndrome diseases on long-term outcomes of chronic hepatitis B patients treated with nucleos(t)ide analogues”
Rui Huang, Mindie H. Nguyen
Clinical and Molecular Hepatology.2026; 32(1): e85. CrossRef

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44 Download
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Correspondence

Revisiting unmet needs in clinical research on direct-acting antiviral therapy for HCC patients: Correspondence to letter to the editor on “Direct-acting antiviral therapy for patients with HCV-related hepatocellular carcinoma: A nationwide cohort study”: Teng-Yu Lee, Pei-Chien Tsai, Shou-Wu Lee, Ming- Lung Yu; Clin Mol Hepatol 2026;32(1):e99-e102.
Published online April 4, 2025; DOI: https://doi.org/10.3350/cmh.2025.0362

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Reviews

Viral hepatitis

Update on the treatment navigation for functional cure of chronic hepatitis B: Expert consensus 2.0: Di Wu, Jia-Horng Kao, Teerha Piratvisuth, Xiaojing Wang, Patrick T.F. Kennedy, Motoyuki Otsuka, Sang Hoon Ahn, Yasuhito Tanaka, Guiqiang Wang, Zhenghong Yuan, Wenhui Li, Young-Suk Lim, Junqi Niu, Fengmin Lu, Wenhong Zhang, Zhiliang Gao, Apichat Kaewdech, Meifang Han, Weiming Yan, Hong Ren, Peng Hu, Sainan Shu, Paul Yien Kwo, Fu-sheng Wang, Man-Fung Yuen, Qin Ning; Clin Mol Hepatol 2025;31(Suppl):S134-S164.
Published online January 22, 2025; DOI: https://doi.org/10.3350/cmh.2024.0780

Abstract
PDF

As new evidence emerges, treatment strategies toward the functional cure of chronic hepatitis B are evolving. In 2019, a panel of national hepatologists published a Consensus Statement on the functional cure of chronic hepatitis B. Currently, an international group of hepatologists has been assembled to evaluate research since the publication of the original consensus, and to collaboratively develop the updated statements. The 2.0 Consensus was aimed to update the original consensus with the latest available studies, and provide a comprehensive overview of the current relevant scientific literatures regarding functional cure of hepatitis B, with a particular focus on issues that are not yet fully clarified. These cover the definition of functional cure of hepatitis B, its mechanisms and barriers, the effective strategies and treatment roadmap to achieve this endpoint, in particular new surrogate biomarkers used to measure efficacy or to predict response, and the appropriate approach to pursuing a functional cure in special populations, the development of emerging antivirals and immunomodulators with potential for curing hepatitis B. The statements are primarily intended to offer international guidance for clinicians in their practice to enhance the functional cure rate of chronic hepatitis B.

Citations

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Residual viral expression in siRNA-treated HBV-replicating cell and mouse models
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Hyung Joon Yim, Seong Hee Kang, Young Kul Jung, Jin Mo Yang
Clinical and Molecular Hepatology.2025;[Epub] CrossRef
Quantitatively Evaluate the Improvement of Functional Cure for the Quality of Life of Chronic Hepatitis B Cases: Evidence from a Cross-Sectional Study in China
Sihui Zhang, Zhiliang Gao, Hui Li, Yi Kang, Lei Fu, Xuebing Chen, Xiaoyuan Xu, Xinyue Chen, Hui Zhuang, Hui Zheng, Fuqiang Cui
Healthcare.2025; 13(20): 2590. 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
An RNA interference therapeutic potentially achieves functional cure of chronic hepatitis B virus infection
Ze-Ao Huang, Yang Yang, Shuo Yang, Guang-Shen Ji, Rui Fu, Zhi-Kang Tian, Yu-Cheng Wu, Geng-Shen Song
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A Study on Serum Protein Tracking in Patients with Low Levels of HBsAg Undergoing Treatment for Chronic Hepatitis B with a Combination of Tenofovir Disoproxil Fumarate and Pegylated Interferon
Yimin Chen, Min Deng, Mingkai Tong, Peixia Lin, Hua Xuan, Dahai Wei
Hepatitis Monthly.2025;[Epub] CrossRef
Machine learning model for HBsAg seroclearance after 48-week pegylated interferon therapy in inactive HBsAg carriers: a retrospective study
Jianxia Dong, Shan Ren, Jing Zhao, Pengxuan Wu, Haitian Yu, Yao Xie, Junliang Fu, Xiaorong Mao, Zhiliang Gao, Bingliang Lin, Qingfa Ruan, Yongfang Jiang, Xiulan Xue, Yueyong Zhu, Haidong Zhao, Haifang Cao, Xinyue Chen, Sujun Zheng
Virology Journal.2025;[Epub] CrossRef

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Viral hepatitis

Prospect of emerging treatments for hepatitis B virus functional cure: Rex Wan-Hin Hui, Lung-Yi Mak, James Fung, Wai-Kay Seto, Man-Fung Yuen; Clin Mol Hepatol 2025;31(Suppl):S165-181.
Published online November 14, 2024; DOI: https://doi.org/10.3350/cmh.2024.0855

Abstract
PDF

Functional cure, defined as sustained hepatitis B surface antigen (HBsAg) seroclearance with unquantifiable hepatitis B virus (HBV) DNA at 24 weeks off treatment, is a favorable treatment endpoint in chronic hepatitis B (CHB). Nonetheless, functional cure is rarely attained with the current treatment modalities of nucleos(t)ide analogues (NUCs) and pegylated interferon alpha. Multiple novel virus-targeting agents and immunomodulators are under development for HBV with functional cure as the treatment goal. Among virus-targeting agents, antisense oligonucleotides and small-interfering RNAs are the most advanced in the developmental pipeline, and can induce potent and sustainable HBsAg suppression. The other virus-targeting agents have varying effects on HBsAg and HBV DNA, depending on the drug mechanism. In contrast, immunomodulators have modest effects on HBsAg and have limited roles in monotherapy. Multiple combination regimens incorporating RNA interference agents with immunomodulators have been studied through many ongoing clinical trials. These combination strategies demonstrate synergistic effects in inducing functional cure, and will likely be the future direction of development. Despite the promising results, research is warranted to optimize treatment protocols and to establish criteria for NUC withdrawal after novel therapies. Functional cure is now an attainable target in CHB, and the emerging novel therapeutics will revolutionize CHB management.

Citations

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Large-scale profile study on hepatitis B surface antigen levels in chronic hepatitis B: implications for drug development targeting functional cure
Rex Wan-Hin Hui, Trevor Kwan-Hung Wu, Karen Cheuk-Ying Ho, Ryan Hin-Man Leung, Matthew Shing-Hin Chung, Danny Ka-Ho Wong, James Fung, Wai-Kay Seto, Lung Yi Mak, Man-Fung Yuen
Gut.2026; 75(1): 119. 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.2026; 32(1): e55. 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
Reply to: “ALT to qHBsAg ratio predicts HBsAg seroclearance in HBeAg-negative patients receiving Peg-IFNα based therapy”
Rex Wan-Hin Hui, Lung-Yi Mak, Man-Fung Yuen
Journal of Hepatology.2025; 82(5): e228. CrossRef
Expanding treatment indications in chronic hepatitis B: Should we treat all patients?
Rex Wan-Hin Hui, Lung-Yi Mak, James Fung, Wai-Kay Seto, Man-Fung Yuen
Hepatology International.2025; 19(2): 304. CrossRef
Combining therapeutic agents to target the immune systems of hepatitis B patients: what do we need to consider?
Shang-Chin Huang, Jia-Horng Kao
Expert Review of Gastroenterology & Hepatology.2025; 19(4): 371. CrossRef
Efficacy of Antiviral Therapy in Chronic Hepatitis B Patients With Normal Alanine Aminotransferase: A Systematic Review and Meta‐Analysis
Yuting Diao, Yueying Zeng, Zhihao Huang, Chunfang You, Kevork M. Peltekian
Canadian Journal of Gastroenterology and Hepatology.2025;[Epub] CrossRef
Hepatitis B: Neue therapeutische Ansätze für eine funktionelle Heilung
Markus Cornberg, Ulrike Protzer
Deutsches Ärzteblatt Online.2025;[Epub] CrossRef
Structural optimization of phthalazine derivatives for anti-HBV activities to improve oral bioavailability
Yurong Yang, Fuling Xiao, Jianping Zuo, Li Yang, Youhong Hu, Wuhong Chen
Bioorganic & Medicinal Chemistry.2025; 128: 118259. CrossRef
Emerging therapies for HBsAg seroclearance: spotlight on novel combination strategies
Rex Wan-Hin Hui, James Fung, Wai-Kay Seto, Man-Fung Yuen, Lung-Yi Mak
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Advancing HIV cure: insights from developing chronic hepatitis b therapies for functional cure
Ana Verma, Raymond T. Chung
Current Opinion in HIV and AIDS.2025; 20(5): 449. CrossRef
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Xu-Ling Liu, Yu-Lang Jiang, Ming-Yu Sun
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Timothy M. Block, Dimitar Gotchev, Yanming Du
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Chih-Lin Lin, Jia-Horng Kao
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Morphometric and structural dynamic parameters of hepatitis viruses: implications for therapeutic and vaccine failure
Saganuwan Alhaji Saganuwan
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Functional cure of chronic hepatitis B virus infection: current therapeutic regimens
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Hepatoma Research.2025;[Epub] CrossRef

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Original Article

Viral hepatitis

Artificial intelligence predicts direct-acting antivirals failure among hepatitis C virus patients: A nationwide hepatitis C virus registry program: Ming-Ying Lu, Chung-Feng Huang, Chao-Hung Hung, Chi‐Ming Tai, Lein-Ray Mo, Hsing-Tao Kuo, Kuo-Chih Tseng, Ching-Chu Lo, Ming-Jong Bair, Szu-Jen Wang, Jee-Fu Huang, Ming-Lun Yeh, Chun-Ting Chen, Ming-Chang Tsai, Chien-Wei Huang, Pei-Lun Lee, Tzeng-Hue Yang, Yi-Hsiang Huang, Lee-Won Chong, Chien-Lin Chen, Chi-Chieh Yang, Sheng‐Shun Yang, Pin-Nan Cheng, Tsai-Yuan Hsieh, Jui-Ting Hu, Wen-Chih Wu, Chien-Yu Cheng, Guei-Ying Chen, Guo-Xiong Zhou, Wei-Lun Tsai, Chien-Neng Kao, Chih-Lang Lin, Chia-Chi Wang, Ta-Ya Lin, Chih‐Lin Lin, Wei-Wen Su, Tzong-Hsi Lee, Te-Sheng Chang, Chun-Jen Liu, Chia-Yen Dai, Jia-Horng Kao, Han-Chieh Lin, Wan-Long Chuang, Cheng-Yuan Peng, Chun-Wei- Tsai, Chi-Yi Chen, Ming-Lung Yu, TACR Study Group; Clin Mol Hepatol 2024;30(1):64-79.
Published online November 21, 2023; DOI: https://doi.org/10.3350/cmh.2023.0287

Background/Aims
Despite the high efficacy of direct-acting antivirals (DAAs), approximately 1–3% of hepatitis C virus (HCV) patients fail to achieve a sustained virological response. We conducted a nationwide study to investigate risk factors associated with DAA treatment failure. Machine-learning algorithms have been applied to discriminate subjects who may fail to respond to DAA therapy.
Methods
We analyzed the Taiwan HCV Registry Program database to explore predictors of DAA failure in HCV patients. Fifty-five host and virological features were assessed using multivariate logistic regression, decision tree, random forest, eXtreme Gradient Boosting (XGBoost), and artificial neural network. The primary outcome was undetectable HCV RNA at 12 weeks after the end of treatment.
Results
The training (n=23,955) and validation (n=10,346) datasets had similar baseline demographics, with an overall DAA failure rate of 1.6% (n=538). Multivariate logistic regression analysis revealed that liver cirrhosis, hepatocellular carcinoma, poor DAA adherence, and higher hemoglobin A1c were significantly associated with virological failure. XGBoost outperformed the other algorithms and logistic regression models, with an area under the receiver operating characteristic curve of 1.000 in the training dataset and 0.803 in the validation dataset. The top five predictors of treatment failure were HCV RNA, body mass index, α-fetoprotein, platelets, and FIB-4 index. The accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the XGBoost model (cutoff value=0.5) were 99.5%, 69.7%, 99.9%, 97.4%, and 99.5%, respectively, for the entire dataset.
Conclusions
Machine learning algorithms effectively provide risk stratification for DAA failure and additional information on the factors associated with DAA failure.

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Review

Viral hepatitis

Safety considerations for withdrawal of nucleos(t)ide analogues in patients with chronic hepatitis B: First, do no harm: Yao-Chun Hsu, Cheng-Hao Tseng, Jia-Horng Kao; Clin Mol Hepatol 2023;29(4):869-890.
Published online March 14, 2023; DOI: https://doi.org/10.3350/cmh.2022.0420

Abstract
PDF

Nucleos(t)ide analogues (NA) are widely used to treat hepatitis B virus (HBV) infection, but they cannot eradicate the virus and treatment duration can be lifelong if the endpoint is set at seroclearance of the hepatitis B surface antigen (HBsAg). As an alternative strategy, finite NA therapy without the prerequisite of HBsAg seroclearance has been proposed to allow treatment cessation in patients with sustained undetectable HBV viremia for two to three years. However, reactivation of viral replication almost always follows NA withdrawal. Whereas HBV reactivation might facilitate HBsAg seroclearance in some, it could lead to serious acute flare-ups in a certain proportion of patients. Occurrence and consequences of NA withdrawal flares are complicated with various factors involving the virus, host, and treatment. Accurate risk prediction for severe flares following NA cessation is essential to ensure patient safety. The risks of life-threatening flares in patients who discontinued NA according to the stopping rules of current guidelines or local reimbursement policies have recently been quantitatively estimated in large-scale studies, which also provided empirical evidence to help identify vulnerable patients at risk of devastating outcomes. Moreover, risk predictors were further explored and validated to hopefully aid in patient selection and management. In this narrative review with a focus on patient safety, we summarize and discuss current literature on the incidence of severe flares following NA cessation, risk stratification for candidate selection, rules of posttreatment monitoring, and indications for treatment resumption. We also share our thoughts on the limitations of existing knowledge and suggestions for future research.

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Editorial

Viral hepatitis

Moving toward hepatitis B virus functional cure - the impact of on-treatment kinetics of serum viral markers: Lilian Yan Liang, Vincent Wai-Sun Wong, Grace Lai-Hung Wong, Terry Cheuk-Fung Yip; Clin Mol Hepatol 2023;29(1):113-117.
Published online October 31, 2022; DOI: https://doi.org/10.3350/cmh.2022.0333

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Original Articles

Viral hepatitis

Sofosbuvir/velpatasvir plus ribavirin for Child-Pugh B and Child-Pugh C hepatitis C virus-related cirrhosis: Chen-Hua Liu, Chi-Yi Chen, Wei-Wen Su, Chun-Jen Liu, Ching-Chu Lo, Ke-Jhang Huang, Jyh-Jou Chen, Kuo-Chih Tseng, Chi-Yang Chang, Cheng-Yuan Peng, Yu-Lueng Shih, Chia-Sheng Huang, Wei-Yu Kao, Sheng-Shun Yang, Ming-Chang Tsai, Jo-Hsuan Wu, Po-Yueh Chen, Pei-Yuan Su, Jow-Jyh Hwang, Yu-Jen Fang, Pei-Lun Lee, Chi-Wei Tseng, Fu-Jen Lee, Hsueh-Chou Lai, Tsai-Yuan Hsieh, Chun-Chao Chang, Chung-Hsin Chang, Yi-Jie Huang, Jia-Horng Kao; Clin Mol Hepatol 2021;27(4):575-588.
Published online July 13, 2021; DOI: https://doi.org/10.3350/cmh.2021.0155

Background/Aims
Real-world studies assessing the effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) plus ribavirin (RBV) for Child-Pugh B/C hepatitis C virus (HCV)-related cirrhosis are limited.
Methods
We included 107 patients with Child-Pugh B/C HCV-related cirrhosis receiving SOF/VEL plus RBV for 12 weeks in Taiwan. The sustained virologic response rates at off-treatment week 12 (SVR₁₂) for the evaluable population (EP), modified EP, and per-protocol population (PP) were assessed. Thesafety profiles were reported.
Results
The SVR₁₂ rates in the EP, modified EP and PP were 89.7% (95% confidence interval [CI], 82.5–94.2%), 94.1% (95% CI, 87.8–97.3%), and 100% (95% CI, 96.2–100%). Number of patients who failed to achieve SVR₁₂ were attributed to virologic failures. The SVR₁₂ rates were comparable regardless of patient characteristics. One patient discontinued treatment because of adverse events (AEs). Twenty-four patients had serious AEs and six died, but none were related to SOF/VEL or RBV. Among the 96 patients achieving SVR₁₂, 84.4% and 64.6% had improved Child-Pugh and model for endstage liver disease (MELD) scores. Multivariate analysis revealed that a baseline MELD score ≥15 was associated with an improved MELD score of ≥3 (odds ratio, 4.13; 95% CI, 1.16–14.71; P=0.02). Patients with chronic kidney disease (CKD) stage 1 had more significant estimated glomerular filtration rate declines than patients with CKD stage 2 (-0.42 mL/min/1.73 m²/month; P=0.01) or stage 3 (-0.56 mL/min/1.73 m²/month; P<0.001).
Conclusions
SOF/VEL plus RBV for 12 weeks is efficacious and well-tolerated for Child-Pugh B/C HCV-related cirrhosis.

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Viral hepatitis

The impact of unrestricted access to direct-acting antiviral among incarcerated hepatitis C virus-infected patients: Yu Jun Wong, Prem Harichander Thurairajah, Rahul Kumar, Kwong Ming Fock, Ngai Moh Law, Sin-Yoong Chong, Fria Gloriba Manejero, Tiing-Leong Ang, Eng Kiong Teo, Jessica Tan; Clin Mol Hepatol 2021;27(3):474-485.
Published online February 19, 2021; DOI: https://doi.org/10.3350/cmh.2021.0015

Background/Aims
Despite the disproportionally high prevalence rates of hepatitis C virus (HCV) amongst the incarcerated population, eradication remains challenging due to logistic and financial barriers. Although treatment prioritization based on disease severity is commonly practiced, the efficacy of such approach remained uncertain. We aimed to compare the impact of unrestricted access to direct-acting antiviral (DAA) among incarcerated HCV-infected patients in Singapore.
Methods
In this retrospective study, we reviewed all incarcerated HCV-infected patients treated in our hospital during the restricted DAA era (2013–2018) and unrestricted DAA access era (2019). Study outcomes included the rate of sustained virological response (SVR), treatment completion and treatment default. Subgroup analysis was performed based on the presence of liver cirrhosis, HCV genotype and HCV treatment types.
Results
A total of 1,001 HCV patients was followed-up for 1,489 person-year. They were predominantly male (93%) with genotype-3 HCV infection (71%), and 38% were cirrhotic. The overall SVR during the restricted DAA access era and unrestricted DAA access era were 92.1% and 99.1%, respectively. Unrestricted access to DAA exponentially improved the treatment access among HCV-infected patients by 460%, resulting in a higher SVR rate (99% vs. 92%, P=0.003), higher treatment completion rate (99% vs. 93%, P<0.001) and lower treatment default rate (1% vs. 9%, P<0.001).
Conclusion
In this large cohort of incarcerated HCV-infected patients, we demonstrated that unrestricted access to DAA is an impactful strategy to allow rapid treatment up-scale in HCV micro-elimination.

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Editorial

Viral hepatitis

Drug-drug interactions with direct-acting antivirals — less is more: Grace Lai-Hung Wong; Clin Mol Hepatol 2021;27(1):81-82.
Published online December 3, 2020; DOI: https://doi.org/10.3350/cmh.2020.0278

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Soon Kyu Lee, Sung Won Lee, Hae Lim Lee, Hee Yeon Kim, Chang Wook Kim, Do Seon Song, U Im Chang, Jin Mo Yang, Sun Hong Yoo, Jung Hyun Kwon, Soon Woo Nam, Seok-Hwan Kim, Myeong Jun Song, Jaejun Lee, Hyun Yang, Si Hyun Bae, Ji Won Han, Heechul Nam, Pil Soo
The Korean Journal of Internal Medicine.2022; 37(6): 1167. CrossRef

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Review

Viral hepatitis

Current and future strategies for the treatment of chronic hepatitis C: Omar Alshuwaykh, Paul Y. Kwo; Clin Mol Hepatol 2021;27(2):246-256.
Published online December 3, 2020; DOI: https://doi.org/10.3350/cmh.2020.0230

Abstract
PDF

Chronic hepatitis C infection is a major cause of liver disease and hepatocellular carcinoma worldwide. While hepatitis C has been treated for decades with some success, the introduction of direct acting antiviral agents has revolutionized the treatment of hepatitis C with finite, highly effective, well-tolerated therapy and there are few populations that cannot be successfully treated now or are complicated to manage. The World Health Organization has released elimination targets in an effort to eliminate viral hepatitis and reduce dramatically the morbidity and mortality caused by both viral hepatitis. While hepatitis C is straightforward to treat, it remains problematic to eliminate on a global scale. Diagnosis of hepatitis C remains the major gap in the cascade of care and numerous screening strategies will be required to reduce this gap. While historically, treatment of hepatitis C has been centralized, decentralized approaches will be required to diagnose, evaluate, and link to care the large population of individuals worldwide with hepatitis C across low-, middle-, and high-income countries. With the introduction of multiple pangenotypic treatment options and reduced cost for these therapies, assessment and treatment for those with hepatitis C has been simplified and made more accessible worldwide. There are multiple populations for whom care models are being developed and refined, including those when inject drugs, those who are incarcerated, those who present with sexually transmitted disease including the men who have sex with men population, amongst many others. While a vaccine for hepatitis C remains elusive these efforts continue. Multiple successful elimination efforts have been reported.

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Original Article

Viral hepatitis

Comedications and potential drug-drug interactions with direct-acting antivirals in hepatitis C patients on hemodialysis: Po-Yao Hsu, Yu-Ju Wei, Jia-Jung Lee, Sheng-Wen Niu, Jiun-Chi Huang, Cheng-Ting Hsu, Tyng-Yuan Jang, Ming-Lun Yeh, Ching-I Huang, Po-Cheng Liang, Yi-Hung Lin, Ming-Yen Hsieh, Meng-Hsuan Hsieh, Szu-Chia Chen, Chia-Yen Dai, Zu-Yau Lin, Shinn-Cherng Chen, Jee-Fu Huang, Jer-Ming Chang, Shang-Jyh Hwang, Wan-Long Chuang, Chung-Feng Huang, Yi-Wen Chiu, Ming-Lung Yu; Clin Mol Hepatol 2021;27(1):186-196.
Published online December 3, 2020; DOI: https://doi.org/10.3350/cmh.2020.0180

Background/Aims
Direct‐acting antivirals (DAAs) have been approved for hepatitis C virus (HCV) treatment in patients with end-stage renal disease (ESRD) on hemodialysis. Nevertheless, the complicated comedications and their potential drug-drug interactions (DDIs) with DAAs might limit clinical practice in this special population.
Methods
The number, class, and characteristics of comedications and their potential DDIs with five DAA regimens were analyzed among HCV-viremic patients from 23 hemodialysis centers in Taiwan.
Results
Of 2,015 hemodialysis patients screened in 2019, 169 patients seropositive for HCV RNA were enrolled (mean age, 65.6 years; median duration of hemodialysis, 5.8 years). All patients received at least one comedication (median number, 6; mean class number, 3.4). The most common comedication classes were ESRD-associated medications (94.1%), cardiovascular drugs (69.8%) and antidiabetic drugs (43.2%). ESRD-associated medications were excluded from DDI analysis. Sofosbuvir/velpatasvir/voxilaprevir had the highest frequency of potential contraindicated DDIs (red, 5.6%), followed by glecaprevir/pibrentasvir (4.0%), sofosbuvir/ledipasvir (1.3%), sofosbuvir/velpatasvir (1.3%), and elbasvir/grazoprevir (0.3%). For potentially significant DDIs (orange, requiring close monitoring or dose adjustments), sofosbuvir/velpatasvir/voxilaprevir had the highest frequency (19.9%), followed by sofosbuvir/ledipasvir (18.2%), glecaprevir/pibrentasvir (12.6%), sofosbuvir/velpatasvir (12.6%), and elbasvir/grazoprevir (7.3%). Overall, lipid-lowering agents were the most common comedication class with red-category DDIs to all DAA regimens (n=62), followed by cardiovascular agents (n=15), and central nervous system agents (n=10).
Conclusions
HCV-viremic patients on hemodialysis had a very high prevalence of comedications with a broad spectrum, which had varied DDIs with currently available DAA regimens. Elbasvir/grazoprevir had the fewest potential DDIs, and sofosbuvir/velpatasvir/voxilaprevir had the most potential DDIs.

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Editorial

Viral hepatitis

More evidence that direct acting antiviral therapy is safe and effective in cirrhosis and chronic kidney disease including peritoneal dialysis: Paul Kwo, Deepti Dronamraju; Clin Mol Hepatol 2020;26(4):489-491.
Published online September 24, 2020; DOI: https://doi.org/10.3350/cmh.2020.0228

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The Korean Journal of Internal Medicine.2022; 37(6): 1167. CrossRef

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Original Articles

Viral hepatitis

An integrated analysis of elbasvir/grazoprevir in Korean patients with hepatitis C virus genotype 1b infection: Youn Jae Lee, Jeong Heo, Do Young Kim, Woo Jin Chung, Won Young Tak, Yoon Jun Kim, Seung Woon Paik, Eungeol Sim, Susila Kulasingam, Rohit Talwani, Barbara Haber, Peggy Hwang; Clin Mol Hepatol 2019;25(4):400-407.
Published online May 28, 2019; DOI: https://doi.org/10.3350/cmh.2019.0006

Abstract
PDF

Background/Aims
In the Republic of Korea, an estimated 231,000 individuals have chronic hepatitis C virus (HCV) infection. The aim of the present analysis was to evaluate the safety and efficacy of elbasvir/grazoprevir (EBR/GZR) administered for 12 weeks in Korean patients who were enrolled in international clinical trial phase 3 studies.
Methods
This was a retrospective, integrated analysis of data from patients with HCV genotype (GT) 1b infection enrolled at Korean study sites in four EBR/GZR phase 3 clinical trials. Patients were treatment-naive or had previously failed interferon-based HCV therapy, and included those with human immunodeficiency virus coinfection or ChildPugh class A cirrhosis. All patients received EBR 50 mg/GZR 100 mg once daily for 12 weeks. The primary endpoint was sustained virologic response at 12 weeks after completion of therapy (SVR12, HCV RNA <15 IU/mL).
Results
SVR12 was achieved by 73 of 74 (98.6%) patients. No patients had virologic failure and one discontinued from the study after withdrawing consent. SVR12 rates were uniformly high across all patient subgroups. A total of 16 patients had nonstructural protein 5A resistance-associated substitutions at baseline (16/73, 22%), all of whom achieved SVR12. Adverse events (AEs) reported in >5% of patients were fatigue (6.8%), upper respiratory tract infection (5.4%), headache (5.4%), and nausea (5.4%). Thirteen patients (17.6%) reported drug-related AEs, two serious AEs occurred, and two patients discontinued treatment owing to an AEs.
Conclusions
In this retrospective analysis, EBR/GZR administered for 12 weeks was well-tolerated and highly effective in Korean patients with HCV GT1b infection.

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Young Eun Chon, Aejeong Jo, Eileen L. Yoon, Jonghyun Lee, Ho Gyun Shin, Min Jung Ko, Dae Won Jun
Gut and Liver.2023; 17(6): 926. CrossRef
Efficacy and safety of direct‐acting antiviral therapy for hepatitis C virus in elderly patients (≥65 years old): A systematic review and meta‐analysis
Jieun Lee, Sang Bong Ahn, Sun Young Yim, Jihyun An, Dae Won Jun, Min Jung Ko, Dong Ah Park, Jeong‐Ju Yoo
Journal of Viral Hepatitis.2022; 29(7): 496. CrossRef
Best therapy for the easiest to treat hepatitis C virus genotype 1b-infected patients
Dorota Zarębska-Michaluk, Michał Brzdęk, Jerzy Jaroszewicz, Magdalena Tudrujek-Zdunek, Beata Lorenc, Jakub Klapaczyński, Włodzimierz Mazur, Adam Kazek, Marek Sitko, Hanna Berak, Justyna Janocha-Litwin, Dorota Dybowska, Łukasz Supronowicz, Rafał Krygier, J
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Effectiveness and safety of elbasvir/grazoprevir in Korean patients with hepatitis C virus infection: a nationwide real-world study
Eun Sun Jang, Kyung-Ah Kim, Young Seok Kim, In Hee Kim, Byung Seok Lee, Youn Jae Lee, Woo Jin Chung, Sook-Hyang Jeong
The Korean Journal of Internal Medicine.2021; 36(Suppl 1): S1. CrossRef
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Jae Hyun Yoon, Chung Hwan Jun, Jeong Han Kim, Eileen L. Yoon, Byung Seok Kim, Jeong Eun Song, Ki Tae Suk, Moon Young Kim, Seong Hee Kang
Journal of Korean Medical Science.2021;[Epub] CrossRef
More evidence that direct acting antiviral therapy is safe and effective in cirrhosis and chronic kidney disease including peritoneal dialysis
Paul Kwo, Deepti Dronamraju
Clinical and Molecular Hepatology.2020; 26(4): 489. CrossRef
Hepatocellular Carcinoma Risk According to Regimens for Eradication of Hepatitis C Virus; Interferon or Direct Acting Antivirals
Hye Won Lee, Dai Hoon Han, Hye Jung Shin, Jae Seung Lee, Seung Up Kim, Jun Yong Park, Do Young Kim, Sang Hoon Ahn, Beom Kyung Kim
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Viral hepatitis

Direct-acting antivirals-based therapy decreases hepatic fibrosis serum biomarker microfibrillar-associated protein 4 in hepatitis C patients: Christian Mölleken, Maike Ahrens, Anders Schlosser, Julia Dietz, Martin Eisenacher, Helmut E. Meyer, Wolff Schmiegel, Uffe Holmskov, Christoph Sarrazin, Grith Lykke Sorensen, Barbara Sitek, Thilo Bracht; Clin Mol Hepatol 2019;25(1):42-51.
Published online November 19, 2018; DOI: https://doi.org/10.3350/cmh.2018.0029

Background/Aims
An estimated 80 million people worldwide are infected with viremic hepatitis C virus (HCV). Even after eradication of HCV with direct acting antivirals (DAAs), hepatic fibrosis remains a risk factor for hepatocarcinogenesis. Recently, we confirmed the applicability of microfibrillar-associated protein 4 (MFAP4) as a serum biomarker for the assessment of hepatic fibrosis. The aim of the present study was to assess the usefulness of MFAP4 as a biomarker of liver fibrosis after HCV eliminating therapy with DAAs.
Methods
MFAP4 was measured using an immunoassay in 50 hepatitis C patients at baseline (BL), the end-of-therapy (EoT), and the 12-week follow-up visit (FU). Changes in MFAP4 from BL to FU and their association with laboratory parameters including alanine aminotransferase (ALT), aspartate aminotransferase (AST), platelets, the AST to platelet ratio index (APRI), fibrosis-4 score (FIB-4), and albumin were analyzed.
Results
MFAP4 serum levels were representative of the severity of hepatic fibrosis at BL and correlated well with laboratory parameters, especially APRI (Spearman correlation, R²=0.80). Laboratory parameters decreased significantly from BL to EoT. MFAP4 serum levels were found to decrease from BL and EoT to FU with high statistical significance (Wilcoxon P<0.001 for both).
Conclusions
Our findings indicate that viral eradication resulted in reduced MFAP4 serum levels, presumably representing a decrease in hepatic fibrogenesis or fibrosis. Hence, MFAP4 may be a useful tool for risk assessment in hepatitis C patients with advanced fibrosis after eradication of the virus.

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Osman Ergün, Muhammet Yusuf Tepebaşi, İbrahim Onaran, Sefa Alperen Öztürk, Mücahit Baltik, Pinar Aslan Koşar
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Reine Kanaan, Myrna Medlej-Hashim, Rania Jounblat, Bartosz Pilecki, Grith L. Sorensen
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Sipin Zhu, Lin Ye, Samuel Bennett, Huazi Xu, Dengwei He, Jiake Xu
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Emma Reungoat, Boyan Grigorov, Fabien Zoulim, Eve-Isabelle Pécheur
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Susanne Gjørup Sækmose, René Holst, Tine Lottenburger, Henriette Ytting, Hans Jørgen Nielsen, Peter Junker, Anders Schlosser, Grith Lykke Sorensen
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Inge Mannaerts, Nathalie Eysackers, Elise Anne van Os, Stefaan Verhulst, Tiffany Roosens, Ayla Smout, Andreas Hierlemann, Olivier Frey, Sofia Batista Leite, Leo A. van Grunsven
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Viral hepatitis

Effect of antiviral therapy in reducing perinatal transmission of hepatitis B virus and maternal outcomes after discontinuing them: Kwang Il Seo, Si Hyun Bae, Pil Soo Sung, Chung-Hwa Park, Hae Lim Lee, Hee Yeon Kim, Hye Ji Kim, Bo Hyun Jang, Jeong Won Jang, Seung Kew Yoon, Jong Young Choi, In-Yang Park, Juyoung Lee, Hyun Seung Lee, Sa-Jin Kim, Jung Hyun Kwon, U Im Chang, Chang Wook Kim, Se Hyun Jo, Young Lee, Fisseha Tekle, Jong-Hyun Kim; Clin Mol Hepatol 2018;24(4):374-383.
Published online June 26, 2018; DOI: https://doi.org/10.3350/cmh.2017.0082

Abstract
PDF

Background/Aims
There have been numerous efforts to reduce mother-to-child transmission (MTCT) of hepatitis B virus (HBV) with antiviral agents during pregnancy. However, there are limited data regarding the outcomes of pregnant women after delivery. This study was performed to evaluate the efficacy of antiviral agents in preventing MTCT of HBV and maternal long-term outcomes.
Methods
The HBV-infected pregnant women treated with antiviral agents to prevent MTCT were retrospectively reviewed. Forty-one pregnant women who received telbivudine or tenofovir during late pregnancy (28-34 week) were analyzed. Hepatitis B virus surface antibody (HBsAb) positivity was tested in 43 infants after 7 months of birth. Eleven mothers were followed >1 year after delivery.
Results
The mean HBV DNA titer before antiviral therapy was 8.67 (6.60–9.49) log copies/mL, and the median age at delivery was 32 years (range, 22–40). Eleven patients were treated with tenofovir and 30 with telbivudine. The median duration was 57 days (range, 23–100), and the median HBV DNA titer at birth was 5.06 log copies/mL (range, 2.06–6.50). Antiviral treatments were associated with significant HBV DNA reduction (P<0.001). Among 43 infants (two cases of twins), HBsAb was not detected in two, subsequently confirmed to have HBV infection. Biochemical flare was observed in two of 11 mothers followed >12 months, and an antiviral agent was administered.
Conclusions
Antiviral treatment during late pregnancy effectively reduced MTCT. Long-term follow-up should be required in such cases. In addition, given that maternal biochemical flare occurred in 18% of mothers, re-administration of antiviral agents might be required.

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Viral hepatitis

Interferon-free treatment for hepatitis C virus infection induces normalization of extrahepatic type I interferon signaling: Pil Soo Sung, Eun Byul Lee, Dong Jun Park, Angelo Lozada, Jeong Won Jang, Si Hyun Bae, Jong Young Choi, Seung Kew Yoon; Clin Mol Hepatol 2018;24(3):302-310.
Published online March 12, 2018; DOI: https://doi.org/10.3350/cmh.2017.0074

Abstract
PDF

Background/Aims
Hepatitis C virus (HCV) replicates in the peripheral blood mononuclear cells (PBMCs), leading to the production of type I interferons (IFNs). It is well known that the gene expression profile of PBMC is similar to that of the liver. The present study explored the dynamic gene expression profile of PBMCs collected from HCV-infected patients undergoing direct-acting antiviral (DAA) therapy.
Methods
A prospective cohort comprising 27 patients under DAA therapy was formed. Expression level of IFN-β and its downstream interferon-stimulated genes (ISGs) was measured in PBMCs before and after DAA treatment. Furthermore, immunoblotting was performed to identify the signaling molecules involved in the expression of ISGs.
Results
The pretreatment expression level of interferon-induced protein 44 (IFI44) and C-X-C motif chemokine ligand 10 (CXCL10) correlated with the pretreatment expression level of IFN-β. After DAA treatment, a significant decrease in the expression levels of IFN-β, IFI44, and CXCL10 was observed in the PBMCs. Furthermore, the pretreatment expression level of IFN-β and ISGs correlated with the level of signal transducer and activator of transcription 1 (STAT1) phosphorylation, and DAA treatment abrogated STAT1 phosphorylation.
Conclusions
Pretreatment activation of IFN-β response is rapidly normalized after DAA treatment. The present study suggests that the decreased type I IFN response by the clearance of HCV might contribute to DAA-induced alleviation of extrahepatic manifestation of chronic HCV infection.

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Current status of Liver diseases in Korea: Hepatitis B: Hee Bok Chae , Jong Hyun Kim , Ja Kyung Kim , Hyung Joon Yim; Korean J Hepatol 2009;15(60):13-24.
Published online December 31, 2009; DOI: https://doi.org/10.3350/kjhep.2009.15.S6.S13

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Original Article

Analysis of the cost-effectiveness of antiviral therapies in chronic hepatitis B patients in Korea: Byung Kook Kim, M.D., So Young Kwon, M.D., Chang Hong Lee, M.D., Won Hyeok Choe, M.D., Hong Mi Choi, M.S.1, Hye Won Koo, M.D.1; Korean J Hepatol 2009;15(1):25-41.
Published online March 31, 2009; DOI: https://doi.org/10.3350/kjhep.2009.15.1.25

Abstract
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Backgrounds/Aims
The purpose of this study was to evaluate the cost-effectiveness of 1 year and up to 5 years of antiviral treatment for chronic hepatitis B (CHB). Methods: Two ten-health-state Markov models were developed for CHB patients. The proportion of patients remaining alive in each health state, and healthcare costs and quality-adjusted life years (QALYs) were determined during annual cycles of these Markov models. The total healthcare costs, life years, and QALYs over the 40-year time horizon of the model were calculated. The perspectives of the cost-effectiveness analysis were the Korean healthcare system and the healthcare needs of the CHB patient. Results: Short-course therapy with α-interferon or 1-year treatment with pegylated interferon α-2a, lamivudine (LMV), or adefovir (ADV) had limited impact on disease progression. In contrast, either LMV-ADV or ADV-LMV as rescue medication administered for 5 years resulted in a more sustained decrease in the rate of disease progression. The cost-effectiveness threshold in Korea was estimated to be approximately 25,000,000 South Korean won. LMV administered for 1 year is cost-effective in comparison with no treatment for both HBeAg-positive and HBeAg-negative CHB patients, but longer duration antiviral therapies administered for up to 5 years in CHB patients were found to be highly cost-effective by international standards. Conclusions: Antiviral treatment of CHB with LMV or ADV for up to 5 years using the alternative antiviral agent as rescue medication appears to be a cost-effective strategy for both HBeAg-positive and HBeAg-negative CHB patients in Korea. Economic evaluation of antiviral therapies should be studied further and updated, particularly for newer agents. (Korean J Hepatol 2008;15: 25-41)

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