Clinical and Molecular Hepatology

"Hepatitis C"

Special Issue

2025 KASL clinical practice guidelines for management of hepatitis C: Eun Sun Jang, Nae Yun Heo, Jae Yoon Jeong, Jung Gil Park, Do Seon Song, Eun Ju Cho, Chang Hun Lee, Jae Seung Lee, Jae Hyun Yoon, Seul Ki Han, Young Kul Jung, on behalf of the Korean Association for the Study of the Liver (KASL); Received July 15, 2025 Accepted October 20, 2025 Published online October 23, 2025; DOI: https://doi.org/10.3350/cmh.2025.0777 [Accepted]

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Research Letter

Contemporary Trends in Extrahepatic Mortality of Chronic Liver Disease in the United States from 2014 to 2023: Donghee Kim, Pojsakorn Danpanichkul, Karn Wijarnpreecha, Aijaz Ahmed; Received July 23, 2025 Accepted July 23, 2025 Published online July 28, 2025; DOI: https://doi.org/10.3350/cmh.2025.0802 [Accepted]

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Original Article

Distinct inflammatory imprint in non-cirrhotic and cirrhotic patients before and after direct-acting antiviral therapy: Moana Witte, Carlos Oltmanns, Jan Tauwaldt, Hagen Schmaus, Jasmin Mischke, Gordon Grabert, Mara Bretthauer, Lennart M. Roesner, Thomas Werfel, Katja Deterding, Benjamin Maasoumy, Heiner Wedemeyer, Tim Kacprowski, Anke R.M. Kraft, Markus Cornberg; Clin Mol Hepatol 2025;31(4):1269-1284.
Published online June 4, 2025; DOI: https://doi.org/10.3350/cmh.2025.0292

Background/Aims
Hepatitis C virus (HCV) infection remains a global health challenge, leading to chronic liver disease, cirrhosis, and hepatocellular carcinoma (HCC). Despite the high efficacy of direct-acting antiviral therapy in achieving sustained virologic response (SVR), concerns persist regarding long-term immune alterations and residual risks, particularly in cirrhotic patients.
Methods
This study investigates 75 soluble immune mediator (SIM) profiles in 102 chronic HCV patients, stratified by cirrhosis status, at therapy initiation, end of treatment, and long-term follow-up (median 96 weeks). Findings were compared with 51 matched healthy controls and validated in an independent cohort of 47 cirrhotic patients, 17 of whom developed HCC.
Results
We observed significant SIM alterations at baseline, with cirrhotic patients displaying a more profoundly dysregulated inflammatory milieu. Despite an overall decline in inflammatory markers following SVR, persistent alterations were evident, particularly in cirrhotic patients. Notably, those with liver stiffness exceeding 14 kPa exhibited sustained inflammatory dysregulation, correlating with liver elastography values. Key SIM such as interleukin (IL)-6, IL-8, urokinase plasminogen activator, and hepatocellular growth factor remained elevated and were associated with HCC development. Network analysis highlighted their roles in liver fibrosis, regeneration, and carcinogenesis.
Conclusions
These findings underscore the importance of early antiviral intervention to prevent cirrhosis-related sequelae. Future studies should explore the mechanistic pathways linking chronic inflammation, fibrosis, and oncogenesis to identify predictive biomarkers and novel therapeutic targets. Addressing persistent immune alterations post-HCV clearance may improve long-term outcomes, particularly in patients with advanced liver disease.

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HBV Dominance Is Associated With a Distinct Inflammatory Milieu in HBV/HCV Coinfection
Carlos Oltmanns, Moana Witte, Anika Wranke, Katja Deterding, Heiner Wedemeyer, Christine S. Falk, Anke R. M. Kraft, Steffen B. Wiegand, Markus Cornberg
Journal of Viral Hepatitis.2025;[Epub] CrossRef

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Research Letter

Contemporary burden of mortality from chronic liver disease by sex and race/ethnicity in the United States: Donghee Kim, Pojsakorn Danpanichkul, Karn Wijarnpreecha, George Cholankeril, Aijaz Ahmed; Clin Mol Hepatol 2025;31(3):e268-e272.
Published online May 8, 2025; DOI: https://doi.org/10.3350/cmh.2025.0384

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Rising drug overdose deaths in chronic liver disease in the United States, 2015–2023
Donghee Kim, Brittany B Dennis, Pojsakorn Danpanichkul, Karn Wijarnpreecha, George Cholankeril, Aijaz Ahmed
Clinical and Molecular Hepatology.2025; 31(3): e277. CrossRef
Advancing Policy and Practice in Alcohol-Associated Liver Disease and Alcohol-Attributable Cancer: Correspondence to the editorial on “Rising Burden of Alcohol-Associated Liver Disease and Cancers: Insights into Sex Disparities and Policy Implications”
Pojsakorn Danpanichkul, Donghee Kim, Karn Wijarnpreecha, Amit G. Singal, Ju Dong Yang
Clinical and Molecular Hepatology.2025;[Epub] CrossRef
Extrahepatic manifestation of metabolic dysfunction-associated steatotic liver disease
Anoushka Shenoy, Aijaz Ahmed, Donghee Kim
Metabolism and Target Organ Damage.2025;[Epub] CrossRef

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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; Received April 2, 2025 Accepted April 2, 2025 Published online April 4, 2025; DOI: https://doi.org/10.3350/cmh.2025.0362 [Epub ahead of print]

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Reply to Correspondence

SHOULD DIRECT-ACTING ANTIVIRAL BE CONSIDERED FOR ALL PATIENTS WITH HCV-RELATED HEPATOCELLULAR CARCINOMA?: Yan Ling ONG, Apichat KAEWDECH, Yu Jun WONG; Received March 5, 2025 Accepted March 10, 2025 Published online March 13, 2025; DOI: https://doi.org/10.3350/cmh.2025.0257 [Accepted]

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Correspondence

Emerging evidence supports direct-acting antiviral therapy for HCC patients beyond the early stage: Correspondence to editorial 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; Received February 28, 2025 Accepted March 1, 2025 Published online March 4, 2025; DOI: https://doi.org/10.3350/cmh.2025.0235 [Epub ahead of print]

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Revisiting unmet needs in clinical research on direct-acting antiviral therapy for HCC patients
Teng-Yu Lee, Pei-Chien Tsai, Shou-Wu Lee, Ming- Lung Yu
Clinical and Molecular Hepatology.2025;[Epub] CrossRef

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Reply to Correspondence

Viral hepatitis

Reply to correspondence on “Adverse impact of metabolic dysfunction on fibrosis regression following direct-acting antiviral therapy: A multicenter study for chronic hepatitis C”: Chen-Hua Liu, Yu-Ping Chang; Clin Mol Hepatol 2025;31(2):e232-e233.
Published online February 26, 2025; DOI: https://doi.org/10.3350/cmh.2025.0203

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Editorials

Editorial on “Direct-acting antiviral therapy for patients with HCV-related hepatocellular carcinoma: A nationwide cohort study”: Yan Ling Ong, Apichat Kaewdech, Daniel Q Huang, Yu Jun Wong; Received February 14, 2025 Accepted February 21, 2025 Published online February 24, 2025; DOI: https://doi.org/10.3350/cmh.2025.0174 [Epub ahead of print]

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Emerging evidence supports direct-acting antiviral therapy for HCC patients beyond the early stage
Teng-Yu Lee, Pei-Chien Tsai, Shou-Wu Lee, Ming- Lung Yu
Clinical and Molecular Hepatology.2025;[Epub] CrossRef

3,565 View
42 Download
Crossref

Viral hepatitis

Metabolic dysfunction in patients following DAA-induced viral cure for HCV infection: A non-negligible risk to liver-related health: Editorial on “Adverse impact of metabolic dysfunction on fibrosis regression following direct-acting antiviral therapy: A multicenter study for chronic hepatitis C”: Chen-Hua Liu, Yu-Ping Chang; Clin Mol Hepatol 2025;31(2):658-661.
Published online February 17, 2025; DOI: https://doi.org/10.3350/cmh.2025.0155

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Correspondence to editorial on “Adverse impact of metabolic dysfunction on fibrosis regression following direct-acting antiviral therapy: A multicenter study for chronic hepatitis C”
Tom Ryu, Young Chang, Seung Up Kim, Jae Young Jang
Clinical and Molecular Hepatology.2025; 31(2): e203. CrossRef
Reply to correspondence on “Adverse impact of metabolic dysfunction on fibrosis regression following direct-acting antiviral therapy: A multicenter study for chronic hepatitis C”
Chen-Hua Liu, Yu-Ping Chang
Clinical and Molecular Hepatology.2025; 31(2): e232. CrossRef
Viral oncogenesis and immune remodeling: Decoding the therapeutic potential of immune checkpoint inhibitors in virus-associated cancers
Lihua Qi, Bai Hu, Canhui Cao, Ting Peng, Miaochun Xu, Shiyi Liu, Yashi Xu, Xiaojie Liu, Wencheng Ding, Li Li, Shitong Lin
Biomedicine & Pharmacotherapy.2025; 191: 118515. CrossRef

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Original Articles

Direct-acting antiviral therapy for patients with hepatitis C virus-related hepatocellular carcinoma: A nationwide cohort study: Shou-Wu Lee, Sheng-Shun Yang, Pei-Chien Tsai, Chung-Feng Huang, Chi-Yi Chen, Chao-Hung Hung, Chien-Hung Chen, Chi-Ming Tai, Pin-Nan Cheng, Hsing-Tao Kuo, Kuo-Chih Tseng, Lein-Ray Mo, Ching-Chu Lo, Yi-Hsiang Huang, Han-Chieh Lin, Pei-Lun Lee, Ming-Jong Bair, Te-Sheng Chang, Chun-Yen Lin, Szu-Jen Wang, Tsai-Yuan Hsieh, Tzeng-Hue Yang, Cheng-Yuan Peng, Chi-Chieh Yang, Lee-Won Chong, Chien-Wei Huang, Chih-Wen Lin, Cheng-Hsin Chu, Ming-Chang Tsai, Jia-Horng Kao, Chun-Jen Liu, Wan-Long Chuang, Teng-Yu Lee, Ming-Lung Yu, on behalf of TACR investigators; Clin Mol Hepatol 2025;31(3):899-913.
Published online February 5, 2025; DOI: https://doi.org/10.3350/cmh.2024.1015

Background/Aims
The survival benefit of direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) infection in patients with hepatocellular carcinoma (HCC), particularly in Barcelona Clinic Liver Cancer (BCLC) stages B/C, remains largely uncertain. We aimed to explore the impact of DAA therapy on overall survival (OS) in HCC patients using a nationwide cohort study.
Methods
We utilized the nationwide Taiwan Association for the Study of the Liver (TASL) HCV Registry (TACR) database to include all adults receiving a DAA therapy for HCV, excluding those with other viral infections, liver transplantation, non-HCC malignancies, and terminal-staged HCC. We respectively analyzed the adjusted odds ratio (aOR) for sustained virological response (SVR) and adjusted hazard ratio (aHR) for OS.
Results
Between December 2013 and December 2020, 2,205 (9.3%) patients with HCC and 21,569 (90.7%) patients without HCC were include. The SVR rates were 96.6% in the HCC group and 98.8% in the non-HCC group (P<0.001), with HCC being an independent risk factor affecting SVR (aOR 0.41; 95% CI 0.31–0.54; P<0.001). In the whole patient cohort, SVR was independently associated with improved OS (aHR 0.46; 95% CI 0.35–0.60; P<0.001). Among patients with baseline HCC, SVR remained an independent factor related to OS (aHR 0.41; 95% CI 0.28–0.59; P<0.001). The impact of SVR on OS persisted significantly across BCLC stages 0/A and stages B/C.
Conclusions
High SVR rates among HCC patients underscore the importance of DAA therapy in enhancing OS, reaffirming its efficacy across various HCC stages.

Citations

Citations to this article as recorded by

Survival impact of hepatitis C virus eradication in patients with or without active hepatocellular carcinoma: A nationwide cohort study
Teng-Yu Lee, Sheng-Shun Yang, Pei-Chien Tsai, Chung-Feng Huang, Chi-Yi Chen, Chao-Hung Hung, Chien-Hung Chen, Chi-Ming Tai, Pin-Nan Cheng, Hsing-Tao Kuo, Kuo-Chih Tseng, Lein-Ray Mo, Ching-Chu Lo, Yi-Hsiang Huang, Han-Chieh Lin, Pei-Lun Lee, Ming-Jong Bai
European Journal of Cancer.2026; 232: 116109. CrossRef
Revisiting unmet needs in clinical research on direct-acting antiviral therapy for HCC patients
Teng-Yu Lee, Pei-Chien Tsai, Shou-Wu Lee, Ming- Lung Yu
Clinical and Molecular Hepatology.2025;[Epub] CrossRef
Emerging evidence supports direct-acting antiviral therapy for HCC patients beyond the early stage
Teng-Yu Lee, Pei-Chien Tsai, Shou-Wu Lee, Ming- Lung Yu
Clinical and Molecular Hepatology.2025;[Epub] CrossRef
HIV, Viral Hepatitis, and Schistosomiasis Association with Liver Cancer: A Systematic Review
Khumbuzile Canham, Pragalathan Naidoo, Sibusiso Senzani, Sayed Shakeel Kader, Zilungile L. Mkhize-Kwitshana
Microorganisms.2025; 13(12): 2753. CrossRef

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1 Web of Science
Crossref

Viral hepatitis

Cost-effectiveness and return on investment of hepatitis C virus elimination in China: A modelling study: Meiyu Wu, Jing Ma, Xuehong Wang, Sini Li, Chongqing Tan, Ouyang Xie, Andong Li, Aaron G Lim, Xiaomin Wan; Clin Mol Hepatol 2025;31(2):394-408.
Published online December 3, 2024; DOI: https://doi.org/10.3350/cmh.2024.0664

Background/Aims
The World Health Organization set the goal of eliminating hepatitis C virus (HCV) by 2030, with 80% and 65% reductions in HCV incidence and mortality rates, respectively. We aimed to evaluate the health benefits, cost-effectiveness and return on investment (ROI) of HCV elimination.
Methods
Using an HCV transmission compartmental model, we evaluated the benefits and costs of different strategies combining screening and treatment for Chinese populations. We identified strategies to achieve HCV elimination and calculated the incremental cost-effectiveness ratios (ICERs) per disability-adjusted life year (DALY) averted for 2022–2030 to identify the optimal elimination strategy. Furthermore, we estimated the ROI by 2050 by comparing the required investment with the economic productivity gains from reduced HCV incidence and deaths.
Results
The strategy that results in the most significant health benefits involves conducting annual primary screening at a rate of 14%, re-screening people who inject drugs annually and the general population every five years, and treating 95% of those diagnosed (P14-R4-T95), preventing approximately 5.75 and 0.44 million HCV infections and deaths, respectively, during 2022–2030. At a willingness-to-pay threshold of $12,615, the P14-R4-T95 strategy is the most cost-effective, with an ICER of $5,449/DALY. By 2050, this strategy would have a net benefit of $120,997 million (ROI=0.868).
Conclusions
Achieving HCV elimination in China by 2030 will require significant investment in large-scale universal screening and treatment, but it will yield substantial health and economic benefits and is cost-effective.

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Cost-Effectiveness of Screening and Treating Chronic Hepatitis C Virus Infection in Zimbabwe
Blessing Dzingirai, Leolin Katsidzira, Maarten J. Postma, Marinus van Hulst, Nyashadzaishe Mafirakureva
International Journal of Environmental Research and Public Health.2025; 22(4): 509. CrossRef
Investing in health: Policy lessons from reimbursing direct-acting antivirals for hepatitis C in Taiwan
Raoh-Fang Pwu, Wen-Wen Yang, Grace Hui-Min Wu, Sheng-Nan Lu, Rong-Nan Chien
Journal of the Formosan Medical Association.2025;[Epub] CrossRef

6,567 View
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Correspondence

Viral hepatitis

HCV self-testing: Bridging screening gaps and ensuring cost-effectiveness for both high-risk and universal populations: Correspondence to editorial on “Self-testing strategy to eliminate hepatitis C as per World Health Organization’s goal: Analysis of disease burden and cost-effectiveness”: Gyeongseon Shin, Beom Kyung Kim, SeungJin Bae, Hankil Lee, Sang Hoon Ahn; Clin Mol Hepatol 2025;31(2):e163-e165.
Published online November 29, 2024; DOI: https://doi.org/10.3350/cmh.2024.1057

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Letter to the Editor

Comment: Non-invasive prediction of post-sustained virological response hepatocellular carcinoma in hepatitis C virus: Xinpu Miao, Haidong Wu, Jinrong Xu, Wei Cheng; Clin Mol Hepatol 2025;31(1):e23-e24.
Published online November 26, 2024; DOI: https://doi.org/10.3350/cmh.2024.1035

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32 Download

Editorial

Viral hepatitis

Universal self-testing as a cost-effective weapon to eliminate hepatitis C virus in the Republic of Korea: Editorial on “Self-testing strategy to eliminate hepatitis C as per World Health Organization’s goal: Analysis of disease burden and cost-effectiveness”: Eun Sun Jang; Clin Mol Hepatol 2025;31(2):596-598.
Published online November 11, 2024; DOI: https://doi.org/10.3350/cmh.2024.0992

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HCV self-testing: Bridging screening gaps and ensuring cost-effectiveness for both high-risk and universal populations: Correspondence to editorial on “Self-testing strategy to eliminate hepatitis C as per World Health Organization’s goal: Analysis of dis
Gyeongseon Shin, Beom Kyung Kim, SeungJin Bae, Hankil Lee, Sang Hoon Ahn
Clinical and Molecular Hepatology.2025; 31(2): e163. CrossRef

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25 Download
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Crossref

Correspondence

Viral hepatitis

Correspondence to letter to the editor on “Contemporary awareness of viral hepatitis between 2012 and 2022 among Korean adults”: Chang Hun Lee, In Hee Kim, Sook-Hyang Jeong; Clin Mol Hepatol 2025;31(2):e149-e151.
Published online November 6, 2024; DOI: https://doi.org/10.3350/cmh.2024.0944

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Letter to the Editor

Viral hepatitis

Contemporary awareness of viral hepatitis between 2012 and 2022 among Korean adults: Donghee Kim, Won Kim, Aijaz Ahmed; Clin Mol Hepatol 2025;31(1):e5-e7.
Published online October 8, 2024; DOI: https://doi.org/10.3350/cmh.2024.0849

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Correspondence to letter to the editor on “Contemporary awareness of viral hepatitis between 2012 and 2022 among Korean adults”
Chang Hun Lee, In Hee Kim, Sook-Hyang Jeong
Clinical and Molecular Hepatology.2025; 31(2): e149. CrossRef

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53 Download
1 Web of Science
Crossref

Original Article

Viral hepatitis

Self-testing strategy to eliminate hepatitis C as per World Health Organization’s goal: Analysis of disease burden and cost-effectiveness: Gyeongseon Shin, Beom Kyung Kim, SeungJin Bae, Hankil Lee, Sang Hoon Ahn; Clin Mol Hepatol 2025;31(1):166-178.
Published online October 4, 2024; DOI: https://doi.org/10.3350/cmh.2024.0484

Background/Aims
The World Health Organization (WHO) aims to eliminate hepatitis C virus (HCV) by 2030; therefore, widespread HCV screening is required. The WHO recommends HCV self-testing (HCVST) as a new approach. We aimed to evaluate disease burden reduction using the HCVST screening strategy and identify the most cost-effective approach.
Methods
We developed a dynamic open-cohort Markov model to assess the long-term effects and costeffectiveness of HCVST in the Republic of Korea from 2024 to 2030. Strategies for comparison included universal, birth cohort, high-risk group screening, and no screening, focusing on the following: (1) incremental costeffectiveness ratio (ICER) per disability-adjusted life-year (DALY) saved; (2) severe liver disease cases; and (3) liverrelated death reduction.
Results
Universal HCVST screening is the most effective strategy for achieving the WHO goal by 2030, substantially lowering the incidence of severe liver disease by 71% and preventing liver-related deaths by 69%, thereby averting 267,942 DALYs. Moreover, with an ICER of US$8,078 per DALY and high cost-effectiveness, the sensitivity results prove that cost-effectiveness is robust. Although high-risk group screening offers the lowest cost compared with other strategies, its effectiveness in preventing severe liver disease is minimal, falling short of the current WHO goal.
Conclusions
Our study confirms that universal HCVST screening is a cost-effective strategy aligned with the WHO goal to eliminate HCV by 2030. Despite its higher costs compared to risk-based screening, the disease burden can be significantly reduced by providing effective HCVST access to individuals who might otherwise not be tested.

Citations

Citations to this article as recorded by

HCV self-testing: Bridging screening gaps and ensuring cost-effectiveness for both high-risk and universal populations: Correspondence to editorial on “Self-testing strategy to eliminate hepatitis C as per World Health Organization’s goal: Analysis of dis
Gyeongseon Shin, Beom Kyung Kim, SeungJin Bae, Hankil Lee, Sang Hoon Ahn
Clinical and Molecular Hepatology.2025; 31(2): e163. CrossRef
Universal self-testing as a cost-effective weapon to eliminate hepatitis C virus in the Republic of Korea: Editorial on “Self-testing strategy to eliminate hepatitis C as per World Health Organization’s goal: Analysis of disease burden and cost-effectiven
Eun Sun Jang
Clinical and Molecular Hepatology.2025; 31(2): 596. CrossRef
Cost-effectiveness and return on investment of hepatitis C virus elimination in China: A modelling study
Meiyu Wu, Jing Ma, Xuehong Wang, Sini Li, Chongqing Tan, Ouyang Xie, Andong Li, Aaron G Lim, Xiaomin Wan
Clinical and Molecular Hepatology.2025; 31(2): 394. CrossRef
Future Perspectives of Liver Research in the Asia‐Pacific Region: Focus on Hepatitis B and C
Beom Kyung Kim
Journal of Gastroenterology and Hepatology.2025; 40(8): 1855. CrossRef
Bridging the Gap in Elimination of Hepatitis C Virus among People Who Use Drugs in South Korea
Beom Kyung Kim
Gut and Liver.2025; 19(5): 635. CrossRef
OraQuick hepatitis C virus self-test: A new frontier in hepatitis C screening
Muneeb Saifullah, Mavra Khan, Muhammad Ashhad Usman, Qasim Mehmood, Abbas M Mehdi
World Journal of Virology.2025;[Epub] CrossRef

5,664 View
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Editorial

Hepatocellular carcinoma surveillance after sustained virological response in chronic hepatitis C: Editorial on “Non-invasive prediction of post-sustained virological response hepatocellular carcinoma in hepatitis C virus: A systematic review and meta-analysis”: Ho Soo Chun, Minjong Lee; Clin Mol Hepatol 2025;31(1):261-263.
Published online September 20, 2024; DOI: https://doi.org/10.3350/cmh.2024.0795

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Original Article

Hepatic neoplasm

Non-invasive prediction of post-sustained virological response hepatocellular carcinoma in hepatitis C virus: A systematic review and meta-analysis: Han Ah Lee, Mi Na Kim, Hye Ah Lee, Miyoung Choi, Jung Hwan Yu, Young-Joo Jin, Hee Yeon Kim, Ji Won Han, Seung Up Kim, Jihyun An, Young Eun Chon; Clin Mol Hepatol 2024;30(Suppl):S172-S185.
Published online August 12, 2024; DOI: https://doi.org/10.3350/cmh.2024.0262

Backgrounds/Aims
Despite advances in antiviral therapy for hepatitis C virus (HCV) infection, hepatocellular carcinoma (HCC) still develops even after sustained viral response (SVR) in patients with advanced liver fibrosis or cirrhosis. This meta-analysis investigated the predictive performance of vibration-controlled transient elastography (VCTE) and fibrosis 4-index (FIB-4) for the development of HCC after SVR.
Methods
We searched PubMed, MEDLINE, EMBASE, and the Cochrane Library for studies examining the predictive performance of these tests in adult patients with HCV. Two authors independently screened the studies’ methodological quality and extracted data. Pooled estimates of sensitivity, specificity, and area under the curve (AUC) were calculated for HCC development using random-effects bivariate logit normal and linear-mixed effect models.
Results
We included 27 studies (169,911 patients). Meta-analysis of HCC after SVR was possible in nine VCTE and 15 FIB-4 studies. Regarding the prediction of HCC development after SVR, the pooled AUCs of pre-treatment VCTE >9.2–13 kPa and FIB-4 >3.25 were 0.79 and 0.73, respectively. VCTE >8.4–11 kPa and FIB-4 >3.25 measured after SVR maintained good predictive performance, albeit slightly reduced (pooled AUCs: 0.77 and 0.70, respectively). The identified optimal cut-off value for HCC development after SVR was 12.6 kPa for pre-treatment VCTE. That of VCTE measured after the SVR was 11.2 kPa.
Conclusions
VCTE and FIB-4 showed acceptable predictive performance for HCC development in patients with HCV who achieved SVR, underscoring their utility in clinical practice for guiding surveillance strategies. Future studies are needed to validate these findings prospectively and validate their clinical impact.

Citations

Citations to this article as recorded by

Comment: Non-invasive prediction of post-sustained virological response hepatocellular carcinoma in hepatitis C virus
Xinpu Miao, Haidong Wu, Jinrong Xu, Wei Cheng
Clinical and Molecular Hepatology.2025; 31(1): e23. CrossRef
Hepatocellular carcinoma surveillance after sustained virological response in chronic hepatitis C: Editorial on “Non-invasive prediction of post-sustained virological response hepatocellular carcinoma in hepatitis C virus: A systematic review and meta-ana
Ho Soo Chun, Minjong Lee
Clinical and Molecular Hepatology.2025; 31(1): 261. CrossRef
Longitudinal Effects of Glecaprevir/Pibrentasvir on Liver Function, Fibrosis, and Hepatocellular Carcinoma Risk in Chronic Hepatitis C: A Prospective Multicenter Cohort Study
Jung Hee Kim, Jae Hyun Yoon, Sung-Eun Kim, Ji-Won Park, Yewan Park, Gi-Ae Kim, Seong Kyun Na, Young-Sun Lee, Jeong Han Kim
Medicina.2025; 61(9): 1601. CrossRef
Precision Strategy for Hepatocellular Carcinoma Surveillance after Hepatitis C Cure: Debates across Guidelines
Masaaki Mino, Eiji Kakazu, Tatsuya Kanto
Gut and Liver.2025; 19(5): 651. CrossRef
Liver Stiffness Measurements After Oral Antivirals Effectively Predict the Risk of HCC in Patients With Chronic Hepatitis C
Yu Rim Lee, Hyun Young Woo, Young Oh. Kweon, Won Young Tak, Se Young Jang, Jung Gil Park, Min Kyu Kang, Jeong Eun Song, Byoung Kuk Jang, Changhyeong Lee, Byung Seok Kim, Jae Seok Hwang, Woo Jin Chung, Jeong Heo, Nae‐Yun Heo, Seung Ha Park, Jun Sik Yoon, J
Journal of Gastroenterology and Hepatology.2025; 40(10): 2568. CrossRef
Diagnostic possibilities of perfusion computed tomography in assessing fibrosis regression in patients with chronic viral hepatitis C: a prospective study
E. A. Ioppa, O. S. Tonkikh, I. Yu. Degtyarev, V. D. Zavadovskaya, E. S. Garganeeva
Diagnostic radiology and radiotherapy.2025; 16(3): 65. CrossRef
Liver Fibrosis Assessment in Chronic Liver Diseases Using Elastography: A Comprehensive Review of Vibration-Controlled Transient Elastography and Shear Wave Elastography
Han Ah Lee
Clinical Ultrasound.2024; 9(2): 70. CrossRef

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Editorial

Viral hepatitis

MASLD after hepatitis C virus eradication: Do not overlook the cardiometabolic risk factors: Editorial on “Dynamic change of metabolic dysfunction-associated steatotic liver disease in chronic hepatitis C patients after viral eradication: A nationwide registry study in Taiwan”: Rex Wan-Hin Hui, Lung-Yi Mak; Clin Mol Hepatol 2025;31(1):290-292.
Published online August 7, 2024; DOI: https://doi.org/10.3350/cmh.2024.0630

Citations

Citations to this article as recorded by

Steatotic liver disease in chronic hepatitis C related hepatocellular carcinoma: Inflictor or bystander?: Correspondence to editorial on “Dynamic change of metabolic dysfunction-associated steatotic liver disease in chronic hepatitis C patients after vira
Chung-Feng Huang, Ming-Lun Yeh, Chia-Yen Dai, Jee-Fu Huang, Wan-Long Chuang, Ming-Lung Yu
Clinical and Molecular Hepatology.2025; 31(1): e64. CrossRef
Reply to comment on “Posttreatment FIB-4 score change predicts hepatocellular carcinoma in chronic hepatitis C patients: Findings from the Taiwan hepatitis C registry program”
Hung-Wei Wang, Cheng-Yuan Peng, Ming-Lung Yu
Journal of the Formosan Medical Association.2025;[Epub] CrossRef

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38 Download
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Correspondence

Viral hepatitis

Correspondence to editorial on “Core indicators related to the elimination of hepatitis B and C virus infection in South Korea: A nationwide study”: Chang Hun Lee, In Hee Kim, Sook-Hyang Jeong; Clin Mol Hepatol 2024;30(4):997-999.
Published online July 29, 2024; DOI: https://doi.org/10.3350/cmh.2024.0588

4,250 View
55 Download

Editorials

Viral hepatitis

Metformin and statins and their role in reducing hepatocellular carcinoma risk: Randomized trials are needed: Editorial on “Metformin and statins reduce hepatocellular carcinoma risk in chronic hepatitis C patients with failed antiviral therapy”: Paul Y. Kwo; Clin Mol Hepatol 2024;30(4):714-717.
Published online June 11, 2024; DOI: https://doi.org/10.3350/cmh.2024.0425

Citations

Citations to this article as recorded by

Reply to correspondence on “Metformin and statins reduce hepatocellular carcinoma risk in chronic hepatitis C patients with failed antiviral therapy”
Seren M. Gedallovich, Paul Y. Kwo
Clinical and Molecular Hepatology.2024; 30(4): 1050. CrossRef
Metformin in Antiviral Therapy: Evidence and Perspectives
Iryna Halabitska, Pavlo Petakh, Oleh Lushchak, Iryna Kamyshna, Valentyn Oksenych, Oleksandr Kamyshnyi
Viruses.2024; 16(12): 1938. CrossRef

5,178 View
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2 Web of Science
Crossref

Viral hepatitis

Meeting the challenges of hepatocellular carcinoma post sustained virologic response in the post-direct- acting antiviral era: A path forward: Editorial on “Unmet needs in the post-direct-acting antivirals era: The risk and molecular mechanisms of hepatocellular carcinoma after hepatitis C virus eradication”: Seren M. Gedallovich, Paul Y. Kwo; Clin Mol Hepatol 2024;30(4):677-681.
Published online June 11, 2024; DOI: https://doi.org/10.3350/cmh.2024.0418

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43 Download

Steatotic liver disease

Metabolic dysfunction-associated fatty liver disease is a ubiquitous latent cofactor in viral- and alcoholic-related hepatocellular carcinoma: Editorial on “Global prevalence of metabolic dysfunction-associated fatty liver disease-related hepatocellular carcinoma: A systematic review and meta-analysis”: Toru Nakamura, Masahito Nakano, Tsubasa Tsutsumi, Keisuke Amano, Takumi Kawaguchi; Clin Mol Hepatol 2024;30(4):705-708.
Published online May 20, 2024; DOI: https://doi.org/10.3350/cmh.2024.0372

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Hepatocellular carcinoma surveillance after sustained virological response in chronic hepatitis C: Editorial on “Non-invasive prediction of post-sustained virological response hepatocellular carcinoma in hepatitis C virus: A systematic review and meta-ana
Ho Soo Chun, Minjong Lee
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Original Article

Viral hepatitis

Metformin and statins reduce hepatocellular carcinoma risk in chronic hepatitis C patients with failed antiviral therapy: Pei-Chien Tsai, Chung-Feng Huang, Ming-Lun Yeh, Meng-Hsuan Hsieh, Hsing-Tao Kuo, Chao-Hung Hung, Kuo-Chih Tseng, Hsueh-Chou Lai, Cheng-Yuan Peng, Jing-Houng Wang, Jyh-Jou Chen, Pei-Lun Lee, Rong-Nan Chien, Chi-Chieh Yang, Gin-Ho Lo, Jia-Horng Kao, Chun-Jen Liu, Chen-Hua Liu, Sheng-Lei Yan, Chun-Yen Lin, Wei-Wen Su, Cheng-Hsin Chu, Chih-Jen Chen, Shui-Yi Tung, Chi‐Ming Tai, Chih-Wen Lin, Ching-Chu Lo, Pin-Nan Cheng, Yen-Cheng Chiu, Chia-Chi Wang, Jin-Shiung Cheng, Wei-Lun Tsai, Han-Chieh Lin, Yi-Hsiang Huang, Chi-Yi Chen, Jee-Fu Huang, Chia-Yen Dai, Wan-Long Chung, Ming-Jong Bair, Ming-Lung Yu, T-COACH Study Group; Clin Mol Hepatol 2024;30(3):468-486.
Published online April 19, 2024; DOI: https://doi.org/10.3350/cmh.2024.0038

Background/Aims
Chronic hepatitis C (CHC) patients who failed antiviral therapy are at increased risk for hepatocellular carcinoma (HCC). This study assessed the potential role of metformin and statins, medications for diabetes mellitus (DM) and hyperlipidemia (HLP), in reducing HCC risk among these patients.
Methods
We included CHC patients from the T-COACH study who failed antiviral therapy. We tracked the onset of HCC 1.5 years post-therapy by linking to Taiwan’s cancer registry data from 2003 to 2019. We accounted for death and liver transplantation as competing risks and employed Gray’s cumulative incidence and Cox subdistribution hazards models to analyze HCC development.
Results
Out of 2,779 patients, 480 (17.3%) developed HCC post-therapy. DM patients not using metformin had a 51% increased risk of HCC compared to non-DM patients, while HLP patients on statins had a 50% reduced risk compared to those without HLP. The 5-year HCC incidence was significantly higher for metformin non-users (16.5%) versus non-DM patients (11.3%; adjusted sub-distribution hazard ratio [aSHR]=1.51; P=0.007) and metformin users (3.1%; aSHR=1.59; P=0.022). Statin use in HLP patients correlated with a lower HCC risk (3.8%) compared to non-HLP patients (12.5%; aSHR=0.50; P<0.001). Notably, the increased HCC risk associated with non-use of metformin was primarily seen in non-cirrhotic patients, whereas statins decreased HCC risk in both cirrhotic and non-cirrhotic patients.
Conclusions
Metformin and statins may have a chemopreventive effect against HCC in CHC patients who failed antiviral therapy. These results support the need for personalized preventive strategies in managing HCC risk.

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Editorial

Viral hepatitis

Toward hepatitis C virus elimination using artificial intelligence: Moon Haeng Hur, Jeong-Hoon Lee; Clin Mol Hepatol 2024;30(2):147-149.
Published online February 23, 2024; DOI: https://doi.org/10.3350/cmh.2024.0135

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Hepatocellular carcinoma surveillance after sustained virological response in chronic hepatitis C: Editorial on “Non-invasive prediction of post-sustained virological response hepatocellular carcinoma in hepatitis C virus: A systematic review and meta-ana
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Original Articles

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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Viral hepatitis

Core indicators related to the elimination of hepatitis B and C virus infection in South Korea: A nationwide study: Chang Hun Lee, Gwang Hyeon Choi, Hwa Young Choi, Sojung Han, Eun Sun Jang, Young Eun Chon, Young Chang, Kyung-Ah Kim, Do Young Kim, Hyung Joon Yim, Hye-Lin Kim, Sook-Hyang Jeong, In Hee Kim; Clin Mol Hepatol 2023;29(3):779-793.
Published online May 15, 2023; DOI: https://doi.org/10.3350/cmh.2023.0110

Background/Aims
To eliminate hepatitis B virus (HBV) and hepatitis C virus (HCV) according to the World Health Organization (WHO) criteria in 2021, this study investigated the national core indicators representing the current status of viral hepatitis B and C in South Korea.
Methods
We analyzed the incidence, linkage-to-care, treatment, and mortality rates of HBV and HCV infection using the integrated nationwide big data of South Korea.
Results
According to data from 2018–2020, the incidence of acute HBV infection in South Korea was 0.71 cases per 100,000 population; tthe linkage-to-care rate was only 39.4%. Among those who need hepatitis B treatment, the treatment rate was 67.3%, which was less than 80% reported in the WHO program index. The annual liver-related mortality due to HBV was 18.85 cases per 100,000 population, exceeding the WHO target of four; the most frequent cause of death was liver cancer (54.1%). The annual incidence of newly diagnosed HCV infection was 11.9 cases per 100,000 population, which was higher than the WHO impact target of five. Among HCV-infected patients, the linkage-to-care rate was 65.5% while the treatment rate was 56.8%, which were below the targets of 90% and 80%, respectively. The liver-related annual mortality rate due to HCV infection was 2.02 cases per 100,000 population.
Conclusions
Many of the current indicators identified in the Korean population did not satisfy the WHO criteria for validation of viral hepatitis elimination. Hence, a comprehensive national strategy should be urgently developed with continuous monitoring of the targets in South Korea.

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Journal of Hepatology.2025; 82(3): 456. CrossRef
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Si Yang, Yujiao Deng, Yi Zheng, Jing Zhang, Dongdong He, Zhijun Dai, Changcun Guo
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Contemporary awareness of viral hepatitis between 2012 and 2022 among Korean adults
Donghee Kim, Won Kim, Aijaz Ahmed
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N. A. Vlasova, V. I. Apanasevich, E. V. Eliseeva, S. S. Startsev
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Viral hepatitis

Next-generation sequencing analysis of hepatitis C virus resistance–associated substitutions in direct-acting antiviral failure in South Korea: Kyung-Ah Kim, Sejoon Lee, Hye Jung Park, Eun Sun Jang, Youn Jae Lee, Sung Bum Cho, Young Suk Kim, In Hee Kim, Byung Seok Lee, Woo Jin Chung, Sang Hoon Ahn, Seungtaek Kim, Sook Hyang Jeong; Clin Mol Hepatol 2023;29(2):496-509.
Published online March 6, 2023; DOI: https://doi.org/10.3350/cmh.2022.0345

Background/Aims
We used next-generation sequencing (NGS) to analyze resistance-associated substitutions (RASs) and retreatment outcomes in patients with chronic hepatitis C virus (HCV) infection who failed direct-acting antiviral agent (DAA) treatment in South Korea.
Methods
Using prospectively collected data from the Korean HCV cohort study, we recruited 36 patients who failed DAA treatment in 10 centers between 2007 and 2020; 29 blood samples were available from 24 patients. RASs were analyzed using NGS.
Results
RASs were analyzed for 13 patients with genotype 1b, 10 with genotype 2, and one with genotype 3a. The unsuccessful DAA regimens were daclatasvir+asunaprevir (n=11), sofosbuvir+ribavirin (n=9), ledipasvir/sofosbuvir (n=3), and glecaprevir/pibrentasvir (n=1). In the patients with genotype 1b, NS3, NS5A, and NS5B RASs were detected in eight, seven, and seven of 10 patients at baseline and in four, six, and two of six patients after DAA failure, respectively. Among the 10 patients with genotype 2, the only baseline RAS was NS3 Y56F, which was detected in one patient. NS5A F28C was detected after DAA failure in a patient with genotype 2 infection who was erroneously treated with daclatasvir+asunaprevir. After retreatment, 16 patients had a 100% sustained virological response rate.
Conclusions
NS3 and NS5A RASs were commonly present at baseline, and there was an increasing trend of NS5A RASs after failed DAA treatment in genotype 1b. However, RASs were rarely present in patients with genotype 2 who were treated with sofosbuvir+ribavirin. Despite baseline or treatment-emergent RASs, retreatment with pan-genotypic DAA was highly successful in Korea, so we encourage active retreatment after unsuccessful DAA treatment.

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Sayali Shinde, Carola Maria Bigogno, Ana Simmons, Nikita Kathuria, Aruni Ghose, Vedika Apte, Patricia Lapitan, Shania Makker, Aydin Caglayan, Stergios Boussios
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Ming-Ying Lu, Ming-Lung Yu
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Reviews

Viral hepatitis

Acute hepatitis C virus infection: clinical update and remaining challenges: Chen-Hua Liu, Jia-Horng Kao; Clin Mol Hepatol 2023;29(3):623-642.
Published online February 20, 2023; DOI: https://doi.org/10.3350/cmh.2022.0349

Abstract
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Acute hepatitis C virus (HCV) infection is a global health concern with substantial geographical variation in the incidence rate. People who have received unsafe medical procedures, used injection drugs, and lived with human immunodeficiency virus are reported to be most susceptible to acute HCV infection. The diagnosis of acute HCV infection is particularly challenging in immunocompromised, reinfected, and superinfected patients due to difficulty in detecting anti-HCV antibody seroconversion and HCV ribonucleic acid from a previously negative antibody response. With an excellent treatment effect on chronic HCV infection, recently, clinical trials investigating the benefit of direct-acting antivirals (DAAs) treatment for acute HCV infection have been conducted. Based on the results of cost-effectiveness analysis, DAAs should be initiated early in acute HCV infection prior to spontaneous viral clearance. Compared to the standard 8–12 week-course of DAAs for chronic HCV infection, DAAs treatment duration may be shortened to 6–8 weeks in acute HCV infection without compromising the efficacy. Standard DAA regimens provide comparable efficacy in treating HCV-reinfected patients and DAA-naïve ones. For cases contracting acute HCV infection from HCV-viremic liver transplant, a 12-week course of pangenotypic DAAs is suggested. While for cases contracting acute HCV infection from HCV-viremic non-liver solid organ transplants, a short course of prophylactic or pre-emptive DAAs is suggested. Currently, prophylactic HCV vaccines are unavailable. In addition to treatment scale-up for acute HCV infection, practice of universal precaution, harm reduction, safe sex, and vigilant surveillance after viral clearance remain critical in reducing HCV transmission.

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Viral hepatitis

Hepatocytes infected with hepatitis C virus change immunological features in the liver microenvironment: Soo-Jeung Park, Young S. Hahn; Clin Mol Hepatol 2023;29(1):65-76.
Published online August 12, 2022; DOI: https://doi.org/10.3350/cmh.2022.0032

Abstract
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Hepatitis C virus (HCV) infection is remarkably efficient in establishing viral persistence, leading to the development of liver cirrhosis and hepatocellular carcinoma (HCC). Direct-acting antiviral agents (DAAs) are promising HCV therapies to clear the virus. However, recent reports indicate potential increased risk of HCC development among HCV patients with cirrhosis following DAA therapy. CD8⁺ T-cells participate in controlling HCV infection. However, in chronic hepatitis C patients, severe CD4⁺ and CD8⁺ T-cell dysfunctions have been observed. This suggests that HCV may employ mechanisms to counteract or suppress the host T-cell responses. The primary site of viral replication is within hepatocytes where infection can trigger the expression of costimulatory molecules and the secretion of immunoregulatory cytokines. Numerous studies indicate that HCV infection in hepatocytes impairs antiviral host immunity by modulating the expression of immunoregulatory molecules. Hepatocytes expressing whole HCV proteins upregulate the ligands of programmed cell death protein 1 (PD-1), programmed death-ligand 1 (PD-L1), and transforming growth factor β (TGF-β) synthesis compared to those in hepatocytes in the absence of the HCV genome. Importantly, HCV-infected hepatocytes are capable of inducing regulatory CD4⁺ T-cells, releasing exosomes displaying TGF-β on exosome surfaces, and generating follicular regulatory T-cells. Recent studies report that the expression profile of exosome microRNAs provides biomarkers of HCV infection and HCV-related chronic liver diseases. A better understanding of the immunoregulatory mechanisms and identification of biomarkers associated with HCV infection will provide insight into designing vaccine against HCV to bypass HCV-induced immune dysregulation and prevent development of HCV-associated chronic liver diseases.

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Viral hepatitis

Cost-effectiveness of chronic hepatitis C screening and treatment: Hye Won Lee, Hankil Lee, Beom Kyung Kim, Young Chang, Jae Young Jang, Do Young Kim; Clin Mol Hepatol 2022;28(2):164-173.
Published online December 27, 2021; DOI: https://doi.org/10.3350/cmh.2021.0193

Hepatitis C virus (HCV) infection is the second most common cause of chronic liver disease in South Korea, with a prevalence ranging from 0.6% to 0.8%, and HCV infection incidence increases with age. The anti-HCV antibody test, which is cheaper than the HCV RNA assay, is widely used to screen for HCV infections; however, the underdiagnosis of HCV is a major barrier to the elimination of HCV infections. Although several risk factors have been associated with HCV infections, including intravenous drug use, blood transfusions, and hemodialysis, most patients with HCV infections present with no identifiable risk factors. Universal screening for HCV in adults has been suggested to improve the detection of HCV infections. We reviewed the cost-effectiveness of HCV screening and the methodologies used to perform screening. Recent studies have suggested that universal HCV screening and treatment using direct-acting antivirals represent cost-effective approaches to the prevention and treatment of HCV infection. However, the optimal timing and frequency of HCV screening remain unclear, and further studies are necessary to determine the best approaches for the elimination of HCV infections.

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Original Articles

Viral hepatitis

A cost-effectiveness study of universal screening for hepatitis C virus infection in South Korea: A societal perspective: Hye-Lin Kim, Kyung-Ah Kim, Gwang Hyun Choi, Eun Sun Jang, Moran Ki, Hwa Young Choi, Sook-Hyang Jeong; Clin Mol Hepatol 2022;28(1):91-104.
Published online November 5, 2021; DOI: https://doi.org/10.3350/cmh.2021.0236

Background/Aims
This study aimed to evaluate the cost-effectiveness of hepatitis C virus (HCV) screening compared to no screening in the Korean population from societal and healthcare system perspectives.
Methods
A published decision-tree plus Markov model was used to compare the expected costs and quality-adjusted life years (QALY) between one-time universal HCV screening and no screening in the population aged 40–65 years using the National Health Examination (NHE) program. Input parameters were obtained from analyses of the National Health Insurance claims data, Korean HCV cohort data, or from the literature review. The population aged 40–65 years was simulated in a model spanning a lifetime from both the healthcare system and societal perspectives, which included the cost of productivity loss due to HCV-related deaths. The incremental cost-effectiveness ratio (ICER) between universal screening and no screening was estimated.
Results
The HCV screening strategy had an ICER of $2,666/QALY and $431/QALY from the healthcare system and societal perspectives, respectively. Both ICERs were far less than the willingness-to-pay threshold of $25,000/QALY, showing that universal screening was highly cost-effective compared to no screening. In various sensitivity analyses, the most influential parameters on cost-effectiveness were the antibodies to HCV (anti-HCV) prevalence, screening costs, and treatment acceptance; however, all ICERs were consistently less than the threshold. If the anti-HCV prevalence was over 0.18%, screening could be cost-effective.
Conclusions
One-time universal HCV screening in the Korean population aged 40–65 years using NHE program would be highly cost-effective from both healthcare system and societal perspectives.

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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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Editorials

Viral hepatitis

Outcomes of Hepatitis C Virus Treatment with Ledipasvir/Sofosbuvir in Mongolian Population: Successes and Challenges Facing Scale-up of Care: Seong Hee Kang, Moon Young Kim; Clin Mol Hepatol 2021;27(1):100-102.
Published online December 3, 2020; DOI: https://doi.org/10.3350/cmh.2020.0312

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Viral hepatitis

Elimination of hepatitis C: What would be the practical approach?: Hyung Joon Yim; Clin Mol Hepatol 2021;27(1):97-99.
Published online December 3, 2020; DOI: https://doi.org/10.3350/cmh.2020.0304

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Real-life experience of ledipasvir and sofosbuvir for HCV infected Korean patients: a multicenter cohort study
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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
Clinical and Molecular Hepatology.2021; 27(3): 474. CrossRef

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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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Real-life experience of ledipasvir and sofosbuvir for HCV infected Korean patients: a multicenter cohort study
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
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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 Articles

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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Mario Enrico Canonico, Giuseppe Damiano Sanna, Roberta Siciliano, Fernando Scudiero, Giovanni Esposito, Guido Parodi
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Viral hepatitis

Efficacy and safety of ledipasvir/sofosbuvir in 5,028 Mongolian patients infected with genotype 1 hepatitis C virus: A multicenter study: Oidov Baatarkhuu, Jae Seung Lee, Jazag Amarsanaa, Do Young Kim, Sang Hoon Ahn, Nyamsuren Naranzul, Damba Enkhtuya, Nagir Choijamts, Purev Batbayar, Radnaa Otgonbayar, Bat-Ulzii Saruul, Chuluunbaatar Gantuul, Baljinnyam Gegeebadrakh, Narangerel Tuvshinbayar, Dorjgotov Badamsuren, Galsan Ulzmaa, Jamiyandorj Otgonbold, Kwang-Hyub Han; Clin Mol Hepatol 2021;27(1):125-135.
Published online November 27, 2020; DOI: https://doi.org/10.3350/cmh.2020.0023

Background/Aims
Ledipasvir/sofosbuvir (LDV/SOF) shows high efficacy and safety in patients with genotype 1-hepatitis C virus (HCV). We aimed to investigate the efficacy and safety of LDV/SOF in real-world Mongolian patients.
Methods
Between 2015 to 2019, 23 (0.5%) and 5,005 patients (99.5%) with genotype 1a and 1b HCV, respectively, were treated with a fixed-dose tablet containing 90 mg ledipasvir and 400 mg sofosbuvir for 12 weeks, and 81 patients (1.6%) with previous experience of interferon (IFN)-based treatment received additional 1,000 mg ribavirin. HCV RNA was measured at 4, 12, and 24 weeks after the first dose to determine rapid virologic response, end of treatment response (ETR), and sustained virologic response at 12 weeks after end of treatment (SVR12).
Results
Most patients (n=5,008; 99.6%) achieved ETR and SVR12 without virologic relapse. Patients with genotype 1a showed low rates of ETR and SVR12 in only 16 patients (69.6%). There was no significant difference in SVR12 rate between patients regardless of IFN experience (n=81; 1.6%), cirrhosis (n=1,151; 22.9%), HCV RNA >6×10⁶ IU/mL (n=866; 17.2%), or liver stiffness >9.6 kPa (n=1,721; 34.2%) (100.0%, 99.3%, 99.4%, and 99.4%, respectively). No severe adverse events (AEs) were reported, and there was no dose reduction or interruption due to AE. The most common AEs were headache (n=472; 9.4%), fatigue (n=306; 6.2%), abdominal discomfort (n=295; 5.9%), and skin rash (n=141; 2.8%).
Conclusions
LDV/SOF showed high efficacy and safety for patients with genotype 1, especially 1b HCV, in Mongolia. The real-world data might be applicable to patients in other Asian-Pacific countries.

Citations

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Long-Term Outcomes of Ledipasvir/Sofosbuvir Treatment in Hepatitis C: Viral Suppression, Hepatocellular Carcinoma, and Mortality in Mongolia
Amgalan Byambasuren, Buyankhishig Gyarvuulkhasuren, Byambatsogt Erdenebat, Khurelbaatar Nyamdavaa, Oidov Baatarkhuu
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Real-life experience of ledipasvir and sofosbuvir for HCV infected Korean patients: a multicenter cohort study
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The Korean Journal of Internal Medicine.2022; 37(6): 1167. CrossRef
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Clinical and Molecular Hepatology.2021; 27(1): 100. CrossRef

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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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Real-life experience of ledipasvir and sofosbuvir for HCV infected Korean patients: a multicenter cohort study
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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Original Article

Viral hepatitis

Use of glecaprevir/pibrentasvir in patients with chronic hepatitis C virus infection and severe renal impairment: Desmond Y. H. Yap, Kevin S. H. Liu, Yu-Chun Hsu, Grace L. H. Wong, Ming-Chang Tsai, Chien-Hung Chen, Ching-Sheng Hsu, Yee Tak Hui, Michael K. K. Li, Chen-Hua Liu, Yee-Man Kan, Ming-Lung Yu, Man-Fung Yuen; Clin Mol Hepatol 2020;26(4):554-561.
Published online August 28, 2020; DOI: https://doi.org/10.3350/cmh.2020.0058

Abstract
PDF

Background/Aims
Data on treatment efficacy and safety of glecaprevir/pibrentasvir (GLE/PIB) for chronic hepatitis C virus (HCV) infection in Asian patients with severe renal impairment are limited. This study aimed to study the treatment and side effects of GLE/PIB in these patients infected with non-1 genotype (GT) HCV.
Methods
We prospectively recruited patients with Child’s A cirrhosis and eGFR <30 mL/min/1.73 m² in Hong Kong and Taiwan during 2017–2018 to receive GLE/PIB treatment.
Results
Twenty-one patients (GT2, n=7; GT3, n=6; and GT6, n=8) received GLE/PIB for 11.2±1.8 weeks. All except one were treatment-naïve. GLE/PIB was initiated in 16 patients while on dialysis (seven on peritoneal dialysis [PD] and nine on hemodialysis) and in five patients before dialysis. One patient died of PD-related peritonitis during treatment and two were lost to follow up. The SVR12 rate in the remaining 18 patients was 100%. All patients achieved undetectable levels at 4-, 12-, 24- and 48-week after treatment. Patients with deranged alanine aminotransferase showed normalization after 4 weeks and the response was sustained for 48 weeks. No significant adverse event was observed.
Conclusions
GLE/PIB treatment was associated with high efficacy and tolerability in HCV-infected patients with severe renal impairment.

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Review

Viral hepatitis

Unmet needs of chronic hepatitis C in the era of direct-acting antiviral therapy: Chung-Feng Huang, Ming-Lung Yu; Clin Mol Hepatol 2020;26(3):251-260.
Published online March 19, 2020; DOI: https://doi.org/10.3350/cmh.2020.0018

Abstract
PDF

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

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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

Influence of some methylated hepatocarcinogenesis-related genes on the response to antiviral therapy and development of fibrosis in chronic hepatitis C patients: Waleed Seif Eldin Mohamed Mostafa, Mohammed Hassan Saiem Al-Dahr, Dalia Abdel Hamid Omran, Zeinab Fathy Abdullah, Suzan Hamdy Elmasry, Mohamed Nabil Ibrahim; Clin Mol Hepatol 2020;26(1):60-69.
Published online October 22, 2019; DOI: https://doi.org/10.3350/cmh.2019.0051

Abstract
PDF

Epigenetics involved in multiple normal cellular processes. Previous research have revealed the role of hepatitis C virus infection in accelerating methylation process and affecting response to treatment in chronic hepatitis patients. This work aimed to elucidate the role of promoter methylation (PM) in response to antiviral therapy, and its contribution to the development of fibrosis through hepatocarcinogenesis-related genes. A total of 159 chronic hepatitis Egyptian patients versus 100 healthy control group were included. The methylation profile of a panel 9 genes (SFRP1, p14, p73, APC, DAPK, RASSF1A, LINE1, O6MGMT, and p16) was detected in patients’ plasma using methylation-specific polymerase chain reaction (MSP). Clinical and laboratory findings were gathered for patients with combined pegylated interferon and ribavirin antiviral therapy. Regarding the patients’ response to antiviral therapy, the percentage of non-responders for APC, O6MGMT, RASSF1A, SFRP1, and p16 methylated genes were significantly higher versus responders (P<0.05). Of the 159 included patients, the most frequent methylated genes were SFRP1 (102/159), followed by p16 (100/159), RASSF1A (98/159), then LINE1 (81/159), P73 (81/159), APC (78/159), DAPK (66/159), O6MGMT (66/159), and p14 (54/159). A total of 67/98 (68.4%) cases of RASSF1A methylated gene (P=0.0.024), and 62/100 (62%) cases of P16 methylated gene (P=0.03) were associated with mild-degree fibrosis. To recapitulate, the PM of SFRP1, APC, RASSF1A, O6MGMT, and p16 genes increases in chronic hepatitis C patients, and can affect patients’ response to antiviral therapy. The RASSF1A and P16 genes might have a role in the distinction between mild and marked fibrosis.

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The COVID-19 legacy: consequences for the human DNA methylome and therapeutic perspectives
Carlo Gaetano, Sandra Atlante, Michela Gottardi Zamperla, Veronica Barbi, Davide Gentilini, Barbara Illi, Marco Malavolta, Fabio Martelli, Antonella Farsetti
GeroScience.2024; 47(1): 483. CrossRef
Variability of the HCV core region and host genetic and epigenetic factors can predict the response to pegylated interferon/ribavirin therapy in genotype 1b hepatitis C patients from Serbia
Nikola Kokanov, Snezana Jovanovic-Cupic, Marina Siljic, Valentina Cirkovic, Nina Petrovic, Bojana Kozik, Milena Krajnovic
Archives of Biological Sciences.2023; 75(3): 251. CrossRef
RASSF1A and p16 promoter methylation and treatment response in chronic hepatitis C genotype 1b patients treated with pegylated interferon/ribavirin
Nikola Kokanov, Milena Krajnovic, Snezana Cupic-Jovanovic, Bojana Kozik, Nina Petrovic, Ana Bozovic, Vesna Mandusic
Archives of Biological Sciences.2022; 74(1): 57. CrossRef
Screening, confirmation, and treatment rates of hepatitis C virus infection in a tertiary academic medical center in South Korea
Jae Seung Lee, Hong Jun Choi, Hye Won Lee, Beom Kyung Kim, Jun Yong Park, Do Young Kim, Sang Hoon Ahn, Seung Up Kim
Journal of Gastroenterology and Hepatology.2021; 36(9): 2479. CrossRef
A longitudinal sampling study of transcriptomic and epigenetic profiles in patients with thrombocytopenia syndrome
Yafen Wang, Shaoqing Han, Ruoxi Ran, Anling Li, Huanyu Liu, Mingjun Liu, Yongwei Duan, Xiong Zhang, Zhigang Zhao, Shihui Song, Xiaocheng Weng, Song-Mei Liu, Xiang Zhou
Nature Communications.2021;[Epub] CrossRef

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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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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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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
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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
Cancers.2020; 12(11): 3414. CrossRef

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Review

Viral hepatitis

Upcoming direct acting antivirals for hepatitis C patients with a prior treatment failure: Tommaso Lorenzo Parigi, Maria Corina Plaz Torres, Alessio Aghemo; Clin Mol Hepatol 2019;25(4):360-365.
Published online May 2, 2019; DOI: https://doi.org/10.3350/cmh.2019.0022

Abstract
PDF

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

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Richard A. Giovane, Kevin deWeber, Uziel Sauceda, Davide Bianchi
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Olga Tronina, Michał Brzdęk, Dorota Zarębska-Michaluk, Dorota Dybowska, Beata Lorenc, Ewa Janczewska, Włodzimierz Mazur, Anna Parfieniuk-Kowerda, Anna Piekarska, Rafał Krygier, Jakub Klapaczyński, Hanna Berak, Jerzy Jaroszewicz, Aleksander Garlicki, Krzys
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ASPARTATE PLATELET RATIO INDEX AS A PREDICTOR OF SEVERITY OF FIBROSIS IN CHRONIC HEPATITS C
KANNAN NARAYANAN, SUE ANN ZACHARIAH, SHEELA KURIAN V
Asian Journal of Pharmaceutical and Clinical Research.2023; : 69. CrossRef
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Caroline E Boeke, Lindsey Hiebert, Imam Waked, Tengiz Tsertsvadze, Lali Sharvadze, Maia Butsashvili, Mamuka Zakalashvili, Win Naing, Neil Gupta, Fredrick Kateera, Craig McClure, John W Ward, Christian B Ramers
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Iman Ibrahim Salama, Hala M Raslan, Ghada A Abdel-Latif, Somaia I Salama, Samia M Sami, Fatma A Shaaban, Aida M Abdelmohsen, Walaa A Fouad
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Evaluation of MicroRNA-122 as a Biomarker for Chronic Hepatitis C Infection and as a Predictor for Treatment Response to Direct-Acting Antivirals
Naglaa S Elabd, Safaa I Tayel, Moamena S Elhamouly, Shaimaa A Hassanein, Samar M Kamaleldeen, Fatma E Ahmed, Mahmoud Rizk, Abdelnaser A Gadallah, Soma E Ajlan, Ahmed S Sief
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Virginia Solitano, Maria Corina Plaz Torres, Nicola Pugliese, Alessio Aghemo
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Pil Soo Sung, Eui-Cheol Shin
International Journal of Molecular Sciences.2020; 21(7): 2583. CrossRef
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Chung-Feng Huang, Ming-Lung Yu
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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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Original Article

Viral hepatitis

Efficacy of L-carnitine on ribavirin-induced hemolytic anemia in patients with hepatitis C virus infection: Shinya Sato, Kei Moriya, Masanori Furukawa, Soichiro Saikawa, Tadashi Namisaki, Mitsuteru Kitade, Hideto Kawaratani, Kosuke Kaji, Hiroaki Takaya, Naotaka Shimozato, Yasuhiko Sawada, Kenichiro Seki, Koh Kitagawa, Takemi Akahane, Akira Mitoro, Yasushi Okura, Junichi Yamao, Hitoshi Yoshiji; Clin Mol Hepatol 2019;25(1):65-73.
Published online February 25, 2019; DOI: https://doi.org/10.3350/cmh.2018.0070

Abstract
PDF

Background/Aims
L-carnitine not only alleviates hyperammonemia and reduces muscle cramps in patients with liver cirrhosis, but also improves anemia in patients with chronic hepatitis and renal dysfunction. This study prospectively evaluated the preventative efficacy of L-carnitine supplementation against hemolytic anemia during antiviral treatment using ribavirin in patients with hepatitis C virus (HCV)-related chronic liver disease.
Methods
A total of 41 patients with chronic hepatitis were consecutively enrolled in this study. Group A (n=22) received sofosbuvir plus ribavirin for 3 months, whereas group B (n=19) was treated with sofosbuvir, ribavirin, and L-carnitine. Hemoglobin concentration changes, the effects of antiviral treatment, and the health status of patients were analyzed using short form-8 questionnaires.
Results
A significantly smaller decrease in hemoglobin concentration was observed in group B compared to group A at every time point. Moreover, the prescribed dose intensity of ribavirin in group B was higher than that of group A, resulting in a higher ratio of sustained virological response (SVR) 24 in group B compared with group A. The physical function of patients in group B was also significantly improved compared to group A at the end of antiviral treatment.
Conclusions
L-carnitine supplementation alleviates ribavirin-induced hemolytic anemia in patients with HCV and helps relieve the physical burden of treatment with ribavirin-containing regimens. These advantages significantly increase the likelihood of achieving SVR.

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Hepatic neoplasm

Direct-acting antivirals response in hepatocellular carcinoma: Does the presence of hepatocellular carcinoma matter?: Chung-Feng Huang, Ming-Lung Yu; Clin Mol Hepatol 2019;25(2):168-171.
Published online February 11, 2019; DOI: https://doi.org/10.3350/cmh.2018.1014

Abstract
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During the clinical trial development of directly acting antivirals (DAAs), evidence regarding the treatment efficacy in chronic hepatitis C patients with hepatocellular carcinoma (HCC) was scarce because these patients have always been excluded. Apart from the clinical trials, more HCC patients are currently being treated in daily practice, given that these treatments are highly effective and involve well-tolerated regimens. Large scale, real-world studies have demonstrated potentially suboptimal antiviral treatment efficacy in HCC patients who received DAAs. It is postulated that the impairment of the bioavailability of DAAs may account for the inferior treatment response. However, the results could not be generalized across all studies. The differing results were attributed to diverse patient characteristics, suboptimal regimens or imprecise definitions of active cancer statuses at the time of treatment initiation. Additional large-scale studies that utilize the treatment of choice in clearly defined HCC patients with different disease severities are warranted to clarify the issue.

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Achieving SVR in patients with hepatitis C-related HCC is associated with an improvement in overall survival: real word data
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The Korean Journal of Internal Medicine.2021; 36(2): 292. CrossRef
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Cancers.2020; 12(11): 3414. CrossRef

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