Clinical and Molecular Hepatology

"Sustained virologic response"

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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Original Article

Switching to besifovir in patients with chronic hepatitis B receiving tenofovir disoproxil fumarate: A randomized trial: Hyung Joon Yim, Yeon Seok Seo, Ji Hoon Kim, Won Kim, Young Kul Jung, Jae Young Jang, Sae Hwan Lee, Yun Soo Kim, Chang Wook Kim, Hyoung Su Kim, Jae-Jun Shim, Eun-Young Cho, In Hee Kim, Byung Seok Lee, Jeong-Hoon Lee, Byung Seok Kim, Jeong Won Jang, Hyun Woong Lee, Jung Hyun Kwon, Moon Young Kim, Do Seon Song, Jung Gil Park, Yoon Seok Lee, Eileen L. Yoon, Han Ah Lee, Seong Hee Kang, Jin Mo Yang; Clin Mol Hepatol 2025;31(3):810-822.
Published online January 17, 2025; DOI: https://doi.org/10.3350/cmh.2024.0819

Background/Aims
Besifovir (BSV) showed comparable antiviral activity and superior safety profiles to tenofovir disoproxil fumarate (TDF) in treatment-naïve chronic hepatitis B (CHB). However, no data are available regarding the antiviral efficacy and safety of BSV in patients with CHB who switched from long-term TDF to BSV. This study aimed to evaluate the outcome of a 48-week BSV therapy in patients with CHB who switched from long-term TDF treatment.
Methods
In this non-inferiority trial, 153 CHB patients treated with TDF for ≥48 weeks who had hepatitis B virus (HBV) DNA <20 IU/mL were randomized to receive either BSV 150 mg or TDF 300 mg for 48 weeks.
Results
The per-protocol analysis included 130 patients (BSV group, 64; TDF group, 66). The median duration of TDF use before enrollment was 4.14 years. After 48 weeks, 100.0% and 98.5% patients in the BSV and TDF groups, respectively, met the primary endpoint (HBV DNA <20 IU/mL), demonstrating the non-inferior antiviral efficacy of BSV to TDF (95% confidence interval –0.01 to 0.04; P>0.999), with a predefined margin of –0.18. The mean percentage changes in estimated glomerular filtration rates were slightly better in the BSV group (1.67±11.73%) than in the TDF group (–1.24±11.02%). The BSV group showed a significant improvement in bone turnover biomarkers compared to the TDF group; accordingly, hip and spine bone mineral density increased in the BSV group.
Conclusions
In patients with CHB receiving long-term TDF, switching to BSV may improve renal and bone safety with non-inferior antiviral efficacy compared to that of maintaining TDF.

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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
Besifovir: a viable option for long-term disease control in chronic hepatitis B: Editorial on “Switching to besifovir in patients with chronic hepatitis B receiving tenofovir disoproxil fumarate: A randomized trial”
Wai-Kay Seto
Clinical and Molecular Hepatology.2026; 32(1): 374. CrossRef
Tenofovir amibufenamide in chronic hepatitis B: Lipid changes and 144-week safety with tenofovir disoproxil fumarate-to-tenofovir amibufenamide switch
Zhi-Hao Zeng, Jin-Qing Liu, Min Zhang, Cai-Liang Qiu, Zhen-Yu Xu
World Journal of Gastroenterology.2025;[Epub] CrossRef

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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

Citations

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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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Kirolos Eskandar
iLIVER.2025; 4(4): 100205. CrossRef
Correspondence on Letter regarding “Toward hepatitis C virus elimination using artificial intelligence”
Ming-Ying Lu, Ming-Lung Yu
Clinical and Molecular Hepatology.2024; 30(2): 274. CrossRef

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Original Article

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.

Citations

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Review

Viral hepatitis

Development and surveillance of hepatocellular carcinoma in patients with sustained virologic response after antiviral therapy for chronic hepatitis C: Seong Kyun Na, Byung-Cheol Song; Clin Mol Hepatol 2019;25(3):234-244.
Published online January 21, 2019; DOI: https://doi.org/10.3350/cmh.2018.0108

Abstract
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Hepatitis C virus (HCV) infection is a major risk factor for liver cirrhosis and hepatocellular carcinoma (HCC), and is a leading cause of liver-related deaths worldwide. Recently available direct-acting antiviral agent is very safe and highly effective (>95% sustained virologic response, SVR) against all genotypes of HCV. Achievement of SVR has been associated with a significant reduction of hepatic decompensation, development of HCC, and liver-related mortality. However, HCC risk is not eliminated even after SVR. The annual incidences of HCC in advanced fibrosis or cirrhosis have been estimated to be up to 2.5–4.5% even in patients with SVR. Therefore, surveillance for HCC is recommended in this high-risk patients. In this review, we will describe the clinical outcomes and the risk of HCC in patients with SVR and suggest who should receive surveillance for HCC.

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Original Article

Viral hepatitis

A reduced dose of ribavirin does not influence the virologic response during pegylated interferon alpha-2b and ribavirin combination therapy in patients with genotype 1 chronic hepatitis C: Byung Chul You, Young Seok Kim, Hun il Kim, Se Hun Kim, Seung Sik Park, Yu Ri Seo, Sang Gyune Kim, Se Whan Lee, Hong Soo Kim, Soung Won Jeong, Jae Young Jang, Boo Sung Kim; Korean J Hepatol 2012;18(3):272-278.
Published online September 25, 2012; DOI: https://doi.org/10.3350/cmh.2012.18.3.272

Abstract
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Background/Aims

When combined with pegylated interferon alpha-2b (Peg-IFN α-2b) for the treatment of genotype 1 chronic hepatitis C (CHC) in Korea, the current guideline for the initial ribavirin (RBV) dose is based on body weight. However, since the mean body weight is lower for Korean patients than for patients in Western countries, current guidelines might result in Korean patients being overdosed with RBV.

Methods

We retrospectively reviewed the medical records of patients with genotype 1 CHC who were treated with Peg-IFN α-2b and RBV combination therapy. We divided the patients into groups A (≥15 mg/kg/day, n=23) and B (<15 mg/kg/day, n=26), given that the standard dose is 15 mg/kg/day. The clinical course in terms of the virologic response, adverse events, and dose modification rate was compared between the two groups after therapy completion.

Results

The early response rates (92.0% vs. 83.3%, P=0.634) and sustained virologic response rates (82.6% vs. 73.1%, P=0.506) did not differ significantly between the two groups. During the treatment period, the RBV dose reduction rate was significantly higher in group A than in group B (60.9% vs. 23.1%, P=0.01).

Conclusions

RBV dose reduction is performed frequently when patients are treated according to the current Korean guidelines. Given that lowering the RBV dose did not appear to decrease the virologic response during therapy, reducing RBV doses below the current Korean guideline may be effective for treatment, especially in low-weight patients.

Citations

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The Impact of Inosine Triphosphatase Variants on Hemoglobin Level and Sustained Virologic Response of Chronic Hepatitis C in Korean
Ju Seung Kim, Sung-Min Ahn, Young Kul Jung, Oh Sang Kwon, Yun Soo Kim, Duck Joo Choi, Ju Hyun Kim
Journal of Korean Medical Science.2013; 28(8): 1213. CrossRef

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The Korean Journals of Hepatology Elsewhere

Role of vitamin D in chronic hepatitis C: Tae Yeob Kim; Korean J Hepatol 2011;17(2):170-172.
Published online June 23, 2011; DOI: https://doi.org/10.3350/kjhep.2011.17.2.170

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Durability of a sustained virologic response in patients with chronic hepatitis C treated with peginterferon and ribavirin: Kyung-Ah Kim; Korean J Hepatol 2011;17(1):84-86.
Published online March 21, 2011; DOI: https://doi.org/10.3350/kjhep.2011.17.1.84

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Recent advances and future directions in the management of hepatitis C infections
Victoria Belousova, Ahmed A. Abd-Rabou, Shaker A. Mousa
Pharmacology & Therapeutics.2015; 145: 92. CrossRef

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Original Articles

Mutations within the interferon sensitivity determining region in Korean patients infected with hepatitis C virus genotype 1b: Young-Joo Jin, M.D., Yoon Kyung Park, M.D., Gui Jun Yun, M.D.2, Han Chu Lee, M.D., Sook-Hyang Jeong, M.D.1, Gang Mo Kim, M.D., Young-Suk Lim, M.D., Young-Hwa Chung, M.D., Yung Sang Lee, M.D., Dong Jin Suh, M.D.; Korean J Hepatol 2010;16(2):158-167.
Published online June 25, 2010; DOI: https://doi.org/10.3350/kjhep.2010.16.2.158

Abstract
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Background/Aims
The treatment response to interferon could differ with mutations in the interferon-sensitivity-determining region (ISDR) in patients infected with hepatitis C virus (HCV) genotype-1b (HCV-Ib). We examined the pattern of ISDR mutations and analyzed whether the number of amino acid substitutions influences the treatment response to peginterferon plus ribavirin in chronic hepatitis or cirrhotic patients infected with HCV-Ib. Methods: The study population comprised 52 patients who visited Seoul Asan Medical Center and Seoul National University Bundang Hospital from January 2006 to December 2008 and who received peginterferon alpha-2a (n=37) or -2b (n=15) plus ribavirin, and whose serum was stored. We analyzed the early virologic response, end-of-treatment response, and sustained virologic response (SVR), and examined the ISDR using direct sequencing. Results: The proportions of patients with ISDR mutation types of wild (0mutations), intermediate (1-3 mutations), and mutant (≥4 mutations) were 50.0%, 42.3%, and 7.7%,respectively, and the corresponding SVR rates were 63%, 50%, and 67% (p>0.05). The SVR rates were 59.4% and 50.0% in patients with <2 and ≥2 mutations, respectively (p>0.05). On univariate analysis, age was the only predictive factor for SVR (p=0.016). The pretreatment HCV RNA titer tended to be lower in those with SVR, but without statistical significance (p=0.069). Conclusions: The frequency of ISDR mutations was low in our cohort of Korean patients infected with HCV-Ib. Therefore, ISDR mutations might not contribute to the response to treatment with peginterferon plus ribavirin.

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Effects of pegylated interferon and ribavirin in Korean patients with chronic hepatitis C virus infection: Myoung Joo Kang, M.D., Eun Uk Jung, M.D., Sang Won Park, M.D., Paul Choi, M.D., Ji Hyun Kim, M.D., Sung Jae Park, M.D., Eun Taek Park, M.D., Youn Jae Lee, M.D., Sang Hyuk Lee, M.D., Sang Yong Seol, M.D.; Korean J Hepatol 2008;14(3):318-330.
Published online September 30, 2008; DOI: https://doi.org/10.3350/kjhep.2008.14.3.318

Abstract
PDF

Background/Aims
We assessed the efficacy and safety of pegylated interferon (peginterferon) plus ribavirin and identified the predictors of a sustained virologic response (SVR) in Korean patients with chronic hepatitis C virus infection. Methods: A total of 192 patients with chronic hepatitis C, treated with both peginterferon (n=141) or conventional interferon (n=51) and ribavirin, were analyzed retrospectively. Peginterferon alfa-2a (180 μg/week) or -2b (1.5 μg/kg/week) or interferon alfa-2a (3 MIU thrice weekly) was administered in combination with ribavirin at 1,000-1,200 mg/day for 48 weeks for genotype 1 and at 800 mg/day for 24 weeks for genotypes 2 and 3. Results: The overall SVR rate was 80.9% (114/141) in the peginterferon group and 52.9% (27/51) in the interferon group (P=0.0001). The SVR rate in genotype 1 was 69.5% (41/59) in the peginterferon group and 31.6% (6/19) in the interferon group (P=0.0033), whereas in genotype 2 or 3 it was 89.0% (73/82) in the peginterferon group and 65.6% (21/32) in the interferon group (P=0.0032). The predictors of SVR in the peginterferon group were genotype, absence of cirrhosis, and early virologic response (P<0.05). Conclusions: In Korean patients with chronic hepatitis C, a regimen of peginterferon and ribavirin was more effective than a regimen of conventional interferon and ribavirin. This result is comparable to those from studies on Western patients as an initial treatment for chronic hepatitis C. (Korean J Hepatol 2008;14: 318-330)

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