Clinical and Molecular Hepatology

"Tenofovir"

Correspondences

Correspondence to editorial on “Switching to besifovir in patients with chronic hepatitis B receiving tenofovir disoproxil fumarate: A randomized trial”: Hyung Joon Yim, Seong Hee Kang, Young Kul Jung, Jin Mo Yang; Clin Mol Hepatol 2026;32(1):e55-e57.
Published online April 15, 2025; DOI: https://doi.org/10.3350/cmh.2025.0379

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Liver Transplantation

Correspondence to editorial on “Optimal tacrolimus levels for reducing CKD risk and the impact of intrapatient variability on CKD and ESRD development following liver transplantation”: Soon Kyu Lee, Jong Young Choi; Clin Mol Hepatol 2025;31(2):e161-e162.
Published online February 13, 2025; DOI: https://doi.org/10.3350/cmh.2025.0121

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Editorial

Viral hepatitis

Reconsidering treatment indications for chronic hepatitis B: Insights from the TORCH-B roll-over study: Editorial on “Antiviral therapy for chronic hepatitis B with mildly elevated aminotransferase: A rollover study from the TORCH-B trial”: Chih-Wen Wang, Ming-Lung Yu; Clin Mol Hepatol 2025;31(2):606-609.
Published online December 3, 2024; DOI: https://doi.org/10.3350/cmh.2024.1078

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Expanding treatment eligibility for chronic hepatitis B: Balancing benefits, limitations, and healthcare access: Correspondence to editorial on “Antiviral therapy for chronic hepatitis B with mildly elevated aminotransferase: A rollover study from the TOR
Yao-Chun Hsu, Chi-Yi Chen, Jaw-Town Lin
Clinical and Molecular Hepatology.2025; 31(2): e169. CrossRef

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Original Articles

Viral hepatitis

Antiviral therapy for chronic hepatitis B with mildly elevated aminotransferase: A rollover study from the TORCH-B trial: Yao-Chun Hsu, Chi-Yi Chen, Cheng-Hao Tseng, Chieh-Chang Chen, Teng-Yu Lee, Ming-Jong Bair, Jyh-Jou Chen, Yen-Tsung Huang, I-Wei Chang, Chi-Yang Chang, Chun-Ying Wu, Ming-Shiang Wu, Lein-Ray Mo, Jaw-Town Lin; Clin Mol Hepatol 2025;31(1):213-226.
Published online October 17, 2024; DOI: https://doi.org/10.3350/cmh.2024.0640

Background/Aims
Treatment indications for patients with chronic hepatitis B (CHB) remain contentious, particularly for patients with mild alanine aminotransferase (ALT) elevation. We aimed to evaluate treatment effects in this patient population.
Methods
This rollover study extended a placebo-controlled trial that enrolled non-cirrhotic patients with CHB and ALT levels below two times the upper limit of normal. Following 3 years of randomized intervention with either tenofovir disoproxil fumarate (TDF) or placebo, participants were rolled over to open-label TDF for 3 years. Liver biopsies were performed before and after the treatment to evaluate histopathological changes. Virological, biochemical, and serological outcomes were also assessed (NCT02463019).
Result
s: Of 146 enrolled patients (median age 47 years, 80.8% male), 123 completed the study with paired biopsies. Overall, the Ishak fibrosis score decreased in 74 (60.2%), remained unchanged in 32 (26.0%), and increased in 17 (13.8%) patients (p<0.0001). The Knodell necroinflammation score decreased in 58 (47.2%), remained unchanged in 29 (23.6%), and increased in 36 (29.3%) patients (p=0.0038). The proportion of patients with an Ishak score ≥ 3 significantly decreased from 26.8% (n=33) to 9.8% (n=12) (p=0.0002). Histological improvements were more pronounced in patients switching from placebo. Virological and biochemical outcomes also improved in placebo switchers and remained stable in patients who continued TDF. However, serum HBsAg levels did not change and no patient cleared HBsAg.
Conclusions
In CHB patients with minimally raised ALT, favorable histopathological, biochemical, and virological outcomes were observed following 3-year TDF treatment, for both treatment-naïve patients and those already on therapy.

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Liver Transplantation

Optimal tacrolimus levels for reducing CKD risk and the impact of intrapatient variability on CKD and ESRD development following liver transplantation: Soon Kyu Lee, Ho Joong Choi, Young Kyoung You, Pil Soo Sung, Seung Kew Yoon, Jeong Won Jang, Jong Young Choi; Clin Mol Hepatol 2025;31(1):131-146.
Published online October 2, 2024; DOI: https://doi.org/10.3350/cmh.2024.0451

Background/Aims
This study aimed to identify the risk factors for chronic kidney disease (CKD) and end-stage renal disease (ESRD) following liver transplantation (LT), with a specific focus on tacrolimus levels and intrapatient variability (IPV).
Methods
Among the 1,076 patients who underwent LT between 2000 and 2018, 952 were included in the analysis. The tacrolimus doses and levels were recorded every 3 months, and the IPV was calculated using the coefficient of variability. The cumulative incidence rates of CKD and ESRD were calculated based on baseline kidney function at the time of LT. The impact of tacrolimus levels and their IPV on the development of CKD and ESRD was evaluated, and the significant risk factors were identified.
Result
s: Within a median follow-up of 97.3 months, the 5-year cumulative incidence rates of CKD (0.58 vs. 0.24) and ESRD (0.07 vs. 0.01) were significantly higher in the acute kidney injury group than in the normal glomerular filtration rate (GFR) group. In the normal GFR group, the tacrolimus levels were identified as a risk factor for CKD, with a level of ≤4.5 ng/mL suggested as optimal for minimizing the risk of CKD. Furthermore, the IPV of tacrolimus levels and doses emerged as a significant risk factor for CKD development in both groups (p<0.05), with tenofovir disoproxil fumarate also being a risk factor in HBV-infected patients. The IPV of tacrolimus levels was also a significant factor in ESRD development (p<0.05).
Conclusions
This study elucidated the optimal tacrolimus trough level and highlighted the impact of IPV on the CKD and ESRD development post-LT.

Citations

Citations to this article as recorded by

Intrapatient variability of tacrolimus trough level may be not the cause, but an indirect parameter of comorbidities: Editorial on “Optimal tacrolimus levels for reducing CKD risk and the impact of intrapatient variability on CKD and ESRD development foll
Jongman Kim
Clinical and Molecular Hepatology.2025; 31(2): 589. CrossRef
Correspondence to letter to the editor on “Optimal tacrolimus levels for reducing CKD risk and the impact of intrapatient variability on CKD and ESRD development following liver transplantation”
Soon Kyu Lee, Jong Young Choi
Clinical and Molecular Hepatology.2025; 31(2): e212. CrossRef
Clinical significance and gene prediction of a novel classification system based on tacrolimus concentration-to-dose ratio in the early post-liver transplant period
Junwei Fan, Peihao Wen, Liyun Yuan, Yan Xia, Shijie Hu, Xiaoqing Zhang, Zhihai Peng
Frontiers in Pharmacology.2025;[Epub] CrossRef
Chronic kidney disease at one year after liver transplantation: Role of changes in immunosuppression over three decades
Alejandro Muñoz-Serrano, María Jesús Citores, Andrea Gutiérrez-Villanueva, Víctor Moreno-Torres, Jorge V López-Ibor, Natalia Vicente, Valentín Cuervas-Mons
World Journal of Transplantation.2025;[Epub] CrossRef

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Viral hepatitis

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

Background/Aims
Chronic hepatitis B (CHB) is related to an increased risk of extrahepatic malignancy (EHM), and antiviral treatment is associated with an incidence of EHM comparable to controls. We compared the risks of EHM and intrahepatic malignancy (IHM) between entecavir (ETV) and tenofovir disoproxil fumarate (TDF) treatment.
Methods
Using data from the National Health Insurance Service of Korea, this nationwide cohort study included treatment-naïve CHB patients who initiated ETV (n=24,287) or TDF (n=29,199) therapy between 2012 and 2014. The primary outcome was the development of any primary EHM. Secondary outcomes included overall IHM development. E-value was calculated to assess the robustness of results to unmeasured confounders.
Result
s: The median follow-up duration was 5.9 years, and all baseline characteristics were well balanced after propensity score matching. EHM incidence rate differed significantly between within versus beyond 3 years in both groups (P<0.01, Davies test). During the first 3 years, EHM risk was comparable in the propensity score-matched cohort (5.88 versus 5.84/1,000 person-years; subdistribution hazard ratio [SHR]=1.01, 95% confidence interval [CI]=0.88–1.17, P=0.84). After year 3, however, TDF was associated with a significantly lower EHM incidence compared to ETV (4.92 versus 6.91/1,000 person-years; SHR=0.70, 95% CI=0.60–0.81, P<0.01; E-value for SHR=2.21). Regarding IHM, the superiority of TDF over ETV was maintained both within (17.58 versus 20.19/1,000 person-years; SHR=0.88, 95% CI=0.81–0.95, P<0.01) and after year 3 (11.45 versus 16.20/1,000 person-years; SHR=0.68, 95% CI=0.62–0.75, P<0.01; E-value for SHR=2.30).
Conclusions
TDF was associated with approximately 30% lower risks of both EHM and IHM than ETV in CHB patients after 3 years of antiviral therapy.

Citations

Citations to this article as recorded by

Chronic hepatitis B, extrahepatic malignancies and the use of antiviral drugs
Meng-Che Wu, Shih-Chi Yang, Shuo-Yan Gau
Clinical and Molecular Hepatology.2025; 31(1): e19. CrossRef
The critical role of ferroptosis in virus-associated hematologic malignancies and its potential value in antiviral-antitumor therapy
Miao Miao, Yuelei Chen, Xuehan Wang, Shengyang Li, Rong Hu
Virulence.2025;[Epub] CrossRef
Antiviral Therapy Reduces Dyslipidemia and Cardiovascular Risk in Chronic Hepatitis B: TDF as the Most Effective Agent
Hyuk Kim, Jae‐Young Kim, Hyun Bin Choi, Ji‐Soo Lee, Yoon E. Shin, Jeong‐Ju Yoo, Sang Gyune Kim, Young‐Seok Kim
Journal of Medical Virology.2025;[Epub] CrossRef
Characteristics and outcomes in atorvastatin therapy for chronic subdural hematoma: a national, observational real-world study in China, 2019–2024
Tao Liu, Zhihao Zhao, Jiao Wang, Xiaoying Chen, Jinhao Huang, Weiwei Jiang, Yunhu Yu, Xide Zhu, Kaijie Wang, Kun Lin, Hu Qin, Baixiang Peng, Guohe Zhang, Zhiyong Liu, Weiliang Chen, Jun Shen, Baozhi Chen, Shengjie Li, Mingqi Liu, Wanqiang Su, Wanhai Ding,
The Lancet Regional Health - Western Pacific.2025; 63: 101688. CrossRef
Association between atherogenic index of plasma and incident aortic disease: a population-based prospective analysis
Cuihong Tian, Xiao Wang, Liang Tao, Wanyi Wei, Xuan Zhang, Haoxian Tang, Yequn Chen, Xuerui Tan
Open Heart.2025; 12(2): e003511. CrossRef
Nucleos(t)ide analog therapy of chronic hepatitis B and extrahepatic cancer risk: Is tenofovir better than entecavir?: Editorial on “Extrahepatic malignancies and antiviral drugs for chronic hepatitis B: A nationwide cohort study”
Yewan Park, Dong Hyun Sinn
Clinical and Molecular Hepatology.2024; 30(4): 718. CrossRef
Effect of SARS-CoV-2 infection on liver function in patients with hepatitis B
Tong Sun, Hongbo Chi, Jing Wang, Yufen Zheng, Hongguo Zhu, Jingxian Zhao, Kai Zhou, Mengyuan Chen, Donglian Wang, Tao-Hsin Tung, Jiaqin Xu, Bo Shen
BMC Infectious Diseases.2024;[Epub] CrossRef

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Reply to Correspondence

Viral hepatitis

Reply to correspondence on “Cardiovascular risk in chronic hepatitis B patients treated with tenofovir disoproxil fumarate or tenofovir alafenamide”: Pin-Nan Cheng, Ming-Lung Yu; Clin Mol Hepatol 2024;30(4):1031-1032.
Published online April 11, 2024; DOI: https://doi.org/10.3350/cmh.2024.0228

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Correspondence

Viral hepatitis

Letter: Cardiovascular risk of tenofovir disoproxil fumarate or tenofovir alafenamide fumarate in patients with chronic hepatitis B: More questions than an answer – author’s reply: Hyeyeon Hong, Jonggi Choi; Clin Mol Hepatol 2024;30(2):272-273.
Published online February 21, 2024; DOI: https://doi.org/10.3350/cmh.2024.0123

Citations

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Reply to correspondence on “Cardiovascular risk in chronic hepatitis B patients treated with tenofovir disoproxil fumarate or tenofovir alafenamide”
Pin-Nan Cheng, Ming-Lung Yu
Clinical and Molecular Hepatology.2024; 30(4): 1031. CrossRef

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90 Download
1 Web of Science
Crossref

Original Article

Viral hepatitis

Cardiovascular risk in chronic hepatitis B patients treated with tenofovir disoproxil fumarate or tenofovir alafenamide: Hyeyeon Hong, Won-Mook Choi, Danbi Lee, Ju Hyun Shim, Kang Mo Kim, Young-Suk Lim, Han Chu Lee, Jonggi Choi; Clin Mol Hepatol 2024;30(1):49-63.
Published online November 20, 2023; DOI: https://doi.org/10.3350/cmh.2023.0328

Background/Aims
Tenofovir disoproxil fumarate (TDF) is known to have a lipid-lowering effect. This is in contrast to tenofovir alafenamide (TAF), which has a lipid-neutral effect. Therefore, concerns have been raised as to whether these differences affect long-term cardiovascular risk. Here, we aimed to evaluate the long-term risk of cardiovascular events in chronic hepatitis B (CHB) patients treated with TAF or TDF.
Methods
We retrospectively analyzed 4,124 treatment-naïve CHB patients treated with TDF (n=3,186) or TAF (n=938) between 2012 and 2022. The primary outcome was a composite endpoint of major adverse cardiovascular events (MACE), including myocardial infarction, ischemic stroke, and hospitalization for unstable angina or heart failure. Serial changes in lipid profiles between two treatments were also explored.
Result
s: The median age of the patients was 50.6 years, and 60.6% of the patients were male. At baseline, 486 (11.8%) and 637 (15.4%) of the patients had dyslipidemia and fatty liver, respectively. A total of 42 MACE occurred, with an annual incidence of 0.2%/100 person-years (PYs). At 1, 3, and 5 years, the cumulative risk of MACE was 0.4%, 0.8%, and 1.2% in patients treated with TDF, and 0.2%, 0.7%, and 0.7% in patients treated with TAF, respectively (p=0.538). No significant differences in the risk of MACE were observed between TDF and TAF. A multivariable analysis found that current smoker and a history of cardiovascular events were risk factors associated with an increased risk of MACE.
Conclusions
Patients treated with TAF had comparable risks of cardiovascular outcomes, defined as MACE, as patients treated with TDF.

Citations

Citations to this article as recorded by

Efficacy and Safety of Tenofovir Alafenamide (TAF) and Tenofovir Disoproxil Fumarate (TDF) Followed by TAF in Chronic Hepatitis B Patients of East Asian Ethnicity Following 5 Years of Treatment
Grace Lai‐Hung Wong, Edward Gane, Calvin Q. Pan, Scott Fung, Mang M. Ma, Namiki Izumi, Shalimar, Seng Gee Lim, Wan‐Long Chuang, Rajiv Mehta, Young‐Suk Lim, Leland J. Yee, John F. Flaherty, Frida Abramov, Hongyuan Wang, Maria Buti
Alimentary Pharmacology & Therapeutics.2026; 63(1): 132. CrossRef
Atherosclerotic Cardiovascular Risk in Patients with Chronic Hepatitis B: Tenofovir Disoproxil Fumarate Vs. Tenofovir Alafenamide: A Korean Nationwide Study
Jiwon Yang, Jihye Lim, Ye‐jee Kim, Hwa Jung Kim, Jonggi Choi
Journal of Medical Virology.2026;[Epub] CrossRef
Evaluating fracture risk with TDF in elderly patients with hepatitis B: A Korean perspective
Yoon E. Shin, Jae Young Kim, Jeong Ju Yoo, Sang Gyune Kim, Young Seok Kim
Journal of Hepatology.2025; 82(6): e301. CrossRef
Tenofovir Disoproxil Fumarate Versus Entecavir: Effects on Lipid Profiles and Cardiovascular Outcomes in People Living With Chronic Hepatitis B
Log Young Kim, Jae Young Kim, Jeong‐Ju Yoo, Sang Gyune Kim, Young‐Seok Kim
Journal of Medical Virology.2025;[Epub] CrossRef
Safety of tenofovir alafenamide in the context of hyperlipidemia and cardiovascular diseases: a nationwide analysis
Jae-Young Kim, Hyuk Kim, Jeong-Ju Yoo, Sang Gyune Kim, Young-Seok Kim
Hepatology International.2025; 19(4): 959. CrossRef
Impact of Tenofovir Alafenamide on Lipid Profiles in Chronic Hepatitis B Patients: Systematic Review and Meta‐Analysis
Ping‐Yu Hsu, Hui‐Chen Su, Mi‐Chia Ma, Chien‐An Chen, Sin‐Yi Yu, Yi‐Ming Hua
Journal of Medical Virology.2025;[Epub] CrossRef
Effect of switching from prior Nucleos(t)ide Analogue(s) to Tenofovir alafenamide on lipid profile and cardiovascular risk in patients with Chronic Hepatitis B
Witchayaporn Praguylertluck, Apichat Kaewdech, Naichaya Chamroonkul, Teerha Piratvisuth, Pimsiri Sripongpun, Tyng-Yuan Jang
PLOS One.2025; 20(5): e0324897. CrossRef
Metabolic effects and cardiovascular disease risks of TDF or TAF in patients with chronic hepatitis B: a systematic review and meta-analysis
Yuan-Hai Zhou, Nan Cai, Yu-Xin Chen, Yong-Lu Su, Peng Hu
Frontiers in Pharmacology.2025;[Epub] CrossRef
Tenofovir alafenamide-related hyperlipidemia and cardiovascular risk
Ankur Jindal, Manoj Kumar
Hepatology International.2025; 19(4): 701. CrossRef
Comparison of bone mineral density changes between denosumab and bisphosphonates in tenofovir-exposed chronic hepatitis B patients with osteoporosis
Yunmi Ko, Byeong Geun Song, Hyunjae Shin, Youngsu Park, Jeayeon Park, Min Kyung Park, Yun Bin Lee, Su Jong Yu, Dong Hyun Sinn, Yoon Jun Kim, Jung-Hwan Yoon, Seung Shin Park, Moon Haeng Hur, Jeong-Hoon Lee
Osteoporosis International.2025; 36(8): 1391. CrossRef
Blood pressure and metabolic outcomes after efavirenz‐ or dolutegravir‐based therapy started in acute HIV infection
Phillip Chan, Sarah Moreland, Carlo Sacdalan, Donn J. Colby, Ferron Ocampo, Pathariya Promsena, Somchai Sriplienchan, Jarawee Wattana, Jintana Intasan, Nittaya Phanuphak, Sandhya Vasan, Robert Paul, Lydie Trautmann, Serena Spudich, Eugène Kroon
HIV Medicine.2025; 26(10): 1619. CrossRef
Pharmacovigilance analysis of metabolic and nutritional adverse reactions associated with entecavir and tenofovir using the FDA adverse event reporting system database
Haomin Zhu, Baolong Ding, Zhuying Jing, Hongting Yao, Yue Li, Lihong Gao, Yulu Zhu, Xin Li
International Journal of Clinical Pharmacy.2025; 47(5): 1510. CrossRef
Antiviral Therapy Reduces Dyslipidemia and Cardiovascular Risk in Chronic Hepatitis B: TDF as the Most Effective Agent
Hyuk Kim, Jae‐Young Kim, Hyun Bin Choi, Ji‐Soo Lee, Yoon E. Shin, Jeong‐Ju Yoo, Sang Gyune Kim, Young‐Seok Kim
Journal of Medical Virology.2025;[Epub] CrossRef
Hepatocellular Carcinoma Risk in Chronic Hepatitis B Patients Treated With Tenofovir Alafenamide or Tenofovir Disoproxil Fumarate
Jiwon Yang, Jihye Lim, Ye‐Jee Kim, Hwa Jung Kim, Jonggi Choi
Liver International.2025;[Epub] CrossRef
Letter: Cardiovascular risk of tenofovir disoproxil fumarate or tenofovir alafenamide fumarate in patients with chronic hepatitis B: More questions than an answer – author’s reply
Hyeyeon Hong, Jonggi Choi
Clinical and Molecular Hepatology.2024; 30(2): 272. CrossRef
Cardiovascular risk of tenofovir disoproxil fumarate or tenofovir alafenamide in patients with chronic hepatitis B: More questions than an answer
Pin-Nan Cheng, Ming-Lung Yu
Clinical and Molecular Hepatology.2024; 30(2): 144. CrossRef
Lipid safety of tenofovir alafenamide during 96-week treatment in treatment-naive chronic hepatitis B patients
Wenjuan Zhao, Yi Liu, Mengdi Zhang, Zixin Cui, Zhan Qu, Yiyang Li, Meijuan Wan, Wen Wang, Yunru Chen, Lei Shi, Jianzhou Li, Feng Ye
Frontiers in Medicine.2024;[Epub] CrossRef
Reply to correspondence on “Cardiovascular risk in chronic hepatitis B patients treated with tenofovir disoproxil fumarate or tenofovir alafenamide”
Pin-Nan Cheng, Ming-Lung Yu
Clinical and Molecular Hepatology.2024; 30(4): 1031. CrossRef
Effects of tenofovir alafenamide fumarate on serum lipid profiles in patients with chronic hepatitis B
Fei Cao, Tao Fan, Xue Jiang, Jian Wang, Yilin Liu, Li Zhu, Ye Xiong, Shaoqiu Zhang, Zhiyi Zhang, Yifan Pan, Yuanyuan Li, Chao Jiang, Juan Xia, Xiaomin Yan, Jie Li, Xingxiang Liu, Chuanwu Zhu, Rui Huang, Chao Wu
Virology Journal.2024;[Epub] CrossRef
Eight‐year efficacy and safety of tenofovir alafenamide for treatment of chronic hepatitis B virus infection: Final results from two randomised phase 3 trials
Maria Buti, Young‐Suk Lim, Henry Lik Yuen Chan, Kosh Agarwal, Patrick Marcellin, Maurizia R. Brunetto, Wan‐Long Chuang, Harry L. A. Janssen, Scott K. Fung, Namiki Izumi, Maciej S. Jablkowski, Dzhamal Abdurakhmanov, Frida Abramov, Hongyuan Wang, Irina Botr
Alimentary Pharmacology & Therapeutics.2024; 60(11-12): 1573. CrossRef

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Editorial

Viral hepatitis

Dyslipidemia in chronic hepatitis B patients on tenofovir alafenamide: Facts and puzzles: Hung-Yao Lin, Tai-Chung Tseng; Clin Mol Hepatol 2022;28(2):181-182.
Published online February 21, 2022; DOI: https://doi.org/10.3350/cmh.2022.0028

Citations

Citations to this article as recorded by

Tenofovir Disoproxil Fumarate Versus Entecavir: Effects on Lipid Profiles and Cardiovascular Outcomes in People Living With Chronic Hepatitis B
Log Young Kim, Jae Young Kim, Jeong‐Ju Yoo, Sang Gyune Kim, Young‐Seok Kim
Journal of Medical Virology.2025;[Epub] CrossRef
Safety of tenofovir alafenamide in the context of hyperlipidemia and cardiovascular diseases: a nationwide analysis
Jae-Young Kim, Hyuk Kim, Jeong-Ju Yoo, Sang Gyune Kim, Young-Seok Kim
Hepatology International.2025; 19(4): 959. CrossRef
Long-Term Safety and Efficacy of Tenofovir Alafenamide in Chronic Hepatitis B: Raising the Need for Studies on Functional Cure—Editorial on “Long-Term Real-World Outcomes of Tenofovir Alafenamide in Chronic Hepatitis B”
Soon Kyu Lee
The Korean Journal of Gastroenterology.2025; 85(3): 245. CrossRef
Risk of dyslipidaemia in people living with HIV who are taking tenofovir alafenamide: a systematic review and meta‐analysis
Jeong‐Ju Yoo, Eun Ae Jung, Sang Gyune Kim, Young Seok Kim, Min Jae Kim
Journal of the International AIDS Society.2024;[Epub] CrossRef
Tenofovir Alafenamide for Multiple Drug-Resistant Chronic Hepatitis B: A 3-Year Clinical Trial
Jonggi Choi, Young-Suk Lim, Ji-Hoon Kim, Kwan Soo Byun, Byung Chul Yoo
Clinical Gastroenterology and Hepatology.2023; 21(12): 3185. CrossRef
Risk of dyslipidemia in chronic hepatitis B patients taking tenofovir alafenamide: a systematic review and meta-analysis
Eui Gwon Hwang, Eun-Ae Jung, Jeong-Ju Yoo, Sang Gyune Kim, Young Seok Kim
Hepatology International.2023; 17(4): 860. CrossRef
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Clinics in Liver Disease.2023; 27(4): 809. CrossRef

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Original Article

Viral hepatitis

Tenofovir alafenamide treatment may not worsen the lipid profile of chronic hepatitis B patients: A propensity score-matched analysis: Joonho Jeong, Jung Woo Shin, Seok Won Jung, Eun Ji Park, Neung Hwa Park; Clin Mol Hepatol 2022;28(2):254-264.
Published online December 28, 2021; DOI: https://doi.org/10.3350/cmh.2021.0314

Background/Aims
Tenofovir alafenamide (TAF) has shown less favorable effect on lipids compared to tenofovir disoproxil fumarate (TDF) in clinical trials. However, data regarding these outcomes in patients with chronic hepatitis B (CHB) are scarce. Therefore, this study aimed to evaluate the effect of TAF on the lipid in patients with CHB.
Methods
A total of 237 TAF-treated CHB patients compared with TDF, inactive CHB, and non-hepatitis B virus (HBV)-infected control groups using propensity score matching (PSM).
Result
s: Following PSM, each analysis was conducted on cohorts via the matching of 70:140 (TAF:TDF), 89:89 (TAF:inactive CHB), 140:560 (TAF:non-HBV infected control), and 368:1,472 (TDF:non-HBV-infected control). A significant decrease in the total cholesterol (TC) level was noted at 48 weeks in the TDF group compared to the TAF group (176.3±32.9 vs. 156.7±27.7, P<0.001) and the non-HBV-infected control group (175.0±29.5 vs. 156.2±28.3, P<0.001). However, no significant change in TC was observed in the TAF group and inactive CHB or non-HBV-infected control groups at 48 weeks. For the subgroup analyses of TAF vs. non-HBV-infected control subjects and inactive CHB patients whose detailed lipid profile information were available, no between-group differences in TC, low-density lipoprotein (LDL)-cholesterol, highdensity lipoprotein (HDL)-cholesterol, TC/HDL ratio, and LDL/HDL ratio were observed at 48 weeks.
Conclusions
TDF seems to have a lipid-lowering effect compared to the non-HBV-infected control and TAF-treated groups. However, in real practice, TAF might not worsen the lipid profiles of subjects compared to non-HBV-infected controls and patients with inactive CHB.

Citations

Citations to this article as recorded by

Efficacy and Safety of Tenofovir Alafenamide (TAF) and Tenofovir Disoproxil Fumarate (TDF) Followed by TAF in Chronic Hepatitis B Patients of East Asian Ethnicity Following 5 Years of Treatment
Grace Lai‐Hung Wong, Edward Gane, Calvin Q. Pan, Scott Fung, Mang M. Ma, Namiki Izumi, Shalimar, Seng Gee Lim, Wan‐Long Chuang, Rajiv Mehta, Young‐Suk Lim, Leland J. Yee, John F. Flaherty, Frida Abramov, Hongyuan Wang, Maria Buti
Alimentary Pharmacology & Therapeutics.2026; 63(1): 132. CrossRef
Atherosclerotic Cardiovascular Risk in Patients with Chronic Hepatitis B: Tenofovir Disoproxil Fumarate Vs. Tenofovir Alafenamide: A Korean Nationwide Study
Jiwon Yang, Jihye Lim, Ye‐jee Kim, Hwa Jung Kim, Jonggi Choi
Journal of Medical Virology.2026;[Epub] CrossRef
Efficacy and Safety of Tenofovir Amibufenamide and Tenofovir Alafenamide for First‐Time HBV‐Related Decompensated Cirrhosis
Xinxin Rong, Guangde Yang, Yuanyuan Xu, He Chen, Xia Wang, Juanjuan Fu, Li Li, Xiucheng Pan
Journal of Viral Hepatitis.2025;[Epub] CrossRef
Tenofovir Disoproxil Fumarate Versus Entecavir: Effects on Lipid Profiles and Cardiovascular Outcomes in People Living With Chronic Hepatitis B
Log Young Kim, Jae Young Kim, Jeong‐Ju Yoo, Sang Gyune Kim, Young‐Seok Kim
Journal of Medical Virology.2025;[Epub] CrossRef
Safety of tenofovir alafenamide in the context of hyperlipidemia and cardiovascular diseases: a nationwide analysis
Jae-Young Kim, Hyuk Kim, Jeong-Ju Yoo, Sang Gyune Kim, Young-Seok Kim
Hepatology International.2025; 19(4): 959. CrossRef
Virological and Biochemical Effects of Tenofovir Alafenamide in Different Patient Groups With Chronic Hepatitis B Virus Infection in Real‐World Cohort
Erdem Bektas, Aysenur Yilmaz, Cevat Ilteris Kikili, Kanan Nuriyev, Zulal Istemihan, Ibrahim Volkan Senkal, Ziya Imanov, Bilger Cavus, Asli Cifcibasi Ormeci, Filiz Akyuz, Kadir Demir, Selman Fatih Besisik, Sabahattin Kaymakoglu, Sreeja Dattachoudhury
International Journal of Hepatology.2025;[Epub] CrossRef
Impact of Tenofovir Alafenamide on Lipid Profiles in Chronic Hepatitis B Patients: Systematic Review and Meta‐Analysis
Ping‐Yu Hsu, Hui‐Chen Su, Mi‐Chia Ma, Chien‐An Chen, Sin‐Yi Yu, Yi‐Ming Hua
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Effect of switching from prior Nucleos(t)ide Analogue(s) to Tenofovir alafenamide on lipid profile and cardiovascular risk in patients with Chronic Hepatitis B
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Review

Viral hepatitis

Entecavir versus tenofovir in patients with chronic hepatitis B: Enemies or partners in the prevention of hepatocellular carcinoma: Sung Won Lee, Jonggi Choi, Seung Up Kim, Young-Suk Lim; Clin Mol Hepatol 2021;27(3):402-412.
Published online June 23, 2021; DOI: https://doi.org/10.3350/cmh.2021.0179

Abstract
PDF

Over the past several decades, entecavir (ETV) and tenofovir disoproxil fumarate (TDF) have remained the first-line antiviral agents in several international guidelines. These two antiviral agents have shown similar short to intermediateterm efficacy, including virologic, biochemical, serologic, and histologic responses. However, huge controversies regarding the antiviral efficacy of ETV and TDF in preventing the development of hepatocellular carcinoma (HCC) still exist. In this review, we summarized recent studies that compared the treatment efficacy of ETV and TDF in terms of HCC development.

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Editorial

Viral hepatitis

Is tenofovir and entecavir combination therapy still the optimal treatment for chronic hepatitis B patients with prior suboptimal response?: Byoung Kuk Jang; Clin Mol Hepatol 2020;26(3):312-314.
Published online July 1, 2020; DOI: https://doi.org/10.3350/cmh.2020.0099

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Original Article

Viral hepatitis

Entecavir+tenofovir vs. lamivudine/telbivudine+adefovir in chronic hepatitis B patients with prior suboptimal response: Hyun Young Woo, Jun Yong Park, Si Hyun Bae, Chang Wook Kim, Jae Young Jang, Won Young Tak, Dong Joon Kim, In Hee Kim, Jeong Heo, Sang Hoon Ahn; Clin Mol Hepatol 2020;26(3):352-363.
Published online May 28, 2020; DOI: https://doi.org/10.3350/cmh.2019.0044n

Abstract
PDF

Background/Aims
Suboptimal responses to lamivudine or telbivudine plus adefovir (LAM/LdT+ADV) rescue therapy are common in patients with LAM-resistant hepatitis B virus (HBV) infections. We compared patients switched to entecavir plus tenofovir (ETV+TDF) to those maintained on LAM/LdT+ADV.
Methods
This prospective randomized controlled trial examined 91 patients whose serum HBV DNA levels were greater than 60 IU/mL after at least 24 weeks of treatment with LAM/LdT+ADV for LAM-resistant HBV. Patients were randomized to receive a new treatment (ETV+TDF, n=45) or maintained on the same treatment (LAM/LdT+ADV, n=46) for 48 weeks. Patients with baseline ADV resistance were excluded.
Result
s: Compared to LAM/LdT+ADV group, ETV+TDF group had more patients with a virologic response (42/45 [93.33%] vs. 3/46 [6.52%], P<0.001) and had a greater mean reduction in serum HBV DNA level from baseline (-4.16 vs. -0.37 log10 IU/mL, P<0.001). Multivariate analysis indicated that high baseline HBV DNA level (P=0.005) and LAM/LdT+ADV maintenance therapy (P=0.001) were negatively associated with virologic response. At week 48, additional ADV- or ETV-associated mutations were cleared in ETV+TDF group, but such mutations were present in 4.3% of patients in LAM/LdT+ADV group (P=0.106). The two groups had similar rates of adverse events.
Conclusions
ETV+TDF combination treatment led to a significantly higher rate of virologic response compared to LAM/LdT+ADV combination treatment in patients with LAM-resistant HBV who had suboptimal responses to LAM/LdT+ADV regardless of HBV genotypic resistance profile (NCT01597934).

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Review

Viral hepatitis

Unmet need in chronic hepatitis B management: Lilian Yan Liang, Grace Lai-Hung Wong; Clin Mol Hepatol 2019;25(2):172-180.
Published online February 12, 2019; DOI: https://doi.org/10.3350/cmh.2018.0106

Abstract
PDF

Despite all these exciting developments, there remain some unmet needs in the management for patients with chronic hepatitis B (CHB). As majority of CHB patients are going to use oral nucleos(t)ide analogues (NAs) for decades, Safety profile of NAs is of no doubt an important issue. The newest nucleotide analogue tenofovir alafenamide is potent in terms of viral suppression, together with favourable renal and bone safety profile. Biochemical response as reflected by alanine aminotransferase (ALT) normalization is recently found to be prognostically important. Patients who achieved ALT normalization have reduced the risk of hepatic events by 49%. Functional cure as reflected by hepatitis B surface antigen seroclearance not only implies patients may stop NA treatment, it also confers to a reduced risk of hepatocellular carcinoma and other hepatic events. Hence functional cure should be the ultimate treatment goal in CHB patients. Preemptive antiviral treatment may reduce mother-to-child transmission of hepatitis B virus, especially if birth dose of vaccination cannot be given in the first two hours after delivery. Lastly, despite the currently first-line NAs have high-genetic barrier to drug resistance mutations, there are still are many patients who were previously treated with low barrier of resistance including lamivudine, telbivudine or adefovir dipivoxil which could lead to antiviral resistance and affecting the choice of NAs.

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Editorial

Viral hepatitis

Is tenofovir monotherapy a sufficient defense line against multi-drug resistant hepatitis B virus?: Yun Bin Lee, Jeong-Hoon Lee; Clin Mol Hepatol 2017;23(3):219-221.
Published online September 19, 2017; DOI: https://doi.org/10.3350/cmh.2017.0045

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Hepatitis B virus resistance to tenofovir: fact or fiction? A systematic literature review and structural analysis of drug resistance mechanisms
Jolynne Mokaya, Anna L. McNaughton, Phillip A Bester, Dominique Goedhals, Eleanor Barnes, Brian D Marsden, Philippa C. Matthews
Wellcome Open Research.2020; 5: 151. CrossRef
Entecavir+tenofovir vs. lamivudine/telbivudine+adefovir in chronic hepatitis B patients with prior suboptimal response
Hyun Young Woo, Jun Yong Park, Si Hyun Bae, Chang Wook Kim, Jae Young Jang, Won Young Tak, Dong Joon Kim, In Hee Kim, Jeong Heo, Sang Hoon Ahn
Clinical and Molecular Hepatology.2020; 26(3): 352. CrossRef

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Original Articles

Viral hepatitis

Efficacy of tenofovir-based rescue therapy for chronic hepatitis B patients with resistance to lamivudine and entecavir: Hee-Jeong Jeon, Seok Won Jung, Neung Hwa Park, Yujin Yang, Jin-Hee Noh, Jae-Sung Ahn, Hyung Rae Kim, Jae Ho Lee, Jung Woo Shin; Clin Mol Hepatol 2017;23(3):230-238.
Published online June 30, 2017; DOI: https://doi.org/10.3350/cmh.2017.0003

Abstract
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Background/Aims
Tenofovir disoproxil fumarate (TDF) monotherapy for 48 weeks provided a virological response comparable to that of TDF and entecavir (ETV) combination therapy in patients infected with ETV-resistant hepatitis B virus (HBV). Little long-term data in routine clinical practice are available regarding the optimal treatment of patients with ETV-resistant HBV.
Methods
We investigated the long-term antiviral efficacy of combination therapy of TDF+lamivudine (LAM) or TDF+ETV compared to that of TDF monotherapy in 73 patients with resistance to both LAM and ETV.
Result
s: Patients were treated with TDF monotherapy (n=12), TDF+LAM (n=19), or TDF+ETV (n=42) for more than 6 months. The median duration of TDF-based rescue therapy was 37 months. Virologic response (VR) was found in 63 patients (86.3%). The rates of VR among the three groups (TDF monotherapy, TDF+LAM, and TDF+ETV) were not statistically different (log-rank P=0.200) at 12 months (59.3%, 78.9%, and 51.8%, respectively) or at 24 months (88.4%, 94.7%, and 84.2%). In addition, treatment efficacy of TDF-based combination or TDF monotherapy was not statistically different with ETV-resistant strains or exposure to other antiviral agents. In multivariate analysis, only lower baseline HBV DNA level was an independent predictor for VR (hazard ratio, 0.723; 95% confidence interval, 0.627-0.834; P<0.001).
Conclusions
TDF monotherapy was as effective as combination therapy of TDF+LAM or TDF+ETV in maintaining long-term viral suppression in chronic hepatitis B patients with resistance to both LAM and ETV. HBV DNA level at the start of TDF rescue therapy was the only independent predictor of subsequent VR.

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Woo Jin Jung, Jae Young Jang, Won Young Park, Soung Won Jeong, Hee Jeong Lee, Sang Joon Park, Sae Hwan Lee, Sang Gyune Kim, Sang-Woo Cha, Young Seok Kim, Young Deok Cho, Hong Soo Kim, Boo Sung Kim, Suyeon Park, Baigal Baymbajav
Medicine.2018; 97(7): e9756. CrossRef
Long-term Outcomes in Patients with HBV Treated with Antiviral Agents
Mauro Viganò, Alessandro Loglio, Pietro Lampertico
Current Hepatology Reports.2018; 17(4): 502. CrossRef
Is tenofovir monotherapy a sufficient defense line against multi-drug resistant hepatitis B virus?
Yun Bin Lee, Jeong-Hoon Lee
Clinical and Molecular Hepatology.2017; 23(3): 219. CrossRef

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Viral hepatitis

Clinical impact of the early alanine amininotransferase flare during tenofovir monotherapy in treatment-naïve patients with chronic hepatitis B: Hee Yeon Seo, Han Ah Lee, Soon Young Ko, Joon Ho Wang, Jeong Han Kim, Won Hyeok Choe, So Young Kwon; Clin Mol Hepatol 2017;23(2):154-159.
Published online May 8, 2017; DOI: https://doi.org/10.3350/cmh.2016.0067

Abstract
PDF

Background/Aims
Little is known about the effect of early flares on response during first-line tenofovir disoproxil fumarate (TDF) treatment for chronic hepatitis B (CHB). The aim of this study was to investigate the incidence and outcome of early alanine aminotransferase (ALT) flare in treatment-naive patients with CHB during long-term TDF monotherapy. Methods: One hundred eighty-one treatment-naive CHB patients were treated with a 300-mg once-daily dose of TDF for more than 12 weeks. Virological markers of hepatitis B virus (HBV) and biochemical data were measured at baseline and every 4-12 weeks during the therapy. The proportion of patients with undetectable HBV DNA level (< 100 copies/mL) was noted. Results: The median age was 48.3 years and 122 patients (67.4%) were men. Hepatitis B envelope antigen (HBeAg) was positive in 101 patients (55.8%). No patient had cirrhosis. The median follow-up duration was 45 weeks (12-155 weeks). ALT flare (>5 × upper limit of the normal range) occurred in seven patients (3%) without viral breakthrough within the first 8 weeks after the start of TDF monotherapy. Among them, six patients were HBeAg-positive and one patient was HBeAg-negative. All cases of early ALT flares resolved within 4 weeks and virologic response was observed in all patients without interruption or discontinuation of treatment. Conclusions: Continuous TDF monotherapy was effective and safe in treatment-naive patients with CHB who experienced early ALT flares followed by a decrease in HBV DNA level.

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Jinlin Hou, Edward Gane, Rozalina Balabanska, Wenhong Zhang, Jiming Zhang, Tien Huey Lim, Qing Xie, Chau-Ting Yeh, Sheng-Shun Yang, Xieer Liang, Piyawat Komolmit, Apinya Leerapun, Zenghui Xue, Ethan Chen, Yuchen Zhang, Qiaoqiao Xie, Ting-Tsung Chang, Tsun
Clinical and Molecular Hepatology.2024; 30(2): 191. CrossRef
DFT, molecular docking and ADME prediction of tenofovir drug as a promising therapeutic inhibitor of SARS-CoV-2 Mpro
Siyamak Shahab, Masoome Sheikhi, Maksim Khancheuski, Hooriye Yahyaei, Hora Alhosseini Almodarresiyeh, Sadegh Kaviani
Main Group Chemistry.2023; 22(1): 115. CrossRef
Switching from Tenofovir-Based Combination Therapy to Tenofovir Monotherapy in Multidrug-Experienced Chronic Hepatitis B Patients: a 5-Year Experience at Two Centers
Jung Hun Kim, Jeong Han Kim, Won Hyeok Choe, So Young Kwon, Byung-chul Yoo, Eileen L. Yoon, Seong Hee Kang
Antimicrobial Agents and Chemotherapy.2022;[Epub] CrossRef
Benefit of transaminase elevations in establishing functional cure of HBV infection during nap‐based combination therapy
Michel Bazinet, Victor Pântea, Gheorghe Placinta, Iurie Moscalu, Valentin Cebotarescu, Lilia Cojuhari, Pavlina Jimbei, Liviu Iarovoi, Valentina Smesnoi, Tatiana Musteata, Alina Jucov, Ulf Dittmer, Adalbert Krawczyk, Andrew Vaillant
Journal of Viral Hepatitis.2021; 28(5): 817. CrossRef
Transaminase Elevations during Treatment of Chronic Hepatitis B Infection: Safety Considerations and Role in Achieving Functional Cure
Andrew Vaillant
Viruses.2021; 13(5): 745. CrossRef
Safety, pharmacokinetics, and antiviral activity of RO7049389, a core protein allosteric modulator, in patients with chronic hepatitis B virus infection: a multicentre, randomised, placebo-controlled, phase 1 trial
Man-Fung Yuen, Xue Zhou, Edward Gane, Christian Schwabe, Tawesak Tanwandee, Sheng Feng, Yuyan Jin, Miriam Triyatni, Annabelle Lemenuel-Diot, Valerie Cosson, Zenghui Xue, Remi Kazma, Qingyan Bo
The Lancet Gastroenterology & Hepatology.2021; 6(9): 723. CrossRef
Tenofovir disoproxil fumarate-induced severe liver injury in a patient with chronic hepatitis B virus infection
Min Kyu Kang, Jung Gil Park
Digestive and Liver Disease.2018; 50(6): 628. CrossRef
Is alanine aminotransferase flare-up in nucleos(t)ide analogue treatment of chronic hepatitis B a promising, rather than a devastating, sign?
Nae-Yun Heo
Clinical and Molecular Hepatology.2017; 23(2): 125. CrossRef

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Viral hepatitis

Tenofovir has inferior efficacy in adefovir-experienced chronic hepatitis B patients compared to nucleos(t)ide-naïve patients: Goh Eun Chung, Eun Ju Cho, Jeong-Hoon Lee, Jeong-ju Yoo, Minjong Lee, Yuri Cho, Dong Hyeon Lee, Hwi Young Kim, Su Jong Yu, Yoon Jun Kim, Jung-Hwan Yoon, Fabien Zoulim; Clin Mol Hepatol 2017;23(1):66-73.
Published online February 14, 2017; DOI: https://doi.org/10.3350/cmh.2016.0060

Abstract
PDF

Background/Aims
A recent study reported that entecavir had inferior efficacy in nucleos(t)ide analogue (NA)-experienced chronic hepatitis B (CHB) patients compared to NA-naïve patients. We sought to compare the efficacy of tenofovir disoproxil fumarate (TDF) in NA-experienced and NA-naïve CHB patients.
Methods
We retrospectively enrolled 252 consecutive patients who had a serum hepatitis B virus (HBV) DNA level greater than 2,000 IU/mL at the initiation of TDF treatment and who received TDF for at least 6 months. Complete virologic suppression (CVS) was defined as undetectable serum HBV DNA. We generated a multivariate Cox proportional-hazard model to examine predictive factors that were independently associated with time to CVS.
Result
s: The mean age of patients was 48.2 years, and the cohort included 181 NA-naïve patients and 71 NA-experienced patients. The median duration of TDF treatment was 14.4 (interquartile range, 9.5-17.8) months. A total of 167 (92.3%) of 181 NA-naïve patients achieved CVS, and 60 (84.5%) of 71 NA-exposed patients achieved CVS. Forty-nine (89.1%) of 55 patients who previously took an NA aside from adefovir and 11 (68.8%) of 16 adefovir-experienced patients achieved CVS. In multivariable analysis, previous adefovir exposure significantly influenced time to CVS (hazard ratio, 0.37; 95% confidence interval, 0.19-0.72; P=0.003), after adjusting for HBeAg positivity, baseline HBV DNA level and cirrhosis.
Conclusions
Tenofovir had inferior efficacy in adefovir-experienced CHB patients compared to NA-naïve patients. The response of patients with previous adefovir exposure to TDF monotherapy should be monitored closely.

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Tenofovir disoproxil fumarate for multiple nucleos(t)ide analogues treatment failure hepatitis B: Is monotherapy enough?
Xieer Liang, Qing Xie, Jia Shang, Hong Tang, Min Xu, Qinghua Meng, Jiming Zhang, Pujun Gao, Jifang Sheng, Hao Wang, Jidong Jia, Guiqiang Wang, Shunquan Wu, Jingna Ping, Jinlin Hou
Journal of Gastroenterology and Hepatology.2022; 37(3): 471. CrossRef
Switching from Tenofovir-Based Combination Therapy to Tenofovir Monotherapy in Multidrug-Experienced Chronic Hepatitis B Patients: a 5-Year Experience at Two Centers
Jung Hun Kim, Jeong Han Kim, Won Hyeok Choe, So Young Kwon, Byung-chul Yoo, Eileen L. Yoon, Seong Hee Kang
Antimicrobial Agents and Chemotherapy.2022;[Epub] CrossRef
Clinical effects of NTCP‐inhibitor myrcludex B
Dongliang Cheng, Bing Han, Wei Zhang, Wei Wu
Journal of Viral Hepatitis.2021; 28(6): 852. CrossRef
Effectiveness of tenofovir alafenamide for chronic hepatitis B patients with a poor response to the previously used nucleos(t)ide analogs
Daiki Yamashige, Tetsuya Hosaka, Fumitaka Suzuki, Shunichiro Fujiyama, Yusuke Kawamura, Hitomi Sezaki, Norio Akuta, Masahiro Kobayashi, Yoshiyuki Suzuki, Satoshi Saitoh, Yasuji Arase, Kenji Ikeda, Mariko Kobayashi, Hiromitsu Kumada
Journal of Gastroenterology.2021; 56(11): 1008. CrossRef
Tenofovir‐based combination therapy or monotherapy for multidrug‐resistant chronic hepatitis B: Long‐term data from a multicenter cohort study
Hyung Joon Yim, Sang Jun Suh, Young Kul Jung, Seong Gyu Hwang, Yeon Seok Seo, Soon Ho Um, Sae Hwan Lee, Young Seok Kim, Jae Young Jang, In Hee Kim, Hyoung Su Kim, Ji Hoon Kim, Young Sun Lee, Eileen L. Yoon, Myeong Jun Song, Jun Yong Park
Journal of Viral Hepatitis.2020; 27(12): 1306. CrossRef
Identification of a quadruple mutation that confers tenofovir resistance in chronic hepatitis B patients
Eun-Sook Park, Ah Ram Lee, Doo Hyun Kim, Jeong-Hoon Lee, Jeong-Ju Yoo, Sung Hyun Ahn, Heewoo Sim, Soree Park, Hong Seok Kang, Juhee Won, Yea Na Ha, Gu-Choul Shin, So Young Kwon, Yong Kwang Park, Byeong-Sun Choi, Yun Bin Lee, Nakcheol Jeong, Yohan An, Youn
Journal of Hepatology.2019; 70(6): 1093. CrossRef
Treatment Outcome and Renal Safety of 3-Year Tenofovir Disoproxil Fumarate Therapy in Chronic Hepatitis B Patients with Preserved Glomerular Filtration Rate
In Suk Min, Chang Hun Lee, Ik Sang Shin, Na Eun Lee, Hong Seon Son, Seung Bum Kim, Seung Young Seo, Seong Hun Kim, Sang Wook Kim, Seung Ok Lee, Soo Teik Lee, In Hee Kim
Gut and Liver.2019; 13(1): 93. CrossRef
KASL clinical practice guidelines for management of chronic hepatitis B

Clinical and Molecular Hepatology.2019; 25(2): 93. CrossRef
Direct Detection of Drug-Resistant Hepatitis B Virus in Serum Using a Dendron-Modified Microarray
Doo Hyun Kim, Hong Seok Kang, Seong-Suk Hur, Seobo Sim, Sung Hyun Ahn, Yong Kwang Park, Eun-Sook Park, Ah Ram Lee, Soree Park, So Young Kwon, Jeong-Hoon Lee, Kyun-Hwan Kim
Gut and Liver.2018; 12(3): 331. CrossRef
Is Combination Antiviral Therapy Mandatory for Maintenance Therapy in Fully Suppressed Multidrug-Resistant Hepatitis B Patients?
Sung Won Chung, Young Chang, Hyo Young Lee, Eun Ju Cho, Jeong-Hoon Lee, Su Jong Yu, Jung-Hwan Yoon, Yoon Jun Kim
Gastroenterology Research and Practice.2018; 2018: 1. CrossRef
Is tenofovir monotherapy a sufficient defense line against multi-drug resistant hepatitis B virus?
Yun Bin Lee, Jeong-Hoon Lee
Clinical and Molecular Hepatology.2017; 23(3): 219. CrossRef

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Editorial

Viral hepatitis

Switch to tenofovir-based therapy or to continue adefovir-based therapy in CHB patients with suboptimal response to adefovir-based combination?: Byung-Cheol Song; Clin Mol Hepatol 2016;22(4):439-442.
Published online December 25, 2016; DOI: https://doi.org/10.3350/cmh.2016.0108

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A Desmethylphosphinothricin Dipeptide Derivative Effectively Inhibits Escherichia coli and Bacillus subtilis Growth
Maxim A. Khomutov, Fabio Giovannercole, Laura Onillon, Marija V. Demiankova, Byazilya F. Vasilieva, Arthur I. Salikhov, Sergey N. Kochetkov, Olga V. Efremenkova, Alex R. Khomutov, Daniela De Biase
Biomolecules.2023; 13(10): 1451. CrossRef

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1 Web of Science
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Original Article

Viral hepatitis

Efficacy of switching from adefovir to tenofovir in chronic hepatitis B patients who exhibit suboptimal responses to adefovir-based combination rescue therapy due to resistance to nucleoside analogues (SATIS study): Hye Won Lee, Jun Yong Park, Beom Kyung Kim, Moon Young Kim, Jung Il Lee, Young Suk Kim, Ki Tae Yoon, Kwang-Hyub Han, Sang Hoon Ahn; Clin Mol Hepatol 2016;22(4):443-449.
Published online November 25, 2016; DOI: https://doi.org/10.3350/cmh.2016.0037

Abstract
PDF

Background/Aims
It remains to be determined whether switching from adefovir (ADV) to tenofovir (TDF) provides better virological outcomes in patients exhibiting suboptimal responses to ADV plus nucleoside analogue (ADV+NA) therapy for NA-resistant chronic hepatitis B (CHB).
Methods
In this prospective trial, patients who showed partial responses (defined as serum hepatitis B virus [HBV] DNA >60 IU/mL) to ADV+NA therapy for NA resistance were randomly allocated to receive TDF plus NA (TDF+NA group, n=16) or to continue their current therapy (ADV+NA group, n=16). The primary end point was the proportion of patients with complete virological response (CVR, defined as serum HBV DNA <60 IU/mL) at 48 weeks.
Result
s: The median age was 52 years (16 men), and 28 were positive for hepatitis B e antigen (HBeAg). The baseline characteristics did not differ significantly between the two groups. The proportion with CVR was significantly higher in the TDF+NA group than in the ADV+NA group at 24 weeks (81.3% vs. 25.0%, P=0.001) and 48 weeks (87.5% vs. 37.5%, P=0.002). Furthermore, a decrease in the serum HBV DNA level of >2log10 IU/mL was more likely in the TDF+NA group at both 24 and 48 weeks (68.8% vs. 56.3%, P=0.014 vs. 81.3% vs. 56.3%, P=0.001, respectively). During the follow-up, the rate of HBeAg seroconversion was higher in the TDF+NA group than the ADV+NA group (12.5% vs. 6.25%, P=0.640), as was that for the hepatitis B surface antigen (6.25% vs. 0%, P=0.080). No serious adverse events due to antiviral agents occurred.
Conclusions
In patients exhibiting suboptimal responses to ADV+NA therapy for NA-resistant CHB, switching from ADV to TDF might provide better virological outcomes.

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Comparative efficacy and safety of pegylated interferon-alpha monotherapy vs combination therapies with entecavir or tenofovir in chronic hepatitis B patients
Huiqing Liang, Xiaoting Zheng, Qianguo Mao, Jiaen Yang, Qingfa Ruan, Chuncheng Wu, Yaoyu Liu, Siyan Chen, Luyun Zhang, Manying Zhang, Hongli Zhuang, Li Lin, Shaodong Chen, Hyun Jin Kwun
Microbiology Spectrum.2025;[Epub] CrossRef
Predictive value of hepatic, hematological, and immunological markers and their temporal dynamics in chronic hepatitis B functional cure
Jianyong Zeng, Caixia Zheng, Yincheng Zheng, Xiulan Xue, Benjamin M. Liu
Microbiology Spectrum.2025;[Epub] CrossRef
Entecavir versus tenofovir on the recurrence of hepatitis B–related HCC after liver transplantation: A multicenter observational study
Deok-Gie Kim, YoungRok Choi, Jinsoo Rhu, Shin Hwang, Young Kyoung You, Dong-Sik Kim, Yang Won Nah, Bong-Wan Kim, Jai Young Cho, Koo Jeong Kang, Jae Do Yang, Donglak Choi, Dong Jin Joo, Myoung Soo Kim, Je Ho Ryu, Jae Geun Lee
Liver Transplantation.2023; 29(12): 1272. CrossRef
KASL clinical practice guidelines for management of chronic hepatitis B

Clinical and Molecular Hepatology.2022; 28(2): 276. CrossRef
Is tenofovir and entecavir combination therapy still the optimal treatment for chronic hepatitis B patients with prior suboptimal response?
Byoung Kuk Jang
Clinical and Molecular Hepatology.2020; 26(3): 312. CrossRef
Long-term Efficacy of Tenofovir Disoproxil Fumarate Monotherapy for Multidrug-Resistant Chronic HBV infection
Hye Won Lee, Jun Yong Park, Jin Woo Lee, Ki Tae Yoon, Chang Wook Kim, Hana Park, Young Seok Kim, Soon Ku Paik, Jung Il Lee, Beom Kyung Kim, Kwang-Hyub Han, Sang Hoon Ahn
Clinical Gastroenterology and Hepatology.2019; 17(7): 1348. CrossRef
Comparison of the long-term efficacy of tenofovir and entecavir in nucleos(t)ide analogue-naïve HBeAg-positive patients with chronic hepatitis B
Dachuan Cai, Chen Pan, Weihua Yu, Shuangsuo Dang, Jia Li, Shanming Wu, Nan Jiang, Maorong Wang, Zhaohua Zhang, Feng Lin, Shaojie Xin, Yongfeng Yang, Baoshen Shen, Hong Ren
Medicine.2019; 98(1): e13983. CrossRef
Switching from tenofovir and nucleoside analogue therapy to tenofovir monotherapy in virologically suppressed chronic hepatitis B patients with antiviral resistance
Dong Yun Kim, Hye Won Lee, Jeong Eun Song, Beom Kyung Kim, Seung Up Kim, Do Young Kim, Sang Hoon Ahn, Kwang‐Hyub Han, Jun Yong Park
Journal of Medical Virology.2018; 90(3): 497. CrossRef
Step-down Strategy in Antiviral Resistant Chronic Hepatitis B Patients Who Achieved Viral Suppression With Rescue Combination Therapy
Dong Yun Kim, Jun Yong Park
Future Virology.2018; 13(10): 711. CrossRef
Efficacy and safety of three adefovir‐based combination therapies in HBeAg‐positive chronic hepatitis B patients with suboptimal response to adefovir monotherapy
M.‐L. Wang, E.‐Q. Chen, D.‐M. Zhang, L.‐Y. Du, L.‐B. Yan, T.‐Y. Zhou, X.‐Z. Lei, B.‐J. Lei, J.‐J. Lu, J. Liao, H. Tang
Journal of Viral Hepatitis.2017; 24(S1): 21. CrossRef

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Crossref

Editorial

Viral hepatitis

Is the tenofovir based therapy almighty for previous treatment failure in chronic hepatitis B?: Hyung Joon Yim; Clin Mol Hepatol 2016;22(2):238-240.
Published online June 25, 2016; DOI: https://doi.org/10.3350/cmh.2016.0103

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Validation of PAGE‐B model in Asian chronic hepatitis B patients receiving entecavir or tenofovir
Mi Na Kim, Seong Gyu Hwang, Kyu Sung Rim, Beom Kyung Kim, Jun Yong Park, Do Young Kim, Sang Hoon Ahn, Kwang‐Hyub Han, Seung Up Kim
Liver International.2017; 37(12): 1788. CrossRef

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Case Report

Viral hepatitis

Tenofovir-associated nephrotoxicity in patients with chronic hepatitis B: two cases: Hyeki Cho, Yuri Cho, Eun Ju Cho, Jeong-Hoon Lee, Su Jong Yu, Kook-Hwan Oh, Kyoungbun Lee, Syifa Mustika, Jung-Hwan Yoon, Yoon Jun Kim; Clin Mol Hepatol 2016;22(2):286-291.
Published online June 25, 2016; DOI: https://doi.org/10.3350/cmh.2015.0066

Abstract
PDF

Tenofovir disoproxil fumarate (TDF) is effective against chronic hepatitis B (CHB) infection and its use is increasing rapidly worldwide. However, it has been established that TDF is associated with renal toxicity in human immunodeficiency virus-infected patients, while severe or symptomatic TDF-associated nephrotoxicity has rarely been reported in patients with CHB. Here we present two patients with TDF-associated nephrotoxicity who were being treated for CHB infection. The first patient was found to have clinical manifestations of proximal renal tubular dysfunction and histopathologic evidence of acute tubular necrosis at 5 months after starting TDF treatment. The second patient developed acute kidney injury at 17 days after commencing TDF, and he was found to have membranoproliferative glomerulonephritis with acute tubular injury. The renal function improved in both patients after discontinuing TDF. We discuss the risk factors for TDF-associated renal toxicity and present recommendations for monitoring renal function during TDF therapy.

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Lung‐Yi Mak, Tsung‐Hui Hu, Desmond Y. H. Yap
Alimentary Pharmacology & Therapeutics.2026;[Epub] CrossRef
Urinary Levels of Neutrophil Gelatinase-associated Lipocalin and Cystatin C in Patients with Hepatitis B on Tenofovir Treatment
Shivani Rani, Himanshu Dandu, Ambuj Yadav, Mahak Lamba, Amit Goel, Wahid Ali, Virendra Atam, Sumit Rungta, Medhavi Gautam, Atin Singhai
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David Sooik Kim, Soo Young Park, Beom Kyung Kim, Jun Yong Park, Do Young Kim, Kwang-Hyub Han, Yu Rim Lee, Won Young Tak, Young Oh Kweon, Inkyung Jung, Minkyung Han, Eun Hwa Kim, Sang Hoon Ahn, Seung Up Kim
Journal of Korean Medical Science.2021;[Epub] CrossRef
Long-term Nucleotide Analogue Treatment Has Higher Levels of Renal Toxicities than Does Entecavir in Patients with Chronic Hepatitis B
Young Youn Cho, Young Chang, Joon Yeul Nam, Hyeki Cho, Eun Ju Cho, Jeong-Hoon Lee, Su Jong Yu, Jung-Hwan Yoon, Yoon Jun Kim
Gut and Liver.2020; 14(2): 225. CrossRef
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Mi Young Jeon, Jae Seung Lee, Hye Won Lee, Beom Kyung Kim, Jun Yong Park, Do Young Kim, Kwang‐Hyub Han, Sang Hoon Ahn, Seung Up Kim
Journal of Viral Hepatitis.2020; 27(9): 932. CrossRef
Editorial: tenofovir disoproxil fumarate vs entecavir in patients with chronic hepatitis B and renal impairment—still an open issue
Sung Won Lee, Seung Up Kim
Alimentary Pharmacology & Therapeutics.2020; 52(5): 889. CrossRef
Tenofovir does not induce renal dysfunction compared to entecavir in post-liver-transplant hepatitis B virus patients
Sang Jin Kim, Jinsoo Rhu, Seo Hee Lee, Jong Man Kim, Gyu-Seong Choi, Kyunga Kim, Jae-Won Joh
Annals of Surgical Treatment and Research.2020; 99(3): 180. CrossRef
A severe case of tenofovir-associated acute kidney injury requiring hemodialysis in a patient with chronic hepatitis B
A Young Cho, Ju Hwan Oh, Hee-Chan Moon, Gum Mo Jung, Young Suk Lee, Yeong Jin Choi, In O Sun, Kwang Young Lee
Kidney Research and Clinical Practice.2020; 39(3): 373. CrossRef
Renal Dysfunction and Tubulopathy Induced by High-Dose Tenofovir Disoproxil Fumarate in C57BL/6 Mice
Eungyeong Jang, Jong Kil Lee, Kyung-Soo Inn, Eun Kyoung Chung, Kyung-Tae Lee, Jang-Hoon Lee
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Application of High-Performance Liquid Chromatography for Simultaneous Determination of Tenofovir and Creatinine in Human Urine and Plasma Samples
Patrycja Olejarz, Grażyna Chwatko, Paweł Kubalczyk, Krystian Purgat, Rafał Głowacki, Kamila Borowczyk
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Fatemeh Ghasemi, Mohammadreza Salehi, Niloofar Khoshnam Rad, Hossein Khalili
American Journal of Therapeutics.2019; 26(5): e639. CrossRef
Tenofovir and Entecavir Have Similar Renal Adverse Events on Hepatocellular Carcinoma Patients Treated with Transarterial Chemoembolization
Young Youn Cho, Young Hwan Choi, Su Jong Yu, Eun Ju Cho, Jeong-Hoon Lee, Yoon Jun Kim, Jung-Hwan Yoon
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Woo Jin Jung, Jae Young Jang, Won Young Park, Soung Won Jeong, Hee Jeong Lee, Sang Joon Park, Sae Hwan Lee, Sang Gyune Kim, Sang-Woo Cha, Young Seok Kim, Young Deok Cho, Hong Soo Kim, Boo Sung Kim, Suyeon Park, Baigal Baymbajav
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Using the chronic kidney disease guidelines to evaluate the renal safety of tenofovir disoproxil fumarate in hepatitis B patients
H. J. Tsai, Y. W. Chuang, S. W. Lee, C. Y. Wu, H. Z. Yeh, T. Y. Lee
Alimentary Pharmacology & Therapeutics.2018; 47(12): 1673. CrossRef
Tenofovir disoproxil fumarate

Reactions Weekly.2016; 1617(1): 214. CrossRef

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Original Articles

Viral hepatitis

The efficacy of tenofovir-based therapy in patients showing suboptimal response to entecavir-adefovir combination therapy: Jeong Han Kim, Sung Hyun Ahn, Soon Young Ko, Won Hyeok Choe, Kyun-Hwan Kim, So Young Kwon; Clin Mol Hepatol 2016;22(2):241-249.
Published online June 15, 2016; DOI: https://doi.org/10.3350/cmh.2015.0053

Abstract
PDF

Background/Aims
Before tenofovir (TDF) become available in South Korea, combination therapy with entecavir (ETV) and adefovir (ADV) was the most potent regimen for chronic hepatitis B (CHB) patients who fail to respond to rescue therapy for drug resistance. We analyzed the efficacy of ETV-ADV combination therapy and investigated the clinical and clonal results of TDF-based rescue therapy in CHB patients refractory to this combination. Methods: We retrospectively reviewed the medical records of CHB patients treated for up to 3 years with ETV-ADV combination therapy as a rescue therapy for drug resistance. In cases refractory to this combination, clinical and clonal analyses were performed for TDF-based rescue therapy. Results: The analysis was performed on 48 patients. Twelve patients achieved a virological response (VR) within 3 years. A VR was subsequently achieved in nine of the ten patients without a VR who switched to TDF monotherapy. A VR was also achieved in six of the seven patients who switched to lamivudine-TDF combination therapy, and in two of the two patients who switched to ETV-TDF combination therapy. In an in vitro susceptibility test, viral replication was detected with TDF monotherapy but not with ETV-TDF combination therapy. Conclusions: The efficacy of ETV-ADV combination therapy was insufficient in CHB patients who were refractory to rescue therapy. A more potent regimen such as ETV-TDF combination therapy may be considered in such refractory cases.

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Switching from Tenofovir-Based Combination Therapy to Tenofovir Monotherapy in Multidrug-Experienced Chronic Hepatitis B Patients: a 5-Year Experience at Two Centers
Jung Hun Kim, Jeong Han Kim, Won Hyeok Choe, So Young Kwon, Byung-chul Yoo, Eileen L. Yoon, Seong Hee Kang
Antimicrobial Agents and Chemotherapy.2022;[Epub] CrossRef
Delayed viral suppression during antiviral therapy is associated with increased hepatocellular carcinoma rates in HBeAg‐positive high viral load chronic hepatitis B
J. Y. Nam, Y. Chang, H. Cho, S. H. Kang, Y. Y. Cho, E. J. Cho, J.‐H. Lee, S. J. Yu, J.‐H. Yoon, Y. J. Kim
Journal of Viral Hepatitis.2018; 25(5): 552. CrossRef
Adherence, virological outcome, and drug resistance in Chinese HIV patients receiving first-line antiretroviral therapy from 2011 to 2015
Pengtao Liu, Lingjie Liao, Wei Xu, Jing Yan, Zhongbao Zuo, Xuebing Leng, Jing Wang, Wei Kan, Yinghui You, Hui Xing, Yuhua Ruan, Yiming Shao
Medicine.2018; 97(50): e13555. CrossRef
Is the tenofovir based therapy almighty for previous treatment failure in chronic hepatitis B?
Hyung Joon Yim
Clinical and Molecular Hepatology.2016; 22(2): 238. CrossRef

13,009 View
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4 Web of Science
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Viral hepatitis

Comparison of tenofovir plus lamivudine versus tenofovir monotherapy in patients with lamivudine-resistant chronic hepatitis B: Chan Ho Park, Seok Won Jung, Jung Woo Shin, Mi Ae Bae, Yoon Im Lee, Yong Tae Park, Hwa Sik Chung, Neung Hwa Park; Clin Mol Hepatol 2016;22(1):152-159.
Published online March 28, 2016; DOI: https://doi.org/10.3350/cmh.2016.22.1.152

Abstract
PDF

Background/Aims
Tenofovir disoproxil fumarate (TDF) exhibits similar antiviral efficacy against treatment-naïve and lamivudine (LAM)-resistant chronic hepatitis B (CHB). However, there are few clinical reports on the antiviral effects of TDF–LAM combination therapy compared to TDF monotherapy in patients with LAM-resistant CHB.
Methods
We investigated the antiviral efficacy of TDF monotherapy vs. TDF–LAM combination therapy in 103 patients with LAM-resistant CHB.
Result
s: The study subjects were treated with TDF alone (n=40) or TDF–LAM combination therapy (n=63) for ≥6 months. The patients had previously been treated with TDF-based rescue therapy for a median of 30.0 months (range, 8–36 months). A virologic response (VR) was achieved in 99 patients (96.1%): 95.0% (38/40) of patients in the TDF monotherapy group and 96.8% (61/63) of patients in the TDF–LAM combination therapy group. The VR rates were not significantly different between the TDF monotherapy and TDF–LAM combination therapy groups (88.9 vs. 87.3% at month 12, and 94.4 vs. 93.7% at month 24, log-rank P=0.652). Univariate and multivariate analyses revealed that none of the pretreatment factors were significantly associated with VR.
Conclusions
TDF monotherapy was as effective as TDF–LAM combination therapy for maintaining viral suppression in the vast majority of patients with LAM-resistant CHB, which suggests that TDF add-on therapy with LAM is unnecessary.

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Research Status of Antiviral Therapy for Chronic Hepatitis B
漫赵
Advances in Clinical Medicine.2025; 15(04): 1194. CrossRef

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Viral hepatitis

Entecavir plus tenofovir versus entecavir plus adefovir in chronic hepatitis B patients with a suboptimal response to lamivudine and adefovir combination therapy: Jung Gil Park, Soo Young Park; Clin Mol Hepatol 2015;21(3):242-248.
Published online September 30, 2015; DOI: https://doi.org/10.3350/cmh.2015.21.3.242

Abstract
PDF

Background/Aims

We compared the efficacies of entecavir (ETV) plus tenofovir (TDF) and ETV plus adefovir (ADV) in chronic hepatitis B (CHB) patients with genotypic resistance to lamivudine (LAM) who showed a suboptimal response to LAM and ADV combination therapy.

Methods

We reviewed 63 CHB patients with genotypic resistance to LAM who showed a suboptimal response to LAM and ADV combination therapy. Among these patients, 30 were treated with ETV + ADV and 33 were treated with ETV + TDF for 12 months.

Results

The only baseline characteristic that differed significantly between the two groups was the ETV resistance profile. The rate of a virologic response [serum hepatitis B virus (HBV) DNA level of <20 IU/mL] was significant higher for ETV+TDF than for ETV+ADV over 12 months (57.6% vs. 23.3%, P=0.006, at 6 months; 84.8% vs. 26.7%, P<0.001, at 12 months). The probability of a virologic response was significantly increased in ETV+TDF (P<0.001, OR=54.78, 95% CI=7.15-419.54) and decreased in patients with higher baseline viral loads (P=0.001, OR=0.18, 95% CI=0.07-0.50) in multivariate analysis. No serious adverse event occurred during the study period.

Conclusions

In patients with CHB who showed a suboptimal response to LAM and ADV combination therapy, ETV+TDF was superior to ETV+ADV in achieving a virologic response regardless of the HBV resistance profile. Further large-scale and long-term follow-up prospective studies are needed to explain these results.

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Tenofovir plus entecavir combination therapy for chronic hepatitis B with nucleos(t)ide analogue failure
Bengü TATAR, Şükran KÖSE
The European Research Journal.2020; 6(4): 270. CrossRef
Entecavir+tenofovir vs. lamivudine/telbivudine+adefovir in chronic hepatitis B patients with prior suboptimal response
Hyun Young Woo, Jun Yong Park, Si Hyun Bae, Chang Wook Kim, Jae Young Jang, Won Young Tak, Dong Joon Kim, In Hee Kim, Jeong Heo, Sang Hoon Ahn
Clinical and Molecular Hepatology.2020; 26(3): 352. CrossRef
Is the tenofovir based therapy almighty for previous treatment failure in chronic hepatitis B?
Hyung Joon Yim
Clinical and Molecular Hepatology.2016; 22(2): 238. CrossRef
Biological Antivirals for Treatment of Adenovirus Infections
Katrin Schaar, Carsten Röger, Tanja Pozzuto, Jens Kurreck, Sandra Pinkert, Henry Fechner
Antiviral Therapy.2016; 21(7): 559. CrossRef

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Viral hepatitis

Tenofovir disoproxil fumarate monotherapy for nucleos(t)ide analogue-naïve and nucleos(t)ide analogue-experienced chronic hepatitis B patients: Sang Kyung Jung, Kyung-Ah Kim, So Young Ha, Hyun Kyo Lee, Young Doo Kim, Bu Hyun Lee, Woo Hyun Paik, Jong Wook Kim, Won Ki Bae, Nam-Hoon Kim, June Sung Lee, Yoon Jung Jwa; Clin Mol Hepatol 2015;21(1):41-48.
Published online March 25, 2015; DOI: https://doi.org/10.3350/cmh.2015.21.1.41

Abstract
PDF

Background/Aims

This study investigated the antiviral effects of tenofovir disoproxil fumarate (TDF) monotherapy in nucleos(t)ide analogue (NA)-naive and NA-experienced chronic hepatitis B (CHB) patients.

Methods

CHB patients treated with TDF monotherapy (300 mg/day) for ≥12 weeks between December 2012 and July 2014 at a single center were retrospectively enrolled. Clinical, biochemical, and virological parameters were assessed every 12 weeks.

Results

In total, 136 patients (median age 49 years, 96 males, 94 HBeAg positive, and 51 with liver cirrhosis) were included. Sixty-two patients were nucleos(t)ide (NA)-naïve, and 74 patients had prior NA therapy (NA-exp group), and 31 patients in the NA-exp group had lamivudine (LAM)-resistance (LAM-R group). The baseline serum hepatitis B virus (HBV) DNA level was 4.9±2.3 log IU/mL (mean±SD), and was higher in the NA-naïve group than in the NA-exp and LAM-R groups (5.9±2.0 log IU/mL vs 3.9±2.0 log IU/mL vs 4.2±1.7 log IU/mL, P<0.01). The complete virological response (CVR) rate at week 48 in the NA-naïve group (71.4%) did not differ significantly from those in the NA-exp (71.3%) and LAM-R (66.1%) groups. In multivariate analysis, baseline serum HBV DNA was the only predictive factor for a CVR at week 48 (hazard ratio, 0.809; 95% confidence interval, 0.729-0.898), while the CVR rate did not differ with the NA experience.

Conclusions

TDF monotherapy was effective for CHB treatment irrespective of prior NA treatment or LAM resistance. Baseline serum HBV DNA was the independent predictive factor for a CVR.

Citations

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Determinants of outcomes in patients with hepatitis B virus-decompensated cirrhosis
Yi-Jie Huang, Jun-Sing Wang, Cheng-Hsu Chen, Shou-Wu Lee, Chung-Hsin Chang, Szu-Chia Liao, Yen-Chun Peng, Teng-Yu Lee, Tsai-Chung Li
Scientific Reports.2025;[Epub] CrossRef
Effectiveness and safety of tenofovir alafenamide in chronic hepatitis B patients over 30 years old with positive hepatitis B virus DNA: a double-center retrospective study
Yinong Feng, Li Zhou, Shaoyuan Shi, Zehong Wang, Xuanxuan Wang, Fan Du
Frontiers in Medicine.2025;[Epub] CrossRef
Changes in liver stiffness values assessed using transient elastography in chronic hepatitis B patients treated with tenofovir disoproxil fumarate: a prospective observational study
Heejin Cho, Yun Bin Lee, Yeonjung Ha, Young Eun Chon, Mi Na Kim, Joo Ho Lee, Hana Park, Kyu Sung Rim, Seong Gyu Hwang
BMC Gastroenterology.2023;[Epub] CrossRef
Switching from Tenofovir-Based Combination Therapy to Tenofovir Monotherapy in Multidrug-Experienced Chronic Hepatitis B Patients: a 5-Year Experience at Two Centers
Jung Hun Kim, Jeong Han Kim, Won Hyeok Choe, So Young Kwon, Byung-chul Yoo, Eileen L. Yoon, Seong Hee Kang
Antimicrobial Agents and Chemotherapy.2022;[Epub] CrossRef
Antiviral Efficacy of Tenofovir Monotherapy in Children with Nucleos(t)ide-naive Chronic Hepatitis B
Jae Young Choe, Jae Sung Ko, Byung-Ho Choe, Jung Eun Kim, Ben Kang, Kyung Jae Lee, Hye Ran Yang
Journal of Korean Medical Science.2018;[Epub] CrossRef
Treatment Efficacy and Safety of Tenofovir-Based Therapy in Chronic Hepatitis B: A Real Life Cohort Study in Korea
Hyo Jun Ahn, Myeong Jun Song, Jeong Won Jang, Si Hyun Bae, Jong Young Choi, Seung Kew Yoon, Haitao Guo
PLOS ONE.2017; 12(1): e0170362. CrossRef
The Effect of Naïve Tenofovir Dipivoxil Fumarate Monotherapy in Patients with Chronic Hepatitis B: 2-Year Results of a Real-world Single-center Study
Sun Hee Oh, Min Ji Park, A Reum Cho, Joo Ah Lee, Joo Ho Park, Ki-Hyun Ryu, Hoon Sup Koo, Kyung Ho Song, Sun Moon Kim, Kyu Chan Huh, Young Woo Choi, Young Woo Kang, Tae Hee Lee
The Korean Journal of Medicine.2017; 92(2): 162. CrossRef
TDF Monotherapy Is Effective Regardless of Prior Nucleos(t)ide Analogue Treatment in Chronic Hepatitis B Patients in China
Mingxing Huang, Guoli Lin, Hong Shi, Yuankai Wu, Yusheng Jie, Zhe Zhu, Yutian Chong
BioMed Research International.2017; 2017: 1. CrossRef
Clinical response to long-term tenofovir monotherapy in Korean chronic hepatitis B patients
Eun-Hyung Yoo, Hyun-Jung Cho
Clinica Chimica Acta.2017; 471: 308. CrossRef
Efficacy of tenofovir-based rescue therapy in patients with lamivudine-resistant hepatitis B virus: A systematic review and meta-analysis
Hui-Lian Wang, Xi Lu, Xudong Yang, Qilan Ning
Clinics and Research in Hepatology and Gastroenterology.2016; 40(4): 447. CrossRef
Modeling the functional state of the reverse transcriptase of hepatitis B virus and its application to probing drug-protein interaction
Xiaojun Xu, Hong Thai, Kathryn M. Kitrinos, Guoliang Xia, Anuj Gaggar, Matthew Paulson, Lilia Ganova-Raeva, Yury Khudyakov, James Lara
BMC Bioinformatics.2016;[Epub] CrossRef
Management of entecavir-resistant chronic hepatitis B with adefovir-based combination therapies
Hyoung Su Kim
World Journal of Gastroenterology.2015; 21(38): 10874. CrossRef
Recent Advances in the Management of Chronic Hepatitis B Including Suppression of Hepatocellular Carcinoma by Entecavir and Interferon
Soo Ki Kim, Soo Ryang Kim, Susumu Imoto, Madoka Tohyama, Yumi Otono, Tomoko Tamura, Ke Ih Kim, Mana Kobayashi, Aya Ohtani, Kayo Sugimoto, Aya Mizuguchi, Yukiko Hiramatsu, Masatoshi Kudo
Oncology.2015; 89(Suppl. 2): 60. CrossRef

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Viral hepatitis

Tenofovir disoproxil fumarate monotherapy for nucleos(t)ide-naïve chronic hepatitis B patients in Korea: data from the clinical practice setting in a single-center cohort: Sung Soo Ahn, Young Eun Chon, Beom Kyung Kim, Seung Up Kim, Do Young Kim, Sang Hoon Ahn, Kwang-Hyub Han, Jun Yong Park; Clin Mol Hepatol 2014;20(3):261-266.
Published online September 25, 2014; DOI: https://doi.org/10.3350/cmh.2014.20.3.261

Abstract
PDF

Background/Aims

This study assessed the antiviral efficacy and safety of tenofovir disoproxil fumarate (TDF) for up to 12 months in Korean treatment-naïve chronic hepatitis B (CHB) patients.

Methods

A total of 411 treatment-naïve CHB patients who had been treated with TDF for at least 3 months (median 5.6) were consecutively enrolled. Clinical, biochemical, virological parameters and treatment adherence were routinely assessed every 3 months.

Results

The median age was 51.3 years, 63.0% of the patients were male, 49.6% were HBeAg (+), and 210 patients had liver cirrhosis. The median baseline HBV DNA was 5.98 (SD 1.68) log₁₀ IU/mL. Among the patients completing week 48, 83.3% had a complete virologic response (CVR, <12 IU/mL by HBV PCR assay), and 88.2% had normalized levels of alanine aminotransferase (ALT). The cumulative probabilities of CVR at 3, 6, 9 and 12 months were 22.8%, 53.1%, 69.3% and 85.0%. During the follow-up period, 9.8% patients achieved HBeAg loss and 7.8% patients achieved HBeAg seroconversion. There was no virological breakthrough after initiating TDF. The most common TDF-related adverse event was gastrointestinal upset, and three patients discontinued TDF therapy. However, no serious life-threatening side effect was noted.

Conclusions

In a clinical practice setting, TDF was safe and highly effective when administered for 12 months to Korean treatment-naïve CHB patients.

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A Young Cho, Ju Hwan Oh, Hee-Chan Moon, Gum Mo Jung, Young Suk Lee, Yeong Jin Choi, In O Sun, Kwang Young Lee
Kidney Research and Clinical Practice.2020; 39(3): 373. CrossRef
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Jae Young Choe, Jae Sung Ko, Byung-Ho Choe, Jung Eun Kim, Ben Kang, Kyung Jae Lee, Hye Ran Yang
Journal of Korean Medical Science.2018;[Epub] CrossRef
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Woo Jin Jung, Jae Young Jang, Won Young Park, Soung Won Jeong, Hee Jeong Lee, Sang Joon Park, Sae Hwan Lee, Sang Gyune Kim, Sang-Woo Cha, Young Seok Kim, Young Deok Cho, Hong Soo Kim, Boo Sung Kim, Suyeon Park, Baigal Baymbajav
Medicine.2018; 97(7): e9756. CrossRef
Treatment Efficacy and Safety of Tenofovir-Based Therapy in Chronic Hepatitis B: A Real Life Cohort Study in Korea
Hyo Jun Ahn, Myeong Jun Song, Jeong Won Jang, Si Hyun Bae, Jong Young Choi, Seung Kew Yoon, Haitao Guo
PLOS ONE.2017; 12(1): e0170362. CrossRef
Effects of Entecavir and Tenofovir on Renal Function in Patients with Hepatitis B Virus-Related Compensated and Decompensated Cirrhosis
Jihye Park, Kyu Sik Jung, Hye Won Lee, Beom Kyung Kim, Seung Up Kim, Do Young Kim, Sang Hoon Ahn, Kwang-Hyub Han, Jun Yong Park
Gut and Liver.2017; 11(6): 828. CrossRef
Treatment of Chronic Hepatitis B with Tenofovir Disoproxil Fumarate in Ivory Coast
Ya Henriette Kissi Anzouan-Kacou, Adjeka Stanislas Doffou, Djeinabou Diallo, Demba Aboubacar Bangoura, Yacouba Adéhouni, Hatrydt Dimitri Kouamé, Alassan Kouamé Mahassadi, Fulgence Yao Bathaix, Koffi Alain Attia, Aya Thérèse Ndri-Yoman
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Medicine.2016; 95(14): e3026. CrossRef
Tenofovir disoproxil fumarate monotherapy for nucleos(t)ide analogue-naïve and nucleos(t)ide analogue-experienced chronic hepatitis B patients
Sang Kyung Jung, Kyung-Ah Kim, So Young Ha, Hyun Kyo Lee, Young Doo Kim, Bu Hyun Lee, Woo Hyun Paik, Jong Wook Kim, Won Ki Bae, Nam-Hoon Kim, June Sung Lee, Yoon Jung Jwa
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