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Efficacy and Safety of Tenofovir Disoproxil Fumarate in Treatment-Naïve Patients with Chronic Hepatitis B in Korea

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Abstract

Aims

To evaluate the efficacy and safety of 144-week tenofovir disoproxil fumarate (TDF) therapy in treatment-naïve chronic hepatitis B (CHB) patients in Korean.

Methods

In total, 579 treatment-naïve CHB patients at 11 medical centers were enrolled retrospective and prospective from September 2015 to January 2016 by design (NCT02533544). We evaluated the complete virologic response (CVR) rate and the renal safety of TDF.

Results

The overall CVR rate was 69.4%, 87.0%, and 89.7% at weeks 48, 96, and 144, respectively. In the HBeAg-positive CHB patients, the CVR rate at weeks 48, 96, and 144 was 61.4%, 83.1%, and 89.6%, respectively. The rates of HBeAg loss and seroconversion at weeks 48, 96, and 144 were 16.6%, 23.5%, 34.1%, and 7.6%, 8.9%, 13.3%, respectively. In HBeAg-negative CHB patients, the CVR rate at weeks 48, 96, and 144 was 82.5%, 93.2%, and 90.0%, respectively. The rate of alanine aminotransferase normalization was 36.9%, 45.4%, and 46.8% at weeks 48, 96, and 144, respectively. Of the CHB patients, 0.9% showed an elevated creatinine (> 0.5 mg/dL from baseline). Age (≥ 60 years) was significantly associated with a decline in renal function at week 144 (P < 0.0001). Comorbidities (diabetes or hypertension) showed the tendency to reduce renal function (P = 0.0624). Hepatocellular carcinoma developed in 10 (1.7%) patients and was related to cirrhosis.

Conclusions

TDF therapy induced sustained viral suppression and had a favorable safety profile over a 3-year period. However, close monitoring of renal function should be mandatory in treating CHB patients receiving TDF, particularly older patients.

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Funding

This study was funded by a grant from Gilead. The study sponsor had no oversight or influence on study design, collection, analysis, and interpretation of data or drafting the manuscript.

Author information

Authors and Affiliations

  1. Division of Hepatology, Department of Internal Medicine, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea

    Jung Hyun Kwon & Soon Woo Nam

  2. Division of Hepatology, Department of Internal Medicine, Daejeon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea

    Myeong Jun Song

  3. Division of Hepatology, Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea

    Jeong Won Jang, Si Hyun Bae, Jong Young Choi & Seung Kew Yoon

  4. Division of Hepatology, Department of Internal Medicine, Uijeongbu St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea

    Hee Yeon Kim & Chang Wook Kim

  5. Division of Hepatology, Department of Internal Medicine, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea

    Do Seon Song, U. Im Chang & Jin Mo Yang

  6. Division of Hepatology, Department of Internal Medicine, St. Paul’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea

    Chan Ran You & Sang Wook Choi

  7. Division of Hepatology, Department of Internal Medicine, Bucheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea

    Hae Lim Lee, Sung Won Lee & Nam Ik Han

  8. Digestive Disease Center, Department of Internal Medicine, Soonchunghyang University College of Medicine, Bucheon, South Korea

    Sang Gyune Kim & Young Seok Kim

  9. Department of Internal Medicine, Chungnam University College of Medicine, Daejeon, South Korea

    Seok Hyun Kim & Byung Seok Lee

  10. Department of Internal Medicine, Konyang University College of Medicine, Daejeon, South Korea

    Tae Hee Lee

  11. Department of Internal Medicine, Wonkwang University School of Medicine, Iksan, South Korea

    Eun-Young Cho

Authors
  1. Jung Hyun Kwon
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  2. Myeong Jun Song
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  4. Si Hyun Bae
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  7. Hee Yeon Kim
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  8. Chang Wook Kim
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  9. Do Seon Song
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  10. U. Im Chang
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  11. Jin Mo Yang
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  12. Chan Ran You
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  13. Sang Wook Choi
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  14. Hae Lim Lee
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  15. Sung Won Lee
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  16. Nam Ik Han
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  17. Soon Woo Nam
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  18. Sang Gyune Kim
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  19. Young Seok Kim
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  20. Seok Hyun Kim
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  21. Byung Seok Lee
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  22. Tae Hee Lee
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  23. Eun-Young Cho
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Contributions

All authors recruited patients and collected data or were involved in data interpretation. All authors were involved in drafting the manuscript and approved the final version of the manuscript.

Corresponding author

Correspondence to Myeong Jun Song.

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Conflicts of interest

The authors have declared that there are no personal interests.

Ethical approval

This study was conducted in accordance with the Declaration of Helsinki, and ethical approval was obtained from the Ethics Review Board of the Catholic University of Korea (XC15OIMI0052D). The study was registered with US ClinicalTrials.gov (Trial ID: NCT ID NCT02533544).

Informed consent

Informed consent was obtained from all individual participants included in this study.

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Kwon, J.H., Song, M.J., Jang, J.W. et al. Efficacy and Safety of Tenofovir Disoproxil Fumarate in Treatment-Naïve Patients with Chronic Hepatitis B in Korea. Dig Dis Sci 64, 2039–2048 (2019). https://doi.org/10.1007/s10620-019-05489-7

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  • DOI: https://doi.org/10.1007/s10620-019-05489-7

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