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

  • Jung Hyun Kwon
  • Myeong Jun SongEmail author
  • Jeong Won Jang
  • Si Hyun Bae
  • Jong Young Choi
  • Seung Kew Yoon
  • Hee Yeon Kim
  • Chang Wook Kim
  • Do Seon Song
  • U. Im Chang
  • Jin Mo Yang
  • Chan Ran You
  • Sang Wook Choi
  • Hae Lim Lee
  • Sung Won Lee
  • Nam Ik Han
  • Soon Woo Nam
  • Sang Gyune Kim
  • Young Seok Kim
  • Seok Hyun Kim
  • Byung Seok Lee
  • Tae Hee Lee
  • Eun-Young Cho
Original Article
  • 28 Downloads

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.

Keywords

Tenofovir disoproxil fumarate Chronic hepatitis B Virologic response Safety 

Notes

Author's contribution

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.

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.

Compliance with ethical standards

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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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  • Jung Hyun Kwon
    • 1
  • Myeong Jun Song
    • 2
    Email author
  • Jeong Won Jang
    • 3
  • Si Hyun Bae
    • 3
  • Jong Young Choi
    • 3
  • Seung Kew Yoon
    • 3
  • Hee Yeon Kim
    • 4
  • Chang Wook Kim
    • 4
  • Do Seon Song
    • 5
  • U. Im Chang
    • 5
  • Jin Mo Yang
    • 5
  • Chan Ran You
    • 6
  • Sang Wook Choi
    • 6
  • Hae Lim Lee
    • 7
  • Sung Won Lee
    • 7
  • Nam Ik Han
    • 7
  • Soon Woo Nam
    • 1
  • Sang Gyune Kim
    • 8
  • Young Seok Kim
    • 8
  • Seok Hyun Kim
    • 9
  • Byung Seok Lee
    • 9
  • Tae Hee Lee
    • 10
  • Eun-Young Cho
    • 11
  1. 1.Division of Hepatology, Department of Internal Medicine, Incheon St. Mary’s Hospital, College of MedicineThe Catholic University of KoreaSeoulSouth Korea
  2. 2.Division of Hepatology, Department of Internal Medicine, Daejeon St. Mary’s Hospital, College of MedicineThe Catholic University of KoreaSeoulSouth Korea
  3. 3.Division of Hepatology, Department of Internal Medicine, Seoul St. Mary’s Hospital, College of MedicineThe Catholic University of KoreaSeoulSouth Korea
  4. 4.Division of Hepatology, Department of Internal Medicine, Uijeongbu St. Mary’s Hospital, College of MedicineThe Catholic University of KoreaSeoulSouth Korea
  5. 5.Division of Hepatology, Department of Internal Medicine, St. Vincent’s Hospital, College of MedicineThe Catholic University of KoreaSeoulSouth Korea
  6. 6.Division of Hepatology, Department of Internal Medicine, St. Paul’s Hospital, College of MedicineThe Catholic University of KoreaSeoulSouth Korea
  7. 7.Division of Hepatology, Department of Internal Medicine, Bucheon St. Mary’s Hospital, College of MedicineThe Catholic University of KoreaSeoulSouth Korea
  8. 8.Digestive Disease Center, Department of Internal MedicineSoonchunghyang University College of MedicineBucheonSouth Korea
  9. 9.Department of Internal MedicineChungnam University College of MedicineDaejeonSouth Korea
  10. 10.Department of Internal MedicineKonyang University College of MedicineDaejeonSouth Korea
  11. 11.Department of Internal MedicineWonkwang University School of MedicineIksanSouth Korea

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