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International Journal of Clinical Pharmacy

, Volume 37, Issue 6, pp 1228–1234 | Cite as

Efficacy and safety of tenofovir in nucleos(t)ide-naïve patients with genotype C chronic hepatitis B in real-life practice

  • Jae Hee Kim
  • Seok Won Jung
  • Sung Soo Byun
  • Jung Woo Shin
  • Bo Ryung Park
  • Min-Ho Kim
  • Chang Jae Kim
  • Neung Hwa ParkEmail author
Research Article

Abstract

Background Tenofovir disoproxil fumarate (TDF) has demonstrated potent antiviral activity against hepatitis B virus (HBV) in clinical trials. Although its efficacy has been demonstrated in Caucasian populations, TDF has not previously been studied in Korean patients who present the predominance of HBV genotype C and of vertical or perinatal transmission. Objective The aim of this study was to evaluate the efficacy of TDF in Korean chronic hepatitis B (CHB) patients in real-life practice, and to determine the clinical variables that contribute to virologic response.Setting Large academic medical center in Korea. Method We retrospectively investigated the efficacy of TDF treatment for more than 6 months in 151 nucleos(t)ide-naïve CHB patients. Main outcome measure The primary endpoint was a virologic response (VR), defined as an HBV DNA level of <12 IU/mL. Secondary endpoints were rates of alanine aminotransaminase (ALT) normalization, hepatitis B e antigen (HBeAg) seroconversion, virologic breakthrough, and safety. Results All patients were the genotype C2. The median duration of TDF treatment was 13 months (range 7–18 months). Ninety-two (61.0 %) patients were HBeAg positive. The mean pre-treatment HBV DNA level was 6.34 ± 1.42 log10 IU/mL. Among the 131 patients with elevated ALT levels at baseline, 128 (97.7 %) patients achieved ALT normalization during TDF treatment. VR was achieved in 97 (64.2 %) patients. The cumulative rates of VR at 6, 9, 12, and 18 months were 47.0, 59.4, 67.9, and 69.3 %, respectively. Among the 92 HBeAg-positive patients, 14 (15.2 %) patients achieved HBeAg seroconversion. In multivariate analysis, absolute HBV DNA levels at baseline (P < 0.001; OR 0.529; 95 % CI 0.560–0.744) and HBeAg positivity (P = 0.015; OR 0.731; 95 % CI 0.615–0.869) were significantly associated with VR. Virologic breakthrough was observed in four patients. These four patients had poor adherence to TDF. Most of the adverse events were mild in severity. No significant changes were observed in serum creatinine and phosphorus levels. Conclusions TDF was effective and well tolerated in Korean genotype C CHB patients in real life practice, consistent with larger registration trials. The absolute HBV DNA levels at baseline and HBeAg positivity were significantly associated with VR.

Keywords

Chronic hepatitis B Korea Nucleos(t)ide-naïve Real-life practice Tenofovir 

Notes

Acknowledgments

This study was supported by Priority Research Center Program through the National Research Foundation of Korea (NRF) funded by the Ministry of Education, Science, and Technology (2009-0094050).

Funding

None.

Conflicts of interest

None of the authors has any conflict of interest to declare.

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Copyright information

© Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie 2015

Authors and Affiliations

  • Jae Hee Kim
    • 1
  • Seok Won Jung
    • 1
  • Sung Soo Byun
    • 1
  • Jung Woo Shin
    • 1
  • Bo Ryung Park
    • 2
  • Min-Ho Kim
    • 2
  • Chang Jae Kim
    • 2
  • Neung Hwa Park
    • 1
    • 2
    Email author
  1. 1.Department of Internal Medicine, University of Ulsan College of MedicineUlsan University HospitalDong-gu, UlsanRepublic of Korea
  2. 2.Biomedical Research Center, University of Ulsan College of MedicineUlsan University HospitalUlsanRepublic of Korea

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