J Korean Med Sci.  2018 Jan;33(2):e11. 10.3346/jkms.2018.33.e11.

Antiviral Efficacy of Tenofovir Monotherapy in Children with Nucleos(t)ide-naive Chronic Hepatitis B

Affiliations
  • 1Department of Pediatrics, Kyungpook National University School of Medicine, Daegu, Korea. bhchoe@knu.ac.kr
  • 2Department of Pediatrics, Seoul National University College of Medicine, Seoul, Korea.

Abstract

BACKGROUND
The purpose was to compare the efficacy between tenofovir disoproxil fumarate (TDF) and lamivudine (LMV) in children with nucleos(t)ide-naive chronic hepatitis B (CHB) infection. Patients with CHB were treated with TDF in the immune-reactive phase and compared with a historical control group of patients treated with LMV before the TDF era.
METHODS
Hepatitis B virus (HBV) DNA titer decrements (> 3 log₁₀ IU/mL) were monitored after treatment initiation. The treatment duration for HBV DNA clearance (< 357 IU/mL) and complete response (HBeAg loss and HBV DNA clearance) were analyzed. The follow-up period was 96 weeks.
RESULTS
Sixteen patients were treated with TDF and compared with a historical control group of 24 patients treated with LMV. HBV DNA decrement (> 3 log₁₀ IU/mL) was achieved in 100% (16/16) of the TDF group but in only 62.5% (15/24) of the LMV group (P = 0.005) at 48 weeks. The HBV DNA clearance (< 357 IU/mL) in the TDF and LMV groups was, respectively, as follows: 62.5% (10/16) and 25.0% (6/24) at 12 weeks (P = 0.018), 81.3% (13/16) and 37.5% (9/24) at 24 weeks (P = 0.006), 93.8% (15/16) and 50.0% (12/24) at 48 weeks (P = 0.004), and 100% (16/16) and 54.2% (13/24) at 96 weeks (P = 0.001). Complete response occurred in 41.7% (5/12) of HBeAg-positive patients in the TDF group and 28.6% (6/21) of the LMV group at 96 weeks (P = 0.443).
CONCLUSION
TDF monotherapy for 96 weeks produced a significantly more effective virologic response than LMV monotherapy in children with nucleos(t)ide-naive CHB.

Keyword

Tenofovir; Lamivudine; Chronic Hepatitis B; Children

MeSH Terms

Child*
DNA
Follow-Up Studies
Hepatitis B virus
Hepatitis B, Chronic*
Hepatitis, Chronic*
Humans
Lamivudine
Tenofovir*
DNA
Lamivudine
Tenofovir
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