Randomized, placebo-controlled trial of tenofovir disoproxil fumarate in adolescents with chronic hepatitis B

Hepatology, 05/03/2012

Tenofovir disoproxil fumarate (tenofovir DF) therapy in hepatitis B virus (HBV)–infected adolescents was well tolerated and highly effective at suppressing HBV DNA and normalizing ALT values in both treatment–na├»ve adolescents and those with prior exposure to HBV therapy.

Methods

  • In this double-blind, placebo-controlled trial, adolescents (12 to <18 years) with CHB were randomized to tenofovir DF 300 mg (n=52) or placebo (n=54) once daily for 72 weeks.
  • The primary end point was virologic response (HBV DNA <400 copies/mL) at week 72.
  • One hundred six patients were enrolled; 101 patients completed 72 weeks of treatment.
  • At baseline, 91% of patients were hepatitis B e-antigen positive and 85% had prior exposure to HBV therapy.

Results

  • A virologic response was observed in 89% (46/52) of patients who received tenofovir DF and 0% (0/54) of patients who received placebo (P < 0.001).
  • Treatment response was not affected by prior HBV treatment.
  • Furthermore, no resistance to tenofovir DF developed through week 72.
  • Among patients with an alanine aminotransferase (ALT) > upper limit of normal baseline, normalization of ALT occurred in 74% of patients receiving tenofovir DF and 31% of patients receiving placebo (P < 0.001).
  • The rate of grade 3/4 adverse events was higher among patients treated with placebo (24%) than patients treated with tenofovir DF (10%).
  • No patients met the safety end point of a 6% decrease in spine bone mineral density at week 72.

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