Randomized, placebo-controlled trial of tenofovir disoproxil fumarate in adolescents with chronic hepatitis B
Hepatology, 05/03/2012Murray KF et al.
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–naïve adolescents and those with prior exposure to HBV therapy.
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.
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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