Premium
Randomized, placebo‐controlled trial of tenofovir disoproxil fumarate in adolescents with chronic hepatitis B
Author(s) -
Murray Karen F.,
Szenborn Leszek,
Wysocki Jacek,
Rossi Stephen,
Corsa Amoreena C.,
Dinh Phillip,
McHutchison John,
Pang Phillip S.,
Luminos Luminita M.,
Pawlowska Malgorzata,
Mizerski Jacek
Publication year - 2012
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.25818
Subject(s) - medicine , placebo , gastroenterology , clinical endpoint , adverse effect , tenofovir , randomized controlled trial , hepatitis b , hepatitis b virus , chronic hepatitis , immunology , virus , human immunodeficiency virus (hiv) , pathology , alternative medicine
Abstract Tenofovir disoproxil fumarate (DF) is highly effective for the suppression of hepatitis B virus (HBV) in chronically infected adults. This study evaluated the safety and efficacy of tenofovir DF in adolescents with chronic hepatitis B (CHB). In this double‐blind, placebo‐controlled trial, adolescents 12 to <18 years of age with CHB were randomized to tenofovir DF 300 mg (n = 52) or placebo (n = 54) once daily for 72 weeks. The primary endpoint 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) level greater than the upper limit of normal at 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 endpoint of a 6% decrease in spine bone mineral density at week 72. Conclusion : Tenofovir DF therapy in 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. (H EPATOLOGY 2012;56:2018–2026)