Science Daily (12.05.12)
Aids Weekly Plus
A recent study led by Dr. Karen Murray, chief of the Division of Gastroenterology and Hepatology at Seattle Children’s Hospital in Washington, showed that tenofovir DF, which is effective in treating adults with chronic hepatitis B virus (HBV) infection, has suppressed HBV in adolescents.
The researchers conducted a double-blind, placebo-controlled trial to evaluate tenofovir DF in 101 adolescents aged 12 to 17 years. The participants were randomized, with 52 of them receiving a 300 mg dose of tenofovir DF daily and 54 receiving a placebo for 72 weeks. At the beginning of the trials, 91 percent of participants tested positive for hepatitis B-e-antigen and 85 percent had received prior treatment. A virologic response was observed in 89 percent of the participants in the tenofovir DF group, while there was no HBV suppression among participants in the placebo group. The drug suppressed HBV and normalized alanine aminotransferase (ALT) levels in participants in the tenofovir DF group in those who had received no prior treatment, as well as those who had been treated previously with other drugs. No safety issues were reported, and participants showed no resistance to the drug.
Dr. Murray concluded that the therapy was well tolerated and effective in suppressing HBV in adolescents. She added that the trial demonstrated that tenofovir is a beneficial therapy for managing chronic HBV in teens. A two-year open-label phase study is planned to investigate the sustained response and safety of the drug.
The study, “Randomized, Placebo-Controlled Trial of Tenofovir Disoproxil Fumarate in Adolescents with Chronic Hepatitis B,” was published in the journal Hepatology (2012; 56(6):2018–2026).