A recent clinical trial found that the adult antiviral drug, tenofovir disoproxil fumarate (tenofovir DF), is safe and effective in treating adolescents with hepatitis B virus (HBV). Trial results published in the December issue of Hepatology, a journal of the American Association for the Study of Liver Diseases (AASLD), show that tenofovir DF suppressed HBV in 89% of pediatric participants.
Chronic HBV is a major health burden that studies estimate affects 350 million people worldwide, with 600,000 deaths attributed to this chronic disease. The Centers for Disease Control and Prevention (CDC) estimate that more than one million Americans have chronic HBV, with most patients infected during childhood. Medical evidence suggests that 90% of patients infected as infants, and up to 50% infected between one and four years of age develop chronic HBV; 25% of adults who become chronically infected in childhood develop cirrhosis or liver cancer.
"Children chronically infected with HBV are at great risk of developing severe liver disease and possible death due to complications from the disease," said Dr. Karen Murray, Chief of the Division of Gastroenterology and Hepatology at Seattle Children's Hospital in Washington and lead researcher of the clinical trial. "Tenofovir DF is highly effective in treating adults with chronic HBV and our trial evaluated safety and efficacy of the drug in adolescents."
This double-blind, placebo-controlled trial was conducted in 101 adolescents aged 12 to 17 years. Participants were randomized with 52 receiving a daily 300 mg dose of tenofovir DF and 54 taking a placebo for 72 weeks. A virologic response-ability of the antiviral medication to suppress the virus in participants-was the main outcome of this clinical trial. At the onset of the trial 91% of participants tested positive for the hepatitis B e-antigen and 85% received prior HBV therapy.