Adult Antiviral Drug Suppresses Hepatitis B in Teens
Virologic response was 89% with tenofovir (Dec. 5)
A recent clinical trial has found that the adult antiviral drug tenofovir disoproxil fumarate (Viread, Gilead Sciences) is safe and effective in treating adolescents with hepatitis B virus (HBV) infection. The findings — published in the December issue of Hepatology — show that tenofovir suppressed HBV in 89% of pediatric participants.
The Centers for Disease Control and Prevention (CDC) estimate that more than 1 million Americans have chronic HBV infection, with most persons infected during childhood. Medical evidence suggests that 90% of persons infected as infants, and up to 50% infected between 1 and 4 years of age, develop chronic HBV infection; 25% of adults who become chronically infected in childhood develop cirrhosis or liver cancer.
The new double-blind, placebo-controlled trial involved 101 adolescents aged 12 to 17 years. The participants were randomly assigned to receive a daily 300-mg dose of tenofovir (n = 52) or placebo (n = 54) for 72 weeks. A virologic response (defined as the ability of the antiviral drug to suppress the virus) was the study’s primary efficacy endpoint. At the onset of the trial, 91% of the participants tested positive for the hepatitis B e-antigen, and 85% had received prior HBV therapy.
HBV was suppressed in 89% of the participants that received tenofovir, whereas none of the patients in the placebo group showed a virologic response. The drug successfully suppressed HBV and normalized alanine aminotransferase (ALT) levels both in adolescents who received no prior treatment and in those previously exposed to HBV therapy. Participants taking tenofovir showed no resistance to the drug.
Source: Wiley; December 5, 2012.