The FDA announced revisions to the Viread label to include use in pediatric patients aged 2 years to less than 12 years with chronic hepatitis B based on 48-week safety and efficacy data.
Investigators administered Viread (tenofovir disoproxil fumarate, Gilead) in treatment-experienced patients during two randomized trials.
Trial 144 comprised 89 pediatric patients who received between 8 mg/kg and 300 mg of tenofovir disoproxil fumarate or placebo. At week 48, 77% of treated patients had HBV DNA less than 400 copies/mL compared with 7% of controls. Additionally, alanine aminotransferase