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Viread label revision includes pediatric patients with chronic HBV

Thursday, December 13, 2018 -- 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