Gilead Sciences announced that the FDA has approved Viread (tenofovir disoproxil fumarate) in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients 2–12 years old. The FDA also approved a supplemental New Drug Application for three lower-strength, once-daily tablets of Viread in doses of 150mg, 200mg and 250mg for children aged 6–12 and an oral powder formulation for children aged 2–5. The approval for pediatric use was based on data from a Phase 3 safety and efficacy study of a Viread-containing antiretroviral regimen compared to an antiretroviral regimen containing zidovudine or stavudine in HIV-infected treatment-experienced children ages 2–12 in which the safety profile observed was consistent with that observed in clinical trials in adults.
Viread is already available in a 300mg dosage strength tablet for use in patients ≥12 years of age for the treatment of HIV-1 infection and chronic hepatitis B virus in adults.
For more information call (800) 445-3235 or visit www.viread.com.