Officials with Gilead Sciences announced they have received approval to expand the indication for emtricitabine/tenofovir disoproxil fumarate tablets (Truvada) for pediatric patients with HIV-1, weighing at least 17kg.
In addition to the updated indication, the Food and Drug Administration (FDA) has approved the company for three additional strengths of Truvada to support its use in the pediatric population: 100/150mg, 133/200mg and 167/250mg tablets. Because it is a fixed-dose tablet, Truvada cannot be adjusted for patients of lower weight nor has it been evaluated in patients weighing less than 17kg.
No clinical trials were conducted in pediatric patients to evaluate the safety and efficacy of Truvada in this population; data from trials conducted on individual drug components (Emtriva, Viread) were used to support dosing recommendations.
For more information visit FDA.gov.
- Birnkrant D. Department of Health and Human Services Supplement Approval NDA 021752/S-047 Reference ID3900321. Silver Springs, MD: U.S. Food and Drug Administration. Accessed March 25, 2016.
This article originally appeared on Infectious Disease Advisor