Gilead Sciences has received approval to expand the indication for Truvada (emtricitabine/tenofovir disoproxil fumarate tablets) for pediatric patients with HIV-1. The approval letter states that based on the fulfillment of the pediatric postmarketing requirement, Truvada is now approved 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.
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. Truvada should only be administered to HIV-1 infected pediatric patients with body weight greater than or equal to 17kg and who are able to swallow a whole tablet. 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.
Truvada is comprised of emtricitabine and tenofovir disoproxil fumarate, both nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs). It is also indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults, as well as for pre-exposure prophylaxsis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk.
For more information visit FDA.gov.