Study suggests paediatric dose of emtricitabine (FTC)

An open-label Phase I trial suggests that an FTC dose of 6 mg/kg (up to a maximum of 200 mg) for children will yield a drug plasma concentration equivalent to that in adults. A Phase II trial is further evaluating the 6-mg/kg dose.

The study involved 25 children, two younger than two years old, eight from two to five years old, eight from six to 12 years old, and seven from 13 to 17 years old. All children received single oral doses of 60 and 120 mg/m2 of the nucleoside in solution to a maximum of 200 mg. Children six years old or older also took a third dose of 120 mg/m2 in capsules.

The trial showed that pharmacokinetics of FTC are comparable in adults and children 22 months to 17 years of age. Plasma concentrations proved 20% higher with the capsule formulation than with solution. Using plasma area under the concentration-time curve (AUC) data at the 120-mg/m2 dose, researchers projected that a 6-mg/kg dose of FTC would produce AUCs in children comparable to those in adults given the standard 200-mg dose.

Wang LH, Wiznia AA, Rathore MH et al. Pharmacokinetics and safety of single oral doses of emtricitabine in human immunodeficiency virus-infected children. Antimicrobial Agents and Chemotherapy 2004;48:183-191.