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Population Pharmacokinetics of Enfuvirtide in HIV-1-Infected Pediatric Patients Over 48 Weeks of Treatment

From Hoffmann–La Roche, Inc, Nutley, New Jersey (Dr Zhang, Dr Lin, Ms Bertasso, Mr Kolis, Dr Salgo, Dr Patel); Roche Products Ltd, Welwyn Garden City, UK (Ms Evans); and XIQ Coordination, Inc, Fort Myers, Florida (Dr Dorr).

The objective of this study was to characterize the population pharmacokinetics of enfuvirtide in HIV-1-infected children and adolescents. HIV-infected patients received combination antiretroviral therapy, including enfuvirtide 2.0 mg/kg subcutaneously, twice daily. Serial and trough blood samples were collected up to 48 weeks. NONMEM was used for population pharmacokinetic analysis. Enfuvirtide exposure was calculated from individual parameter estimates derived from the final model. A total of 218 samples from 43 patients were included in the analysis. Enfuvirtide plasma concentration–time data were described by a 1-compartment model with first-order absorption and elimination. The addition of each subject's actual body weight as a covariate affected CL/F but not V/F or K_a. The population CL/F, V/F, and K_a for a 33-kg reference patient was 1.31 L/h, 2.31 L, and 0.105 h^–1, respectively. The final model was CL/F (L/h) = 1.31 · (body weight/33 [kg])^0.721. Age did not affect enfuvirtide exposure. These results confirm the appropriateness of body weight–based pediatric enfuvirtide dosing.

Key Words: Enfuvirtide • population pharmacokinetics • pediatric • fusion inhibitors • human immunodeficiency virus • HIV • pharmacodynamics

Address for reprints: Xiaoping Zhang, PhD, Hoffmann–La Roche Inc, 340 Kingsland Street, Nutley, NJ 07110; e-mail: Xiaoping.zhang{at}roche.com.

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