Clinical and Laboratory ObservationsMaintaining the nelfinavir trough concentration above 0.8 mg/L improves virologic response in HIV-1–infected children
Section snippets
Methods
This pharmacokinetic study was conducted as a substudy of the Pediatric European Network for Treatment of AIDS (PENTA) 5 trial. Details on PENTA 5 are provided elsewhere.6
A nelfinavir trough concentration was measured between week 20 and week 80 in the morning just before the next intake of medication. A nelfinavir trough concentration below 0.8 mg/L was considered subtherapeutic, based on a recent consensus document for target trough concentrations to be used in therapeutic drug monitoring
Results
A total of 44 children participated in this substudy. For various reasons, data from 12 children were not evaluable: insufficient sample volume (n = 1), once-daily use of nelfinavir (n = 1), inadvertent intake of nelfinavir before sampling (n = 6), undetectable nelfinavir troughs, suggesting nonadherence (n = 4) (Table).
A total of 7 children (22%) had a concentration below 0.8 mg/L, ranging from 0.10 to 0.57 mg/L. The remaining 25 children all had a nelfinavir trough concentration above 0.8 mg/L, with
Discussion
This pharmacokinetic substudy of PENTA 5 in treatment-naive HIV-infected children confirms previous observations of a positive association between nelfinavir plasma levels and virologic response in HIV-infected adults.1., 2., 3., 4. Children who had a nelfinavir trough concentration >0.8 mg/L had a better virologic response than children with a value below this threshold (Figure). These data are consistent with the concept that the advised target concentration of 0.8 mg/L for a nelfinavir
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