Chronic administration of nevirapine during pregnancy: impact of pregnancy on pharmacokinetics

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Abstract
Objectives: To determine the impact of pregnancy on the pharmacokinetics (PK) of nevirapine (NVP) during chronic dosing in HIV‐infected women and appropriate NVP dosing in this population.Methods: Twenty‐six pregnant women participating in two open‐label Pediatric AIDS Clinical Trials Group studies (P1022 and P1026S) were evaluated. Each patient received 200 mg NVP every 12 h and had PK evaluations during the second or third trimester; these evaluations were repeated postpartum. Paired maternal and cord blood NVP concentrations were collected at delivery in nine patients. Ante‐ and postpartum comparisons were made using pairedt‐tests and using a ‘bioequivalence’ approach to determine confidence interval (CI).Results: The average NVP Area Under the Curve (AUC) was 56 ± 13 mcg*h/mL antepartum and 61 ± 15 mcg*h/mL postpartum. The typical parameters ± standard error were apparent clearance (CL/F)=3.51 ± 0.18 L/h and apparent volume of distribution (Vd/F)=121 ± 19.8 L. There were no significant differences between antepartum and postpartum AUC or pre‐dose concentrations. The AUC ratio was 0.90 with a 90% CI of the mean equal to 0.80–1.02. The median (± standard deviation) cord blood to maternal NVP concentration ratio was 0.91 ± 0.90.Conclusions: Pregnancy does not alter NVP PK and the standard dose (200 mg every 12 h) is appropriate during pregnancy.

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