Hoffmann, R. A wiki for the life sciences where authorship matters. Nature Genetics (2008)

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Capparelli, E.V. et al.

E.V. Capparelli, F. Aweeka, J. Hitti, A. Stek, C. Hu, S.K. Burchett, B. Best, E. Smith, J.S. Read, H. Watts, S. Nachman, E.M. Thorpe, S.A. Spector, E. Jimenez, W.T. Shearer, M. Foca, M. Mirochnick,

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

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 paired t-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.[1]

References

Chronic administration of nevirapine during pregnancy: impact of pregnancy on pharmacokinetics. Capparelli, E.V., Aweeka, F., Hitti, J., Stek, A., Hu, C., Burchett, S.K., Best, B., Smith, E., Read, J.S., Watts, H., Nachman, S., Thorpe, E.M., Spector, S.A., Jimenez, E., Shearer, W.T., Foca, M., Mirochnick, M. HIV Med. (2008) [Pubmed]

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