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

E. V. Capparelli, F. Aweeka, J. Hitti, A. Stek, Chengcheng 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

Research output: Contribution to journalArticle

34 Citations (Scopus)

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 200mg NVP every 12h 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 ± 13mcg*h/mL antepartum and 61 ± 15mcg*h/mL postpartum. The typical parameters ± standard error were apparent clearance (CL/F)=3.51 ± 0.18L/h and apparent volume of distribution (Vd/F)=121 ± 19.8L. 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 NVPPK and the standard dose (200 mg every 12h) is appropriate during pregnancy.

Original languageEnglish (US)
Pages (from-to)214-220
Number of pages7
JournalHIV Medicine
Volume9
Issue number4
DOIs
StatePublished - Apr 2008
Externally publishedYes

Fingerprint

Nevirapine
Pharmacokinetics
Pregnancy
Postpartum Period
Area Under Curve
Fetal Blood
Mothers
Confidence Intervals
Therapeutic Equivalency
Third Pregnancy Trimester
Second Pregnancy Trimester
Pregnant Women
Acquired Immunodeficiency Syndrome
Clinical Trials
HIV
Pediatrics
Population

Keywords

  • HIV
  • Nevirapine
  • Non-nucleoside reverse transcriptase
  • Pharmacokinetics
  • Pregnancy

ASJC Scopus subject areas

  • Virology
  • Medicine(all)
  • Immunology

Cite this

Capparelli, E. V., Aweeka, F., Hitti, J., Stek, A., Hu, C., Burchett, S. K., ... Mirochnick, M. (2008). Chronic administration of nevirapine during pregnancy: Impact of pregnancy on pharmacokinetics. HIV Medicine, 9(4), 214-220. https://doi.org/10.1111/j.1468-1293.2008.00553.x

Chronic administration of nevirapine during pregnancy : Impact of pregnancy on pharmacokinetics. / Capparelli, E. V.; Aweeka, F.; Hitti, J.; Stek, A.; Hu, Chengcheng; 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.

In: HIV Medicine, Vol. 9, No. 4, 04.2008, p. 214-220.

Research output: Contribution to journalArticle

Capparelli, EV, Aweeka, F, Hitti, J, Stek, A, Hu, C, Burchett, SK, Best, B, Smith, E, Read, JS, Watts, H, Nachman, S, Thorpe, EM, Spector, SA, Jimenez, E, Shearer, WT, Foca, M & Mirochnick, M 2008, 'Chronic administration of nevirapine during pregnancy: Impact of pregnancy on pharmacokinetics', HIV Medicine, vol. 9, no. 4, pp. 214-220. https://doi.org/10.1111/j.1468-1293.2008.00553.x
Capparelli, E. V. ; Aweeka, F. ; Hitti, J. ; Stek, A. ; Hu, Chengcheng ; 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. / Chronic administration of nevirapine during pregnancy : Impact of pregnancy on pharmacokinetics. In: HIV Medicine. 2008 ; Vol. 9, No. 4. pp. 214-220.
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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 200mg NVP every 12h 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 ± 13mcg*h/mL antepartum and 61 ± 15mcg*h/mL postpartum. The typical parameters ± standard error were apparent clearance (CL/F)=3.51 ± 0.18L/h and apparent volume of distribution (Vd/F)=121 ± 19.8L. 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 NVPPK and the standard dose (200 mg every 12h) is appropriate during pregnancy.",
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T1 - Chronic administration of nevirapine during pregnancy

T2 - Impact of pregnancy on pharmacokinetics

AU - Capparelli, E. V.

AU - Aweeka, F.

AU - Hitti, J.

AU - Stek, A.

AU - Hu, Chengcheng

AU - Burchett, S. K.

AU - Best, B.

AU - Smith, E.

AU - Read, J. S.

AU - Watts, H.

AU - Nachman, S.

AU - Thorpe, E. M.

AU - Spector, S. A.

AU - Jimenez, E.

AU - Shearer, W. T.

AU - Foca, M.

AU - Mirochnick, M.

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N2 - 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 200mg NVP every 12h 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 ± 13mcg*h/mL antepartum and 61 ± 15mcg*h/mL postpartum. The typical parameters ± standard error were apparent clearance (CL/F)=3.51 ± 0.18L/h and apparent volume of distribution (Vd/F)=121 ± 19.8L. 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 NVPPK and the standard dose (200 mg every 12h) is appropriate during pregnancy.

AB - 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 200mg NVP every 12h 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 ± 13mcg*h/mL antepartum and 61 ± 15mcg*h/mL postpartum. The typical parameters ± standard error were apparent clearance (CL/F)=3.51 ± 0.18L/h and apparent volume of distribution (Vd/F)=121 ± 19.8L. 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 NVPPK and the standard dose (200 mg every 12h) is appropriate during pregnancy.

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KW - Non-nucleoside reverse transcriptase

KW - Pharmacokinetics

KW - Pregnancy

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