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Pharmacokinetic Interactions between the Hormonal Emergency Contraception, Levonorgestrel (Plan B), and Efavirenz

Objectives. Compare the Plan B levonorgestrel (LNG) area under the concentration- time curve (AUC(12)) prior to and with efavirenz (EFV). Design. Prospective, open-label, single-arm, equivalence study. Methods. Healthy HIV-negative subjects underwent 12 hr intensive pharmacokinetic (PK) sampling fol...

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Autores principales: Carten, Monica L., Kiser, Jennifer J., Kwara, Awewura, Mawhinney, Samantha, Cu-Uvin, Susan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Hindawi Publishing Corporation 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3299227/
https://www.ncbi.nlm.nih.gov/pubmed/22536010
http://dx.doi.org/10.1155/2012/137192
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author Carten, Monica L.
Kiser, Jennifer J.
Kwara, Awewura
Mawhinney, Samantha
Cu-Uvin, Susan
author_facet Carten, Monica L.
Kiser, Jennifer J.
Kwara, Awewura
Mawhinney, Samantha
Cu-Uvin, Susan
author_sort Carten, Monica L.
collection PubMed
description Objectives. Compare the Plan B levonorgestrel (LNG) area under the concentration- time curve (AUC(12)) prior to and with efavirenz (EFV). Design. Prospective, open-label, single-arm, equivalence study. Methods. Healthy HIV-negative subjects underwent 12 hr intensive pharmacokinetic (PK) sampling following single dose LNG alone and after 14 days of EFV. Geometric means, Geometric Mean Ratios, and 90% confidence intervals (CI) are reported for PK Parameters. T-tests were utilized. Clinical parameters and liver function tests (LFTs) were assessed. Results. 24 women enrolled and 21 completed the study. With EFV, LNG AUC(12) was reduced 56% (95% CI: 49%, 62%) from 42.9 to 17.8 ng∗hr/mL, and maximum concentration (C(max⁡)) was reduced 41% (95% CI: 33%, 50%) from 8.4 to 4.6 ng/mL. LNG was well tolerated with no grade 3 or 4 treatment-related toxicities. Conclusions. EFV significantly reduced LNG exposures. Higher LNG doses may be required with EFV. These results reinforce the importance of effective contraception in women taking EFV.
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spelling pubmed-32992272012-04-25 Pharmacokinetic Interactions between the Hormonal Emergency Contraception, Levonorgestrel (Plan B), and Efavirenz Carten, Monica L. Kiser, Jennifer J. Kwara, Awewura Mawhinney, Samantha Cu-Uvin, Susan Infect Dis Obstet Gynecol Clinical Study Objectives. Compare the Plan B levonorgestrel (LNG) area under the concentration- time curve (AUC(12)) prior to and with efavirenz (EFV). Design. Prospective, open-label, single-arm, equivalence study. Methods. Healthy HIV-negative subjects underwent 12 hr intensive pharmacokinetic (PK) sampling following single dose LNG alone and after 14 days of EFV. Geometric means, Geometric Mean Ratios, and 90% confidence intervals (CI) are reported for PK Parameters. T-tests were utilized. Clinical parameters and liver function tests (LFTs) were assessed. Results. 24 women enrolled and 21 completed the study. With EFV, LNG AUC(12) was reduced 56% (95% CI: 49%, 62%) from 42.9 to 17.8 ng∗hr/mL, and maximum concentration (C(max⁡)) was reduced 41% (95% CI: 33%, 50%) from 8.4 to 4.6 ng/mL. LNG was well tolerated with no grade 3 or 4 treatment-related toxicities. Conclusions. EFV significantly reduced LNG exposures. Higher LNG doses may be required with EFV. These results reinforce the importance of effective contraception in women taking EFV. Hindawi Publishing Corporation 2012 2012-02-28 /pmc/articles/PMC3299227/ /pubmed/22536010 http://dx.doi.org/10.1155/2012/137192 Text en Copyright © 2012 Monica L. Carten et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Clinical Study
Carten, Monica L.
Kiser, Jennifer J.
Kwara, Awewura
Mawhinney, Samantha
Cu-Uvin, Susan
Pharmacokinetic Interactions between the Hormonal Emergency Contraception, Levonorgestrel (Plan B), and Efavirenz
title Pharmacokinetic Interactions between the Hormonal Emergency Contraception, Levonorgestrel (Plan B), and Efavirenz
title_full Pharmacokinetic Interactions between the Hormonal Emergency Contraception, Levonorgestrel (Plan B), and Efavirenz
title_fullStr Pharmacokinetic Interactions between the Hormonal Emergency Contraception, Levonorgestrel (Plan B), and Efavirenz
title_full_unstemmed Pharmacokinetic Interactions between the Hormonal Emergency Contraception, Levonorgestrel (Plan B), and Efavirenz
title_short Pharmacokinetic Interactions between the Hormonal Emergency Contraception, Levonorgestrel (Plan B), and Efavirenz
title_sort pharmacokinetic interactions between the hormonal emergency contraception, levonorgestrel (plan b), and efavirenz
topic Clinical Study
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3299227/
https://www.ncbi.nlm.nih.gov/pubmed/22536010
http://dx.doi.org/10.1155/2012/137192
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