Cargando…
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...
Autores principales: | , , , , |
---|---|
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 |
_version_ | 1782226090803068928 |
---|---|
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. |
format | Online Article Text |
id | pubmed-3299227 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2012 |
publisher | Hindawi Publishing Corporation |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT cartenmonical pharmacokineticinteractionsbetweenthehormonalemergencycontraceptionlevonorgestrelplanbandefavirenz AT kiserjenniferj pharmacokineticinteractionsbetweenthehormonalemergencycontraceptionlevonorgestrelplanbandefavirenz AT kwaraawewura pharmacokineticinteractionsbetweenthehormonalemergencycontraceptionlevonorgestrelplanbandefavirenz AT mawhinneysamantha pharmacokineticinteractionsbetweenthehormonalemergencycontraceptionlevonorgestrelplanbandefavirenz AT cuuvinsusan pharmacokineticinteractionsbetweenthehormonalemergencycontraceptionlevonorgestrelplanbandefavirenz |