Record Details
Effect of Protease Inhibitors on Steady-State Pharmacokinetics of Oral Norethindrone Contraception in HIV-Infected Women
ScholarsArchive at Oregon State University
| Field | Value |
|---|---|
| Title | Effect of Protease Inhibitors on Steady-State Pharmacokinetics of Oral Norethindrone Contraception in HIV-Infected Women |
| Names |
Atrio, Jessica
(creator) Stanczyk, Frank Z. (creator) Neely, Michael (creator) Cherala, Ganesh (creator) Kovacs, Andrea (creator) Mishell, Daniel R., Jr. (creator) |
| Date Issued | 2014-01-01 (iso8601) |
| Note | This is the publisher’s final pdf. The published article is copyrighted by Lippincott Williams & Wilkins and can be found at: http://journals.lww.com/jaids/Pages/default.aspx. This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially. |
| Abstract | OBJECTIVE: Pharmacokinetic interactions exist between combined oral contraceptives and protease inhibitors (PI). However, such information is lacking for progestin-only oral contraception. We sought to define the steady-state pharmacokinetic interaction between norethindrone (NET) and PI in HIV-infected women. METHODS AND DESIGN: We conducted an open-label, prospective, nonrandomized trial to characterize the steady-state pharmacokinetics of serum NET in HIV-infected women receiving PI compared with a control group of HIV-infected women receiving other noninteracting drugs. After 21 days of 0.35 mg of NET ingestion once daily, serial serum samples were obtained at 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours. The area under the curve between 0 and 72 hours after ingestion was calculated by trapezoidal approximation. RESULTS: Thirty-five women were enrolled, 2 withdrew. Sixteen women in the PI group and 17 controls completed the study. NET half-life and maximum concentration were not significantly different between the 2 groups. Minimum concentration of NET was significantly higher in the PI group (P = 0.01). The ratio of the geometric mean NET area under the curve in the PI group compared with controls was 1.5 (90% confidence interval: 1.21 to 1.86). NET serum concentrations were significantly higher in HIV-infected women taking a PI compared with controls (P = 0.004). CONCLUSIONS: Coadministration of PI inhibits NET metabolism as shown by higher serum NET area under the curve levels, a surrogate marker for therapeutic contraceptive efficacy. This study supports the increased utilization of progestin-only pills in HIV-infected women receiving certain PI regimens. |
| Genre | Article |
| Access Condition | http://creativecommons.org/licenses/by-nc-nd/3.0/us/ |
| Topic | HIV |
| Identifier | Atrio, J., Stanczyk, F. Z., Neely, M., Cherala, G., Kovacs, A., & Mishell Jr, D. R. (2014). Effect of Protease Inhibitors on Steady-State Pharmacokinetics of Oral Norethindrone Contraception in HIV-Infected Women. Journal of Acquired Immune Deficiency Syndromes, 65(1), 72-77. doi:10.1097/QAI.0b013e3182a9b3f1 |
