Efavirenz, in contrast to nevirapine, is associated with unfavorable progesterone and antiretroviral levels when coadministered with combined oral contraceptives

Journal of Acquired Immune Deficiency Syndromes

Volumn 62, Issue 5, 2013, Pages 534-539

  Landolt, Nadia Kancheva ^a   Phanuphak, Nittaya ^b,c   Ubolyam, Sasiwimol ^a   Pinyakorn, Suteeraporn ^a   Kriengsinyot, Rosalin ^b   Ahluwalia, Jennisa ^a   Thongpaeng, Parawee ^a   Gorowara, Meena ^a   Thammajaruk, Narukjaporn ^a   Chaithongwongwatthana, Surasith ^d   Lange, Joep M A ^e   Ananworanich, Jintanat ^a,b,c,d  

^a THAI RED CROSS AIDS RESEARCH CENTRE   (Thailand)

^b THAI RED CROSS AIDS RESEARCH CENTRE   (Thailand)

^c SEARCH   (Thailand)

^d CHULALONGKORN UNIVERSITY   (Thailand)

^e UNIVERSITY OF AMSTERDAM   (Netherlands)

Author keywords

Combined oral contraceptives; Desogestrel ethinyl estradiol; Efavirenz; HIV positive women; Nevirapine

Indexed keywords

DESOGESTREL PLUS ETHINYLESTRADIOL; EFAVIRENZ; NEVIRAPINE; PROGESTERONE;

ADULT; ARTICLE; BREAST TENDERNESS; CLINICAL ARTICLE; CLINICAL TRIAL; CONTRACEPTION; DIZZINESS; DRUG BLOOD LEVEL; DRUG SAFETY; FEMALE; HEADACHE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IRREGULAR UTERINE BLEEDING; MOOD CHANGE; NAUSEA; OPEN STUDY; OVULATION; PRIORITY JOURNAL; PROGESTERONE BLOOD LEVEL; PROSPECTIVE STUDY; SIDE EFFECT; UTERUS BLEEDING;

ADOLESCENT; ADULT; ANTI-HIV AGENTS; BENZOXAZINES; CONTRACEPTIVES, ORAL, SYNTHETIC; DESOGESTREL; DRUG INTERACTIONS; ETHINYL ESTRADIOL; FEMALE; HIV; HIV INFECTIONS; HUMANS; LOGISTIC MODELS; MIDDLE AGED; NEVIRAPINE; PROGESTERONE; PROSPECTIVE STUDIES; THAILAND; YOUNG ADULT;

EID: 84876418415     PISSN: 15254135     EISSN: 10779450     Source Type: Journal    
DOI: 10.1097/QAI.0b013e31827e8f98     Document Type: Article

References (37)

1. WHO. Medical Eligibility Criteria for Contraceptive Use. Geneva, Switzerland: WHO; 2004. Available at: http://whqlibdoc.who.int/publications/ 2010/9789241563888-eng.pdf. Accessed August 1, 2012.
2. Centers for Disease Control and Prevention (CDC). Update to CDC's U.S. Medical Eligibility Criteria for Contraceptive Use, 2010. MMWR Morb Mortal Wkly Rep. 2012;61:449-452.
3. Mildvan D, Yarrish R, Marshak A, et al. Pharmacokinetic interaction between nevirapine and ethinyl estradiol/norethindrone when administered concurrently to HIV-infected women. J Acquir Immune Defic Syndr. 2002;29:471-477.
4. Stuart GS, Moses A, Corbett A, et al. Combined oral contraceptives and antiretroviral PK/PD in Malawian women: pharmacokinetics and pharmacodynamics of a combined oral contraceptive and a generic combined formulation antiretroviral in Malawi. J Acquir Immune Defic Syndr. 2011;58:e40-e43.
5. Joshi AS, Fiske WD, Benedek IH, et al. Lack of a pharmacokinetic interaction between efavirenz (DMP 266) and ethinyl estradiol in healthy female volunteers. Conf Retrovir Oppor Infect. 1998;5:abstract no. 348.
6. Carten ML, Kiser JJ, Kwara A, et al. Pharmacokinetic interactions between the hormonal emergency contraception, levonorgestrel (Plan B), and Efavirenz. Infect Dis Obstet Gynecol. 2012;2012:Article 137192.
7. Sevinsky H, Eley T, Persson A, et al. The effect of efavirenz on the pharmacokinetics of an oral contraceptive containing ethinyl estradiol and norgestimate in healthy HIV-negative women. Antivir Ther. 2011; 16:149-156.
8. Cohn SE, Park JG, Watts DH, et al. Depo-medroxyprogesterone in women on antiretroviral therapy: effective contraception and lack of clinically significant interactions. Clin Pharmacol Ther. 2007;81: 222-227.
9. Nanda K, Amaral E, Hays M, et al. Pharmacokinetic interactions between depot medroxyprogesterone acetate and combination antiretroviral therapy. Fertil Steril. 2008;90:965-971.
10. Schöller-Gyüre M, Kakuda TN, Woodfall B, et al. Effect of steady-state etravirine on the pharmacokinetics and pharmacodynamics of ethinylestradiol and norethindrone. Contraception. 2009;80:44-52.
11. Crauwels H, van Heeswijk R, Cornelis L, et al. Pharmacokinetic Interaction Study between TMC278, an NNRTI, and the Contraceptives Norethindrone Plus Ethinylestradiol. Presented at the 12th European AIDS Conference, November 11-14, 2009, Cologne, Germany.
12. Kearney BP, Mathias A. Lack of effect of tenofovir disoproxilfumarate on pharmacokinetics of hormonal contraceptives. Pharmacotherapy. 2009;29:924-929.
13. MARVELON- 150/30 tablets. Available at: http://home.intekom.com/-pharm/ donmed/marvelon.html. Accessed August 1, 2012.
14. Droste JA, Verweij-Van Wissen CP, Burger DM. Simultaneous determination of the HIV drugs indinavir, amprenavir, saquinavir, ritonavir, lopinavir, nelfinavir, the nelfinavir hydroxymetabolite M8, and nevirapine in human plasma by reversed-phase high-performance liquid chromatography. Ther Drug Monit. 2003;25:393-399.
15. Aarnoutse RE, Grintjes KJ, Telgt DS, et al. The influence of efavirenz on the pharmacokinetics of a twice-daily combination of indinavir and low-dose ritonavir in healthy volunteers. Clin Pharmacol Ther. 2002; 71:57-67.
16. Burger D, Teulen M, Eerland J, et al. The international interlaboratory quality control program for measurement of antiretroviral drugs in plasma: a global proficiency testing program. Ther Drug Monit. 2011; 33:239-243.
17. Schwartz JL, Creinin MD, Pymar HC, et al. Predicting risk of ovulation in new start oral contraceptive users. Obstet Gynecol. 2002;99:177-182.
18. Leth FV, Kappelhoff BS, Johnson D, et al. Pharmacokinetic parameters of nevirapine and efavirenz in relation to antiretroviral efficacy. AIDS Res Hum Retroviruses. 2006;22:232-239.
19. Warne DW, Tredway D, Schertz JC, et al. Midluteal serum progesterone levels and pregnancy following ovulation induction with human folliclestimulating hormone: results of a combined-data analysis. J Reprod Med. 2011;56:31-38.
20. National Institute of Health (NIH). Progesterone. Historical reference range (2012). Available at: http://cclnprod.cc.nih.gov/dlm/testguide.nsf/Index/ CB26894E1EB28DEF85256BA5005B000E?OpenDocument. Accessed August 1, 2012.
21. Sustiva, package insert (2012). Available at: http://packageinserts.bms. com/pi/pi-sustiva.pdf. Accessed August 1, 2012.
22. Ford N, Mofenson L, Kranzer K, et al. Safety of efavirenz in firsttrimester of pregnancy: a systematic review and meta-analysis of outcomes from observational cohorts. AIDS. 2010;24:1461-1470.
23. Leticee N, Viard JP, Yamgnane A, et al. Contraceptive failure of etonogestrel implant in patients treated with antiretrovirals including efavirenz. Contraception. 2012;85:425-427.
24. Matiluko AA, Soundararjan L, Hogston P. Early contraceptive failure of Implanon in an HIV-seropositive patient on triple antiretroviral therapy with zidovudine, lamivudine and efavirenz. J Fam Plann Reprod Health Care. 2007;33:277-278.
25. Manosuthi W, Kiertiburanakul S, Chaovavanich A, et al. Plasma nevirapine levels and 24-week efficacy of a fixed-dose combination of stavu-dine, lamivudine and nevirapine (GPO-VIR) among Thai HIV-infected patients. J Med Assoc Thai. 2007;90:244-250.
26. Langmann P, Weissbrich B, Desch S, et al. Efavirenz plasma levels for the prediction of treatment failure in heavily pretreated HIV-1 infected patients. Eur J Med Res. 2002;7:309-314.
27. Speroff L, Fritz MA. Clinical Gynecologic Endocrinology and Infertility. Philadelphia, PA: Lippincott Williams & Wilkins; 2005:862-940.
28. Viramune, package insert (2011). Available at: http://bidocs.boehringer- ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/ Prescribing+Information/PIs/Viramune/Viramune.pdf. Accessed August 1, 2012.
29. Intelence, package insert (2008). Available at: http://www.intelence- info.com/sites/default/files/pdf/INTELENCE-Booklet-Package-Insert-hcp.pdf. Accessed August 1, 2012.
30. Edurant, package insert (2011). Available at: http://dailymed.nlm.nih. gov/dailymed/drugInfo.cfm?id=44060. Accessed August 1, 2012.
31. Wang B, Sanchez RI, Franklin RB, et al. The involvement of CYP3A4 and CYP2C9 in the metabolism of 17 alpha-ethinylestradiol. Drug Metab Dispos. 2004;32:1209-1212.
32. Liptrott NJ, Pushpakom S, Wyen C, et al. Association of ABCC10 polymorphisms with nevirapine plasma concentrations in the German Competence Network for HIV/AIDS. Pharmacogenet Genomics. 2012;22: 10-19.
33. Weiss J, Herzog M, König S, et al. Induction of multiple drug transporters by efavirenz. J Pharmacol Sci. 2009;109:242-250.
34. Heil SG, van der Ende ME, Schenk PW, et al. Associations between ABCB1, CYP2A6, CYP2B6, CYP2D6, and CYP3A5 alleles in relation to efavirenz and nevirapine pharmacokinetics in HIV-infected individuals. Ther Drug Monit. 2012;34:153-159.
35. Beitins IZ, Dufau ML. Pulsatile secretion of progesterone from the human corpus luteum: poor correlation with bioactive LH pulses. Acta Endocrinol (Copenh). 1986;111:553-557.
36. Rossmanith WG, Laughlin GA, Mortola JF, et al. Secretory dynamics of oestradiol (E2) and progesterone (P4) during periods of relative pituitary LH quiescence in the midluteal phase of the menstrual cycle. Clin Endocrinol (Oxf). 1990;32:13-23.
37. Sitruk-Ware R. Pharmacological profile of progestins. Maturitas. 2004; 47:277-283.