The authors concluded that co-administration of oral contraception containing EE/NGM and FTC/TAF was generally safe and well tolerated. No loss of contraceptive efficacy was seen as no pharmacokinetic or pharmacodynamics interactions were observed.
Emtricitabine/tenofovir alafenamide vs ethinyl estradiol/norgestimate
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Study Design
Thirteen healthy, non-pregnant, non-lactating, non-smoking, premenopausal females were enrolled in this study and received a lead-in phase; 28 day cycle of ethinyl estradiol / norgestimate (EE/NGM\p\g cycle 1 (days 1-28): a 28 day cycle of EE/NGM; and cycle 2 (days 29-56): a 28 day cycle of EE/NGM co-administered daily with concurrent doses of emtricitabine/tenofovir alafenamide (FTC/TAF) on days 29-42. Pharmacokinetic assessments were performed on days 14 and 42. Pharmacodynamic assessment for follicle stimulating hormone (FSH) and luteinizing hormone (LH) were done on days 14 and 42 and progesterone was collected on days 21 and 49. Statistical comparisons were made using GMR with 90% CI no effect boundary of 70% - 143%.
Study Results
Systemic exposures were not altered for NGMN, NG, or EE with the oral contraceptive was given with FTC/TAF. The GMR and the associated 90% CI were all within specified no effect boundary of 70% - 143%. (Actual data not reported.) Median concentrations of LH, FSH, and progesterone were all comparable across treatment cycles. Progesterone and LH median values were slightly lower than expected in luteal and ovulatory phases, respectively. Follicle Stimulating Hormone was in the lower range for ovulatory phase.
References
Custodio JM, Ting LS, G Ma, J Ling, D SenGupta, H Martin. Lack of pharmacokinetic interaction between emtricitabine/tenofovir alafenamide and oral contraceptive ethinyl estradiol/norgestimate. 17th International Workshop On Clinical Pharmacology Of Hiv And Hepatitis Therapy. Washington, DC. ; 2016.
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