Doravirine + Ethinylestradiol = Unknown or no reaction

Effect on Concentration

Doravirine
Unknown
Applies within class?
No
Ethinylestradiol
No change
Applies within class?
No

Pharmacologic Effects

Effect
N/A
Applies within class?
No
Effect
N/A
Applies within class?
No

Interaction History

N/A

Last Updated 22-Nov-2022

Summary

Co-administration of multiple-dose doravirine 100 mg with an oral contraceptive containing EE and LNG did not affect the PK of EE to a clinically meaningful extent.

Sources

Study Design

In an open-label, fixed-sequence study, 20 healthy post menopausal or oophorectomized adult female subjects received a single dose of ethinyl estradiol/levonorgestrel (EE/LNG; 0.03 mg/0.15 mg tablet; Nordette®-28) on Day 1 (period 1). Following a 7-day washout, subjects received doravirine (formerly known as MK-1439) 100 mg once daily for 17 days (Days 1-17; Period 2), with coadministration of EE 0.03 mg/LNG 0.15 mg once daily plus doravirine 100 mg once daily on Day 14 of period 2.

Study Results

When patients were given doravirine 100 mg once daily together with EE/LNG, doravirine had no significant effect on the pharmacokinetics (PK) of EE. The geometric mean ratios (GMRs; doravirine + EE/LNG / EE/LNG) [90% CIs] for EE were: 0.83 [0.80, 0.87] for Cmax and 0.98 [0.94, 1.03] for AUC.

Study Conclusions

References

M S Anderson, D Kaufman, P Castronuovo, et al. Effect of doravirine (mk-1439) on the pharmacokinetics of an oral contraceptive (ethinyl estradiol [ee] and levonorgestrel [lng]). 16th International Workshop On Clinical Pharmacology Of Hiv ; Hepatitis Therapy. Washington, DC. ; 2015.