Daclatasvir + Ethinylestradiol = Unknown or no reaction

Effect on Concentration

Daclatasvir
No change
Applies within class?
No
Ethinylestradiol
No change
Applies within class?
No

Pharmacologic Effects

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

Interaction History

N/A

Last Updated 18-Jul-2018

Summary

Sources

Daclatasvir versus Ethinylestradiol ^

Study Design

In an open-label, single sequence study, healthy HCV-uninfected females (n=20) received norgestimate (NGM) 0.18/0.125/0.25 mg QD for 7/7/7 days with ethinyl estradiol (EE) 35 ug QD x 21days, Ortho Tri-CyclenŽ) for 2 cycles (Days 1-56).1 Subjects then received NGM/EE for 11 days (Days 57-67), followed by coadministration of NGM/EE and daclatasvir (DCV) 60 mg once daily for 10 days (Days 68-77) in cycle 3.

Study Results

The geometric mean ratios (GMRs; DCV + NGM/EE / NGM/EE) [90% CIs] of EE were 1.11 [1.02, 1.20] for Cmax and 1.01 [0.95, 1.07] for AUC.

Study Conclusions

When subjects were given NGM/EE together with DCV 60 mg daily for 10 days, DCV had no significant effect on PK parameters of EE.1 The manufacturer states that no interaction is expected when this combination is utilized, and the use of an oral contraceptive containing EE 35 mcg and NGM 0.18/0.215/0.25 mg with DCV is recommended

References

Bifano M, Sevinsky H, Hwang C. Effect of the coadministration of daclatasvir on the pharmacokinetics of a combined oral contraceptive containing ethinyl estradiol and norgestimate. Antiviral Therapy. 2014; 5: 511-519.