Daclatasvir + Norgestimate = Unknown or no reaction

Effect on Concentration

Daclatasvir
No change
Applies within class?
No
Norgestimate
No change
Applies within class?
No

Pharmacologic Effects

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

Interaction History

N/A

Last Updated 18-Jul-2018

Summary

Sources

Daclatasvir versus Norgestimate ^

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 norelgestromin (NGMN) were 1.06 [0.99, 1.14] for Cmax and 1.12 [1.06, 1.17] for AUC. GMRs (DCV + NGM/EE / NGM/EE) [90% CIs] of norgestrel (NG; metabolite of NGMN), were 1.07 [0.99, 1.16] for Cmax and 1.12 [1.02, 1.23] for AUC.

Study Conclusions

When healthy subjects were given NGM/EE together with DCV 60 mg daily for 10 days, DCV had no significant effect on PK parameters of norelgestromin (NGMN) and norgestrel (NG; metabolite of NGMN).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.