Dasabuvir/Ombitasvir/Paritaprevir/Ritonavir + Ethinylestradiol = Prohibited

Effect on Concentration

Dasabuvir/Ombitasvir/Paritaprevir/Ritonavir
No change
Applies within class?
No
Ethinylestradiol
Unknown
Applies within class?
No

Pharmacologic Effects

Dasabuvir/Ombitasvir/Paritaprevir/Ritonavir
Effect
N/A
Applies within class?
No
Ethinylestradiol
Effect
N/A
Applies within class?
No

Interaction History

N/A

Last Updated 13-Jul-2018

Summary

Sources

Dasabuvir/Ombitasvir/Paritaprevir/Ritonavir vs Ethinylestradiol ^

Study Design

This was a 2-period crossover study in healthy subjects to evaluate drug-drug interactions between Paritaprevir/Ritonavir/Ombitasvir + Dasabuvir (ABT-450/r/ABT-267 + ABT-333, also known as 3D regimen) and ethinyl estradiol, given with norgestimate. The 3D drugs were dosed as paritaprevir/ritonavir 150/100mg QD, ombitasvir 25mg QD, and dasabuvir 400mg BID or 250mg BID (the two strengths were from two different formulations which provided similar exposures). The ethinyl estradiol dose administered was 35mcg. In period 1, ethinyl estradiol was given alone on days 1-9. During period 2, ethinyl estradiol was given with the 3D regimen on days 10-21, followed by the 3D regimen alone on days 22-28.

Study Results

Enrollment was stopped early due to grade 3 alanine aminotransferase increase in 2 subjects. This includes participants taking the full 3D regimen as well as the 2D (paritaprevir/ritonavir + ombitasvir).

Study Conclusions

Coadministration of the 3D regimen with ethinyl estradiol-containing products is contraindicated. Ethinyl estradiol-containing medications can be restarted approximately 2 weeks following completion of treatment with VIEKIRA PAK.

References

Menon RM, Badri PS, Wang T, Polepally AR, Zha J, Khatri A, Awni WM. Drug-drug interaction profile of the all-oral anti-hepatitis c virus regimen of paritaprevir/ritonavir, ombitasvir, and dasabuvir. Journal Of Hepatology. 2015; 1: 20-29.