Contraindication Added to OCs, Other Ethinyl Estradiol-Containing Drugs

Concomitant use of ombitasvir, paritaprevir/ritonavir, with or without dasabuvir contraindicated
Concomitant use of ombitasvir, paritaprevir/ritonavir, with or without dasabuvir contraindicated

The Food and Drug Administration (FDA) has approved new labeling for a number of ethinyl estradiol-containing medications to warn about the use of these drugs with certain hepatitis C (HCV) drug combinations.

Specifically, the concomitant use of HCV drug combinations containing ombitasvir, paritaprevir/ritonavir, with or without dasabuvir is contraindicated due to the potential for liver enzyme elevations. In clinical trials, women using ethinyl estradiol-containing medications, such as combined oral contraceptives, were significantly more likely to have ALT elevations, in some cases greater than 20 times the upper limit of normal.

As such, ethinyl estradiol-containing medications should be discontinued before starting therapy with these HCV combination drug regimens; they can be restarted approximately two weeks following completion of the HCV regimen.

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HCV medications that contain these specific ingredients include Viekira XRViekira Pak, and Technivie.

For more information visit FDA.gov.