A new contraindication is being added to birth control pills and other treatments containing the hormone ethinyl estradiol regarding the use of these drugs with certain hepatitis C (HCV) drug combinations.
Specifically, using HCV drug combinations containing ombitasvir, partiaprevir/ritonavir, with or without dasabuvir is contraindicated because there is a risk for liver enzyme elevations. This was observed in clinical trials with women using ethinyl estradiol-containing medications, such as combined oral contraceptives. These women were significantly more likely to have ALT elevations that in some cases was greater than 20 times the upper limit of normal.
ALT, or alanine transaminase, are specific liver enzymes. Liver disease is the most common reason for higher than normal levels of ALT. Mild elevations are generally considered to be two to three times higher than the normal range. Very high levels of ALT are considered more than 10 times normal and are usually due to acute hepatitis, sometimes due to a viral infection.
The new labeling recommends that ethinyl estradiol-containing medications should be discontinued before starting therapy with these HCV combination drug regimens. They can be restarted about two weeks after the HCV regimen has been completed.
HCV medications that contain these specific ingredients include Viekira XR, Viekira Pak, and Technivie. This safety label update has been approved by the Food and Drug Administration.