- VIEKIRA XR is contraindicated: in patients with moderate to severe hepatic impairment; with certain drugs that are highly dependent on CYP3A for clearance; moderate or strong inducers of CYP3A; strong inducers and inhibitors of CYP2C8; and in patients with known hypersensitivity to ritonavir.
- When VIEKIRA XR is administered with RBV, the contraindications, warnings and precautions (particularly pregnancy avoidance), and adverse reactions for RBV also apply to this combination regimen. Refer to the RBV prescribing information.
- Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported mostly in patients with advanced cirrhosis. Monitor for clinical signs and symptoms of hepatic decompensation.
- ALT elevations >5x upper limit of normal (ULN) occurred in 1% of all subjects and were significantly more frequent in females using ethinyl estradiol-containing medications, which are contraindicated. Perform hepatic lab testing on all patients.
- Due to risk of HIV-1 protease inhibitor drug resistance, HCV/HIV-1 co-infected patients should be on a suppressive antiretroviral drug regimen.
VIEKIRA XR™ (dasabuvir, ombitasvir, paritaprevir, and ritonavir) extended-release tablets is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV):
- genotype 1b infection without cirrhosis or with compensated cirrhosis.
- genotype 1a infection without cirrhosis or with compensated cirrhosis for use in combination with ribavirin.