HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use VIEKIRA XR safely and effectively. See full prescribing information for VIEKIRA XR.
VIEKIRA XR(dasabuvir, ombitasvir, paritaprevir, and ritonavir) extended-release tablets, for oral use
Initial U.S. Approval: 2014
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
Hepatitis B virus (HBV) reactivation has been reported, in some cases resulting in fulminant hepatitis, hepatic failure, and death. (5.1)
RECENT MAJOR CHANGES
BOXED WARNING 2/2017
Dosage and Administration (2.1) 2/2017
Contraindications (4) 3/2017
Warnings and Precautions (5.1) 2/2017
INDICATIONS AND USAGE
VIEKIRA XR includes dasabuvir, a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor, ombitasvir, a hepatitis C virus NS5A inhibitor, paritaprevir, a hepatitis C virus NS3/4A protease inhibitor, and ritonavir, a CYP3A inhibitor and 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. (1)
DOSAGE AND ADMINISTRATION
Testing Prior to the Initiation of Therapy:
Test all patients for HBV infection by measuring HBsAg and anti-HBc. (2.1)
Assess for laboratory and clinical evidence of hepatic decompensation. (2.1)
Recommended dosage: Three tablets taken once daily. VIEKIRA XR must be taken with a meal because administration under fasting conditions may result in reduced virologic response and possible development of resistance. (2.2)
Treatment Regimen and Duration by Patient Population
Patient Population Treatment* Duration
Genotype 1a,
without cirrhosis VIEKIRA XR + ribavirin 12 weeks
Genotype 1a,
with compensated cirrhosis VIEKIRA XR + ribavirin 24 weeks**
Genotype 1b,
with or without compensated cirrhosis VIEKIRA XR 12 weeks
*Note: Follow the genotype 1a dosing recommendations in patients with an unknown genotype 1 subtype or with mixed genotype 1 infection.
**VIEKIRA XR administered with ribavirin for 12 weeks may be considered for some patients based on prior treatment history [See Clinical Studies (14.3)].
HCV/HIV-1 co-infection: For patients with HCV/HIV-1 co-infection, follow the dosage recommendations in the table above. (2.2)
Liver Transplant Recipients: In liver transplant recipients with normal hepatic function and mild fibrosis (Metavir fibrosis score ≤2), the recommended duration of VIEKIRA XR with ribavirin is 24 weeks. (2.4)
DOSAGE FORMS AND STRENGTHS
Extended-release tablets: 200 mg dasabuvir, 8.33 mg ombitasvir, 50 mg paritaprevir, and 33.33 mg ritonavir (3)
CONTRAINDICATIONS
Patients with moderate to severe hepatic impairment. (4, 5.2, 8.6, 12.3)
If VIEKIRA XR is administered with ribavirin, the contraindications to ribavirin also apply to this combination regimen. (4)
Co-administration with drugs that are: highly dependent on CYP3A for clearance; moderate or strong inducers of CYP3A or strong inducers of CYP2C8; and strong inhibitors of CYP2C8. (4)
Known hypersensitivity to ritonavir (e.g. toxic epidermal necrolysis, St