Product: Viekira Pak
Pharmacologic class: HCV NS5A inhibitor/HCV NS3/4A protease inhibitor/CYP3A inhibitor + HCV non-nucleoside NS5B palm polymerase inhibitor.
Active ingredient(s): Ombitasvir/paritaprevir/ritonavir; 12.5 mg/75 mg/50 mg; with dasabuvir 250 mg; tablets.
Indication(s): Chronic hepatitis C virus (HCV) genotype 1 infection, with or without ribavirin, including those with compensated cirrhosis. Limitations of use: not for use in patients with decompensated liver disease.
Pharmacology: Ombitasvir is an inhibitor of HCV NS5A, which is essential for viral RNA replication and virion assembly. Paritaprevir is an inhibitor of the HCV NS3/4A protease which is necessary for the proteolytic cleavage of the HCV encoded polyprotein and is essential for viral replication. Ritonavir increases peak and trough plasma drug concentrations of paritaprevir and overall drug exposure. Dasabuvir is a non-nucleoside inhibitor of the HCV RNA-dependent RNA polymerase encoded by the NS5B gene, which is essential for replication of the viral genome.
Legal classification: ℞
Adults: Take with a meal. ≥18 years: Give 2 ombitasvir/paritaprevir/ritonavir tabs once daily (in AM) and 1 dasabuvir tab twice daily (AM and PM). Genotype 1a without cirrhosis or genotype 1b with cirrhosis: treat for 12 weeks with ribavirin. Genotype 1a with cirrhosis: treat for 24 weeks with ribavirin (based on prior treatment history, 12 weeks treatment may be considered for some patients). Genotype 1b without cirrhosis: treat for 12 weeks. HCV/HIV-1 co-infection: follow recommendations above. Liver transplant recipients (with mild fibrosis): treat for 24 weeks with ribavirin. In combination with ribavirin: see full labeling.