Pharmacological Class:
HCV NS5A inhibitor/HCV NS3/4A protease inhibitor/CYP3A inhibitor + HCV non-nucleoside NS5B palm polymerase inhibitor.

Active Ingredient(s):
Ombitasvir/paritaprevir/ritonavir; 12.5mg/75mg/50mg; with dasabuvir 250mg; tablets.

Company
AbbVie
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:
Rx

Adults:
Take with a meal. ≥18 years: Give 2 ombitasvir/paritaprevir/ritonavir tabs once daily (in AM) and 1 dasabuvir tab twice daily (AM & 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.

Children:
<18 years: not established.

Contraindication(s):
Severe hepatic impairment. Concomitant alfuzosin, carbamazepine, phenytoin, phenobarbital, gemfibrozil, rifampin, ergot derivatives, ethinyl estradiol-containing products, St. John’s Wort, lovastatin, simvastatin, pimozide, efavirenz, sildenafil (as Revatio), triazolam, oral midazolam. When coadministered with ribavirin, its contraindications also apply to this combination regimen (eg, Pregnancy Category X).

Warnings/Precautions:
Monitor hepatic function prior to initiation, during the first 4 weeks, and thereafter. Consider discontinuing if ALT persistently >10XULN. Discontinue if ALT elevation is accompanied with liver inflammation or increasing conjugated bilirubin, alkaline phosphatase, or INR. HCV/HIV-1 co-infected: give suppressive antiretroviral regimen. Dialysis: not studied. Moderate hepatic impairment: not recommended. Pregnancy (Category B). Use progestin-only contraception or non-hormonal methods, if necessary. Nursing mothers.

Interaction(s)
See Contraindications. Discontinue ethinyl estradiol-containing products prior to starting; may resume 2 weeks after therapy completion. May potentiate substrates of CYP3A, UGT1A1, BCRP, OATP1B1, or OATP1B3. Potentiated by strong CYP3A inhibitors or CYP2C8, P-gp, BCRP, OATP1B1, or OATP1B3 inhibitors. Potentiates ketoconazole (limit max 200mg/day), pravastatin (max 40mg/day), rosuvastatin (max 10mg/day), cyclosporine (reduce to 1/5 of current dose and monitor renal function). Concomitant calcineurin inhibitors (in liver transplant): adjust dose of these. Concomitant tacrolimus (use reduced dose): do not administer on same day as initiating Viekira Pak; monitor tacrolimus levels and renal function. Concomitant fluticasone may reduce serum cortisol; consider alternatives. Concomitant voriconazole, darunavir/ritonavir, lopinavir/ritonavir, rilpivirine, salmeterol: not recommended. May decrease exposure to omeprazole; consider increasing omeprazole dose: max 40mg/day. Concomitant atazanavir 300mg (without ritonavir): give only in the AM. Caution with antiarrhythmics (eg, amiodarone, bepridil, disopyramide, flecainide, systemic lidocaine, mexiletine, propafenone, quinidine); monitor. Monitor with amlodipine, furosemide, buprenorphine/naloxone, alprazolam.

Adverse Reaction(s)
Fatigue, nausea, pruritus, other skin reactions, insomnia, asthenia.

Notes:
For ribavirin specific dosing and safety information, refer to the respective prescribing information.

How Supplied:
Monthly carton— 4 x 7 daily dose packs

LAST UPDATED:
3/9/2015