Generic Name and Formulations:
Ombitasvir 12.5mg, paritaprevir 75mg, ritonavir 50mg; tabs.

Company:
AbbVie
Indications for TECHNIVIE:
Chronic HCV genotype 4 infection without cirrhosis, in combination with ribavirin.

Limitations Of use:
Not for use in patients with moderate hepatic impairment.

Adult:
Take with a meal. ≥18yrs: 2 tabs once daily in the AM for 12 weeks with ribavirin. Treatment-naive (or ribavirin intolerant): may consider administering without ribavirin for 12 weeks.

Children:
<18yrs: not established.

Contraindications:
Severe hepatic impairment. Concomitant alfuzosin, carbamazepine, phenytoin, phenobarbital, rifampin, ergots, ethinyl estradiol, 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 Cat.X).

Warnings/Precautions:
Monitor hepatic function prior to initiation, during the first 4 weeks, and as clinically indicated 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. Pregnancy (Cat.B). Use progestin-only contraception or non-hormonal methods during therapy. Nursing mothers.

Interactions:
See Contraindications. Increased risk of ALT elevations esp. in females using ethinyl estradiol-containing drugs; discontinue prior to starting; may resume 2 weeks after Technivie completion. May potentiate substrates of CYP3A, P-gp, BCRP, OATP1B1, or OATP1B3. Potentiated by strong CYP3A inhibitors or P-gp, BCRP, OATP1B1, or OATP1B3 inhibitors. Potentiates ketoconazole (limit max 200mg/day), pravastatin (max 40mg/day), cyclosporine (reduce to 1/5 of current dose and monitor renal function). Concomitant voriconazole, atazanavir, atazanavir/ritonavir, lopinavir/ritonavir, rilpivirine, salmeterol: not recommended. Concomitant tacrolimus (use reduced dose): do not administer on same day as initiating Technivie; monitor tacrolimus levels and renal function. Concomitant quetiapine: consider alternative anti-HCV therapy; if necessary, reduce quetiapine to 1/6 of current dose and monitor. Concomitant fluticasone may reduce serum cortisol; consider alternatives. Concomitant darunavir 800mg (without ritonavir): take at same time as Technivie. May decrease exposure to omeprazole; consider increasing omeprazole dose: max 40mg/day. Caution with antiarrhythmics (eg, amiodarone, bepridil, disopyramide, flecainide, systemic lidocaine, mexiletine, propafenone, quinidine); monitor. Monitor digoxin levels; decrease digoxin dose by 30–50%. Monitor with amlodipine, furosemide, buprenorphine/naloxone, alprazolam.

Pharmacological Class:
HCV NS5A inhibitor + HCV NS3/4A protease inhibitor + CYP3A inhibitor.

Adverse Reactions:
Asthenia, fatigue, nausea, insomnia, pruritus, skin reactions; ALT and bilirubin elevations.

Note:
For ribavirin specific dosing and safety information, refer to the full prescribing information.

Generic Availability:
NO

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