Chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in patients with compensated liver disease, including cirrhosis, who are treatment-naïve or who have previously been treated with interferon-based therapy, including prior null responders, partial responders, and relapsers. Not for use as monotherapy.
Adult Dose for INCIVEK:
Take with food (not low fat). 1125mg twice daily (10–14hrs apart). Treat for 12 weeks (with peginterferon + ribavirin). Monitor HCV-RNA levels at Weeks 4 and 12 to determine combination treatment duration and assess for treatment futility; see full labeling. Do not reduce dose or interrupt therapy to prevent treatment failure.
Children's Dose for INCIVEK:
<18yrs: not established.
Hepatitis C virus NS3/4A protease inhibitor.
Concomitant strong CYP3A inducers (eg, rifampin, St. John’s wort, carbamazepine, phenobarbital, phenytoin), or narrow therapeutic index CYP3A substrates (eg, alfuzosin, cisapride, ergots, lovastatin, pimozide, simvastatin, sildenafil/tadalafil for PAH, triazolam, oral midazolam). Women who are or may become pregnant. Men whose female partners are pregnant. Review peginterferon and ribavirin contraindications.
Female patients/partners of male patients must have (–) pregnancy test before therapy; use 2 effective non-hormonal methods of contraception during and for 6 months after treatment completion; perform routine monthly pregnancy test. Risk of serious skin reactions (eg, Stevens-Johnson syndrome, DRESS, TEN) occur; monitor. Moderate/severe hepatic impairment (Child-Pugh B or C, score >7), decompensated liver disease: not recommended. Coinfection with HBV or HIV. Organ transplant recipients. Monitor hemoglobin and CBC with differential prior to initiation, at Weeks 2, 4, 8 and 12 during treatment. Monitor HCV-RNA at Weeks 4 and 12, and clinical chemistry frequently. Maintain adequate hydration. Elderly. Pregnancy (Cat. B). Nursing mothers: not recommended.
See Contraindications. Avoid concomitant atorvastatin. Concomitant colchicine w/renal or hepatic impairment, voriconazole; lopinavir, fosamprenavir, darunavir (all w/ritonavir): not recommended. May be potentiated by macrolides, azole antifungals. May be antagonized by anticonvulsants, rifabutin, dexamethasone, HIV protease inhibitors, efavirenz. May potentiate antiarrhythmics, digoxin, macrolides, carbamazepine, trazodone, azole antifungals, colchicine, rifabutin, alprazolam, midazolam, calcium channel blockers, corticosteroids, bosentan, atazanavir, tenofovir, immunosuppressants, salmeterol, PDE5 inhibitors for ED (reduce dose), fentanyl. May antagonize escitalopram, zolpidem, efavirenz, ethinyl estradiol, methadone. Monitor warfarin, repaglinide.
Rash (if severe; discontinue therapy and treat, do not restart), pruritus, anemia, nausea, hemorrhoids, diarrhea, anorectal effects, dysgeusia, fatigue, vomiting, hyperbilirubinemia, hyperuricemia.
Tabs—168 (7 blister strips x 6 tabs/ blister strip x 4 weekly cartons)