The film-coated tablets are for oral use. Patients should be instructed to swallow the tablets whole (i.e. patients should not chew, break or dissolve the tablet). To maximise absorption, Viekirax tablets should be taken with food, without regard to fat and calorie content (see section 5.2).
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Patients with severe hepatic impairment (Child-Pugh C) (see section 5.2).
Use of ethinylestradiol-containing medicinal products such as those contained in most combined oral contraceptives or contraceptive vaginal rings (see section 4.4 and 4.5).
Medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma levels are associated with serious events must not be co-administered with Viekirax (see section 4.5). Examples are provided below.
CYP3A4 substrates:
• alfuzosin hydrochloride
• amiodarone
• astemizole, terfenadine
• cisapride
• colchicine in patients with renal or hepatic impairment
• ergotamine, dihydroergotamine, ergonovine, methylergometrine
• fusidic acid
• lovastatin, simvastatin, atorvastatin
• oral midazolam, triazolam
• pimozide
• quetiapine
• quinidine
• salmeterol
• sildenafil (when used for the treatment of pulmonary arterial hypertension)
• ticagrelor
Co-administration of Viekirax with or without dasabuvir with medicinal products that are strong or moderate enzyme inducers is expected to decrease ombitasvir, paritaprevir, and ritonavir plasma concentrations and reduce their therapeutic effect and must not be co-administered (see section 4.5). Examples of contraindicated strong or moderate enzyme inducers are provided below.
Enzyme inducers:
• carbamazepine, phenytoin, phenobarbital
• efavirenz, nevirapine, etravirine
• enzalutamide
• mitotane
• rifampicin
• St. John's Wort (Hypericum perforatum)
Co-administration of Viekirax with or without dasabuvir with medicinal products that are strong inhibitors of CYP3A4 is expected to increase paritaprevir plasma concentrations and must not be co-administered with Viekirax (see section 4.5). Examples of contraindicated strong CYP3A4 inhibitors are provided below.
CYP3A4 inhibitors:
• cobicistat
• indinavir, lopinavir/ritonavir, saquinavir, tipranavir,
• itraconazole, ketoconazole, posaconazole, voriconazole
• clarithromycin, telithromycin
• conivaptan
General
Viekirax is not recommended for administration as monotherapy and must be used in combination with other medicinal products for the treatment of hepatitis C infection (see sections 4.2 and 5.1).
Genotype-specific activity
Concerning recommended regimens with different HCV genotypes, see section 4.2. Concerning genotype-specific virological and clinical activity, see section 5.1.
The e
