Viekirax 12.5 mg/75 mg/50 mg film-coated tablets
Each film-coated tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir and 50 mg of ritonavir.
For the full list of excipients, see section 6.1.
Film-coated tablet (tablet).
Pink, oblong, biconvex, film-coated tablets of dimensions 18.8 mm x 10.0 mm, debossed on one side with 'AV1'.
Viekirax is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4, and 5.1).
For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.
Treatment with Viekirax should be initiated and monitored by a physician experienced in the management of chronic hepatitis C.
Posology
The recommended oral dose of Viekirax is two 12.5 mg / 75 mg / 50 mg tablets once daily with food.
Viekirax should be used in combination with other medicinal products for the treatment of HCV (see Table 1).
Table 1. Recommended co-administered medicinal product(s) and treatment duration for Viekirax by patient populationFor specific dosage instructions for dasabuvir and ribavirin, including dose modification, refer to the respective Summaries of Product Characteristics.
Missed doses
In case a dose of Viekirax is missed, the prescribed dose can be taken within 12 hours. If more than 12 hours have passed since Viekirax is usually taken, the missed dose should NOT be taken and the patient should take the next dose per the usual dosing schedule. Patients should be instructed not to take a double dose.
Special populations
HIV-1 Co-infection
Follow the dosing recommendations in Table 1. For dosing recommendations with HIV antiviral agents, refer to section 4.4 (Treatment of patients with HIV co-infection) and section 4.5. See section 5.1 for additional information.
Liver transplant recipients
Viekirax and dasabuvir in combination with ribavirin is recommended for 24 weeks in liver transplant recipients with genotype 1 HCV infection. Viekirax in combination with ribavirin is recommended in genotype 4 infection. Lower ribavirin dose at initiation may be appropriate. In the post-liver transplant study, ribavirin dosing was individualized and most subjects received 600 to 800 mg per day (see section 5.1). For dosing recommendations with calcineurin inhibitors see section 4.5.
Elderly
No dose adjustment of Viekirax is warranted in elderly patients (see section 5.2).
Renal impairment
No dose adjustment of Viekirax is required for patients with mild, moderate, or severe renal impairment (see section 5.2).
Hepatic impairment
No dose adjustment of Viekirax is required in patients with mild hepatic impairment (Child-Pugh A). The safety and efficacy of Viekirax have not been established in HCV-infected patients with moderate hepatic impairment (Child-Pugh B); however, no dose adjustment is expected to be required based on pharmacokinetic studies. Viekirax is contraindicated in patients with severe hepatic impairment (Child-Pugh C) (see sections 4.3 and 5.2).
Paediatric population
The safety and ef
