Ravida must not be administered as monotherapy. Ravida must be administered in combination with other medicinal products for the treatment of chronic HCV infection (see Indications/Uses and Dosage & Administration).
If the other associated medicinal products used in combination with Ravida are permanently discontinued, Ravida must not be given as monotherapy (see Dosage & Administration).
Consult the monograph for the other co-administered medicinal products before starting therapy with Ravida.
Genotype-specific activity: Concerning genotype-specific virological activity and clinical outcomes, see Pharmacology: Pharmacodynamics under Actions. In the pivotal clinical study (STORM-C-1), the majority of patients were infected with HCV genotypes 1 or 3. There are limited data from this study inpatients with HCV genotypes 2 and 6 and no data on patients with genotype 4 or 5 (see Pharmacology: Pharmacodynamics under Actions).
HCV/HBV (hepatitis B virus) co-infection: Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral agents (DAAs). HBV screening should be performed in all patients before initiation of treatment. HBV/HCV co-infected patients are at risk of HBV reactivation, and should therefore be monitored and managed according to current clinical guidelines.
Patients who have previously failed therapy with an NS5A-containing regimen: The safety and efficacy of Ravida in patients who have previously failed treatment with an NS5A-containing regimen have not been assessed.
Interactions with medicinal products: Co-administration of Ravida can alter the concentration of other medicinal products and other medicinal products may alter the concentration of ravidasvir. Refer to Contraindications for a listing of medicinal products that are contraindicated for use with Ravida due to potential loss of therapeutic effect. Co-administration with moderate P-gp inducers (e.g. oxcarbazepine or rifapentine) is not recommended since it may decrease ravidasvir plasma concentration leading to reduced therapeutic effect of Ravida (see Interactions).
Use in diabetic patients: Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV DAA treatment. The physician in charge of the diabetic care of the patient should be informed when treatment with Ravida is initiated.
Decompensated cirrhosis: The safety and efficacy of Ravida have not been assessed in patients with decompensated cirrhosis.
Liver transplant patients: The safety and efficacy of Ravida in the treatment of HCV infection in patients who are post-liver transplant have not been assessed.
Important information about some of the ingredients in Ravida: This medicinal product contains isomalt. Due to the presence of isomalt in the formulation, patients with rare hereditary problems of fructose intolerance should not take Ravida.
Low sodium diet information: This medicinal product contains less than 1 mmol sodium (23 mg) per dose and is considered as essentially 'sodium-free'.
Effects on Ability to Drive and Use Machines: Patients should be informed that dizziness, lethargy, somnolence and blurred vision have been reported during treatment with Ravida. No studies on the effects of Ravida on the ability to drive and use machines have been performed. Patients treated with Ravida should be warned not to drive or use machines if they feel tired or dizzy.
Hepatic impairment: No dose adjustment of Ravida is required for patients with mild hepatic impairment. The safety and efficacy of Ravida have been assessed in patients with compensated cirrhosis but not in patients with decompensated cirrhosis. The safety and efficacy of Ravida administration in patients with severe hepatic impairment has not been assessed (see Adverse Reactions and Pharmacology: Pharmacokinetics under Actions).
Use in Pregnancy and contraception requirements: Ravida is not recommended during pregnancy based on teratogenic and/or embryotoxic effects in rabbits exposed to ravidasvir. There are very limited data on exposure during pregnancy in humans.
Women of childbearing potential should use effective contraception methods before starting treatment with Ravida and continue until 1 month after completion of Ravida treatment (see Use in Pregnancy & Lactation).
Use in Lactation: Ravida is not recommended during breast-feeding based on the evidence that ravidasvir is able to pass through the blood-milk barrier in rats and the absence of data in human.
Use in Children: Ravida is not recommended for use in children and adolescents aged below 18 years as the safety and efficacy have not been assessed in this population (see Adverse Reactions and Pharmacology: Pharmacodynamics under Actions).