Virso Dosage/Direction for Use

VIRSO treatment should be initiated and monitored by a physician experienced in the management of patients with CHC.
Posology: The recommended dose is one 400 mg tablet, taken orally, once daily with food (see Pharmacology: Pharmacokinetics under Actions).
VIRSO should be used in combination with other medicinal products. Monotherapy of VIRSO is not recommended (see Pharmacology: Pharmacodynamics under Actions).
Refer also to the Summary of Product Characteristics of the medicinal products that are used in combination with VIRSO. The recommended co administered medicinal product(s) and treatment duration for VIRSO combination therapy are provided in Table 18. (See Table 18.)

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VIRSO in combination with ribavirin for 24 weeks can be considered as a therapeutic option for CHC patients with genotype 1 infection who are ineligible to receive an interferon-based regimen. (see Precautions and Pharmacology: Pharmacodynamics under Actions).
Treatment decision should be guided by an assessment of the potential benefits and risks for the individual patient.
The dose of ribavirin, when used in combination with VIRSO is weight based (<75 kg = 1,000 mg and ≥75 kg = 1,200 mg) and administered orally in two divided doses with food.
Concerning co administration with other direct acting antivirals against HCV, see Precautions.
Dose modification: Dose reduction of VIRSO is not recommended.
If sofosbuvir is used in combination with peginterferon alfa, and a patient has a serious adverse reaction potentially related to this drug, the peginterferon alfa dose should be reduced or discontinued. Refer to the peginterferon alfa Summary of Product Characteristics for additional information about how to reduce and/or discontinue the peginterferon alfa dose.
If a patient has a serious adverse reaction potentially related to ribavirin, the ribavirin dose should be modified or discontinued, if appropriate, until the adverse reaction abates or decreases in severity. Table 19 provides guidelines for dose modifications and discontinuation based on the patient's haemoglobin concentration and cardiac status. (See Table 19.)

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Once ribavirin has been withheld due to either a laboratory abnormality or clinical manifestation, an attempt may be made to restart ribavirin at 600 mg daily and further increase the dose to 800 mg daily. However, it is not recommended that ribavirin be increased to the original assigned dose (1,000 mg to 1,200 mg daily).
Discontinuation of dosing: If the other medicinal products used in combination with VIRSO are permanently discontinued, VIRSO should also be discontinued (see Precautions).
Special patient populations: Elderly: No dose adjustment is warranted for elderly patients (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment of VIRSO is required for patients with mild or moderate renal impairment. The safety and appropriate dose of sofosbuvir have not been established in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m²) or end stage renal disease (ESRD) requiring haemodialysis (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment of VIRSO is required for patients with mild, moderate or severe hepatic impairment (Child-Pugh-Turcotte [CPT] class A, B or C) (see Pharmacology: Pharmacokinetics under Actions).
The safety and efficacy of VIRSO have not been established in patients with decompensated cirrhosis.
Patients awaiting liver transplantation: The duration of administration of VIRSO in patients awaiting liver transplantation should be guided by an assessment of the potential benefits and risks for the individual patient (see Pharmacology: Pharmacodynamics under Actions).
Liver transplant recipients: VIRSO in combination with ribavirin is recommended for 24 weeks in liver transplant recipients. A starting ribavirin dose of 400 mg administered orally in two divided doses with food is recommended. If the starting dose of ribavirin is well-tolerated, the dose can be titrated up to a maximum of 1,000 - 1,200 mg daily (1,000 mg for patients weighing <75 kg and 1,200 mg for patients weighing ≥75 kg). If the starting dose of ribavirin is not well-tolerated, the dose should be reduced as clinically indicated based on haemoglobin levels (see Pharmacology: Pharmacodynamics under Actions).
Paediatric population: The safety and efficacy of VIRSO in children and adolescents aged <18 years have not yet been established. No data are available.
Route of administration: To be administered orally.