Epclusa treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection.
Posology
The recommended dose of Epclusa is one tablet, taken orally, once daily with or without food (see section 5.2).
Table 1: Recommended treatment and duration for all HCV genotypes
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Patient populationa
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Treatment and duration
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Patients without cirrhosis and patients with compensated cirrhosis
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Epclusa for 12 weeks
Addition of ribavirin may be considered for genotype 3 infected patients with compensated cirrhosis (see section 5.1.)
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Patients with decompensated cirrhosis
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Epclusa + ribavirin for 12 weeks
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a. Includes patients co-infected with human immunodeficiency virus (HIV) and patients with recurrent HCV post-liver transplant (see section 4.4.).
When used in combination with ribavirin, refer also to the Summary of Product Characteristics of the medicinal product containing ribavirin.
The following dosing is recommended where ribavirin is divided in two daily doses and given with food:
Table 2: Guidance for ribavirin dosing when administered with Epclusa to patients with decompensated cirrhosis
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Patient
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Ribavirin Dose
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Child-Pugh-Turcotte (CPT) Class B cirrhosis pre-transplant
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1,000 mg per day for patients < 75 kg and 1,200 mg for those weighing ≥ 75 kg
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CPT Class C cirrhosis pre-transplant
CPT Class B or C post-transplant
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Starting dose of 600 mg, which can be titrated up to a maximum of 1,000/1,200 mg (1,000 mg for patients weighing < 75 kg and 1,200 mg for patients weighing ≥ 75 kg) if well tolerated. If the starting dose is not well tolerated, the dose should be reduced as clinically indicated based on haemoglobin levels
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If ribavirin is used in genotype 3 infected patients with compensated cirrhosis (pre- or post-transplant) the recommended dose of ribavirin is 1,000/1,200 mg (1,000 mg for patients weighing < 75 kg and 1,200 mg for patients weighing ≥ 75 kg).
For ribavirin dose modifications, refer to the Summary of Product Characteristics of the medicinal product containing ribavirin.
Patients should be instructed that if vomiting occurs within 3 hours of dosing an additional tablet of Epclusa should be taken. If vomiting occurs more than 3 hours after dosing, no further dose of Epclusa is needed (see section 5.1).
If a dose of Epclusa is missed and it is within 18 hours of the normal time, patients should be instructed to take the tablet as soon as possible and then patients should take the next dose at the usual time. If it is after 18 hours then patients should be instructed to wait and take the next dose of Epclusa at the usual time. Patients should be instructed not to take a double dose of Epclusa.
Patients who have previously failed therapy with an NS5A-containing regimen
Epclusa + ribavirin for 24 weeks may be considered (see section 4.4).
Elderly
No dose adjustment is warranted for elderly patients (see section 5.2).
Renal impairment
No dose adjustment of Epclusa is required for patients wi
