Sofosbuvir/Velpatasvir tablet is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults
Posology and method of administration
Sofosbuvir/Velpatasvir tablet treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection.
The recommended dose of Sofosbuvir/Velpatasvir tablet is one tablet, taken orally, once daily with or without food
Table 1: Recommended treatment and duration for all HCV genotypes
|Patient populationa||Treatment and duration|
|Patients without cirrhosis and patients with compensated cirrhosis||Sofosbuvir/Velpatasvir tablet for 12 weeks
Addition of ribavirin may be considered for genotype 3 infected patients with compensated cirrhosis
|Patients with decompensated cirrhosis||Sofosbuvir/Velpatasvir tablet + ribavirin for 12 weeks|
aIncludes patients co-infected with human immunodeficiency virus (HIV) and patients with recurrent HCV post-liver transplant
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 Sofosbuvir/Velpatasvir tablet to patients with decompensated cirrhosis
|Child-Pugh-Turcotte (CPT) Class B cirrhosis pre-transplant||1,000 mg per day for patients < 75 kg and 1,200 mg for those weighing ≥ 75 kg|
|CPT Class C cirrhosis pre-transplant
CPT Class B or C post-transplant
|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|
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 Sofosbuvir/Velpatasvir tablet should be taken. If vomiting occurs more than 3 hours after dosing, no further dose of Sofosbuvir/Velpatasvir tablet is needed
If a dose of Sofosbuvir/Velpatasvir tablet 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 Sofosbuvir/Velpatasvir tablet at the usual time. Patients should be instructed not to take a double dose of Sofosbuvir/Velpatasvir tablet.
Patients who have previously failed therapy with an NS5A-containing regimen
Sofosbuvir/Velpatasvir tablet + ribavirin for 24 weeks may be considered
No dose adjustment is warranted for elderly patients
No dose adjustment of Sofosbuvir/Velpatasvir tablet is required for patients with mild or moderate renal impairment. The safety and efficacy of Sofosbuvir/Velpatasvir tablet has not been assessed 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
No dose adjustment of Sofosbuvir/Velpatasvir tablet is required for patients with mild, moderate, or severe hepatic impairment (CPT Class A, B, or C). Safety and efficacy of Sofosbuvir/Velpatasvir tablet have been assessed in patients with CPT Class B cirrhosis, but not in patients with CPT Class C cirrhosis.
The safety and efficacy of Sofosbuvir/Velpatasvir tablet in children and adolescents aged less than 18 years have not yet been established. No data are available.