Classes
DEA Class; Rx
Common Brand Names; Epclusa
- HCV NS5A Inhibitors;
- HCV Polymerase Inhibitors
Description
Combination oral product
Used to treat adults and pediatric patients 3 years and older infected with chronic hepatitis C virus (HCV), with and without cirrhosis
First regimen approved for all HCV genotypes
Indications
Indicated for chronic hepatitis C virus (HCV) infection in adults with HCV genotypes 1, 2, 3, 4, 5, and 6 without cirrhosis or with compensated cirrhosis; or with decompensated cirrhosis for use in combination with ribavirin
Treatment duration for treatment-naïve and treatment-experienced liver transplant recipients
Contraindications
Sofosbuvir/velpatasvir plus ribavirin combination regimen is contraindicated in patients for whom ribavirin is contraindicated
Adverse Effects
Without cirrhosis or with compensated cirrhosis
Headache (22%)
Fatigue (15%)
With decompensated cirrhosis
Fatigue (32%)
Anemia (26%)
Hemoglobin <10 g/dL (23%)
Nausea (15%)
Headache 11%)
Insomnia (11%)
Warnings
—
Pregnancy and Lactation
Contraindicated if administered with ribavirin in pregnant women and in men whose female partners are pregnant
Unknown if sofosbuvir, velpatasvir, or their metabolites are distributed in human breast milk
Maximum Dosage
400 mg/day PO for sofosbuvir; 100 mg/day PO for velpatasvir.
400 mg/day PO for sofosbuvir; 100 mg/day PO for velpatasvir.
400 mg/day PO for sofosbuvir; 100 mg/day PO for velpatasvir.
3 to 12 years weighing 30 kg or more: 400 mg/day PO for sofosbuvir; 100 mg/day PO for velpatasvir.
3 to 12 years weighing 17 to 29 kg: 200 mg/day PO for sofosbuvir; 50 mg/day PO for velpatasvir.
3 to 12 years weighing less than 17 kg: 150 mg/day PO for sofosbuvir; 37.5 mg/day PO for velpatasvir (oral pellets only).
1 to 2 years: Safety and efficacy not established.
Safety and efficacy not established.
Safety and efficacy not established.
How supplied
Sofosbuvir/velpatasvir
tablet
- 400mg/100mg
