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Sofosbuvir/​Velpatasvir

    Brands

    DEA Class; Rx

    Common Brand Names; Epclusa

    • HCV NS5A Inhibitors; 
    • HCV Polymerase Inhibitors

    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

    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

    Sofosbuvir/velpatasvir plus ribavirin combination regimen is contraindicated in patients for whom ribavirin is contraindicated

    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%)

    —

    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

    Adults

    400 mg/day PO for sofosbuvir; 100 mg/day PO for velpatasvir.

    Geriatric

    400 mg/day PO for sofosbuvir; 100 mg/day PO for velpatasvir.

    Adolescents

    400 mg/day PO for sofosbuvir; 100 mg/day PO for velpatasvir.

    Children

    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.

    Infants

    Safety and efficacy not established.

    Neonates

    Safety and efficacy not established.

    Sofosbuvir/velpatasvir

    tablet

    • 400mg/100mg