SOFOSBUVIR/VELPATASVIR = SOF/VEL oral

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    Last updated: September 2023

     

    Prescription under medical supervision

     

    Therapeutic action

    • Combination of two direct-acting antivirals: a NS5B polymerase inhibitor (sofosbuvir) and a NS5A inhibitor (velpatasvir)

    Indications

    • Treatment of chronic hepatitis C

    Forms and strengths

    • 400 mg sofosbuvir/100 mg velpatasvir co-formulated tablet

    Dosage and duration

    Genotypes 1, 2, 3, 4, 5, 6 with no cirrhosis or compensated cirrhosis

    • Adult: one 400 mg/100 mg tablet once daily for 12 weeks

     

    Genotypes 1, 2, 3, 4, 5, 6 with decompensated cirrhosis

    • Adult: one 400 mg/100 mg tablet once daily for 24 weeks

    Contra-indications, adverse effects, precautions

    • Do not administer to patients with allergy to sofosbuvir or velpatasvir.
    • May cause: fatigue, headache, insomnia, nausea, rash.
    • Administer with caution to patients co-infected with hepatitis B virus (risk of HBV reactivation). 
    • Do not combine with: carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin, rifapentine, efavirenz, nevirapine, etravirine (decreased sofosbuvir and/or velpatasvir plasma concentrations); amiodarone (risk of severe bradycardia and heart block)
    • Administer with caution and monitor combination with: tenofovir, atorvastatin, digoxin (increased plasma concentration of these drugs)
    • Do not administer simultaneously with:
      • omeprazole: take sofosbuvir/velpatasvir 4 hours before omeprazole, with food;
      • antacids (aluminium/magnesium hydroxide, etc.), calcium carbonate: take 4 hours apart.
    • Closely monitor blood glucose levels in patients with diabetes (risk of hypoglycemia); adjust the antidiabetic treatment if necessary.
    • Pregnancy and breast-feeding: CONTRA-INDICATED (safety not established)

    Remarks

    • Tablets have a bitter taste, they should be swallowed whole (not crushed or chewed), with meals.
    • If the patient vomits within 3 hours after administration: take the same dose.
    • If the patient misses a dose, the dose should be taken as soon as possible if remembered within 18 hours of the usual time. After 18 hours or more, the dose should be skipped, and the next dose taken at the usual time.
    • Also comes in 200 mg sofosbuvir/50 mg velpatasvir co-formulated tablet for paediatric use.

    Storage  

     
    –  Below 30 °C 
    Path