SOFOSBUVIR/DACLATASVIR = SOF/DCV oral

Select language:
Enter
Permalink
Download
Comment
Return to top
On this page

    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 (daclatasvir)

    Indications

    • Treatment of chronic hepatitis C

    Forms and strengths

    • 400 mg sofosbuvir/60 mg daclatasvir co-formulated tablet

    Dosage and duration

    Genotypes 1, 2, 4, 5, 6 without cirrhosis or with compensated cirrhosis and genotype 3 without cirrhosis

    • Adult: one 400 mg/60 mg tablet once daily for 12 weeks

     

    Genotype 3 with compensated cirrhosis or genotypes 1, 2, 3, 4, 5, 6 with decompensated cirrhosis

    • Adult: one 400 mg/60 mg tablet once daily for 24 weeks

    Contra-indications, adverse effects, precautions

    • Do not administer to patients with allergy to sofosbuvir or daclatasvir.
    • May cause: fatigue, headache, insomnia, dizziness, gastrointestinal disturbances, arthralgia.
    • 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, oral or injectable dexamethasone (decreased sofosbuvir and/or daclatasvir plasma concentrations); amiodarone (risk of severe bradycardia and heart block).
    • Administer with caution and monitor combination with:
      • efavirenz, etravirine, nevirapine (decreased daclatasvir plasma concentrations);
      • clarithromycin, erythromycin, itraconazole, atazanavir/ritonavir (increased daclatasvir plasma concentrations);
      • digoxin (increased digoxin plasma concentrations).
    • Closely monitor blood glucose levels in patients with diabetes (risk of hypoglycaemia); adjust the antidiabetic treatment if necessary.
    • Provide effective contraception in women of childbearing age.
    • 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 2 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 single drug formulations (sofosbuvir 200 mg tablet and daclatasvir 60 mg tablet) for paediatric use.

    Storage 

     
    –  Below 30 °C 
    Path