SOFOSBUVIR/DACLATASVIR = SOF/DCV oral

Last updated: October 2021

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 tablet once daily for 12 weeks

– Genotype 3 with compensated cirrhosis or genotypes 1, 2, 3, 4, 5, 6 with decompensated cirrhosis
Adult: one 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 diabetic patients (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. 
Storage: below 30°C -