SOFOSBUVIR = SOF oral

Prescription under medical supervision


Therapeutic action

– Direct-acting antiviral (NS5B polymerase inhibitor)

Indications

– Treatment of chronic hepatitis C, in combination with daclastasvir or other antivirals

Forms and strengths

– 400 mg tablet

Dosage and duration

– Genotypes 1, 2, 4, 5, 6 without cirrhosis or with compensated cirrhosis and genotype 3 without cirrhosis
Adult: 400 mg once daily (in combination with daclatasvir) for 12 weeks

– Genotype 3 with compensated cirrhosis
Adult: 400 mg once daily (in combination with daclatasvir) for 24 weeks

Genotypes 1, 2, 3, 4, 5, 6 with decompensated cirrhosis
Adult: 400 mg once daily (in combination with daclatasvir) for 24 weeks

Contra-indications, adverse effects, precautions

– Do not use as monotherapy.
– Do not administer to patients with allergy to sofosbuvir.
– May cause: fatigue, headache, insomnia, nausea.
– Administer with caution to patients co-infected with HBV (risk of HBV reactivation).
– Do not combine with: carbamazepine, phenobarbital, phenytoin, rifampicin, rifapentine (decreased sofosbuvir plasma concentrations); amiodarone (risk of severe bradycardia and heart block).
– Closely monitor blood glucose levels in diabetic patients (risk of hypoglycaemia); 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 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 fixed-dose combination tablets containing sofosbuvir/daclatasvir, and sofosbuvir/velpatasvir.
Storage: below 30 °C -