DACLATASVIR = DCV oral

Prescription under medical supervision


Therapeutic action

– Direct-acting antiviral (NS5A inhibitor)

Indications

– Treatment of chronic hepatitis C, in combination with sofosbuvir

Forms and strengths

– 30 mg and 60 mg tablets
– 60 mg breakable tablet

Dosage and duration

– Genotypes 1, 2, 4, 5, 6 without cirrhosis or with compensated cirrhosis and genotype 3 without cirrhosis
Adult: 60 mg once daily (in combination with sofosbuvir) for 12 weeks

– Genotype 3 with compensated cirrhosis
Adult: 60 mg once daily (in combination with sofosbuvir) for 24 weeks

– Genotypes 1, 2, 3, 4, 5, 6 with decompensated cirrhosis
Adult: 60 mg once daily (in combination with sofosbuvir) for 24 weeks

Contra-indications, adverse effects, precautions

– Do not use as monotherapy.
– Do not administer to patients with allergy to daclatasvir.
– May cause:  fatigue, headache, insomnia, dizziness, gastrointestinal disturbances, arthralgia.
– Administer with caution to patients co-infected with HBV (risk of HBV reactivation).
– Do not combine with: carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin, rifapentine, systemic dexamethasone (decreased daclatasvir plasma concentrations); amiodarone (risk of severe bradycardia and heart block).
– Administer with caution and monitor combination with:
• efavirenz, etravirine, nevirapine (increase daclatasvir dose);
• clarithromycin, erythromycin, itraconazole, atazanavir/ritonavir (reduce daclatasvir dose);
• 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 bad taste, they should be swallowed whole (not crushed or chewed).
– If the patient misses a dose, the dose should be taken as soon as possible if remembered within 20 hours of the usual time. After 20 hours or more, the dose should be skipped, and the next dose taken at the usual time.
– Also comes as fixed-dose combination tablets containing daclatasvir 60 mg/sofosbuvir 400 mg.
Storage: below 25 °C