Daclatasvir / Sofosbuvir

What it is and how it works

Combines daclatasvir, an inhibitor of the HCV NS5A protein, with sofosbuvir, a nucleotide prodrug whose active triphosphate inhibits the HCV NS5B RNA-dependent RNA polymerase as a chain terminator. Together they provide pangenotypic suppression of HCV replication.

Indications

Treatment of chronic hepatitis C virus infection in adults, across genotypes, in line with WHO and national treatment guidelines.

Dosage and administration (summary)

One tablet (daclatasvir 60 mg / sofosbuvir 400 mg) orally once daily, usually for 12 weeks; longer duration or addition of ribavirin may be required in cirrhosis according to guidelines.

Contraindications

Co-administration with strong CYP3A4 or P-glycoprotein inducers (e.g. rifampicin, carbamazepine, phenytoin, St John’s wort).

Warnings and precautions

Serious symptomatic bradycardia can occur with amiodarone and the combination should be avoided. Screen for hepatitis B before treatment because of the risk of HBV reactivation. Experience is limited in severe renal impairment.

Pregnancy

Not recommended in pregnancy; use effective contraception during treatment.

Storage and supply

Store below 30 °C in the original package.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.