Products
Daclatasvir was approved in the EU in 2014 and in many countries in 2015 in film-coated tablet form (Daklinza, Bristol-Myers Squibb).
Structure and properties
Daclatasvir (C40H50N8O6, Mr = 738.9 g/mol) is present in the drug product as daclatasvir dihydrochloride.
Effects
Daclatasvir (ATC J05AX14) has antiviral properties. The effects are due to binding to the viral protein NS5A (nonstructural protein 5A). Unlike other HCV antiviral drugs, this is not an enzyme but a phosphoprotein that plays a role in RNA replication and assembly. Daclatasvir, when combined with sofosbuvir, can lead to elimination of the virus, which is equivalent to curing the chronic infection.
Indications
For the treatment of chronic hepatitis C (combination therapy).
Dosage
According to the SmPC. Tablets are taken once daily, regardless of meals. The half-life is between 12 to 15 hours.
Contraindications
Daclatasvir is contraindicated in the presence of hypersensitivity and in combination with strong CYP3A4 and P-gp inducers. For complete precautions, see the drug label.
Interactions
Daclatasvir is a substrate of CYP3A4 and P-gp, and corresponding drug-drug interactions are possible. Inducers may reduce the efficacy of the drug.
Adverse effects
The most common potential adverse effects include fatigue, headache, and nausea.
