Products
Ledipasvir is approved as a fixed combination with sofosbuvir in the form of film-coated tablets (Harvoni). It was released in many countries in 2014. The high price of the drug is controversial (see Sofosbuvir). Cheaper generics are available in India: MyHep LVIR.
Structure and properties
Ledipasvir (C49H54F2N8O6, Mr = 888.9 g/mol) is practically insoluble in water at neutral pH.
Effects
Ledipasvir (ATC J05AX65) has antiviral properties against the HCV virus. The effects are due to binding to the viral protein NS5A (Non-Structural Protein 5A). Unlike other HCV antiviral drugs, the drug target is not an enzyme but a phosphoprotein that plays a role in RNA replication and assembly.
Indications
For the treatment of chronic hepatitis C in combination with sofosbuvir.
Dosage
According to the SmPC. Tablets are taken once daily, independent of meals. Duration of therapy is 12 or 24 weeks, depending on the exact indication.
Contraindications
- Hypersensitivity
- Combination with rosuvastatin or St. John’s wort
Full precautions can be found in the drug label.
Interactions
Ledipasvir is a substrate of P-glycoprotein and BCRP. P-gp inducers may lead to a decrease in plasma concentrations.
Adverse effects
The most common potential adverse effects include headache and fatigue.
