Developed for chronic hepatitis c to target viral replication and support systemic viral clearance.
Mechanism of Action
Ledipasvir inhibits the HCV NS5A protein required for RNA replication. Sofosbuvir is a prodrug that inhibits NS5B RNA-dependent RNA polymerase, leading to termination of the viral chain.
Route of Administration
Oral
Onset Time
2–4 weeks
Duration
12–24 weeks (treatment course)
Contraindications
Concurrent use of amiodarone, Concurrent use of potent CYP inducers, Hypersensitivity to ledipasvir or sofosbuvir
Severe Adverse Events
Severe bradycardia, Hepatitis b virus reactivation, Anaphylaxis — requires immediate medical attention
Common Side Effects
Fatigue, Headache, Nausea
Uncommon Side Effects
Diarrhea, Insomnia, Irritability
Drug Interactions
Amiodarone, Rifampin, St. John's Wort, Alcohol, Digoxin
Pregnancy Safety Warnings
FDA Category B: No evidence of fetal risk. Breastfeeding: Excretion in milk is unknown; use with caution.
Age Restrictions
Safety and efficacy established in pediatric patients three years and older.
Information related to Harvoni is compiled and periodically reviewed with reference to established medical sources and prescribing guidance. Content is provided for general reference and should be confirmed with a registered healthcare professional before use.
