Drug information of ledipasvir and sofosbuvir

ledipasvir and sofosbuvir

Drug group: NS5A Inhibitor

Ledipasvir and sofosbuvir are antiviral medications that prevent hepatitis C virus (HCV) from multiplying in your body. Ledipasvir and sofosbuvir is a combination medicine used to treat hepatitis C in adults.

Mechanism of effect

Ledipasvir inhibits the HCV NS5A protein necessary for viral replication; sofosbuvir is a prodrug converted to its pharmacologically active form (GS-461203), inhibits NS5B RNA-dependent RNA polymerase, also essential for viral replication, and acts as a chain terminator.


Ledipasvir in combination with sofosbuvir, or in combination with sofosbuvir and ribavirin, is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults.


Ledipasvir and sofosbuvir are well absorbed. Ledipasvir: Slow oxidative metabolism via an unknown mechanism; Sofosbuvir: Hepatic. Excretion:Ledipasvir: Feces (~86%), urine (1%); Sofosbuvir: Urine (80%), feces (14%) Time to Peak:Ledipasvir: 4 to 4.5 hours; Sofosbuvir: ~0.8 to 1 hour. Half-Life Elimination:Ledipasvir: 47 hours; Sofosbuvir: ~0.5 hours. Protein Binding:Ledipasvir: >99.8%; Sofosbuvir: 61% to 65%.


Usual Adult Dose for Chronic Hepatitis C 1 tablet orally once a day Duration of Therapy: -Therapy-naive patients without cirrhosis: 12 weeks; 8 weeks can be considered if pretreatment HCV RNA less than 6 million international units/mL -Therapy-naive patients with cirrhosis: 12 weeks -Therapy-experienced patients without cirrhosis: 12 weeks -Therapy-experienced patients with cirrhosis: 24 weeks


1-Amiodarone: Symptomatic bradycardia (some requiring pacemaker intervention) and fatal cardiac arrest has occurred in patients receiving amiodarone and ledipasvir/sofosbuvir. 2- Avoid concurrent use with other sofosbuvir-containing products.

Points of recommendation

1-Oral: Administer with or without food. 2-During therapy: CBC, serum creatinine, calculated GFR, hepatic function panel (after 4 weeks of therapy and as clinically indicated); quantitative HCV viral load testing (after 4 weeks of therapy and at 12 weeks after completion of therapy). If quantitative HCV viral load is detectable at treatment week 4, repeat testing is recommended after 2 additional weeks of treatment (treatment week 6).

Pregnancy level


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