← Search & browse all drugs

sofosbuvir and ledipasvir

J05AP51

Forms & Strengths

Tablet: 400 mg sofosbuvir / 90 mg ledipasvir
Pellets: 200 mg sofosbuvir / 45 mg ledipasvir

Adult Dosing

Chronic Hepatitis C genotype 1, 4, 5, or 6: One tablet (400 mg/90 mg) orally once daily for 8 to 24 weeks depending on treatment history, cirrhosis status, and baseline HCV RNA viral load.

Pediatric Dosing

Pediatric patients 3 years and older: Dosed by weight using tablets or oral pellets.
Weight >= 35 kg: One 400 mg/90 mg tablet once daily.
Weight 17 kg to < 35 kg: One 200 mg/45 mg pellet packet once daily.

Indications

Treatment of chronic hepatitis C virus (HCV) genotype 1, 4, 5, or 6 infection in adults and pediatric patients aged 3 years and older without cirrhosis or with compensated cirrhosis.

Mechanism of Action

Ledipasvir: Inhibits HCV NS5A protein, which is essential for viral RNA replication and virion assembly.
Sofosbuvir: Nucleotide analog inhibitor of HCV NS5B RNA-dependent RNA polymerase, acting as a chain terminator during viral replication.

Contraindications

Hypersensitivity to sofosbuvir, ledipasvir, or any excipient.
Coadministration with potent P-glycoprotein inducers (e.g., rifampin, St. John's wort) due to risk of significantly reduced plasma concentrations.

Adverse Reactions

Fatigue
Headache
Nausea
Insomnia
Asthenia
Serious: Bradycardia when coadministered with amiodarone

Drug Interactions

P-gp inducers (rifampin, carbamazepine, St. John's wort): Decreases sofosbuvir and ledipasvir concentrations; coadministration is contraindicated.
Amiodarone: Coadministration may result in serious symptomatic bradycardia; avoid use.
Antacids, H2-receptor antagonists, and proton pump inhibitors: May decrease solubility and absorption of ledipasvir; follow specific administration separation guidelines.

Curated Content: Needs Vetting Before Put to Clinical Use