Ledipasvir/Sofosbuvir
Mechanism :
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.
Indication :
- Treatment of chronic hepatitis C virus (HCV) genotype 1, 4, 5, or 6 infection in combination with ribavirin.
Contraindications :
Hypersensitivity to any component of the formulation.
Dosing :
Children and Adolescents ≥12 years or weighing ≥35 kg:
Available as ledipasvir 90 mg/sofosbuvir 400 mg tablet.
Chronic hepatitis C infection:
1 tablet orally once daily. Give for 12 weeks in genotype 1,4,5 and 6 and for 24 weeks in genotype 1 who are treatment experienced.
Adverse Effect :
Headache, fatigue, weakness, irritability, insomnia, dizziness, depression, nausea, increased serum lipase, hyperbilirubinemia, myalgia, increased creatine phosphokinase, cough, dyspnea.
Interaction :
Amiodarone: Sofosbuvir may enhance the bradycardic effect of Amiodarone.
Antacids: May decrease the serum concentration of Ledipasvir.
Colchicine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Colchicine.
Lumacaftor: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. Lumacaftor may increase the serum concentration of P-glycoprotein/ABCB1 Substrates.
P-glycoprotein/ABCB1 Inducers: May decrease the serum concentration of Sofosbuvir and Ledipasvir.
Phenobarbital, Primidone, Rifabutin: May decrease the serum concentration of Sofosbuvir and Ledipasvir.
Hepatic Dose :
No dose adjustments are recommended.