Ledipasvir and Sofosbuvir combination is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults.
This is a fixed-dose combination tablet containing ledipasvir and sofosbuvir for oral administration. Ledipasvir is an HCV NS5A inhibitor and sofosbuvir is a nucleotide analog inhibitor of HCV NS5B polymerase. Following oral administration of this tablet, ledipasvir median peak concentrations were observed 4 to 4.5 hours post-dose.
Recommended dosage : One tablet (90 mg of Ledipasvir and 400 mg of Sofosbuvir) taken orally once daily with or without food Recommended treatment duration : Treatment-naive with or without cirrhosis: 12 weeks Treatment-experienced without cirrhosis: 12 weeks Treatment-experienced with cirrhosis: 24 weeks A dose recommendation cannot be made for patients with severe renal impairment or end stage renal disease.
The most common adverse reactions (incidence greater than or equal to 10%, all grades) observed with treatment with this tablet for 8, 12, or 24 weeks are fatigue, headache, nausea, diarrhea and insomnia.
Always consult a registered doctor before taking any medicine. This information is for general knowledge only.
This combination is contraindicated in patients with Known hypersensitivity to Ledipasvir, Sofosbuvir or any other ingredient in the product.
Coadministration with amiodarone may result in serious symptomatic bradycardia. Use of Ledipasvir and Sofosbuvir combination with Amiodarone is not recommended P-gp inducers (e.g., Rifampin, St. John’s wort): May alter concentrations of Ledipasvir and Sofosbuvir. Use of Ledipasvir and Sofosbuvir combination with P-gp inducers is not recommended
Bradycardia with amiodarone coadministration: Serious symptomatic bradycardia may occur in patients taking amiodarone, particularly in patients also receiving beta-blockers or those with underlying cardiac comorbidities and/or advanced liver disease. Coadministration of amiodarone with this tablet is not recommended. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Use with other drugs containing sofosbuvir, is not recommended.