Active Substance: Ledipasvir, Sofosbuvir.
Overview
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This medicine contains an important and useful components, as it consists of
Ledipasvir, Sofosbuviris available in the market in concentration
Ledipasvir + Sofosbuvir
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 Ledipasvir and Sofosbuvir combination is not recommended. In patients without viable treatment options, cardiac monitoring is recommended. Lactation: Unknown if distributed in human breast milk
Chronic hepatitis C (CHC) genotype 1, 4 & 6 infection in adults.
Hypersensitivity.
>10% Asthenia (31-36%),Fatigue (4-18%),Headache (13-29%),Cough (5-11%) 1-10% Nausea (6-9%),Diarrhea (3-7%),Dizziness (1-5%),Dyspnea (3-9%),Insomnia (3-6%),Increased bilirubin >1.5 x ULN (<1 to 3%),Increased lipase >3 x ULN (<1 to 3%),Myalgia (4-9%),Irritability (7-8%) Frequency Not Defined Asymptomatic creatine kinase elevation, Grades 3/4
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Ledipasvir is an HCV NS5A inhibitor and Sofosbuvir is a nucleotide analog inhibitor of HCV NS5B polymerase. Ledipasvir is a potent inhibitor of HCV NS5A, a viral phosphoprotein that plays an important role in viral replication, assembly, and secretion. Sofosbuvir is a nucleotide analog inhibitor of hepatitis C virus NS5B polymerase—the key enzyme mediating HCV RNA replication. The triphosphate form of sofosbuvir (GS-461203) mimics the natural cellular uridine nucleotide and is incorporated by the HCV RNA polymerase into the elongating RNA primer strand, resulting in chain termination.
Reduced therapeutic effect w/ drugs that are potent P-gp inducers in the intestine (eg rifampicin, St. John's wort, carbamazepine & phenytoin), modafinil, phenobarb/oxcarbazepine, rifabutin/rifapentine. P-gp &/or BCRP inhibitors. May result in serious symptomatic bradycardia when co-administered w/ amiodarone in combination w/ another direct acting antiviral.
Information not available