Type:Tablet
Generic Name:Ledipasvir + Sofosbuvir
Manufacturer:Incepta Pharmaceuticals Ltd.
Price:৳1000.00
Chronic hepatitis C (CHC), genotype 1, 4 & 6 infection in adults.
Can be taken with or without food.
Oral Hepatitis C Indicated for adults with chronic hepatitis C virus (HCV) genotypes 1, 4, 5, or 6 infection Recommended dosage: One tablet (90 mg of Ledipasvir and 400 mg of Sofosbuvir) taken once daily. Recommended treatment duration: Treatment-naive with or without cirrhosis: 12 weeks Treatment-experienced without cirrhosis: 12 weeks Treatment-experienced with cirrhosis: 24 weeks Hepatic impairment Mild, moderate, or severe: No dosage adjustment required Decompensated cirrhosis: Safety and efficacy not established
Safety and efficacy not established
Renal impairment Mild or moderate: No dosage adjustment required Severe (eGFR <30 mL/min/1.73 m²) or ESRD: No dosage recommendation can be given
Hypersensitivity.
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.
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
>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
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.
