Dualvir Tablet: Each tablet contains Ledipasvir INN 90 mg & Sofosbuvir INN 400 mg.
Ledipasvir is an inhibitor of the HCV NS5A protein, which is required for viral replication. Resistance selection in cell culture and cross-resistance studies indicate ledipasvir targets NS5A as its mode of action. Sofosbuvir is an inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is required for viral replication. Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator.
Dualvir is indicated for the treatment of chronic hepatitis C (CHC) genotype 1,4, 5 & 6 infection in adults.
Dosage & Administration
The recommended dosage of Ledipasvir & sofosbuvir is one tablet taken orally once daily with or without food. Relapse rates are affected by baseline host and viral factors and differ between treatment durations for certain subgroups.
Recommended Treatment Duration for Ledipasvir & Sofosbuvir:
|Patients Type||Treatment Duration|
|Treatment-naïve with or without cirrhosis||12 weeks|
|Treatment-experienced without cirrhosis||12 weeks|
|Treatment-experienced with cirrhosis||24 weeks|
Severe Renal Impairment and End Stage Renal Disease: No dose recommendation can be given for patients with severe renal impairment or with end stage renal disease due to higher exposures of the predominant sofosbuvir metabolite.
Patients with Hepatic Impairment: No dosage adjustment of Ledipasvir & Sofosbuvir is required for patients with mild, moderate or severe hepatic impairment.
The most common adverse reactions were fatigue and headache in subjects treated with 8, 12, or 24 weeks of Ledipasvir & Sofosbuvir.
Ledipasvir & sofosbuvir are substrates of drug transporters P-gp. P-gp inducers may decrease plasma concentrations. Drugs that increase gastric pH are expected to decrease concentration of ledipasvir. It is recommended to separate antacid by 4 hours, H2-receptor by 12 hours. Coadministration of Ledipasvir & Sofosbuvir with Digoxin may increase the concentration of digoxin. Coadministration of Ledipasvir & Sofosbuvir with rifabutin or rifapentine carbamazepine, phenytoin, phenobarbital or oxcarbazepine, tipranavir/ritonavir are expected to decrease the concentration of ledipasvir & sofosbuvir. Concentrations of ledipasvir and simprevir are increased when simeprevir is coadministered with ledipasvir. Coadministration of Ledipasvir & Sofosbuvir with rosuvastatin may significantly increase the concentration of rosuvastatin which is associated with increased risk of myopathy, including rhabdomyolysis.
Use in special groups
Use in pregnancy: Pregnancy category B
Use in lactating mother: It is not known whether Ledipasvir & Sofosbuvir and its metabolites are present in human breast milk.
Use in pediatric patients: Safety and effectiveness of Ledipasvir & Sofosbuvir have not been established in pediatric patients.
Use in geriatric patients: No dose adjustment of Ledipasvir & Sofosbuvir is warranted in geriatric patients.
- Each box contains 7 tablets in Alu-Alu blister pack.
- Each bottle contains 28 tablets.