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HEPCVIR L Tablets

HEPCVI



HEPCVIR L Tablet is a fixed-dose combination (FDC) of ledipasvir and sofosbuvir, which are direct-acting antiviral agents against the Hepatitis C virus (HCV). Ledipasvir is an inhibitor of the HCV NS5A protein, which is required for viral replication. 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 (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator.Hepcvir L Tablet is the first once-a-day, fixed-dose oral combination therapy that has been approved for chronic hepatitis C genotype 1 patients. Based on a generic version of Gilead Sciences Inc’s Harvoni tablets, Hepcvir-L will be sold in India at Rs 25,000 (~US$377) for a bottle of 28 tablets.

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Relative to fasting conditions, the administration of a single dose of ledipasvir -sofosbuvir FDC with a moderate fat (~600 kcal, 25% to 30% fat) or high fat (~1,000 kcal, 50% fat) meal increased sofosbuvir AUC0-inf by approximately 2-fold, but did not significantly affect sofosbuvir Cmax. The exposures of GS-331007 and ledipasvir were not altered in the presence of either meal type. The response rates in Phase 3 trials were similar in HCV-infected subjects who received ledipasvir -sofosbuvir FDC with food or without food. Ledipasvir-sofosbuvir FDC can be administered without regard to food.

 

 

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