Brand Name: Harvoni
Generic Name: ledipasvir and sofosbuvir
Medication Class: Direct-acting Antiviral Agent
Manufacturer: Gilead Sciences, Inc.
FDA Approval Date: October 10, 2014
What is Harvoni and its mechanism of action?
Harvoni is the first combination drug FDA approved for treatment of chronic hepatitis C (hep C) virus (HCV) genotype 1. Harvoni is a fixed-dose combination tablet of ledipasvir 90 mg and sofosbuvir 400 mg taken orally. Sofosbuvir is a prodrug that is metabolized (converted) to a nucleotide analog polymerase inhibitor. It is a direct-acting antiviral agent, meaning it will directly block the life cycle of the hep C virus. It prevents virus replication by interfering with the HCV enzyme called NS5B.
Ledipasvir is an inhibitor of HCV NS5A enzyme, which is required for viral replication. Inhibition of NS5A blocks viral production at an early stage of assembly. Both drugs in Harvoni interfere with enzymes needed by HCV to multiply and make new viruses, thus reducing the overall viral load.
What is Harvoni used for treating?
Hepatitis is defined as inflammation of the liver, and Hepatitis C is a type of hepatitis caused by the hepatitis C virus (HCV). Hepatitis C is a leading cause of chronic liver disease and liver failure in the US. Currently, there are 6 different genotypes identified in HCV and genotype 1 is the most prevalent in the US.
Harvoni is the first FDA-approved combination drug for treatment of chronic HCV genotype 1 infection. It is approved with or without ribavirin for treatment of subjects infected with HCV genotype 1, 4, 5, or 6.
Next: Efficacy Results