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sofosbuvir (GS-7977)/ledipasvir (GS-5885) (Harvoni)

Also known as: sofosbuvir/ledipasvir (GS-7977/GS-5885)

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Company Gilead Sciences Inc.
DescriptionFixed-dose combination of Sovaldi sofosbuvir, a nucleotide analog HCV NS5B polymerase inhibitor, and ledipasvir, an HCV NS5A protein inhibitor
Molecular Target HCV NS5B polymerase ; HCV NS5A protein
Mechanism of ActionHCV non-structural protein 5B inhibitor
Therapeutic ModalitySmall molecule: Combination
Latest Stage of DevelopmentRegistration
Standard IndicationHepatitis C virus (HCV)
Indication DetailsTreat chronic HCV genotype 1 infection in treatment-experienced patients; Treat chronic HCV genotype 1 infection in treatment-naive patients; Treat chronic HCV genotype 1 infection in treatment-naïve, non-cirrhotic patients; Treat chronic HCV infection; Treat HCV genotype 1 infection; Treat nosocomial HCV genoytpe 1 infection
Regulatory Designation

U.S. - Breakthrough Therapy (Treat HCV genotype 1 infection);
U.S. - Priority Review (Treat HCV genotype 1 infection);
EU - Accelerated Assessment (Treat HCV genotype 1 infection)

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