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Sovaldi, sofosbuvir (GS-7977) (formerly PSI-7977)

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Collapse Summary General Information
Company Gilead Sciences Inc.
DescriptionNucleotide analog HCV NS5B polymerase inhibitor
Molecular Target HCV NS5B polymerase
Mechanism of ActionViral polymerase inhibitor
Therapeutic ModalitySmall molecule
Latest Stage of DevelopmentMarketed
Standard IndicationHepatitis C virus (HCV)
Indication DetailsPrevent recurrent chronic HCV infection following liver transplantation; Treat chronic HCV genotype 1 infection in patients who failed prior therapy; Treat chronic HCV genotype 1, 2 and 3 infection in treatment-naïve patients; Treat chronic HCV genotype 1, 4, 5 and 6 infection in treatment-naïve patients; Treat chronic HCV genotype 2 and 3 infection in treatment-naïve patients; Treat chronic HCV genotype 2 infection; Treat chronic HCV genotypes 2 and 3 infection in treatment-experienced patients; Treat chronic HCV genotypes 2 or 3 infection; Treat chronic HCV infection; Treat chronic HCV infection in treatment-naïve patients; Treat chronic HCV with cirrhosis and portal hypertension with or without liver decompensation; Treat HCV genotype 1 infection; Treat HCV genotype 1, 2 or 3 infection in patients co-infected with HIV; Treat HCV infection; Treat recurrent chronic HCV infection following liver transplantation; Treat severe recurrent HCV following liver transplantation
Regulatory Designation

U.S. - Fast Track (Treat chronic HCV infection);
U.S. - Priority Review (Treat chronic HCV infection);
EU - Accelerated Assessment (Treat chronic HCV infection)

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