Gilead Sciences announced that the Food and Drug Administration (FDA) has approved Harvoni (ledipasvir/sofosbuvir), the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults ages ≥18.

The approval was based on data from three Phase 3 studies (ION-1, ION-2 and ION-3) evaluating 8, 12, or 24 weeks of treatment with Harvoni, with or without ribavirin, among nearly 2,000 genotype 1 hepatitis C virus (HCV) patients with compensated liver disease, including non-cirrhotic treatment-naïve patients (ION-3), cirrhotic and non-cirrhotic treatment-naïve patients (ION-1), and cirrhotic and non-cirrhotic patients who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor (ION-2). Between 94–99% of trial participants in the ribavarin-free arm achieved sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12).

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Ledipasvir, a NS5A inhibitor and Sovaldi (sofosbuvir), a nucleotide analog polymerase inhibitor, was previously approved as a component of a combination antiviral treatment regimen for chronic hepatitis C (CHC) genotype 1, 2, 3, or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplant), and those with HCV/HIV-1 co-infection.

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