Gilead announced that the Food and Drug Administration (FDA) has approved new indications for Harvoni (ledipasvir/sofosbuvir) for use in chronic hepatitis C patients with advanced liver disease. 

Harvoni in combination with ribavirin for 12 weeks is now approved for use in chronic hepatitis C virus (HCV) genotype 1- or 4-infected liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and for HCV genotype 1-infected patients with decompensated cirrhosis (Child-Pugh B/C), including those who have undergone liver transplantation.

RELATED: Harvoni Approved to Treat More HCV Patient Populations

The FDA approval was based on data from the Phase 2, open-label SOLAR-1 and SOLAR-2 trials. They evaluated 12 and 24 weeks of treatment with Harvoni in combination with ribavirin in HCV treatment-naive and treatment-experienced patients with genotype 1 and 4 infection who had undergone liver transplantation and/or who had decompensated liver disease. Pooled data showed that sustained virologic response at Week 12 (SVR12) among genotype 4 HCV post-transplant patients without cirrhosis, or with compensated cirrhosis, were similar to the reported genotype 1 SVR12 rates. 

The expanded indications allow Harvoni to be used in more patient populations, including HCV genotypes 1, 4, 5, and 6, HCV/HIV-1 co-infection, HCV genotype 1 and 4 liver transplant recipients, and genotype 1-infected patients with decompensated cirrhosis. 

Harvoni combines ledipasvir, an HCV NS5A inhibitor, and sofosbuvir, an HCV NS5B polymerase inhibitor. It is available as 90mg/400mg strength tablets in 28-count bottles. 

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