FDA approves Harvoni (ledipasvir + sofosbuvir) for hepatitis C with liver disease- Gilead Sciences

The FDA has approved Harvoni (ledipasvir + sofosbuvir) plus ribavirin (RBV) for 12 weeks as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 hepatitis C virus (HCV) infection patients with cirrhosis. The sNDA approval of Harvoni with RBV for 12 weeks for genotype 1 treatment-experienced HCV patients with cirrhosis was supported by data from the Phase II SIRIUS study, which evaluated Harvoni plus RBV for 12 weeks or Harvoni without RBV for 24 weeks in genotype 1 HCV-infected patients with compensated cirrhosis who failed prior therapy. Seventy four of 77 patients (96%) treated with Harvoni plus RBV for 12 weeks, and 97% (75/77) of patients treated with Harvoni for 24 weeks without RBV, achieved SVR12.

The most common adverse reactions (occurring in at least 10% of subjects) among patients receiving Harvoni plus RBV for 12 weeks were asthenia (36%), headache (13%) and cough (11%). In patients receiving Harvoni for 24 weeks, these were asthenia (31%), headache (29%) and fatigue (18%).

The European Medicines Agency also recently approved updates to the Harvoni label to allow for the use of shorter durations of therapy with Harvoni in combination with RBV. Specifically, these include the use of Harvoni plus RBV for 12 weeks in genotypes 1 and 4 HCV-infected patients with compensated cirrhosis, decompensated cirrhosis and post-liver transplant patients. The new label also includes data further supporting use of Harvoni for 12 weeks in patients with genotypes 1 or 4 who are co-infected with HIV and in patients who had previously failed treatment with sofosbuvir plus RBV with or without pegylated interferon.