FDA expands Gilead's Harvoni label for advanced cirrhosis patients
- The FDA on Tuesday expanded the label for Gilead's Harvoni to allow the treatment of hepatitis c patients with advanced cirrhosis, including those with liver transplants.
- Gilead relied on pooled data from two studies enrolling 307 patients (Solar-1 and Solar-2) to support the expansion. Post-transplant, 98% of patients with genotype 1 hepatitis c virus and compensated cirrhosis had a sustained virologic response at 12 weeks. Among those with decompensated cirrhosis (CPT B), 89% experienced a sustained response.
- The expanded label for Harvoni further adds to its competitive advantage over other hep C meds, which has led to its dramatic commercial success.
According to the Centers for Disease Control and Prevention (CDC), 5% to 20% of patients with chronic HCV will develop cirrhosis within 20 to 30 years. Cirrhosis, or scarring and debilitated functioning of the liver, leads to death in roughly one-quarter of those patients.
Traditionally, treating HCV in patients with cirrhosis has been difficult because of low response rates and a higher-than-normal frequency of adverse events. The approval of Harvoni for treatment of patients with cirrhosis effectively enables this population to potentially clear HCV without undergoing a liver transplant.
Harvoni is also indicated for treatment of some patients who have already undergone liver transplantation, broadening the patient population to include the sickest patients.
Harvoni is a fixed-dose combination of ledipasvir, a HCV NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor. It is indicated for the treatment of chronic HCV genotype 1, 4, 5 or 6 infection.