FDA approves Epclusa (sofosbuvir and velpatasvir) to treat adult patients with chronic hepatitis C virus- Gilead Sciences

The FDA has approved Epclusa (sofosbuvir and velpatasvir), from Gilead Sciences, to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For patients with moderate to severe cirrhosis (decompensated cirrhosis), Epclusa is approved for use in combination with the drug ribavirin. Epclusa is the first to treat all six major forms of HCV.

The safety and efficacy of Epclusa for 12 weeks was evaluated in three Phase III clinical trials of 1,558 subjects without cirrhosis or with compensated cirrhosis (mild cirrhosis). Results demonstrated that 95�99 percent of patients who received Epclusa had no virus detected in the blood 12 weeks after finishing treatment, suggesting the patients� infections had been cured. The safety and efficacy of Epclusa was also evaluated in a clinical trial of 267 subjects with decompensated cirrhosis (moderate to severe cirrhosis), of whom 87 subjects received Epclusa in combination with ribavirin for 12 weeks, and 94 percent of these patients had no virus detected in the blood 12 weeks after finishing treatment. The most common side effects of Epclusa include headache and fatigue. Epclusa and ribavirin combination regimens are contraindicated for patients for whom ribavirin is contraindicated.