FDA Issues Approval for Epclusa to Treat Chronic Hepatitis C Virus

A clinical trial showed that 95 to 99 percent of patients showed signs of their infection being cured

FDA Issues Approval for Epclusa to Treat Chronic Hepatitis C Virus
June 29, 2016

For individuals suffering from chronic hepatitis C virus (HCV), there may be a new treatment option on the horizon.

The Food and Drug Administration (FDA) has approved Epclusa to treat adult patients with chronic 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.

"This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C," said Edward Cox, in a written statement. Cox is the director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.

Epclusa is sold as a fixed-dose tablet. This tablet contains sofosbuvir, a drug approved in 2013, and velpatasvir, a new drug. It is the first to treat all six major forms of HCV.

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or failure. According to the Centers for Disease Control and Prevention (CDC), HCV infection becomes chronic in approximately 75 to 85 percent of cases. Patients who suffer from chronic HCV infection over many years may have complications, such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections, liver cancer and death.

The safety and efficacy of Epclusa was evaluated in three clinical trials including 1,558 subjects without cirrhosis or with compensated cirrhosis (mild cirrhosis). Results demonstrated that 95 to 99 percent of patients who received Epclusa had no virus detected in the blood 12 weeks after finishing treatment, suggesting the infections had been cured.

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.

Epclusa was reviewed under the FDA's priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.

The drug is manufactured and marketed by Gilead Sciences, Inc.