FDA Approves Gilead’s New Hep C Drug Epclusa

EPCLUSA2On June 28th theFDA approved Gilead’s new combination treatment for chronic hepatitis C, Epclusa, It is approved for patients with and without cirrhosis and is also approved for all hepatitis C genotypes.

Epclusa is a single tablet regimen containing 400mg of sofosbuvir and 100mg velpatasvir. 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 carries a warning for patients and health care providers that serious slowing of the heart rate (symptomatic bradycardia) and cases requiring pacemaker intervention have been reported when amiodarone is used with sofosbuvir in combination with another HCV direct-acting antiviral. Co-administration of amiodarone with Epclusa is not recommended. Epclusa also carries a warning not to use with certain drugs that may reduce the amount of Epclusa in the blood, which could lead to reduced efficacy of Epclusa.

Always provide your doctor and pharmacist with a full list of all your medications you get on prescription, over the counter, vitamins, and supplements to avoid any serious drug interactions.

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 cost for 12 weeks of treatment with Epclusa is $74,760

For more information on Epclusa you can go to www.Gilead.com and you can also click here to see the Patient Information