New Hepatitis C Rx Approved

Gilead's Epclusa (sofosbuvir, velpatasvir) approved to treat all major hepatitis C virus forms

/ Author:  / Reviewed by: Anyssa Garza, PharmD

(RxWiki News) The US Food and Drug Administration (FDA) has approved a new hepatitis C medication.

That medication is Gilead's Epclusa. This new treatment option is available in a fixed-dose combination tablet that contains two medications: sofosbuvir and velpatasvir. Sofosbuvir was approved in 2013, and velpatasvir is a new medication.

This medication is approved to treat chronic hepatitis C infection in adults with or without cirrhosis (advanced liver disease). When treating moderate to severe cirrhosis, Epclusa is to be given in combination with ribavirin. 

Epclusa is the first treatment option available to treat all six major forms of the hepatitis C virus. 

Epclusa gained approval after it appeared safe and effective in three phase III trials. 

The most commonly reported side effects were headache and fatigue.

This medication carries a boxed warning regarding the risk for slow heart rate in cases in which amiodarone, sofosbuvir and another hepatitis C medication were given. That said, amiodarone is not to be given with Epclusa.

Epclusa is not to be given with certain medications that lower the amount of Epclusa in the blood and, therefore, reduce how well it works, the FDA noted. 

Speak with your doctor about the best hepatitis C treatment for you. 

Reviewed by: 
Review Date: 
June 28, 2016
Last Updated:
June 30, 2016