Olysio Approved as Hepatitis C Treatment
Drug blocks protein that helps virus replicate
MONDAY, Nov. 25, 2013 (HealthDay News) -- Olysio (simeprevir) has been approved by the U.S. Food and Drug Administration to treat chronic hepatitis C infection in adults.
The hepatitis C virus causes inflammation of the liver, which can inhibit the organ's function and ultimately lead to deadly liver failure. Most people have no symptoms until the virus causes liver damage, the agency said in a news release. Complications of the disease, which affects some 3.2 million Americans, could include a yellowing of the eyes and skin known as jaundice, abdominal fluid accumulation or liver cancer.
The new drug was approved to be used with two other antiviral medications to treat people who have cirrhosis but whose liver is still functioning, people who haven't been treated for hepatitis C previously, or for people who haven't responded to other therapies, the FDA said. The new drug should only be used in combination with peginterferon-alfa and ribavirin, and should not be administered by itself, the agency warned.
Olysio, combined with the other two drugs, was evaluated in clinical studies involving more than 2,000 people. Common side effects included rash, itching and nausea. Noting the potential for serious reactions involving light exposure, users are advised to avoid the sun and to use sunscreen and other protective measures during treatment, the FDA said.
Olysio is marketed by Raritan, N.J.-based Janssen Pharmaceuticals.
The U.S. Centers for Disease Control and Prevention has more about hepatitis C.