Incivek Approved for Hepatitis C

MONDAY May 23, 2011 -- Incivek (telaprevir) has been approved by the U.S. Food and Drug Administration for adults with chronic hepatitis C infection who either haven't received standard interferon therapy or haven't responded to it.

The standard treatment for the chronic liver disease is a combination of peginterferon alfa and ribavirin, taken for 48 weeks. But fewer than half of people with chronic hepatitis C given this therapy respond to it, the FDA said in a news release.

Incivek, combined with standard interferon therapy, was evaluated in clinical studies involving about 2,250 people. Among those previously untreated, 79 percent had no hepatitis C infection detected in the blood 24 weeks after stopping treatment. This was 20 percent to 45 percent higher than people who received standard therapy alone, the FDA said.

Chronic hepatitis C infection often leads to cirrhosis of the liver, which can cause complications including bleeding, jaundice, abdominal fluid buildup or liver cancer, the agency said.

Most people who received the Incivek regimen were able to stop treatment within 24 weeks, rather than the recommended 48 weeks, the FDA said. Common side effects of the treatment included rash, anemia, nausea, fatigue, headache and diarrhea.

Incivek, marketed by Massachusetts-based Vertex Pharmaceuticals, is the second hepatitis C drug approved by the FDA this month. On May 13, the agency sanctioned Merck & Co.'s Victrelis.

More information

To learn more about hepatitis C, visit the U.S. Department of Veteran Affairs.

Posted: May 2011


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