MONDAY, May 23 (HealthDay News) -- 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.
To learn more about hepatitis C, visit the U.S.
Department of Veteran Affairs.