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Novel Hepatitis C Drug Holds Promise: FDA
Date:4/27/2011

WEDNESDAY, April 27 (HealthDay News) -- An experimental new drug that may treat hepatitis C more effectively than earlier medications will be reviewed Thursday by a panel of experts for the U.S. Food and Drug Administration.

Telaprevir, made by Vertex Pharmaceuticals of Cambridge, Mass., would be prescribed in combination with two existing drugs to help reduce levels of the virus, which can cause severe liver damage, according to documents posted by the FDA on its website in advance of the meeting.

While the older drugs -- pegylated interferon-alfa and ribavirin -- are intended to bolster the immune system's response to hepatitis, the new drug works differently, blocking protease, an enzyme that enables the hepatitis C virus to reproduce. Together, the combined medications may offer new hope for the thousands of Americans with the contagious liver disease.

"A drug like telaprevir does an amazing job clearing the virus, but there's a small portion that is just intrinsically less responsive and it's the job of the older drugs to clear up that mess that's left behind," Dr. Camilla Graham, Vertex's vice president for global medical affairs, told the Associated Press.

According to one of the Vertex studies reviewed by the FDA, 79 percent of hepatitis C patients treated for the first time with the three-drug cocktail -- telaprevir and the two older drugs -- were cured, compared to 46 percent of patients given the earlier drugs alone, the AP reported.

The three-drug combo also worked better than the earlier drugs for patients previously treated for hepatitis C. Sixty-five percent of the telaprevir patients were cured, compared with 17 percent of those taking the older medications, the news service said.

By adding telaprevir to the medication regimen, most patients are cured in six months, instead of 12 months, which reduces their exposure to uncomfortable side effects, the AP reported.<
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