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Novel Hepatitis C Drug Holds Promise: FDA

Novel Hepatitis C Drug Holds Promise: FDA

04/27/11

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.

The new drug was less effective for blacks than whites, the FDA said.

On Wednesday FDA reviewers were expected to study a similar drug, boceprevir, made by Merck & Co.

Telaprevir's cure rates appear to be better than boceprevir's, the AP reported.

On Thursday, the committee of outside experts will be asked for its comments and recommendations on telaprevir. The FDA is not required to follow the advice of its advisory panels, but it usually does so.

The U.S. Centers for Disease Control and Prevention estimated 17,000 new hepatitis C virus infections in the United States in 2007. Many people with the disease have no symptoms until it has caused liver damage, sometimes so severe that a liver transplant is needed.

Until the early 1990s, when testing of the nation's blood supply became routine, hepatitis C was often contracted from blood transfusions. Today it is most commonly associated with injection drug use. It is also transmitted through sexual contact with an infected person, the CDC said.

Earlier this year, a study from the Johns Hopkins School of Public Health called for greater efforts to reduce the population of hepatitis C-infected injection drug users. That study found that new cases of hepatitis C were decreasing only among younger injection drug users who had recently starting using the drugs.

More information

To learn more about hepatitis C, visit the U.S. National Library of Medicine.

Copyright © 2011 HealthDay. All rights reserved.

Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.

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