Novel Hepatitis C Drug Holds Promise: FDA04/27/11
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
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
The new drug was less effective for blacks than whites, the FDA
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,
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
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.
To learn more about hepatitis C, visit the
U.S. National Library of Medicine.
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