THURSDAY, April 28 (HealthDay News) -- Two new drugs that could
change the way hepatitis C is treated have been unanimously
recommended for approval by a panel of U.S. health experts.
On Thursday, a Food and Drug Administration advisory committee
voted 18-0 that telaprevir, made by Vertex Pharmaceuticals Inc., is
both safe and effective despite a high rate of rashes that has been
reported among those taking it. On Wednesday, the same panel threw
its full support behind boceprevir, a new medication from Merck
Although not required to follow the recommendations of its
expert panels, the FDA typically does; a final decision is expected
by May 23. The agency convened the two-day meeting to review both
drugs, which block the enzyme that allows the hepatitis virus to
replicate. Many experts believe that, if approved, boceprevir and
telaprevir could revolutionize treatment of hepatitis C-linked
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
Intravenous drug users are particularly susceptible to the
Studies found that when used with two older drugs, boceprevir
reduced levels of the virus more effectively than the existing
treatments. Merck hopes to sell the medication under the brand name
Victrelis, according to
Debra Birnkrant, director of the FDA's antiviral drugs division,
said that both medications appear to increase the cure rate "to
more than 30 percent above what we have today,"
Dow Jones reported.
The new drugs take treatment of hepatitis C in a new direction.
Both boceprevir and telaprevir block protease, an enzyme that helps
the virus reproduce. The earlier drugs, pegylated interferon and
ribavirin, were meant to boost the immune system's defense against
the virus. Together, the combined medications may offer new hope
for the thousands of Americans with the contagious liver
Asked if the available data supported use of boceprevir in
combination with standard treatment of pegylated interferon and
ribavirin, the panel of medical experts voted 18-0 in favor of its
approval on Wednesday,
Dow Jones reported.
One of the boceprevir studies found it effective for 66 percent
of patients taking the three-drug regimen compared to 38 percent of
those who received the standard two-drug treatment,
Dow Jones said.
Some concerns still need to be addressed, including how to treat
black patients, for whom the drugs seem to be less effective.
Studies submitted by the manufacturers showed the new drugs,
when added to existing treatments, shortened the length of
medication therapy, thereby reducing potential side effects.
Patients currently require nearly 12 months of treatment.
Telaprevir's cure rates appear to be better than boceprevir's,
Associated Press reported.
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.