Apr 25, 2011 10:52 AM by Nichole Larkey & AP

FDA says Merck drug successfully fights hepatitis

WASHINGTON (AP) - Federal health officials said Monday a highly-anticipated drug to treat hepatitis C made by Merck appears to cure more patients in less time than established drugs that have
been used for 20 years. But the agency has questions about how the drug should be combined with older medicines for the maximum
The Food and Drug Administration posted its review of Merck & Co. Inc.'s boceprevir ahead of a public meeting Wednesday to consider whether to approve the medication. The meeting brings to a
head more than 15 years of research to find a better therapy for a virus that infects about 3.2 million people in the U.S.
On Thursday Vertex Pharmaceuticals Inc. will bring a similar drug before the FDA's panel. Both drugs are considered breakthrough medications with the potential to rack up over a billion dollars in
annual sales.
Both new drugs works by blocking the enzyme protease, which
allows the hepatitis virus to reproduce. The tablet-based drugs
differ from the older medications - ribavirin pills and
interferon-alpha injections - that are designed to boost the immune
Like HIV drugs, the new drugs from Merck and Vertex will be
prescribed as part of a cocktail with the two older drugs to help
lower viral levels.
FDA scientists said the two studies submitted by Merck achieved
their goal of showing patients had undetectable virus levels six
months after completing treatment with boceprevir.
The current two-drug treatment for the virus cures only about 40
percent of people and causes side effects like nausea, fatigue and
Merck & Co.'s boceprevir has been shown to boost cure rates as
high as 75 percent when combined with the older drugs. Merck's
studies were designed to show that the drug combination could cure
most patients in six months - cutting the standard treatment time
in half and reducing exposure to negative side effects from the
older drugs.
But the FDA said in its review that some late-responding
patients may need to take the drugs for eight months to eliminate
the virus. The agency also suggested that other groups of patients
should receive longer therapy, including African Americans, who did
not respond as well as other racial groups. African Americans make
up more than 20 percent of hepatitis C carriers in the U.S.,
according to the Centers for Disease Control and Prevention.
The FDA said the primary side effect with Merck's drug was
anemia, or weakness and fatigue caused by a lack of oxygen-carrying
red blood cells.
An outside panel of viral experts will vote on the safety and
efficacy of the drug Wednesday. The FDA often follows the guidance
of its panels, though it is not required to do so.
Hepatitis C is a major cause of liver transplants, and it kills
about 12,000 U.S. patients a year, a number expected to triple by
2030 as baby boomers succumb to the disease.
The disease is often associated with users of illegal injectable
drugs like heroin, though it could also be picked up from blood
transfusions before 1992, when testing of the blood supply began.
Most people with hepatitis C don't even know they have the virus
until years later when liver damage has occurred, which can cause
abdominal pain, fatigue, itching and dark urine.
"The liver has a huge capacity of going about its business
until it fails," said Dr. Eliav Barr, Merck's vice president for
infectious diseases. "So you have chronic damage that gets worse
and worse but you yourself can't tell until a fair bit of damage is
Whitehouse Station, N.J.-based Merck was the first company to
market a drug for hepatitis C in 1991 when it launched
interferon-alpha. The company began developing boceprevir soon


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