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ROCKVILLE, Md., Dec. 9 (UPI) _ The
U.S. Food & Drug Administration has approved the first pill for the treatment
of hepatitis B, a sometimes fatal liver disease that affects about 350 million people
worldwide.
The agency also expanded the use of
a treatment for hepatitis C cleared in June.
The hepatitis B pill, called Epivir,
is one of the virus-fighting medications now used in the treatment of AIDS.
The hepatitis B formula contains a
lower dose of the same active ingredient _ called lamivudine or 3TC _ used in AIDS
therapies.
The drug was developed by BioChem
Pharma, of Laval, Quebec, which licensed it to Glaxo Wellcome Inc., of Research Triangle
Park, N.C.
Glaxo Wellcome's Dr. Marc Rubin says,
This once a day oral tablet may provide a convenient and generally well-tolerated
treatment option.
Dr. Heidi Jolson said today: "This
is a very important approval. It provides an important alternative to currently approved
interferon for hepatitis B."
Jolson says there are no studies comparing
the drugs, so there is no way to tell whether the new treatment works better.
Jolson, who is the director of the
division of anti-viral drug products for the FDA , says doctors considering treating
hepatitis patients with Epivir should first test them of HIV, the virus that causes
AIDS.
Giving low doses of the drug could
promote the development of resistant strains of AIDS in a person carrying HIV, says
Jolson.
Hepatitis B is a chronic viral infection
that leads to liver inflammation, and could progress to cirrhosis _ liver scarring
_ and cancer. The World Health Organization says hepatitis B is the ninth most common
cause of death worldwide.
The Centers for Disease Control and
Prevention in Atlanta says that about 1 million Americans have hepatitis B, which
can be spread through sex, blood transfusions, needle sharing among injection drug
users, or from mother to baby.
Glaxo Wellcome says the drug does
not reduce the risk of a mother passing the virus on to her child.
Until the approval, the only treatment
for hepatitis B was alpha interferon, a drug that must be injected and has a success
rate of about 30 percent, said Dr. Julie Lehane, a spokeswoman for the American Liver
Foundation in New York City.
The FDA also approved an expanded
use of combination therapy for hepatitis C, another liver infection that affects
four million Americans.
Researchers say the disease is the
most common reason for liver transplants in the United States.
The new treatment, called Rebetron
Combination Therapy, is two drugs _ Intron A, also known as interferon alpha, and
ribavirin.
In June, the FDA approved the combination
for patients who had relapsed after treatment with interferon alone.
The new FDA approval is for the treatment
of patients with chronic hepatitis C who do not have other drugs. The combination
appears to have more virus-fighting power than Intron A alone, says the FDA.
Rebetron is marketed by the Schering
Corp. of Kenilworth, N.J.
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