- WASHINGTON (AP) -- The Food and Drug Administration approved the first oral
therapy for liver-destroying hepatitis B today - a drug already used to
fight AIDS.
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- Glaxo Wellcome Inc.'s drug 3TC, or lamivudine,
helps protect against liver damage caused by chronic hepatitis B.
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- The FDA approved use of a lower 3TC dose
for hepatitis patients than is taken by patients with the AIDS virus. Glaxo
will sell the special hepatitis dose under the brand name Epivir HBV. The
daily hepatitis dose will cost $3.41 wholesale, half the price of the higher
AIDS dose.
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- 3TC cannot cure hepatitis B, which infects
an estimated 1 million Americans and can cause cirrhosis or liver cancer.
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- But 3TC is one of several drugs that
block production of reverse transciptase, an enzyme used by both HIV, the
AIDS virus, and the hepatitis B virus to reproduce. Using it thus lowers
the hepatitis in patients' blood and improves the liver's health, studies
show.
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- In one study of Americans with mild to
moderate infection, 55 percent who took 3TC pills showed improvement when
doctors took liver biopsies, vs. 25 percent of patients who took a dummy
pill.
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- Until now, the only FDA-approved treatment
for hepatitis B was injections of a drug called interferon-alpha.
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- No one yet knows how long hepatitis patients
should take 3TC, which was studied for just a year, the FDA said.
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- The biggest warning: Hepatitis patients
need an HIV test before trying the new hepatitis drug, and repeated testing
during therapy. That's because if they have undiagnosed HIV, taking too
low a 3TC dose could cause the HIV to develop dangerous drug resistance.
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- The drug's side effects also include
nausea, diarrhea, and occasionally more serious effects like liver enlargement,
although more problems are reported at the higher HIV dose, the FDA said.
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