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http://www.washingtonpost.com/wp-dyn/articles/A7786-2002Apr18.html
Doctors Close In on Hepatitis C Suppression, Data Show
By Justin Gillis, Washington Post Staff Writer
Thursday, April 18, 2002; 10:30 AM
New research released today suggests that doctors are closing in
on a long-sought goal: being able to suppress the potentially
deadly hepatitis C virus in a majority of infected patients.
The new data carry significant implications for public health in
the United States, because about 1 percent of the population, or
2.7 million Americans, is infected with hepatitis C, making the
infection four times as common as AIDS.
Vast numbers of baby boomers were infected with hepatitis C in the
1960s while experimenting with illegal drugs. The virus can take
decades to produce symptoms, and federal health authorities say as
many as two-thirds of these people don't yet know they suffer from
a potentially fatal illness. In a large study whose results were
reported today at a medical conference in Madrid, a new
experimental drug made by F. Hoffmann-La Roche Ltd. was tested in
combination with an older antiviral drug called ribavirin. The
combination suppressed the hepatitis C virus in 61 percent of
patients, the highest such figure ever reported in a comparable
study.
More significant to many American doctors, the study showed a
response rate of 51 percent in patients carrying the strain of
hepatitis C most common in North America, a strain that is
particularly difficult to treat. That appears to be just a slight
improvement over the 42 to 48 percent rate shown in studies of a
similar drug combination that went on the market late last year,
but doctors say it is a psychological breakthrough. "You used to
have to give patients the bad news"–namely, that they could
take an arduous drug regimen for a year but would be unlikely to
suppress the virus, noted Henry C. Bodenheimer Jr., chief of the
division of digestive diseases at Beth Israel Medical Center in New
York and a researcher in the new study. "Now, in the most difficult
patients to successfully treat, we have a better-than-even chance
of eliminating the virus. That's the first time we can say
that."
The new study sets up a potential marketing war between Roche, of
Basel, Switzerland, and the Schering-Plough Corp. of Kenilworth,
N.J. Roche has applied for approval from the Food and Drug
Administration and hopes to put its drug, Pegasys, on the market by
late this year. Schering-Plough won approval late last year to
market PEG-Intron, a product similar to the one Roche is
testing.
Both drugs are improved versions of interferon, a naturally
occurring protein that, when given in high doses, helps the body
fight viral infection. But the formulations differ, and liver
doctors have long speculated that the Roche drug would prove
slightly more effective. Studies accepted by the FDA when it
approved the Schering-Plough drug showed that, in combination with
ribavirin, it suppressed hepatitis C in about 52 percent of
patients, compared to the 61 percent reported in the new studies
for the Roche drug.
Robert Consalvo, a spokesman for Schering-Plough, emphasized
yesterday that the two drugs have not been compared head-to-head in
studies, and he said no firm conclusions can be drawn about their
relative effectiveness. Schering-Plough has also achieved a 61
percent suppression rate in some studies by tweaking drug dosage,
he said, but the company is still doing studies to prove that claim
to U.S. regulators.
Roche, though a year behind Schering-Plough in putting a new
interferon on the market, is plainly banking on the favorable data
to win favor with liver doctors. "We're thrilled," said George
Harb, medical director for Pegasys development at Roche's U.S.
headquarters in Nutley, N.J. "These data are going to change the
treatment paradigm for hepatitis C."
Many people unknowingly contracted hepatitis C decades ago from
injection drug use–or even from one-time use of a shared
cocaine straw. The virus can silently attack the liver for decades
before the illness becomes obvious, often as liver cancer or liver
failure. The virus is the nation's leading cause of liver
transplants.
Tests in recent years have measured the ability of combination drug
regimens to suppress the virus. These regimens can be hard to take,
as they can cause anemia, depression and numerous other problems.
But when they work, the drugs send the virus into sustained
remission. Doctors won't call that a cure, because in theory the
virus can crop up again, but it certainly looks like a cure to the
average person–the virus seems to go away for many years and
the liver recuperates.
"Everybody has difficulty with the word 'cure,' but this is as
close as you can come to it without taking the people apart to try
to find a piece of virus," Bodenheimer said. "We're looking at
long-term, and maybe lifelong, elimination of the virus from the
blood."
With that goal still out of reach in 40 to 50 percent of patients,
however, researchers are wondering whether they can use a lifetime
drug regimen to keep the virus under control, in much the way AIDS
is now treated. A massive study sponsored by the National
Institutes of Health is under way to answer that question, using
the Roche drug as a centerpiece.
© 2002 The Washington Post Company
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