Regimen suppresses hepatitis C
Research hailed as major step forward for treating the
By Justin Gillis, THE WASHINGTON POST , New York
April 19, 2002 — Research released yesterday 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
The new data carry significant implications for public health in
the United States, where about 1 percent of the population, or 2.7
million people, 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 know they
have the potentially fatal illness.
In a large study whose results were reported yesterday at a
medical conference in Madrid, an 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 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 is a slight improvement over
the 42 percent 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”
— 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 study sets up a potential marketing war between Roche, of
Basel, Switzerland, and 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
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 Advertisement patients, compared
with the 61 percent reported in the new studies for the Roche
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 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.
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 E. 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
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
© 2002 The Washington Post Company
Read more about Pegasys here
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