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
http://www.washingtonpost.com/wp-dyn/articles/A7786-2002Apr18.html