Doctors Close In on Hepatitis C Suppression, Data Show


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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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