Interferon Update: New Study Results

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Study: Regimen Suppresses Most Hepatitis C Cases washingtonpost.com Justin Gillis 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 infected patients. 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 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 with 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 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 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 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. For more news, or to subscribe to the newspaper, please visitwww.washingtonpost.com Copyright 2002 The Washington Post Company