Genetic Test to Give Clues on Treatment of Hepatitis C

Celera Genomics plans to announce today that it has developed a genetic test it says can help predict which patients with hepatitis C will eventually suffer liver scarring and so are in most need of treatment. The test, which looks at variations in seven genes, represents another step toward personalized medicine, in which treatments are tailored to patients. Various companies are selling or developing such tests, for purposes that include detecting cancer early, monitoring heart transplants and choosing which drugs may work best to treat cancer, AIDS and heart disease. In the case of hepatitis C, therapy is expensive and can cause severe fatigue, fever, depression and other side effects. Although there is some disagreement about this, it has been estimated that only 20 percent of the roughly three million Americans chronically infected with the virus will develop cirrhosis, the severe scarring that can lead to liver failure or liver cancer. But it has not been possible to predict which patients are at greatest risk. Celera's new test is meant to gauge an individual patient's odds. "The current therapies to treat hepatitis C are fairly noxious," said Dr. Scott L. Friedman, chief of the division of liver diseases at the Mount Sinai School of Medicine in Manhattan, who collaborated with Celera to help develop the test. "One of the tough decisions we face as clinicians is who should be treated with current antiviral therapies and who can afford to wait." He said the test "represents a potential breakthrough once it's validated independently in large numbers of patients." Celera will present data on its test Friday in Vienna at the annual meeting of the European Association for the Study of the Liver. Kathy P. Ordonez, the president of Celera, said the company hoped to license the test to a laboratory that could offer it as early as the end of this year. Tests performed by a single laboratory do not require approval from the Food and Drug Administration. Ms. Ordonez said pricing would be up to the laboratory, but she expected it to cost $1,000 or a bit less. She said Celera would also seek F.D.A. approval so it could sell the test widely, but that would take more time, particularly if the agency were to require more data. Treatment of hepatitis C now involves weekly injections of alpha interferon for periods of a few months to more than a year. The therapy, which also includes the pill ribavirin, can cost more than $30,000 a year. Yet many people can live with the virus for decades without needing treatment. Dr. David A. Brenner, the chairman of medicine at Columbia University's College of Physicians and Surgeons and editor in chief of the journal Gastroenterology, urged caution about Celera's announcement, saying other researchers had tried to find genetic predictors of liver disease but the findings had not held up. "A lot of these papers look good in the first data set and the next data set is not encouraging," he said. He added that while Celera seemed to have gone about its study in the correct way, he did not think the test was ready to be used to decide on patient treatment. Celera, based in Rockville, Md., developed its test by scanning the DNA of about 1,000 people who had hepatitis C for 10 years or more, long enough that many would have developed cirrhosis. The company looked at 25,000 genetic variations in each patient and found seven that could best be used to calculate a risk of developing cirrhosis. It then tested DNA samples from 448 other longtime patients and found that the test fairly accurately predicted which of them had cirrhosis. Of those with early-stage liver disease, patients with a high-risk gene pattern had about a sixfold chance of developing cirrhosis compared with those with low-risk gene patterns. Celera, whose stock trades as a subsidiary of the Applera Corporation, was co-founded by the maverick scientist J. Craig Venter in 1998 and raced against the publicly financed Human Genome Project to determine the complete sequence of human DNA, with President Clinton declaring a tie in 2000. Since then, the company has floundered. The original business plan to sell access to its DNA information failed because the public genome project offered its information free. Celera switched to developing drugs, and Mr. Venter was replaced. Earlier this year, Celera largely abandoned drug development to focus instead on diagnostic tests, which can be brought to market more quickly and make better use of the company's genetics expertise. Celera, which is losing money, had revenue of $31 million in the 2005 fiscal year. Its stock, which has traded in the range of $9 to more than $13 in the last year, closed yesterday at $11.37, up a penny. "Source":[http://www.nytimes.com/2006/04/26/business/26liver.html].

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