Currently, patients with hepatitis C face a long road of expensive treatments, but a new test may make sorting out who needs this treatment a little easier.
A genetic test has been developed to predict which patients with hepatitis C will develop cirrhosis, or scarring, of the liver, a serious side effect of the disease that often leads to the need for a liver transplant. Since treatment for hepatitis C is costly and comes with serious side effects, this screening test may allow doctors to sort out who is most in need of immediate treatment and who can wait.
"Use of this information to select and treat the patients at highest risk for progression earlier may help prevent irreversible liver damage," said Kathy Ordonez, president of Celera Genomics, the company that developed the test.
In many patients, hepatitis C causes no symptoms and may never cause any liver damage. However, the disease can also cause a chronic liver disease, including cirrhosis, liver failure and liver cancer. Of the estimated 4 million Americans with hepatitis C, 70 percent will develop chronic liver disease and 5 to 20 percent will develop cirrhosis, a leading cause of death in hepatitis C patients.
Determining which patients will end up at this dangerous end of the spectrum is key in preventing liver damage.
According to Dr. David Speechly, determining which patient will develop liver damage as a result of hepatitis C is basically a "flip of a coin." Doctors will look at several factors to try to determine a patient's risk of developing liver disease, including age, gender and alcohol consumption. Liver biopsies, too, are often done to determine the current amount of damage done to the liver, but it cannot predict how much damage will occur in the future.
Celera's test checks for seven genetic variations that seem to increase a patient's risk of developing cirrhosis. In a study, researchers found that those with these genetic variations and particular lifestyle factors, like alcohol consumption, are more than eight times as likely to develop cirrhosis than a patient without either. The results of the study were presented at the annual meeting of The European Association for the Study of the Liver.
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Currently, if a doctor does suspect that a patient will develop cirrhosis, he will likely prescribe a combination of medications that can top $30,000 a year and cause major side effects, including chronic flu-like symptoms and nausea. Therefore, if a genetic test can pinpoint which patients truly need treatment, it could prevent unnecessary pain and expense.
"This study confirms that the genetic makeup of each patient is the most important factor in determining which patients are likely to develop [cirrhosis of the liver]," said Dr. Mitchell L. Schiffman, study author and chief of hepatology of the liver transplant program at Virginia Commonwealth University Medical Center.
Celera Genomics is currently seeking FDA approval for this test, which is estimated to cost around $1,000.
