NEW GENETIC TEST IDENTIFIES HIGH RISK VS LOW RISK HCV INFECTED

TO EVALUATE NEED FOR EARLY TREATMENT OR DELAYED TREATMENT

Researchers at five major medical centers helped confirm the reliability of a new genetic test, the first of its kind that can identify patients who are at high risk of developing cirrhosis from chronic hepatitis C infection. This means high-risk patients could be directed toward early treatment that is usually a long course of expensive, often debilitating drug therapy, while low-risk patients might be better off delaying treatment.

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The lead author of the paper is Hongjin Huang, PhD, associate director of

liver diseases at Celera in Alameda, Calif. Huang and her Celera colleagues
developed the test by initially scanning the DNA of more than 1,000 people
who had hepatitis C. Out of 25,000 genetic variations tested, the researchers

discovered seven that could be used together as a "signature" for predicting progression

to cirrhosis in Caucasians.

The resulting gene signature - the Cirrhosis Risk Score - was then independently validated on 154 hepatitis C patients at Stanford, the University of Illinois-Chicago and California Pacific Medical Center. Among patients with early-stage liver disease, the researchers were able to divide them into a high-risk category based on their gene pattern, compared with those who had low-risk gene patterns. "The Cirrhosis Risk Score was superior to the known clinical factors, such as alcohol consumption, in predicting the risk of developing cirrhosis," said Cheung.

"This test allows both physicians and patients to make an intelligent
decision about the urgency of beginning antiviral therapy," he said. "If a
patient turns out to be low-risk, we might advise the patient to consider
deferring treatment, avoiding unnecessary side effects and expense of
current therapy."

Hepatitis C infection is the most common reason people need a liver
transplant in the United States and is responsible for between 8,000 and
10,000 U.S. deaths annually.

But in the majority of people chronically infected with hepatitis C, the
virus causes either no symptoms or vague, nonspecific ones. In around
one-third of people chronically infected with the virus, the disease
progression is slow and they may never develop cirrhosis, even after decades
of infection.

The dilemma physicians face, explained Cheung, is deciding who to treat and
who can wait for better therapies to come along. The key is being able to
determine which patients are likely to see the infection progress to
cirrhosis. The new test assessed by Cheung and his colleagues is a new way

to evaluate patients for treatment.

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