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FDA Approves First Genotyping Test for Patients With Hepatitis C Virus

Therapeutic aid isn’t designed for diagnosis or screening (June 20)

The FDA has approved a test that identifies the genotype of hepatitis C virus (HCV) that a patient is carrying. The Abbott RealTime HCV Genotype II (Abbott Molecular Inc.) — which can differentiate genotypes 1, 1a, 1b, 2, 3, 4, and 5 using a sample of an infected patient’s blood plasma or serum — will aid health care professionals in determining the appropriate approach to treatment. Because the various HCV genotypes respond differently to available drug therapies, knowing the type of HCV with which a person is infected can result in better patient outcomes, the FDA says.

According to the Centers for Disease Control and Prevention (CDC), HCV is the most common chronic blood-borne infection in the U.S. and the leading cause of liver transplants. About 3.2 million people in the U.S. have a chronic HCV infection, and approximately 15,000 people die from the effects of the virus each year. Most of the people infected with HCV (75% to 85%) are not able to fight off the virus on their own and develop a chronic HCV infection that requires treatment. Untreated chronic HCV infections may lead to liver cancer, severe liver damage, and liver failure.

HCV is transmitted through blood and other bodily fluids. Injection drug users who share needles are at the highest risk for HCV infection. Health care workers stuck by needles that have been used on HCV-infected patients and children born to HCV-infected mothers are also at risk.

The Abbott RealTime HCV Genotype II is approved for individuals known to be chronically infected with HCV. It is not approved for use as a diagnostic test or as a screening test for the presence of HCV genetic material in blood, blood products, or tissue donors. It has not been evaluated in newborns or pediatric patients, or in patients with compromised immune systems, such as people with acquired immunodeficiency syndrome (AIDS).

The FDA based its approval, in part, on an assessment of the test’s accuracy in differentiating specific HCV viral genotypes compared with a validated gene-sequencing method. The FDA also reviewed data demonstrating the relationship between a patient’s HCV genotype and the effectiveness of drug therapy.

Source: FDA; June 20, 2013.

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