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FDA approved a test that identifies the genotype of hepatitis C virus (HCV) that a patient is carrying.
FDA 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) can differentiate genotypes 1, 1a, 1b, 2, 3, 4, and 5 using a sample of an infected patient’s blood plasma or serum, which will aid healthcare professionals in determining the appropriate approach to treatment, resulting in better patient outcomes. Various HCV genotypes respond differently to available drug therapies.
“The approval of the first genotyping test for individuals with hepatitis C can be viewed as an improved method of guiding therapeutic selections in this patient population based on the identification of their particular genotype,” said Abimbola Farinde, PharmD, MS, clinical staff pharmacist at Clear Lake Regional Medical Center, Webster, Texas. “This approval has the potential to optimize treatment approaches as well as improve treatment outcomes once providers are aware of the type of genotype that exists within any given patient.”
HCV is the most common chronic blood-borne infection in the United States and the leading cause of liver transplants, according to the Centers for Disease Control and Prevention. 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. Seventy-five to 85% of people infected with HCV 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. Drug users who share needles are at the highest risk for HCV infection. Healthcare workers accidentally 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 for screening blood, plasma serum, or tissue donors for HCV, or to be used as a diagnostic test to confirm the presence of HCV infection.
FDA based its approval of the Abbott RealTime HCV Genotype II, in part, on the assessment of the test's accuracy in differentiating specific HCV viral genotypes compared to a validated gene sequencing method. FDA also reviewed data from investigators demonstrating the relationship between HCV genotype and effectiveness of drug therapy.