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FDA Approves First Test for Genotyping Hepatitis C Virus

FDA Approves First Test for Genotyping Hepatitis C Virus

The US Food and Drug Administration has approved a test that identifies the genotype of hepatitis C virus (HCV) that has infected a patient. This can be expected to improve the effectiveness of treatment for chronic hepatitis C with new antivirals.

The Abbott RealTime HCV Genotype II, can differentiate genotypes 1, 1a, 1b, 2, 3, 4, and 5, in blood or serum.
Knowing the genotype of the hepatitis C virus that has infected a particular patient is an “important consideration … in determining if and when to initiate treatment and the appropriate type of treatment, “ said Alberto Gutierrez PhD, director of the FDA Office of In Vitro Diagnostics and Radiological Health, in an announcement. 

Several new direct-acting antivirals have transformed the treatment of hepatitis C in recent years, and newer ones are anticipated for approval within the coming year. These antivirals have varying effects depending on the genotype of the infecting HCV, and the test should optimize the effectiveness of the newer agents. FDA reviewed data demonstrating the relationship between HCV genotype and effectiveness of drug therapy in weighing the approval.
Although injection drug users who share needles and healthcare workers stuck by contaminated needles are at highest risk, HCV infection also threatens patients with rheumatic disorders whose immune systems are weakened by treatment for their conditions. Approval of the Abbott virus-genotyping test for individuals known to be chronically infected with HCV should improve the outlook for patients with rheumatic diseases at risk of this infection.

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