FDA approves new test to detect HIV drug-resistance mutations

The Food and Drug Administration yesterday approved the first test to use next generation sequencing technology to detect HIV drug-resistance mutations in patients taking or about to start antiviral therapy. “The right combination of antivirals can lower viral loads, or the amount of virus in the blood stream, and help keep patients with HIV healthy for many years,” said Peter Marks, M.D., director of FDA’s Center for Biologics Evaluation and Research. “However, according to a recent report from the Centers for Disease Control and Prevention and the World Health Organization, the percentage of people living with HIV around the world that have resistance to some HIV drugs has increased from 11% to 29% since 2001.”