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News From the Food and Drug Administration
December 17, 2019

Test for HIV Drug–Resistance Mutations

JAMA. 2019;322(23):2277. doi:10.1001/jama.2019.19710

The first test using next-generation sequencing (NGS) to detect drug-resistance mutations in HIV-1 recently received FDA marketing authorization. The Sentosa SQ HIV Genotyping Assay is intended for use among patients with HIV-1 who are about to start or are already taking antiretroviral therapy.

The prevalence of drug-resistant HIV infections has increased from 11% to 29% since the global introduction of antiretroviral therapy in 2001, according to a 2017 report. Patients with drug-resistant infections are less likely to achieve viral suppression and are more likely to discontinue treatment and acquire new HIV drug-resistance mutations.