Despite continuing advances in treatment for HIV‐1 infection, antiretroviral therapy (ART) may fail due to the accumulation of drug resistance mutations or the transmission of drug resistance mutations pre‐therapy. Identifying such mutations can optimize and guide selection of antiretroviral drugs. Thus, detection of mutations associated with antiviral resistance is recommended at entry into care, when ART is initiated or changed, when treatment failure is suspected, or when otherwise clinically indicated. When virologic failure is suspected, resistance testing should be performed while the patient is taking the drug or within 3 weeks after discontinuing it.
This HIV‐1 Integrase Genotype test is designed to detect mutations associated with resistance to integrase class of inhibitors (INI) also known as HIV integrase strand transfer inhibitor (INSTI). These INI’s represent a new antiretroviral drug class in which the catalytic activity of integrase enzyme is inhibited, thereby preventing formation of the HIV provirus required for viral propagation and integration into host chromosome. The major mutations associated with raltegravir (RTG) resistance include N155H, Q148H/K/R, and Y143C/H/R.3,4 and for elvitegravir (EVG) resistance mutations include T66A/K/I, E92Q/G, T97A, S147G, Q148H/K/R, N155H5,6 (**Note cross‐resistant profiles of INI6,,7,8) and the mutations E92Q, L101I, T124A, Q148H/R, and S153Y/F7,8,9 for dolutegravir, the experimental expanded access second generation INI. In addition, minor mutations that may contribute to drug resistance as compensatory, Resistance Associated Mutations (RAM), are reported, as well as non‐RAM polymorphisms (mutations that do not have reported resistance effects) which make up the virus “Polymorphic Fingerprint”.
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