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Differences can exist between the viral population circulating in the plasma and the proviral DNA archived in infected cells. HIV-1 viral loads and standard resistance assays analyze HIV-1 RNA in plasma. GenoSure Archive® analyzes archived HIV-1 proviral DNA embedded in host cells during virus replication.
GenoSure Archive® uses next-generation sequencing methods to provide a list of the archived mutations and then assigns susceptibility calls of "sensitive", "resistant", or "resistance possible" based on those mutations for nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), integrase inhibitors (INIs) and protease inhibitors (PIs). It can be useful when considering regimen changes due to:
Side effects
Adverse events
Regimen simplification
Drug-drug interactions
Concern for long-term toxicities
Regimen intolerance
The next-generation sequencing genotypic resistance assays that analyze proviral DNA can be considered for individuals, particularly if complex or semi-complex pre-existing resistance is suspected. In individuals who have experienced multiple prior failures, have a prolonged history of prior ARV regimens, and/or for whom prior genotypic resistance test results are not available, it may be appropriate to utilize proviral DNA genotypic testing. Results should be combined with all prior genotypic and phenotypic test results to construct a cumulative genotype, which incorporates all current and previously detected drug-resistance mutations. As with all genotypic resistance testing, results from proviral DNA genotypes should be interpreted with caution, as these assays might miss some or all previously existing drug-resistance mutations.1
