Pharmacist with multiple bottles of medication at a work station

GenoSure Archive®

GenoSure Archive® is designed to provide HIV-1 antiretroviral (ARV) drug resistance data from archived viral DNA templates embedded in patient cells. The assay can be used when standard resistance testing cannot be performed due to inadequate plasma viral load.

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The Viral Archive—A Second Source 
of Resistance Information

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 (NGS) 

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

GenoSure Archive® may also be considered for patients initiating therapy when conventional HIV RNA drug resistance testing is unsuccessful or unavailable as noted in the DHHS guidelines.1

References

  1. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. Department of Health and Human Services. Available at https://clinicalinfo.hiv.gov/sites/default/files/guidelines/archive/AdultandAdolescentGL_2021_08_16.pdf. Accessed April 30, 2021.