HIV & ART
It is estimated that 1.2 million people over the age of 13 live with HIV in the US with 50,000 new HIV infections occurring every year (Prevalence of diagnosed and undiagnosed HIV infection-United States, 2015). Of the 86 % who have been diagnosed, 37% receive antiretroviral therapy (ART) (Vital Signs: HIV diagnosis, care and treatment among persons living with HIV-United States, 2011, 2014). Conventional ART involves a regimen of antiretroviral drugs (ARV) that optimally suppress the HIV viral load of the patient to stop advancement of the disease and is recommended as an initial therapy to HIV positive patients to conserve viral loads below the limit of detection (Treatment and Care).
The major contributor to ART failure is lack of therapy adherence, and occurs in approximately 5-10% of HIV patients per year. When ART failure happens, viral loads rise and drug resistance can develop. The development of HIV drug resistance means that certain ART regimens will no longer be effective for that patient, and that perhaps the patient could spread this resistance to their partners, i.e. transmitted drug resistance (TDR) (Tilghman, et al., 2014) (Attia, Egger, Muller, Zwhalen, & Low, 2009). More specifically, risk of HIV transmission and potential acquired/transmitted drug resistance increases when viral loads exceed 1000 viral copies/mL (Attia, Egger, Muller, Zwhalen, & Low, 2009). Thus, ART failure needs to be diagnosed quickly to prevent disease progression in that patient and to prevent transmission of the virus to a sexual or needle sharing partner (Loutfy, 2013) (WHO, Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection, 2013)
Viral load tests are administered to ART receiving patients 2-3 times per year to monitor ART (Blair, Fagan, & Frazier, 2014). The current standard for viral load detection takes upwards of 1 week for a clinician to acquire an actionable result using a centralized lab. This delay is a time period where a patient with ART failure can transmit the virus and/or develop drug resistance. Laboratories, while using the most advanced technology to achieve appropriate sensitivity, have turna-round times (TATs) that are too long, from sample preparation and handling, to achieve clinical relevance that will best benefit the patient (Sanavio & Krol, 2015).
The Fluxergy Analyzer Beta and HIV-1 Viral RNA assay provide a rapid, cost-effective solution for HIV viral load detection without sample preparation. With immediate and reliable results in less than 30 minutes, a laboratory, hospital or clinic can speed up TATs such that a clinician can prescribe an appropriate regimen to a patient at the point of care and avoid the costly risks associated with infectious levels of HIV.