Millions of patients in primary healthcare settings, including newborns, could gain access to a potentially life-changing test for HIV viral load monitoring, thanks to a new development effort from Cepheid, Sunnyvale, Calif, that is being funded in part by a grant from the Bill & Melinda Gates Foundation.

The development effort is targeting a new test that is designed to deliver lab-quality results from a few drops of fingerstick-collected blood at remote patient sites, in contrast to existing human immunodeficiency virus (HIV) viral load tests that require venipuncture and separation of plasma from venous blood at a limited number of molecular lab locations.

Currently, patients in resource-limited settings can wait weeks to months for the results of HIV viral load tests that could support better management of antiretroviral therapy. Even worse, it has been estimated that in some countries, as much as 50% of centralized laboratory results are never delivered to the patient.1

The Xpert fingerstick HIV-1 viral load assay, now in development, builds on Cepheid’s existing plasma-based test for HIV viral load, and is expected to deliver results within 1 hour. The test is designed to enable same-visit test-and-treat algorithms, even in the most remote and challenging environments.

“A fingerstick whole blood HIV quantitative assay that can reliably differentiate viral load levels at the 1,000 copies/mL level could dramatically impact the course of the HIV epidemic,” says Ian Sanne, founding director and chief executive officer of Right to Care. “This would enable better clinical management of HIV patients and make the UNAIDS 90-90-90 target a reality. Clinicians challenged the diagnostics industry over 10 years ago to come up with a simple, cost-effective, bedside test that has a cut-off relevant for the treatment of HIV. Cepheid may be the first to deliver.”

“Coupled with Cepheid’s innovative Omni point-of-care system, we believe the Xpert fingerstick HIV-1 viral load assay has the potential to revolutionize the management of HIV patients on a worldwide basis,” says John Bishop, Cepheid’s chairman and chief executive officer.

The UNAIDS 90-90-90 target has a goal to ensure that by the year 2020 90% of individuals worldwide with HIV know their status, 90% of diagnosed individuals have initiated antiretroviral treatment, and 90% of those on treatment achieve viral suppression.1 Cepheid’s test is designed to detect HIV viral load levels—the standard method of monitoring the amount of HIV in the blood—and is anticipated to be accurate, precise, and conform to World Health Organization (WHO) guidelines, which define treatment failure at an HIV viral load of 1,000 copies/mL or more.

The assay is currently in Phase I development. Cepheid’s current Xpert test menu includes Xpert HIV-1 Qual, which has been awarded WHO prequalification, and Xpert HIV-1 viral load, both available outside the United States.

For more information, visit Cepheid.

REFERENCE 

1. 90-90-90: an ambitious treatment target to help end the AIDS epidemic. Geneva: Joint United Nations Program on HIV/AIDS, 2014. Available at: www.unaids.org/sites/default/files/media_asset/90-90-90_en_0.pdf. Accessed October 3, 2016.