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JAMA 296(12):1498-506, 2006

The Failure of Viral Load Tests

JAMA Study Shakes AIDS Science, Angers HIV Advocates

A nationwide team of orthodox AIDS researchers led by doctors Benigno Rodriguez and Michael Lederman of Case Western Reserve University in Cleveland are disputing the value of viral load tests, a standard used since 1996 to assess health, predict progression to disease, and grant approval to new AIDS drugs after their study of 2,800 HIV positives concluded viral load measures failed in more than 90% of cases to predict or explain immune status.

Published in the September 27, 2006 issue of the Journal of the American Medical Association (JAMA), the findings by Rodriguez et al shake the foundation of the past decade of AIDS science to its core, inciting skepticism and anger among many HIV adherents.

Belief in viral load spread quickly following the 1996 publication of a paper in the journal Science authored by Dr John Mellors and colleagues at the University of Pittsburgh. Mellor et al claimed that numbers produced by the viral load test could accurately predict progression to disease in HIV positives. Soon, use of this new technology extended far beyond conclusions drawn by the study and its approval by the FDA as a prognostic tool.

Claiming viral load numbers corresponded to actual amounts of infectious virus, scientists used the test as a glib response to unanswered questions about how HIV could cause AIDS. Pharmaceutical companies jumped on the bandwagon, using changes in viral load numbers in place of actual health or survival benefits to gain FDA approval of highly toxic protease inhibitors, a primary ingredient of today's HAART. Treatment advocates began using viral load to encourage healthy HIV positives with unhealthy numbers to hit early and hard with the newly approved drugs, while AIDS doctors throughout the world started using viral load for everything from diagnosing illness to confirming HIV infection.

The new uses for viral load emerged and gained popular acceptance despite the fact that, according to manufacturers literature, the viral load test is not intended to be used as a screening test for HIV or as a diagnostic to confirm the presence of HIV infection.

In a September 29th news article regarding the Rodriguez study, Mellors announced he doesn't agree with the paper at all, insisting that viral load is the most powerful predictor of time to AIDS and death." Some AIDS rethinkers note that in defending his opinion, Mellors describes viral load as powerful, an adjective frequently found in the headlines of AIDS drug ads--drugs approved for use based on their ability to affect viral load numbers rather than to produce clinical health benefits or increase survival.

While Mellors and others protest or down play the significance of the JAMA article, Rodriguez's group stands by its conclusion that viral load is only able to predict progression to disease in 4% to 6% of HIV-positives studied, challenging much of the basis for current AIDS science and treatment policy.

For further information see: Cohen J. Study says HIV blood levels don't predict immune decline. Science 313(5795):1868, 2006; Rodriquez B, Sethi AK, Cheruvu VK, et al. Predictive value of plasma HIV RNA level on rate of CD4 T-cell decline in untreated HIV infection. JAMA 296(12):1498-506, 2006