Viral Load: Inconclusive FDA Hearing

On March 21, the FDA's Blood Products Advisory Committee (plus members of the Antiviral Drugs Advisory Committee, the group which usually reviews AIDS issues) met to discuss the first application for formal FDA approval of a viral load testing kit, for the Amplicor HIV Monitor(TM) assay of Hoffmann-La Roche. There was little community input at this hearing -- not because of lack of interest, but because it was widely believed that viral load is almost certain to be approved anyway, so community support would not be necessary. (Viral load has long been available without formal approval, but approval would be advantageous for a number of reasons.)

But now there is concern that while the FDA is indeed likely to approve viral load tests, it may approve them for prognosis only -- which managed care and insurance companies could use as an excuse to pay for no more than one or two tests in a patient's lifetime. That, of course, would not be the way practicing physicians want to employ these tests. Many physicians see them as essential for effective use of the protease inhibitors, and for making intelligent choices among the far greater number of combination regimens now becoming available. But this view was not well represented at the FDA's hearing. Some activists are now concerned that the FDA may be about to make a serious mistake, by discouraging the use of viral load testing to help in choosing the best antiviral regimen for each patient.

Sometimes scientific confusion is really the projection of a political landscape beneath. We are preparing a longer report on the current status of viral load.