AIDS/HIV Research, Testing, Therapeutics, Policy at FDA

In the early years of the AIDS epidemic, when the pathological signs were understood and the sudden growth of cases were documented while the etiology remained unclear, the Office of Biologics Research and Review (as the principal functions of the FDA Bureau of Biologics were renamed when the drugs and biologics functions were combined under the Center for Drug and Biologics from 1982 to 1987) and other components of the Public Health Service were gathered to understand and combat this outbreak. The Office of Biologics Research and Review (OBRR) investigated the virology and immunology of the syndrome, how it affected various biological products, and staff screened new biologics that might be brought to bear against AIDS. For example, the observation that AIDS patients could not manufacture the necessary T-cell response to address one common opportunistic infection—from cytomegalovirus, suggested (based in part on in vitro tests) that interleukin-2 deficiency could be behind the syndrome.  FDA and NIH collaborated on a phase 1 study in this regard. 

As the clinical trials involving IL-2 progressed through 1983, OBRR continued its collaborations on other lymphokines in AIDS patients. For example, lymphoblastoid interferon yielded some benefit in Kaposi’s sarcoma, a systemic cancer primarily affecting those with AIDS, but has done little to alter the immunodeficiency or the course of the virus.  Gamma interferon fared likewise. Preliminary results with IL-2 revealed some effect on immunity.  

Assessing the impact of the epidemic on the blood supply and how to mitigate risk was the subject of many workshops and meetings that the Office participated in with the Departmental Task Force, industry, patient groups such as the National Hemophilia Foundation and the National Gay Task Force, blood collection organizations such as the American Association of Blood Banks and the American Red Cross, academe, the agency’s Blood Products Advisory Committee, and others.

On March 4, 1985, HHS Secretary Margaret Heckler announced that FDA had licensed the first test to detect exposure to the virus responsible for AIDS. The virus, known then in the U. S. as HTLV-III, had been identified and isolated in September 1984. The licensee, Abbott Laboratories, soon distributed the test to more than 2000 blood banks and plasma centers, as well as other laboratories serving clinics and physicians.

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OBRR licensed the Western Blot test to screen blood and validate previous tests for antibodies to the AIDS virus on 30 April 1987. This approval provides increased accuracy in testing blood.  A combination test the detected antibodies to both HIV-1 and the much less common AIDS virus, HIV-2, was licensed in 1991. CBER had licensed a test for the latter virus the prior year, but many blood banks did not test for that virus given its very low frequency.  FDA believed a combination test would be embraced more widely and lessen the risk of HIV transmission through the blood supply.

In 1988, CBER licensed a rapid screening test for AIDS that can be done without sophisticated equipment. Employing genetically engineered proteins and microscopic latex beads, the latex agglutination test could be performed in five minutes. However, this was not intended to replace tests used by blood banks and clinics, but it was expected to serve as a preliminary test where the results could be interpreted by a medical professional.

Also in 1988, CBER licensed alpha interferon for the treatment of Kaposi’s sarcoma. Multiple studies at NIAID and elsewhere indicated that up to about 50 percent of the patients in earlier stages of AIDS saw significant reduction of tumor sizes with high doses of interferon.

Though not suitable for application in blood collection and processing facilities, CBER licensed the first clinical diagnostic test for direct detection of the HIV virus in 1989. Previous tests operated on the basis of indirect detection, based on an antibody response. The new test, HIVAG-1, detected HIV antigens in the patient’s serum or plasma, and it was expected to help physicians track the progress of their AIDS patients.

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