Important note: Information in this article was accurate in 1989. The state of the art may have changed since the publication date.
Food and Drug Administration, U.S. Department of Health and Human Services - February 6, 1989
Brad Stone (FDA); (301) 443-3285; Elaine Baldwin (NIAID) (301) 496-5717
Under the conditions of the FDA-approved protocol, the drug will be recommended for use in AIDS virus-infected individuals who have had at least one episode of the pneumonia or who have T4 helper cell counts of 200 per cubic millimeter or less. T4 helper cells are white blood cells that are critical components of the body's immune system which are destroyed by the AIDS virus. Healthy individuals normally have T4 helper cell counts of 1,000 or more.
The drug should be administered to patients through the Respirgard II nebulizer and at a recommended effective dosage of 300 milligrams every four weeks, based on recently available clinical data from the comparative dose trial conducted by the San Francisco Community Consortium, a group of physicians with experience treating people with AIDS. In this study, headed by Bruce Montgomery, M.D., David W. Feigel, M.D., M.P.H., and Gifford Leoung, M.D., individuals infected with the AIDS virus who were at high risk of developing the pneumonia had a lower incidence of infection when treated with this dose than similar patients treated with lower doses. This regimen is different from that used by many physicians who have tried this therapy on individual patients. This is the first treatment IND emanating from a clinical trial sponsored jointly by a community research initiative and a pharmaceutical company.
In addition, an epidemiologic study supported by the National Institute of Allergy and Infectious Diseases helped to determine the patient population that might benefit the most from the use of aerosolized pentamidine.
Injectable pentamidine, as distinct from aerosolized pentamidine, was approved in 1984 for the treatment of those already suffering from Pneumocystis carinii pneumonia.
FDA's announcement will make the aerosolized product available under the agency's "treatment IND" regulations -- a plan for the use of an investigational new drug (IND) in selected patients facing serious or life-threatening conditions.
FDA Commissioner Frank E. Young, M.D., Ph.D., estimated that perhaps 50,000 AIDS patients would benefit from this treatment IND.
Dr Young added, "Thanks to the work of the San Francisco Community Consortium and the NIAID, we now have a much better understanding of how aerosolized pentamidine might be used. The work also showed that in many cases the cost of prophylaxis represents only a fraction of the cost of treating patients with Pneumocystis carinii pneumonia."
The consortium initiated the clinical study of AIDS-infected individuals at high risk for developing Pneumocystis carinii pneumonia in 1987.
The clinical study compared the safety and efficacy of aerosolized pentamidine at 30 mg every two weeks, 150 mg every two weeks, or 300 mg every four weeks, and showed effective results with the last regimen. This did not provide complete protection, but did demonstrate the ability to significantly reduce the incidence of this pneumonia.
A large, long-term epidemiologic study undertaken by NIAID showed that a significant percentage of persons who have been infected with the AIDS virus and who have T4 helper cell counts of 200 or less are at risk of developing Pneumocystis carinii pneumonia even if they have no symptoms of HIV infection.
Anthony S. Fauci, M.D., NIAID director, said, "NIAID is sharing these important study results before scientific publication to speed patients' access to this 'state of the art' therapy. We believe that aerosolized pentamidine will help to prevent recurrent episodes of Pneumocystis carinii pneumonia and also help prevent initial occurrences of the infection."
In addition to sponsoring this epidemiologic study, NIAID through its AIDS Program provided valuable technical assistance in formulating and developing of the treatment IND protocol.
Aerosolized pentamidine can provoke severe wheezing and coughing. The long term risks associated with aerosolized pentamidine are unknown.
LyphoMed Inc. of Rosemont, Ill., which markets pentamidine, partially underwrote the San Francisco Community Consortium study and will sponsor the treatment IND protocol. The company has also filed a new drug application with FDA seeking marketing approval for this version of the drug. Aerosolized pentamidine is the third AIDS-related therapy to have received "treatment IND" status under new FDA regulations.
Physicians interested in learning about the details of this protocol can contact a hotline set up by the company at 1-800-PCP-7003.
The Respirgard II nebulizer, a filtered system used in the studies, is manufactured by the Marquest Corp. of Engelwood, Colo.
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SOURCE: Food and Drug Administration (FDA).
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