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Experimental AIDS Drug Conditionally Approved For Another Illness

December 17, 1985

NEW YORK (AP) _ A drug being tested against AIDS has won conditional government approval for use against an infection in children, which could make it more widely available to AIDS patients, officials said Tuesday.

The drug, called ribavirin, is the first of a growing number of experimental AIDS drugs to receive any kind of government approval, although the U.S. Food and Drug Administration has not approved the drug for use with AIDS patients, and its effectiveness against AIDS has not been demonstrated.

Final approval of ribavirin could come in a matter of weeks, said Brad Stone, a spokesman for the FDA.

The drug is being approved for treatment of infants with respiratory syncytial virus, or RS virus, a common infection that can be fatal in premature infants and in those with heart or lung disease, said Dr. Caroline Breese Hall of the University of Rochester Medical Center in New York.

FDA regulations allow doctors leeway in the use of approved drugs, meaning that doctors will be able to prescribe ribavirin for their AIDS patients. But the drug is being approved in an aerosol form meant to be inhaled by infants, which might make it impractical for use with AIDS patients, Stone said.

There is at present no treatment for AIDS. Doctors can treat the infections and cancers that result from AIDS, but cannot attack the disease directly. Some of them may, therefore, be eager to prescribe ribavirin to their AIDS patients, doctors say.

The FDA told the drug’s maker, Viratek, of Costa Mesa, Calif., that approval will be granted if certain changes are made in the proposed labelling of the drug, Stone said. ICN Pharmaceuticals, Viratek’s parent firm, had no comment.

In a separate development, the FDA said that Dr. Michael Scolaro and colleagues at St. Vincent Medical Center in Los Angeles had applied for permission to give AIDS patients combination therapy of ribavirin and Isoprinosine.

Isoprinosine is a stimulator of the immune system, and ribavirin is an anti-viral agent. Some researchers believe that such drugs must be used in combination to kill the AIDS virus and to restore the immune cells the virus has destroyed.

AIDS, or acquired immune deficiency syndrome, is caused by a virus that attacks certain white blood cells called T-4 lymphocytes, which are a central component of the body’s immune system.

Both ribavirin and Isoprinosine have been under study separately for treatment of AIDS, but the studies have not yet been completed.

Combination studies with other drugs for AIDS patients are under way at the National Institutes of Health, Stone said.

Isoprinosine has been available in limited quantities since mid-May to doctors who requested it from its manufacturer, Newport Pharmaceuticals of Newport Beach, Calif.

Under a compassionate use provision of the FDA’s regulations, doctors could obtain the drug for their patients even though its effectiveness has not yet been shown, said Luana Kruse, a spokeswoman for Newport Pharmaceuticals.

Some 70 patients are now being treated, she said. She had no comment on the St. Vincent proposal to combine Isoprinosine with ribavirin.

Hall at the University of Rochester said that ribavirin’s approval might be just in time to help control an especially bad seasonal outbreak of respiratory syncytial virus.

The virus generally appears sometime between Thanksgiving and Christmas and disappears in the spring. This year’s outbreak began early, however, in mid- November.

″It’s the earliest RS season we’ve had,″ said Hall. ″We’re just overwhelmed. Our whole intensive care unit is filled.″

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