The Associated Press - Friday, November 22, 1996.
Lauran Neergaard, Associated Press Writer

Pharmacia & Upjohn had argued that delavirdine would help kill the HIV virus in early-stage patients' blood and slightly boost their immune system when used in combination with older medicines.

But the improvement was so slight -- and the drug failed to do any good for late-stage patients -- that advisers to the Food and Drug Administration were left wondering how any doctor would know how to prescribe delavirdine.

"We're in a tough position," said Dr. Wayne Greaves of Howard University Hospital, before the panel voted 4-4 on whether the drug should be approved. "There are still patients who need additional drugs."

"A year ago, I would have viewed this very differently," said Dr. Christopher Mathews of the University of California, San Diego, who questioned approving a drug that showed such minimal effect when just this year three powerful new medicines began selling, promising patients significant improvement.

But the panel urged the FDA not to make a final decision until doctors finish analyzing an additional study to confirm the drug's impact, data due to be completed in mid-January.

The tie vote came after mothers tearfully protested that Pharmacia, like almost every AIDS drug manufacturer, had not even begun testing to determine whether delavirdine would help HIV-infected children.

Of the nine AIDS drugs sold Friday, only three are approved for children's use -- and they do not include the newest, most potent AIDS therapies. The mothers accused drug makers and the FDA of ignoring children's desperate need in the race to sell AIDS medicines to adults.

"Love will not stop the virus," said Deborah Scheer of Sonoma County, Calif., as her HIV-infected son, Dylan, gazed at the panelists. "I cannot protect him alone and I need your help."

The panel issued a stern warning to drug makers not to seek approval for any more AIDS therapies without at least preliminary testing in children.

But for delavirdine, the issue was whether the drug even works in adults.

One study of 720 patients showed it modestly helped adults who were not yet seriously ill, when used in combination with the oldest AIDS drug, AZT. Patients who took both drugs saw a slight rise in important immune cells called CD4s, gaining about 30 cells per milliliter of blood after a year of therapy while those who took AZT alone lost CD4 cells. The delavirdine patients also lost about twice as much of the virus floating in their blood as did those who took just AZT.

But a study of severely ill patients found delavirdine taken with another older medicine, ddI, found that small benefit lasted only 12 weeks. By year's end, not only were delavirdine patients doing no better but 66 of them had died, compared with 61 who took ddI alone.

Worse, the scientists said, delavirdine hasn't been tested in combination with the three newest AIDS drugs, a new class of drugs called protease inhibitors that has proved so potent that a three-drug combination including one of these medicines has become standard care for advanced patients.

Delavirdine doesn't attack the HIV virus in the same manner as protease inhibitors, working instead more similarly to AZT.

But Pharmacia argued delavirdine does have potential. Genetics testing of 34 patients suggested when the drug is combined with AZT, it can halt or even reverse the AIDS virus' dangerous ability to mutate until AZT is useless. That study showed delavirdine caused an 85-fold increase in patients' susceptibility to AZT treatment.

And the panelists agreed that delavirdine is "leaps and bounds safer" than most other AIDS drugs. Its chief side effect was a skin rash.

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