Newsday - April 21, 1992
Laurie Garrett

A yet to be approved drug doubles the benefit of AZT in fighting off AIDS, an advisory panel of the Food and Drug Administration was told last night.

The panel heard that ddC (dideoxycytidine) when taken with AZT (azidothymidine) boosted crucial elements of patients' immune systems twice as much as AZT alone. Patients who stayed on the combined therapy for a year still had a higher immune response than those on AZT alone, according to the data presented by ddC manufacturer Hoffmann-La Roche Inc. in support of its application for federal approval.

"Here today we are presenting all of the information we have. Not ideal, okay. But it's what we have," Hoffmann-La Roche's Dr. Whaijen Soo told the FDA's AIDS advisory panel, adding, "And we heartily believe it supports our application for approval of ddC," both as a therapy by itself and in combination with AZT.

Soo repeatedly conceded that the numbers of participants in the company's ddC clinical trials were very low, and the drop-out rates very high. One study, for example, compared 320 ddC users to 315 AZT patients. Long before the study-year ended, a third of the participants in both groups had dropped out for a variety of reasons, including the high incidence of neurological toxicity with ddC.

Overall, 16 percent of the patients in five different studies of ddC suffered severe peripheral neuropathy, Hoffmann-La Roche's Dr. Miklos Salgo said. For between 6 to 12 percent of the patients in all five studies the neuropathy, which included nerve tingling, paralysis, loss of motor coordination and other neurological symptoms, was severe enough to force discontinuation of drug use.

On the other hand, patients able to tolerate ddC without such neurological problems showed clear and sustained elevation of crucial disease-fighting immune system cells, called CD4 cells. Hoffmann-La Roche did not show that the CD4 elevation clearly correlated with clinical benefits, such as longer life or fewer secondary infections. But the FDA previously approved another drug, ddI, on the basis of similar data.

Only one patient in the five studies was believed to have died a ddC-induced toxicity death. Overall, however, studies conflicted as to survival: In one study, nearly twice as many ddC users died as AZT. In another, nearly the reverse was true.

Today the panel will hear more ddC evidence and vote whether or not to approve licensing of the drug.

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