Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.
The Associated Press - Saturday, May 21, 1994
Lauran Neergaard, Associated Press Staff Writer
An advisory committee to the Food and Drug Administration said Friday that Stavudine, or d4T, probably provides some benefit over the three existing AIDS drugs. But the panel couldn't say just who would benefit, just how safe it was or whether the manufacturer was on the right track to answer the many questions.
"I'm not sure how good our advice was today," said Dr. Deborah Cotton, a Harvard professor who chaired the panel.
The FDA is considering whether to permit the sale of d4T under a special procedure that allows promising drugs for life-threatening diseases on the market before their makers prove definitively that they work. Permission could be revoked if the drug maker failed to meet FDA's conditions.
The FDA has not said when it will decide on d4T. It is not bound by advisory board decisions, but generally follows them.
Bristol-Myers Squibb says d4T appears to help raise the immunity of people with HIV, the AIDS virus, while causing fewer side effects than other AIDS drugs.
Currently, there are three approved AIDS drugs: AZT, or Zidovudine, ddI, or Didanosine; and ddC, or Zalcitabine. Each works by blocking the action of an enzyme called reverse transcriptase that the virus uses to replicate. All cause fairly severe side effects and the virus can mutate to resist them. Some patients experience resistance to AZT, the most widely used drug, as soon as six months after starting treatment.
d4T works in a similar manner.
But there are major unsettled questions about the new drug: Who will it benefit? Are there short-term benefits? Does it increase AIDS patients' survival? Are there fewer side effects, as the manufacturer claims?
The company asked the FDA to approve d4T for AIDS patients who cannot take any of the other drugs because of serious side effects or drug resistance.
It has studied 10,000 such people, all serously ill, giving them two different doses of d4T. After a year and a half, 79 percent are still alive, but 21 percent have experienced some peripheral neuropathy, a painful nerve disorder, which some critics called an unacceptable risk.
But the study, still incomplete, could not prove whether the neuropathy was caused by d4T or by AIDS.
The advisory committee said the best test given so far was in 359 moderately ill patients who had taken AZT for six months. Half were given d4T and the rest continued taking AZT. Preliminary data show those on d4T had a very small increase. in CD4 cells, the body's master immune cell.
The increase - though only about 20 to 25 cells per milliliter of blood-was significant because the CD4 cells in AZT patients continuously dropped.
The d4T patients also experienced a small weight gain, and told the company through questionnaires that they felt some improvement in quality of life.
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