San Francisco Chronicle - Tuesday, October 6, 1992

Developed originally as a potential cancer treatment, d4T is a chemical cousin of three other drugs -- AZT, ddI and ddC -- already approved as inhibitors of the human immunodeficiency virus, which causes AIDS.

As the newest in a string of drugs used to fight HIV, it has also become the latest hope for tens of thousands of people whose immune systems are being eroded by the slow-acting AIDS virus. Although it does not cure AIDS, the drug in early tests prompted a significant and sustained increase in infection-fighting white blood cells in some patients who took it. "It's not a revolutionary drug, but it's a step in the right direction," said John James, editor of AIDS Treatment News. "We haven't had a lot of progress. We don't have a lot of other options."

Early tests suggest that d4T has fewer side effects than other AIDS drugs, although patients taking high doses suffered painful nerve damage to the hands and feet.

The d4T distribution program is the first test of revamped FDA rules designed to speed access to potentially lifesaving drugs while they undergo the rigorous testing required for formal approval. Known as "parallel track," the new rules are modeled after a program New York-based Bristol-Myers created to make ddI available to AIDS patients before it was approved for marketing.

Bristol-Myers gave away ddI to more than 23,000 patients during a 16-month period until the drug won FDA clearance in December. A year's supply of ddI now costs approximately $2,000.

Dr. Marcus Conant, a San Francisco AIDS physician, said that, because of the ground broken in the ddI approval process, he expects d4T to win approval more quickly if the results of clinical trials are positive. "One of the hardest things in dealing with a bureaucracy is to get them to change. From then on, the process of making it faster and smoother goes better," he said.

Under conditions approved by the FDA, Bristol-Myers will make d4T available to qualifying patients through their doctors. To qualify, a patient must show that he or she is unable to take both ddI and AZT or is failing to respond to treatment with those drugs.

Although advocates for AIDS patients were pleased that d4T would be made more readily available, they criticized the eligibility rules as too restrictive.

"The criteria are so tight, it will once again force many people to turn to the underground for the drug," said James Driscoll, vice president of Direct Action for Treatment Access.

Bristol-Myers spokeswoman Elizabeth Sigler said the company has no idea how many patients will be enrolled in the program. Those interested in participating may call 1 (800) 842-8036.

Researchers will be monitoring the safety and effectiveness of d4T among those enrolled in the program. Participating patients will be assigned randomly to either a high dose or a low dose of the drug. Results from earlier studies of the drug, expected in about 14 months, will be used as a basis for seeking formal marketing approval of d4T.

Always watch for outdated information. This article first appeared in 1992. This material is designed to support, not replace, the relationship that exists between you and your doctor.

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