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New AIDS Drug to Be Offered Via Lottery : Health: About 2,000 patients in advanced stages of illness will receive promising but still experimental Invirase.

June 22, 1995|From Associated Press

WASHINGTON — The first of a promising but still experimental new class of AIDS drugs will be made available free to about 2,000 patients through a government-sanctioned lottery.

Manufacturer Hoffman-La Roche will offer Invirase to patients in the advanced stages of AIDS who are not participating in clinical trials of the class of drugs known as protease inhibitors, which appear to be the most potent yet at reducing the amount of HIV virus in a patient's blood.

Twelve companies are racing to develop protease inhibitors, which are designed to keep the virus from reproducing by disabling a crucial enzyme, but none has yet filed an application with the Food and Drug Administration. Still, the FDA agreed that early data indicates the Roche drug appears worthy enough to give to certain patients before testing is complete. It is discussing a similar arrangement for Merck & Co.'s protease inhibitor.

"We obviously have in hand information at this stage that shows this to be a promising agent," FDA spokesman Arthur Whitmore said.

Early data indicates that protease inhibitors lower the HIV levels in the blood while raising a type of immune cell called CD4 that HIV kills, possibly with fewer side effects than AIDS drugs now on the market.

However, Roche and Merck, both based in New Jersey, report that, like existing AIDS drugs, the virus can form resistance to protease inhibitors. They're still investigating how quickly resistance forms and what that means for patients trying to decide among AIDS therapies.

The promising data prompted AIDS activists to demand that manufacturers make protease inhibitors available to desperate patients while the testing continues.

Only a limited number of patients who meet strict criteria are allowed into clinical trials of drugs. And while dying patients outside of trials have long been allowed special access to experimental drugs, it is so difficult to make protease inhibitors that companies feared they wouldn't have enough doses to go around if they allowed compassionate use, said Dr. Alberto Avendano of the National Assn. of People With AIDS.

Avendano proposed a lottery, and Roche and the FDA agreed.

It is the first time AIDS drugs have had to be rationed through a lottery, Avendano said. Doctors and patients can request information and lottery registration forms by calling (800) 332-2144. Registration forms must be received by July 21, and the drug will be shipped to selected patients' doctors in August.

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