AIDS-Related Complex Found Slowed by AZT

A new study shows that AZT “significantly” slows the progression of disease in persons with early AIDS-related complex, offering the first real evidence that the drug benefits those with the beginning symptoms of infection, federal health officials announced Thursday.

“We’re very excited about this,” Dr. Anthony Fauci, the federal AIDS chief, said in an interview. “This will have a significant impact on large numbers of people.”

The federal government has estimated that as many as 1.5 million Americans may be infected with the human immunodeficiency virus (HIV), which causes AIDS. Of these, Fauci said, between 95,000 and 200,000 individuals may already be experiencing the early stages of disease and could benefit from AZT.

Similar Study in Progress

Researchers are also awaiting the results of a similar study of AZT being conducted on infected individuals who do not yet have symptoms. Similar findings in that study could greatly expand the number of individuals who could benefit from the anti-viral drug.

AIDS-related complex, or ARC, can in its advanced stages be as debilitating and as fatal as AIDS, but it is usually described as the condition that occurs between infection without symptoms and the clear diagnosis of AIDS. Fully developed AIDS is defined by the onset of serious opportunistic infections and other rare disorders.

ARC frequently involves such symptoms as fever, swollen lymph nodes, weight loss, diarrhea and skin problems.

Fauci said that the study findings reinforced the argument that people at risk should undergo the AIDS antibody test to determine whether they are infected, in addition to tests that measure the level of the body’s T4 cells, the immune system cells that are the primary target of the AIDS virus.

Recently, the Public Health Service recommended greatly expanded voluntary AIDS antibody testing, with the aim of preventing the onset of pneumocystis carinii pneumonia, an AIDS-related respiratory infection that can now be staved off with a drug called aerosol pentamidine.

“This is another solid scientific reason why people who feel they are at risk should absolutely find out if they are infected . . . because there’s something that can be offered to them,” said Fauci, the director of AIDS activities for the National Institutes of Health and director of its National Institute of Allergy and Infectious Diseases.

The results of the clinical trial, which began in August, 1987, were so compelling that an independent board of scientists monitoring it decided in a meeting Wednesday to stop the trial and make AZT available to all its participants. Those who were not given AZT in the study had been taking a medically worthless placebo.

The study involved 713 HIV-infected persons with T4 levels between 200 and 800 per cubic millimeter of blood, compared to the normal level of 1,000 to 3,000. The test subjects also had one or two symptoms, including oral thrush--a fungal condition associated with immune dysfunction--chronic rash or intermittent diarrhea.

By July, 50 of the 713 participants had progressed to advanced ARC or AIDS. Of these, 36 had been taking the placebo and only 14 had been taking AZT.

Also important, Fauci said, was that less than 5% of the patients enrolled in the study experienced significant side effects from the drug, which has proved highly toxic in many AIDS patients. That finding indicated that AZT may be better tolerated early in the disease.

“We can say that AZT will delay progression to forms of the disease associated with mortality, and we can also say it is safe,” said Dr. Margaret Fischl of the University of Miami, the coordinator of the multicenter study.

Fischl said in an interview that some of the patients in the study had been under treatment for 20 months and were “not only stable, but improved.” She said, however, that researchers do not know at this point how long the improvements will last.

She added: “This study shows that early intervention may stabilize the immune system and prevent progression to more serious disease. Also--and this is very important--it may be that individuals early in the disease may have the best benefit from single-drug therapy. It may be that others, in progression, may need combination therapy.”

“This is an important study because it extends the spectrum of disease that’s treatable with AZT,” said Dr. Thomas C. Merigan, director of Stanford University’s AIDS research center and one of the study scientists. “We’ve found a new place to use it. And it’s one where it might have an even more important role because it isn’t as toxic as where we first discovered its usefulness.”

AZT, also known as zidovudine, is already on the market. Until now, however, it has only been proved effective in treating fully developed AIDS or advanced ARC and has only been recommended for use in those cases. The drug is manufactured by Burroughs Wellcome Co. of Research Triangle Park, N. C.

Dr. Frank E. Young, commissioner of the Food and Drug Administration, said Thursday that his agency intends to “translate these exciting results into wider availability of zidovudine to this category of symptomatic HIV-infected persons as quickly as possible.”

Rep. Henry A. Waxman (D-Los Angeles), chairman of the House Energy and Commerce subcommittee on health, hailed the study findings as “wonderful news.” But he urged policy-makers to ensure that AZT is available to those who cannot afford it. AZT, which costs the typical user about $8,000 to $12,000 a year, is not covered by all private insurance and is covered by Medicaid only under certain circumstances.

“It’s not enough to develop a drug, we must also get it to the people who need it,” Waxman said.