San Francisco Chronicle - Friday, August 4, 1989
Randy Shilts, National Correspondent

The studies also found that people with early symptoms of AIDS-related complex (ARC) not only can benefit from AZT but suffer far fewer of the toxic side effects that mark the use of the drug among people with AIDS.

"I think this is extremely exciting and really of great importance," said Dr. Anthony Fauci, associate NIH director for AIDS research. "This has potential impact on a large number of people."

An estimated 1.5 million Americans who have not contracted AIDS are infected with the human immunodeficiency virus that causes the disease. Of those, 95,000 to 200,000 people are believed to have experienced early ARC symptoms.

Doctors in the gay community have already been prescribing AZT to ARC patients, but yesterday's announcement marks the first time the drug's benefits have been scientifically proved for such people.

Studies demonstrated nearly three years ago that AZT is effective at prolonging the lives of people with full-blown AIDS. Since then, the key scientific question has been whether the anti-viral treatment would prove effective for those people who are infected with HIV but who have not yet developed AIDS.

To answer part of this question, researchers at 29 research institutions affiliated with the National Institute of Allergy and Infectious Diseases (NIAID) have been studying the effects of AZT on 713 ARC sufferers since August 1987.

To qualify for the study, participants had to have a level of T-4 cells - the key immune system cells attacked by the AIDS virus - above 200 per cubic millimeter of blood but below 800. Subjects had to have experienced one or two symptoms of HIV infection, such as fatigue, rapid weight loss or various minor ailments associated with ARC.

Once the study began, half the subjects were given AZT and the other half given an inert placebo. Of those receiving the placebo, or no treatment, 36 went on to develop severe ARC symptoms or AIDS. Of those taking AZT, only 14 developed the more serious symptoms.

Along with this "highly significant" difference in disease progression, Fauci said that only 5 percent of the ARC patients suffered severe side effects from AZT, compared with 40 percent of AIDS patients who experience adverse reactions.

"For the first time, the benefits for early retroviral treatment for early symptomatic HIV infection has been clearly shown," said Fauci, who also serves as NIAID director. "It has further been shown that anti-HIV drugs are better tolerated in people with early ARC."

The research was terminated when researchers noted the drug's effectiveness in a routine monitoring of the study Wednesday night, Fauci said, because they no longer considered it ethical to conduct a study in which some participants were not being treated.

Researchers also are awaiting results of a study on the effect of AZT on HIV-infected people who have no symptoms of immunological problems. Fauci said that preliminary data from this study was analyzed this week but that the research was not yet conclusive on AZT's benefits for such patients.

Scientists and AIDS patient advocates enthusiastically hailed the advance announced yesterday.

"This is not . . . the cure of AIDS, but this is the announcement of real progress," said Dr. Samuel Broder, director of the National Cancer Institute. "We're now in an era where we can provide meaningful hope to people. Not hope that's grounded in wishful thinking, but hope that's grounded in science."

Broder, who conducted some of the earliest AZT research, said the study shows that science is slowly taking steps to change HIV infection from a fatal condition to being a manageable chronic disease.

Dr. Thomas Merrigan, chief of the NIAID study branch at Stanford University Medical Center, one of the centers participating in the study, said, "By catching patients at earlier stages, we'll be able to control the disease much better and give people a longer life."

Martin Delaney, co-director of Project Inform, a San Francisco-based AIDS information and lobbying group, said the results reaffirm the group's advocacy of early testing for people at risk for AIDS so that HIV-infected people can take advantage of AIDS treatments.

Proponents of more federal money for programs to encourage early intervention also said the research will bolster their efforts. On Tuesday, the Bush administration's top health official, assistant secretary for health Dr. James Mason, said such early intervention programs will have a low priority in the federal government.

The new findings "demand a response from the federal government to give resources necessary to save hundreds of thousands of lives," said Representative Nancy Pelosi of San Francisco. "Early intervention dollars now will save an astronomical sum of money down the road in terms of future costs for hospitalization" that occur when HIV-infected people fall ill because they are not treated, she said.

Burroughs Wellcome, the manufacturer of AZT, said a year's supply of AZT costs about $7,000. Other estimates are between $8,000 and $12,000.

Commissioner Frank Young of the Food and Drug Administration said yesterday that the FDA could move quickly to expand its recommendations on AZT prescriptions.

Although doctors can now prescribe AZT to any patient they see fit, the FDA labeling calls for its use only in patients whose T-cell counts fall below 200. Some doctors will not prescribe a medication outside FDA recommendations. Many insurers have refused to reimburse patients for AZT use outside these limits.

Fauci said new recommendations will advise the use of AZT for patients with T-cell counts below 500. Because relatively few of the study subjects had T-cell levels between 500 and 800, the drug's utility for such patients had yet to be established, he said.

"AZT is analogous to saying the Wright brothers can fly," Broder said. "The Wright brothers did not design the 747 that you can fly to Europe. AZT has made it possible to see that something can work against the retrovirus that causes AIDS."

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