Study may predict AIDS development

Published: Thursday, March 14, 1996

By Andrew Scholer

Daily Bruin Contributor

Doctors may be able to predict patients' chances of progressing to AIDS by monitoring their HIV levels early on, researchers discovered.

The study, published in the New England Journal of Medicine, established blood levels of human HIV as an early indicator of drug effectiveness.

"It has long been thought that if a drug lowers the levels of the virus, then the drug was effective," said William O'Brien, an associate professor at the UCLA School of Medicine and lead author of the study.

It often takes years for individuals with HIV to develop AIDS, so it can take the better part of a decade to prove the effectiveness of a new drug.

In contrast, the new study reports that a drop in the amount of virus present can show a drug's effectiveness within six months.

"This is the first report to show that measures of virus in the blood can be used to show efficiency of a drug," O'Brien said. "Researchers used to have to wait for the progression to full-blown AIDS to evaluate a treatment's effectiveness."

The study used blood samples collected and frozen during an earlier trial of the drug AZT on patients in Veterans Affairs hospitals. Samples from the AZT trial were tested for the presence of the genetic material contained in HIV.

Because the study used samples taken during an already completed study, it was possible to compare the amount of the virus in an individual's blood during the first six months of treatment with whether or not they had later developed AIDS. Researchers found that a sustained decrease in the level of HIV indicated a patient was less likely to progress to AIDS.

With the merit of testing HIV levels established, new drug studies can use the measure to demonstrate their effectiveness in fighting AIDS.

Steven Miles, an assistant professor at UCLA associated with the Clinical AIDS Research and Education (CARE) Center, explained that the HIV measure has already been directly responsible for winning Food and Drug Administration approval for new drug therapies.

Although the ability to evaluate drug effectiveness within months instead of years has speeded up the drug approval process, long-term trials are still necessary.

"What this test does not replace is long term studies of toxicology. We can show a drug's effectiveness within four weeks, but that does not tell us how the body will react to taking the drug for years," Miles said.

In addition to speeding up drug trials, the rapid availability of treatment results holds mixed implications for the ease of conducting research.

One necessity of a drug trial is that only some of the patients actually receive the real drug. Researchers must be able to show that the two groups, similar except for the fact that one group receives the drug and one group does not, show different chances of progressing to AIDS. Participants know this, and that if a drug does not appear to be working they may be tempted to drop from the study.

"We have to have something like this, a rapid measure," O'Brien said. "In the very early years of anti-retroviral trials there were only one or two drugs. To get them you had to take part in a study."

Now that there are more treatments available, patients have more options.

"If they can see they are getting sick, they are going to drop the experiment and get on another drug," said O'Brien. Reducing the time participants need to stay in a trial may reduce their chances of abandoning it.

Indeed, the new measure may become very important for individuals racing to find an effective treatment.

"It is very important for a patient to know they have a response to a drug," said O'Brien. "You don't want to wait until (the deterioration of the immune system) to know a drug failed."

Many large AIDS practice groups already look at levels of the virus to asses a drug's affect on individuals. Unfortunately, teaching hospitals and similar institutions will not use the measure until insurance companies are willing to reimburse them for the test.

"The FDA needs to approve the test first, then chances are that insurance companies will reimburse hospitals for the test," said Ruben Gamundi, program manager for the Treatment Education Program at AIDS Projects Los Angeles. Unfortunately, FDA approval for such tests can take many years. Despite this hurdle in the path to everyday use, Gamundi said, "I am sure it is going to become a standard in monitoring HIV disease."

One necessity of a drug trial is that only some of the patients actually receive the real drug.

ANDREW SCHOLER/Daily Bruin

Dr. William O'Brien led the study that attempts to predict whether or not individuals with HIV will advance to full-blown AIDS.

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