Study may predict AIDS development

Study may predict AIDS development

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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