Federal Panel Pushes New AIDS Drug Strategy

Physicians who treat AIDS patients should no longer automatically prescribe the drug AZT to infected individuals whose immune systems have begun to deteriorate but who have not yet developed symptoms of the disease, a federal advisory panel has concluded.

The recommendation represents a major departure from current medical practice, which has been to give AZT routinely to patients not yet showing symptoms but whose immune-system cell count has fallen below a certain level.

Instead, the panel said, doctors should discuss with their patients the best time to begin administering the antiviral drug--weighing its side effects and other factors along with recent findings that throw doubt on the long-term survival benefits of taking the drug at an earlier stage.

The panel’s recommendations, while not federal policy, are intended to give physicians guidance in treating adults who are infected with the human immunodeficiency virus, which causes AIDS.

The new guidelines are expected to be treated seriously by physicians and will likely alter the way AZT is prescribed.

Panel members “are saying: ‘Hey, wait a minute.’ It isn’t an automatic thing anymore--there are now pros and cons,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. Fauci’s agency convened the meeting, but he did not serve on the panel.

“With such advice and counsel, patients and their care-givers can make the most informed decisions about whether to begin, change or combine therapies,” he said.

Doctors now generally prescribe AZT to patients whose CD4 immune-system cells have fallen below 500 per cubic millimeter of blood; the normal level is 800 to 1,200.

At the 500 level, patients become vulnerable to the so-called opportunistic infections that eventually kill people with AIDS.

Studies have shown that taking AZT at this point can delay the onset of these symptoms. However, the results of a large study released earlier this month demonstrated that patients who took AZT at this stage ultimately lived no longer than those who started taking it after they became sick.

The new recommendation means that patients, working with their doctors, now must attempt to strike a critical balance.

They will have to weigh the potential benefits of taking the drug at an early stage against the possibilities of experiencing toxic side effects and drug resistance--along with the knowledge that they will likely live no longer than those who wait.

AZT, the most widely prescribed AIDS antiviral drug, has shown clear benefits for most patients regardless of when it is taken, but researchers had hoped that earlier intervention would result in an increased life span among those infected with the virus.

Studies have shown that in addition to delaying the onset of AIDS in people who are not showing symptoms of disease, AZT also has helped patients with fully developed AIDS who start taking the drug after developing symptoms.

In these patients, AZT has resulted in fewer episodes of infection and other improvements, such as increased weight gain.

However, AZT can cause serious side effects--among them anemia, headaches and gastrointestinal problems--and patients can develop resistance to the drug.

Some researchers say they believe that patients who take AZT earlier in the infection become sicker once they develop symptoms than those who start AZT after they become ill.

The study released earlier this month found no difference in long-term survival between both groups of patients.

The results of the study threw current guidelines into confusion and led to the three-day meeting last week of an independent scientific panel to reassess current policy. Panel members reached their conclusions late Friday.

“We . . . recognize that no ‘average patient’ exists,” said Dr. Merle A. Sande, head of the panel and chief of medical services at San Francisco General Hospital. “Some patients will do better, and others worse, than what clinical studies would predict. Doctors and patients should work as a team to design a treatment strategy that is both clinically sound and appropriate for each individual patient’s needs, priorities and circumstances of daily life.”

The committee said patients with CD4 cell counts greater than 500 should not start taking AZT or any other antiviral drug and should continue to be monitored--already the current accepted practice.

It also said AZT should be the first-line therapy in HIV patients who have not yet taken antiviral drugs, and that patients who begin experiencing symptoms of AIDS but who have not taken antiviral drugs should begin taking AZT.

However, patients who cannot medically tolerate AZT, or whose disease progresses despite AZT therapy, should switch to another antiviral drug, the panel said.

The two other antiviral drugs are DDI and DDC. Some researchers believe patients who are not helped by AZT can be helped by changing to another drug.