The San Francisco Examiner - Wednesday, Jan. 29, 1997
Lisa M. Krieger of the Examiner Staff

"After Vancouver, there was a quota of undue optimism," said Dr. Julio Montaner, who follows hundreds of patients through the Canadian HIV Trials Network.

"But very major progress has been made, beyond our original expectations. This is a reality, it's not a petri dish," he said.

Doctors are confident new therapies are helping patients but seem less hopeful about prospects for a cure. Although some spoke of possibly eradicating HIV in patients who are newly infected, many believe the virus may persist in most infected people, at least in the near future.

Similarly, a consensus is emerging that patients should be treated early, before the virus shatters the immune system.

Doctors treating AIDS patients need to take an aggressive approach early on so the disease won't become resistant to the drugs that are prescribed, according to conference organizer Dr. Douglas Richman of UC-San Diego.

Experts have known for years that HIV can mutate and become resistant to drugs. In the past, it was accepted as part of the difficulty in treating AIDS patients. Now, Richman said, with the emergence of powerful drugs and many more choices, doctors need to move from passive to aggressive strategies in making their treatment decisions.

"The strategy is shifting from contending with it to preventing it," Richman said.

No one has reliable estimates of how many patients respond to the new drugs, and reports from doctors vary widely.

And no one can be confident these drugs will work indefinitely, without engendering resistance that will let the virus evade the drugs.

But good news came out of the meeting, such as:

*It's becoming easier to treat babies and children who have HIV.

Researcher Katherine Luzuriaga of the University of Massachusetts at Worcester reported that one baby after 18 months of therapy has undetectable levels of virus and that her twin also was brought down to undetectable levels after one setback that required a change in medication. But the twins remain on virus-suppressing drugs and cannot be considered cured. Six other babies did not fare as well, she reported.

The drug AZT has brought down the rate at which HIV is transmitted from pregnant women to their babies, according to three independent groups of researchers in North Carolina, France and New York.

At least five major studies are getting under way to find easier and less expensive ways to prevent the spread of HIV from mother to infant, a tragedy that has killed more than 1 million children worldwide. One of the simplest regimens uses just two doses of a single drug, nevirapine. The idea is to give a pill to the mother when she comes to the hospital in labor, the other to the baby soon after birth. This treatment would cost only $2, according to researchers.

*Among patients with advanced AIDS taking a three-drug regimen that included a protease inhibitor, the AIDS virus in their blood dropped to undetectable levels.

In 65 percent of 320 patients whose CD4 counts were below 50 - which means their immune systems were severely damaged - HIV could not be detected with standard tests after 24 weeks of therapy, according to the study. The patients' CD4 counts jumped an average of 50 to 100 cells.

For the study, the patients took AZT, 3TC and indinavir, a protease inhibitor made by Merck Research Labs.

In closing comments at the conference, experts said that long, intricate and expensive clinical studies are needed to help doctors and patients cope with the increasing complexity of AIDS treatments. These trials, which form the basis of licensing drugs, must reflect the current scientific thinking in anti-viral research - or they will be obsolete before completion, they said.

Many AIDS experts are concerned that research is moving so fast that trials may still be testing some drugs that are not as effective as others or are not the best targets for research.

Dr. Joep M.A. Lange, a leading AIDS expert at the Academic Medical Centre in Amsterdam, urged his colleagues to improve the quality of the clinical trials, contending that many were testing "suboptimal therapies."

He also criticized some drug companies for insisting on testing "incestuous combinations" of drugs made by the same company, for not including drugs made by competitors in clinical trials, and for not releasing the complete findings of trials - good news and bad.

"There is lots of data coming out of clinical trials, but they are never published," Lange said. "If trials are successful, they will be published immediately, but industry has a tendency to hold up data if they don't look so good," Lange said. He said the industry should be required to publish promptly all relevant data about products.

The problem is further exacerbated by medical journals, which decline to publish reports of studies that reached negative conclusions, he said.

Experts plan to review the trials to determine if improvements could be made, countered Dr. Robert Schooley of the University of Colorado Health Sciences Center in Denver, who is involved in the U.S. clinical trial effort.

National Institute of Allergy and Infectious Diseases director Dr. Anthony Fauci said trials that had a problem would be revised or stopped. Fauci estimated that about a dozen such trials would be reviewed in the next several weeks.

The toll

Robert M. Sciarrilli, 39, an accounts manager at Blue Shield of California, remembered by friends for his warmth and dedication at work and home ... Kaci Kevin "Dog" Joy, 43, a transsexual activist and art student ... Mark Petkovic, 35, who loved art and architecture.

Date

reported / Cases / Deaths

S.F. 1/1 23,841 16,604

Calif. 1/1 97,690 63,063

U.S. 1/1 548,102 343,000

WHO(rprtd) 1/1 8,400,000 6,400,000

Figures are cumulative since June 1981.

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