United Press International - Wednesday, September 29, 1999
Ed Susman

Disappointed researchers today admitted that trials designed to see if patients could keep HIV, the virus that causes AIDS, suppressed after they stopped taking anti-AIDS medication have failed.

In two trials, the virus rebounded -- and rebounded rapidly -- in 24 of 25 patients who discontinued all anti-HIV medications.

"These discouraging results show us that current drug regimens are not sufficient to eradicate the virus," said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

Fauci and colleagues at NAIAD enrolled 21 patients in the discontinuation study. To be eligible patients had to have been taking a highly active antiretroviral therapy (HAART) that had successfully reduced virus in the blood to undetectable levels -- and had to have sustained that level for more than a year.

Having achieved that, the patients were again tested in Fauci's laboratory to see if the virus remained undetectable in even more stringent examinations.

Then they were taken off all medications to see if the undetectable levels could be sustained or if the virus would rebound.

"The virus rebounded in 20 or 21 cases," said Fauci. "And it rebounded rapidly, in as little as three to five weeks for most of the patients."

Included among those patients were two subjects who were treated with standard HAART regimens and in addition received additional immunemodulators. Fauci said there was no detectable virus in their blood even after hundreds of million of cells were examined.

"Yet, the virus rebounded in these two patients as well," he told United Press International. "The viral cells are still there and they are quite capable of replicating without the antiretroviral medication."

Fauci said there was some good news: "In every single case we were able to reduce the virus to undetectable levels in the blood by restarting the same HAART regimens. There was concern that we would not be able to do this because of viral resistance to the regimen, but we did not find this to be a problem."

Data from Fauci's as yet unpublished data and another study from the Aaron Diamond AIDS Research Center in New York were presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy, an infectious diseases meeting of the American Society for Microbiology in San Francisco.

Dr. Martin Markowitz of the Rockefeller University-based Aaron Diamond institution reported that four patients being treated there had opted to go off medication following three years of therapy in which viral levels in the blood remained undetectable. These were four of 14 recently infected individuals who underwent treatment almost immediately after they became infected.

Researchers had postulated that the best chance of eradicating the virus was to drive levels of the organism to undetectable levels as soon as possible after initial infection.

Markowitz said the patients who decided to go off treatment were self-selected. Virus reappeared in the patients in 14 to 26 days after suspending treatment. One patient elected to return to HAART treatment; the other three remained off treatment with measurable but stable viral loads.

Dr. Mary Romeyn, an AIDS clinician and assistant clinical professor of medicine at the University of California, San Francisco, said, "It seems pretty universal that eradication is not going to work. I hope we have learned something here. I wonder if these studies are fulfilling the needs of the researchers rather than the needs of the patients. "We only have one or two chances to get our foot on this disease and keep it in check," she said. "I don't know where they get patients to do these studies."

However, Fauci said there are still patients who are anxious to be included in the eradication research even though it may fail. He said he still has patients who want to enroll in the study. Fauci who had predicted the virus would return when he announced the discontinuation studies last February said that because the subjects were able to regain control of the virus, he is devising another program that would allow patients a drug holiday regimen.

"We have written a protocol and have submitted it to our institutional review board," he said. The general study embraces an intermittent treatment schedule: one or two months on therapy followed by a month or two off treatment with the idea of restarting treatment before rebound occurs. Other groups are also experimenting with intermittent treatment.
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