Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.

Reuters NewMedia, Inc. - Monday September 29 10:34 PM EDT
Andrea Orr

Researchers at the University of California said Monday they looked at 136 patients who had taken the drug outside of a clinical trial. In more than half those patients -- 53 percent -- the treatment failed to significantly reduce the presence of the HIV virus in their bodies.

"This was a 'real world' study," said Dr. Steven Deeks, assistant professor of medicine at the University of California at San Francisco, in a statement. "We were looking at patients who were not the idealized research patient typically found in a clinical trial, but the average patients seen by our physicians in a public health hospital."

Deeks' study looked at the impact of protease inhibitors retrospectively by reviewing the medical charts of patients treated at San Francisco General Hospital.

Their conclusions differed dramatically from other clinical trials to date, which have shown a much lower treatment failure rate of 10 to 20 percent. Deeks presented the results in Toronto at the 37th Interscience Conference on Antimicrobial Agents and Chemotherapy.

Deeks' researchers found that the patients who failed treatment were usually those who were in an advanced stage of the disease, had developed a resistance to some drugs, or had problems complying with the treatment regimen.

Protease inhibitors are most commonly prescribed as part of a three-drug "cocktail," used to attack the HIV virus. Many patients who have used the treatment have had their virus drop to nondetectable levels.

But the cocktail treatment often requires that the patient take several pills throughout the day in a complex dosing schedule. Failure to take the drugs at the right time can limit their effectiveness. Some patients have had to go off the treatment after finding the side effects intolerable.

"Clinical trials tend to enroll patients who are healthy, who haven't been on much therapy in the past and who are highly motivated; they aren't the typical patient," Deeks said.

He said his research focused on patients who were in relatively advanced stages of the disease.

"We don't know the long-term activity of protease inhibitors for healthy people who begin them in combination with other drugs, as is currently recommended," he said.

But Deeks added that since all patients did not have access to protease inbitors when they first contracted the HIV virus, better treatments for more seriously ill AIDS patients should be developed.

In other AIDS news Monday, a triple cocktail using the newest class of AIDS drug pushed the HIV virus down to undetectable levels in more than half of patients, researchers told a conference Monday.

The combination of nevirapine -- a non-nucleoside reverse transcriptase inhibitor (NNRTI) -- with the older AIDS drugs AZT and ddI (didanosine) also boosted immune system levels, the researchers said.

"These results are promising because a majority of study participants showed a sustained increase in CD4 cells, as well as potent viral load reductions from an average of 500,000 copies to below the limit of detection," Stefano Vella of the Instituto Superiore di Sanita in Rome said.

Vella's group presented their findings at the 37th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Toronto.

Earlier research has found similar effects for nevirapine, marketed under the name Viramune.

Viramune was the first NNRTI to get approval from the U.S. Food and Drug Administration. It is marketed by Columbus, Ohio-based Roxane Laboratories and was developed by Boehringer Ingelheim Pharmaceuticals Inc.

AZT is made by Glaxo-Wellcome and ddI by Bristol Myers Squibb.

Also, the Food and Drug Administration said Monday it had approved the first pill that combines AZT and another popular AIDS drug -- Glaxo Wellcome's Combivir.

Combivir consists of both AZT, as well as lamivudine, also known as 3TC.

People infected with HIV now have to take more than a dozen pills a day, at regimented times. Many complain that the schedule is hard to stick to.

"Combining these two drugs, which are commonly prescribed with one another, into one tablet could decrease the number of pills people with HIV have to take daily," the FDA said in a statement.

The Combivir tablet contains 300 milligrams of AZT, sold as Retrovir, and 150 milligrams of lamivudine, sold as Epivir.

The drugs all attack the HIV virus at different stages in its cycle of replication.

The drugs can make people sick and the FDA pointed out that Combivir had the same adverse side effects as the two drugs used alone -- nausea, diarrhea, anemia, low white blood cell count and effects on the pancreas and nerves in the hands and feet.

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