United Press International - Wednesday, 12 July 2000

Apparently not, researchers said Wednesday at the 13th International AIDS Conference in Durban, South Africa.

"I think we need more potent regimens to deal with human immunodeficiency virus," said Dr. Joseph Eron, associate professor of medicine at the University of North Carolina-Chapel Hill, "but those regimens need to be more compact."

In reporting results from a 64-week study, Eron showed data revealing that when regimen dropouts were figured in the results, patients on the three-drug combination did better than those getting four drugs.

"We leaned a couple of things from this study," Eron said, "And one of them was that the tolerability of this regimen was much worse than we expected."

The researchers enrolled 152 HIV-infected patients, about 90 percent men with an average age of 35, into a treatment program that included the protease inhibitor nelfinavir and the nucleoside analogues AZT and 3TC. Another 150 subjects were recruited to receive four drugs -- a protease inhibitor amprenavir and three nucleosides AZT, 3TC and abacavir. Although both regimens were able to reduce circulating virus in the blood well, the patients in the four-drug group "could not tolerate the Herculean regimen" that included 20 pills a day.

In fact, more of the four-drug patients suppressed the virus better than those getting the three-drug regimen, but the toxicity of the four drugs forced 18 patients to drop out of the study, compared with two in the three-drug group. Another 26 dropped out of the four-drug regimen for other reasons, compared with 15 in the three-drug group, and that spelled the end of the study.

Eron said the safety and monitoring board that oversees clinical trials halted the trial early when it became obvious that patients were doing better overall with three drugs.

"We have to be careful in thinking that more means more," said Dr. Janet Darbyshire, director of the Clinical Trials Unit of the Medical Research Council, London. "The more tablets you take, the less the compliance will be."

Dr. Christine Katlama, an AIDS researcher at Groupe Hospitalier Pitie-Salpetriere, Paris, questioned why doctors would attempt to add additional drug on top of an already potent of therapy. "We are not using common sense ... if you keep adding more and more and more, you have to pay," she said.

All of the drugs in the quadruple arm are marketed by GlaxoWellcome. Eron publicly thanked the company for supporting the trial, and allowing the results to be reported even though the outcome was negative.
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