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Intriguing 'Drug Holidays' From HIV Treatment

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"But this is just five patients," Dybul said, "and you really can't say anything about five patients."

"If you say you can't say anything about five patients, why are you presenting this data?" asked Brian Gazzard, MD, chief of AIDS treatment at Chelsea and Westminster Hospitals in London. Gazzard said he was concerned that others would try to repeat the trials on their own.

Jules Levin, an AIDS activist and editor in New York, also criticized reporting the sketchy data, said, "By discussing these things in public, you may be encouraging people to try these things. People will hear about this and say, 'It must be okay to do these things.'"

"I share your concern," Dybul said. "We are emphasizing that this is just a research tool and that no one -- patients or doctors -- should try these treatments outside a clinical trial. We think these interesting data ought to be exchanged."

In another study, Eron said he found out that adding even more pills did not improve a patient's response to treatment. He reported on a trial in which patients were put on a four-drug combination of treatment and were compared to patients on a standard three-drug regimen.

The study was designed in 1997, Eron said, when doctors believed that if they hit the virus hard enough, early enough, they might be able to kill the virus completely. He said researchers considered that if one drug could reduce the drug to undetectable levels, then maybe four drugs could drive it out of the body.

"We learned 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."

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

Also at the meeting, new data was presented on the newest class of drugs that is moving to market, the so-called fusion inhibitors, which block HIV from target cells. "They hold significant promise for the treatment of HIV," Cal Cohen, MD, said.

The drug nearing the market is Trimeris Inc.'s experimental T-20. Cohen, of the Community Research Initiative of New England, presented data on about 70 patients who took T-20 after failing all the standard drugs. Fourteen did not get better, and 16 others dropped out of the study for a variety of personal reasons. But after one year, about 40 are still in the study and responding well to the treatment.

 

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