To improve adherence to the lengthy regimen of current tuberculosis medicines, the WHO recommends that healthcare workers directly observe patients taking their medications, a practice called "DOTS," for "Directly Observed Treatment, Short Course."
"This system is very effective but puts undue strain to the healthcare system. A shorter TB drug regimen will radically improve treatment and compliance, accelerate the reach of DOTS and allow more patients to be treated," Andries said.
"Compliance is an important problem in some areas," he added. "It can be rather difficult explaining to patients that they have to continue taking those nasty drugs even months after their symptoms have disappeared."
In their Science study, the researchers also report the results of the first phase of testing the drug in humans. Like all phase I trials, the study used healthy volunteers to test the drug's safety. The study involved 81 volunteers, a portion of whom received a placebo instead of the drug.
The symptoms that researchers developed were "mild" and what researchers would normally see when testing a drug that caused no serious effects, according to Andries.
"So far the safety of this compound is really fine. Of course we caution that we have only studied a limited number of people for limited amount of time, so further research is necessary," Andries said. Phase 2 clinical trials to measure the drug's efficacy are currently underway. Phase 3 trials would compare it with standard treatments.
During the study, the drug levels in the volunteers' plasma reached levels that were about seven times higher than they were in the mice that had been successfully treated.
"Barring any unsuspected si
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Contact: Jessica Lawrence-Hurt
jlawrenc@aaas.org
1-202-326-7088
American Association for the Advancement of Science
9-Dec-2004