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| |  New Two-Drug HIV Therapy Shown to Be Safe, Effective ATLANTA, April 8, 1997 – A new therapy combining two familiar AIDS medicines has been shown to be a safe, effective alternative to more complicated therapies. A new study that followed patients for one year suggests that the treatment -- a combination of stavudine, or d4T, and didanosine, or ddI -- may expand the options for physicians and patients who may consider other therapies too arduous or risky. The study's lead author believes that the six-pill-per-day combination should be as easy to manage as two-drug approaches requiring patients to take as many or more pills. Moreover, the drugs' effects should last longer because HIV develops resistance to d4T and ddI much more slowly than it does to other antiviral drugs, such as AZT and 3TC. The study is the first to show that d4T and ddI are safe in combination. "Until this study, doctors had been reluctant to use d4T and ddI together," says Dr. Richard Pollard, the study's principal investigator, who will present the findings today (April 8) at the 10th International Conference on Antiviral Research in Atlanta. Pollard is chief of the AIDS Care and Clinical Research program at the University of Texas Medical Branch at Galveston, which enrolled nearly half the study's patients. D4T and ddI dramatically improved two crucial indicators of HIV disease prognosis, viral levels and CD4 immune cell counts. The study followed patients for up to one year, and the presentation is the final report on all data. Improvements were equivalent to those achieved by existing two-drug therapies. The new combination is among the least expensive of existing two-drug therapies. The research was conducted jointly with the Houston Clinical Research Network, Northwestern University and Rush Medical College in Chicago, the University of Texas Southwestern Medical Center at Dallas, and the University of California at Los Angeles. It was funded by Bristol-Myers Squibb Co., which makes d4T (brand name Zerit) and ddI (sold as Videx). The U.S. Food and Drug Administration (FDA) approved the drugs in 1991 and 1994, respectively. D4T and ddI were given to 86 patients. The combination cut levels of virus in some patients by as much as 99 percent. Nearly two-thirds of the patients experienced a 90 percent drop in HIV levels, measured by copies of viral RNA, HIV's genetic material, in the blood. In those patients, viral load fell from an average of 10,000 copies of RNA per milliliter of blood to 1,000 copies. Another 20 percent to 30 percent of the patients experienced a 99 percent decrease in viral levels, to 100 RNAs per milliliter. Treatment also boosted by as much as 48 percent the patients' levels of virus-fighting CD4 cells. Only two of the 86 individuals suffered the most common adverse effect of the medicines, peripheral neuropathy. That condition, in these cases characterized by moderate leg pain and slight losses of sensation, also was observed in earlier clinical trials which tested d4T and ddI separately on patients with advanced AIDS. The recent, combination trial purposely used lower doses of both drugs and enrolled patients who were in the early stages of HIV disease who had never before received antiretroviral drugs, Long-term studies are needed to determine which drug combinations work best for which people, Pollard says, but he predicts the d4T/ddI approach may be useful to stave off HIV progression in early-stage patients with relatively little virus in their blood -- patients who are unlikely to develop clinical symptoms for a long time and who may not need more cumbersome three-drug therapies immediately. The d4T/ddI combination will enter a phase III trial in April to attempt to determine the best dosage for the drugs. The pair of drugs will be tested by itself and as part of a three-drug combination with indinavir, a protease inhibitor sold as Crixivan by Merck & Co. The University of Texas Medical Branch at Galveston will be one of the test sites.
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