
The Associated Press - Wednesday, 9 October 1996.
But a second study released at the same time suggests that treatment with a particular combination of drugs apparently offers no added benefit for patients whose immune systems have already been severely crippled with the AIDS virus, HIV.
In the first experiment, a group led by Dr. Scott Hammer of Harvard Medical School found that adding the drugs didanosine or zalcitabine to AZT therapy slowed the progression of the disease by more than 37 percent.
The second study, led by Dr. Louis Saravolatz of St. John Hospital in Detroit, involved sicker patients. The researchers found the drug combinations provided little added benefit.
The findings, published in Thursday's New England Journal of Medicine, suggest that everyone infected with HIV should be getting anti-AIDS medicine, especially once a test that counts white blood cells shows the number of CD4 cells has dropped below 500, according to an editorial by Drs. Lawrence Corey and King Holmes of the University of Washington in Seattle.
Corey and Holmes said doctors should put aside economic pressures and skepticism about the value of such treatments because "the rationale has never been stronger for the early detection of infection and initiation of therapy among those with HIV infection."
The studies show AZT alone is no longer the best initial treatment for HIV. Instead, they suggest the best way to assess the progress of infection and gauge the effectiveness of treatment is to measure the amount of HIV circulating in the blood, known as viral load, directly. The standard method is to count CD4 white, or T-, cells in a tiny volume of blood.
In the Hammer study, the researchers randomly assigned 2,467 people to receive AZT alone, AZT plus zalcitabine, AZT plus didanosine, or didanosine alone. All the volunteers had CD4 counts under 500, which is thought to indicate some compromise of the immune system.
The researchers then assessed how many volunteers progressed to one of three negative benchmarks: development of AIDS, a 50 percent drop in their CD4 count or death. Among AZT recipients 32 percent hit one of those benchmarks, compared to 22 percent who took didanosine alone, 18 percent who took AZT plus didanosine and 20 percent who got AZT plus zalcitabine.
Hammer's team also confirmed earlier research suggesting that assessing the amount of HIV genetic material in the blood is a better indicator of how the infection is progressing.
In the Saravolatz study, the 1,102 volunteers had CD4 counts below 200, which usually signifies that the HIV infection is more advanced. The researchers found it made little difference which drug combination the patients received. There was no statistically significant decline in the death rate or other pre-assigned benchmarks used to assess the disease's progression.
AZT, formally known as zidovudine, is sold under the brand name Retrovir by Glaxo Wellcome. Didanosine is sold by Bristol-Myers Squibb as Videx. Zalcitabine is made by Hoffmann-LaRoche, which sells it under the brand name Hivid.
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