Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.
The Associated Press - 14 Sep 95
The National Institute of Allergy and Infectious Diseases announced Thursday that a drug called ddI reduced the rate of death by 50 percent among HIV patients when compared with the use of AZT alone over 147 weeks.
The conclusion came from a study of 2,500 HIV patients who were without symptoms of AIDS and were at an intermediate stage of the disease. The patients were divided into groups and given different combinations of the drugs. Researchers then compared the effects.
Dr. Scott Hammer of Harvard Medical School and New England Deaconess Hospital said that ddI alone, or combinations of ddI and AZT, or of a combination of AZT and another drug, ddC, were superior in all measures to AZT alone.
By using drugs other than AZT alone, he said, "we have shown that we can prolong survival."
AZT, manufacturer by Glaxo-Wellcome Co., was the first anti-viral approved for treatment of HIV and continues to the be the recommended first treatment for the killer virus.
The other two drugs, ddI and ddC, were developed after AZT and are now in wide use, but they have generally been considered a second line of defense, used after the failure of AZT.
Hammer said that may change.
"Based on this single study, it is likely that AZT will be reconsidered" as the first-line therapy, said Hammer. Bristol-Myers Squibb Inc. makes ddI and Hoffmann-La Roche Inc. makes ddC. These companies and Glaxo-Wellcome donated the drugs used in the study.
A survival advantage over AZT for ddI or a combinations of drugs was shown in an arm of the study that involved 1,400 patients who had HIV, but were without symptoms, and who had previously taken AZT. These patients, called the experienced group because of their AZT history, had CD4 T cell counts of 200 to 500 per cubic millimeter. CD4 cells are the primary target of HIV.
Hammer said patients in this group taking ddI alone experienced a death rate of 5 percent over 147 weeks. Patients taking AZT alone had a death rate of 10 percent. Those taking ddC and AZT had a death rate of 9 percent, while the rate was 6 percent for those taking a combination of ddI and AZT.
For patients who have never taken AZT, Hammer said, there was a trend both in survival and in slowing disease progression that favored ddI, a combination of ddI and AZT, or a combination of ddC and AZT when compared to the use of AZT alone.
Conclusions about relative effects of the drugs were based on clinical findings such as the drop in CD4 cell counts or the development of AIDS-related diseases. In those cases, also, said Hammer, a combination of drugs or ddI alone showed a statistical advantage over AZT alone.
Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said the study shows for the first time that antiviral treatment "can reduce the risk of death in asymptomatic people with intermediate-stage HIV disease."
The study was supported by the NIAID. The complete findings are to be reported at the Interscience Conference on Antimicrobial Agents and Chemotherapy meeting in San Francisco next week. Patients in the study were enrolled at 52 locations.
Copyright 1995/The Associated Press. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, The Associated Press, 50 Rockefeller Plaza, New York, NY 10020.
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