(ATDN) Treatment Briefs: Good Results for Stavudine (d4T)
Treatment Review; August 1995
In June, 1994 the FDA approved the drug d4T, a nucleoside analogue similar to 3TC, AZT, ddI, and ddC. A randomized trial comparing AZT and d4T, the preliminary results of which were originally presented to the FDA for approval, was recently concluded and presented along with data from the d4T parallel track program. In the first study, participants who took d4T developed fewer opportunistic infections and sustained T-cell counts over those who continued on AZT. This benefit has not been seen in clinical trials involving a switch from AZT to ddI or ddC. Quality of life was also improved in participants who switched to d4T. In terms of side effects, the rate of peripheral neuropathy was higher in participants who switched to d4T, whereas the rate of anemia and neutropenia was higher in participants who remained on AZT.
The open label parallel track trial in 12,551 participants compared a dose of 40 mg. twice daily of d4T to a lower dose of 20 mg. twice daily. The trial concluded that both doses are safe and that the higher dose is slightly superior to the lower dose in prolonging survival. Increased weight and fewer hospitalizations were also seen in the higher dose. More data will be required to learn more about the effectiveness in HIV+ people who have no previous AZT therapy. Furthermore, the impact of d4T on viral load and the possibilities of combination therapy will also need to be studied further.
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ATR1910
Always watch for outdated information. This article first appeard in 1995. This material is designed to support, not replace, the relationship that exists between you and your doctor.
This information is designed to support, not replace, the relationship that exists between you and your doctor.