The Body Covers: The 5th Conference on Retroviruses and Opportunistic Infections
Session 84, Abstract 661: A Randomized Double-Blind Study of d4T + ddI versus ZDV + ddI as Initial Treatment in Subjects with CD4 Count <= 500 cells/mm3
February 4, 1998
In this study by Fisher, et al., 137 treatment-naïve patients with fewer than 500 T-cells were randomized to receive either d4T+ddI or AZT+ddI to determine tolerability and antiretroviral effect. The poster presented in Chicago showed data on 112 patients after 24 weeks of therapy, 65 patients at 36 weeks, and 12 patients at 48 weeks, in an ongoing study. The median viral load was 4.56 log, and the median CD4 cell count was 303.
After 24 weeks of treatment, the median viral load decrease between the two arms was virtually identical (a decrease of 1.5 log for d4T+ddI, and 1.6 log for AZT+ddI). However, at week 36, a trend began to emerge favoring the d4T+ddI arm, with patients on that regimen experiencing a 1.8 log drop in viral RNA, as compared to a 1.5 log drop for those on AZT+ddI. This trend was not statistically significant, but it did indicate a trend towards the d4T arm.
A similar trend ? again, worthy of note but not statistically significant ? was seen in analysis of changes in CD4 cell count. At week 24, there was no difference between arms, with a median increase of 115 cells for the d4T arm and 116 for the AZT arm, but after 36 weeks, patients on d4T+ddI had a median CD4 cell rise of 154 cells, while AZT+ddI patients median increase actually fell from the 24 week point, to 99 cells.
Adverse events of differing types occurred, but in equal proportion in each group. As would be expected with this combination, the d4T+ddI arm experienced mild to moderate peripheral neuropathy, while the AZT+ddI patients experienced more severe laboratory toxicities. None of these events were different from what one would expect in a clinical setting.
These data again confirm the safety and efficacy of d4T+ddI as an option when selecting a nucleoside combination as part of aggressive initial treatment regimens. Most significantly, Fisher et al., point out that the minimal evidence of development of viral resistance to d4T, when compared to the well-documented emergence of AZT resistance, makes d4T even more attractive. The researchers stress, however, that any two nukes alone, without a protease inhibitor, would not be adequate, appropriate treatment for any patient with HIV.
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