AEGiS-GMHC: NUCLEOSIDE NOTES: New Findings AZT/ddI Combinations

Important note: Information in this article was accurate in 1992. The state of the art may have changed since the publication date.

NUCLEOSIDE NOTES: New Findings AZT/ddI Combinations

TREATMENT ISSUES, Volume 6, Number 5; The Gay Men's Health Crisis Newsletter of Experimental Therapies - May/June 1992
David Gold

A small study conducted by Dr. Robert Yarchoan at the National Cancer Institute (NCI) compared the combination of AZT (300 mg/ day) and ddI (250 mg/day) to a regimen in which the drugs were alternated (AZT 600 mg/day for 3 weeks and then ddI 500 mg/day for three weeks).[1] Forty participants with AIDS or with symptomatic HIV infection (under 350 T4 cells) were randomly assigned to either the combination or the alternating regimen. None of the patients had a prior history of AZT or ddI use. Results showed that after 49 weeks both regimens were well tolerated. (One participant taking combination drug had to stop AZT for four weeks due to anemia.) After 18 weeks, average T4 cell counts increased by 99 cells in participants taking the combination AZT and ddI, compared to only 33 cells in participants alternating the drugs every three weeks. After 27 weeks of the therapies, increases in T4 cells were 80 for combination and 29 for alternating regimen. All study participants reported increased energy and appetite and experienced weight gain. It is hoped that this ongoing study will yield further information concerning the relative merits of combination versus alternating ddI/AZT therapy.

ACTG Reports on ddI vs. AZT

Data from a large AIDS Clinical Trials Group (ACTG) study of ddI versus AZT was presented at the 14th ACTG Meeting in Washington, D.C.[2] In the study, 913 participants were assigned randomly to ddI (either 500 mg/day or 750 mg/day) or AZT (500mg/ day). These participants had been on AZT for at least four months. They had AIDS, ARC (defined as symptomatic HIV infection and fewer than 300 T4 cells) or asymptomatic infection and fewer than 200 T4 cells. Study results indicate that participants who were switched to 500 mg of ddI developed fewer AIDS-related infections and yielded fewer drop-outs from the study. Additionally, those with ARC or asymptomatic infection who were switched to either dose of ddI were less likely to develop AIDS-related infections and had modestly better T4 levels than those who remained on AZT. People with AIDS had no significant differences in the effectiveness of AZT as compared to ddI. For all patient groups no significant difference in survival rates was found.

The benefits of switching to ddI were not related to length of time on AZT. Two people died from pancreatitis (both on high doses of ddI) and anemia was reported by patients taking AZT.

This study provides some indication that ddI may yet prove to be equal or superior to AZT as a front-line therapy in individuals with ARC and asymptomatic HIV infection. Additionally, these data suggest that a lower dose of ddI (500 mg) is preferable to the standard dose (750 mg/day).

---------- References

1. Keystone Symposia on Molecular & Cellular Biology, Silverthorne, Co. Abstract # Q561, Washington D.C., March 1992.

2. 14th AIDS Clinical Trials Group. Oral Presentation, Washington, D.C., April, 1992.

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