Being Alive Newsletter; December 1992
Mark Katz MD and reported by Jim Stoecker

This expansion of the guidelines for ddI use is based on the results of the ACTG 116B/117 study that were published last summer. In that study, researchers compared two doses of ddI to a standard dose of AZT. About a thousand people were involved in the study and all had been on AZT for at least 16 weeks prior to the start of the study.

What the researchers found was that those on low dose ddI had statistically significant lower incidence of AIDS defining diseases or death than those on either high dose ddI or AZT. Does this mean that ddI is superior in efficacy to AZT? That is a question that cannot be answered yet. In 116B, all participants had prior AZT therapy, so the complicating factor of viral resistance to AZT needs to be considered. ACTG 116A is a similar study of AZT and ddI, but all participants have no prior antiviral therapy. Results of this study, when available, may help to provide some answers.

In the meantime, we have the FDA saying that ddI can be used for those on "prolonged" AZT therapy, even if there is no evidence of failure or intolerance. The standard of care, however, is not necessarily changing. People doing well on AZT are generally staying with it. There may be, however, a move to an AZT/ddI combination, especially after a long period of AZT monotherapy.
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