(ATN) ddI: FDA Approves Additional Indication

(ATN) ddI: FDA Approves Additional Indication

AIDS Treatment News #160, October 2, 1992
John S. James

On September 28 the U. S. Food and Drug Administration officially approved an additional indication (use) for ddI -- for treatment of patients who had already received prolonged prior treatment with AZT. Previously, ddI had only been officially approved for persons who could not tolerate AZT or had significantly worsened while using it. While the new approval does not give physicians any power which they did not already have, it will in practice encourage wider use of ddI. [Physicians can prescribe an approved drug for other than its approved indications, but many are reluctant to do so. Also, some third-party payers refuse to reimburse for expensive drugs which are used "off label" (for conditions other than the FDA-approved indications) -- despite the fact that FDA indications were never intended to be used in this way, since the standard of care in medicine often includes unlabeled use of approved drugs, especially for serious diseases such as cancer and AIDS.]

The new ddI approval is based on results of a major study by the AIDS Clinical Trials Group of the U. S. National Institute of Allergy and Infectious Diseases (James O. Kahn, Stephen W. Lagakos, Douglas D. Richman and other, "A Controlled Trial Comparing Continued Zidovudine with Didanosine in Human Immunodeficiency Virus Infection," New England Journal of Medicine, August 27, 1992, pages 581-587.) This study enrolled 913 volunteers who had successfully tolerated AZT for at least 16 weeks; they were randomly assigned to either continue AZT, switch to low-dose ddI, or switch to high-dose ddI. The low-dose ddI group did best, with significantly fewer deaths and AIDS-defining events than the group assigned to AZT. The researchers were surprized that it did not matter how long the patients had been on AZT before switching.

Another major study (ACTG 116A) has compared first-line use of ddI vs AZT, but the results are not known yet. They are expected later this year.

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