(BETA) News Briefs: Renewed Interest in d4T


(BETA) News Briefs: Renewed Interest in d4T

Bulletin of Experimental Treatments for AIDS, No. 26 September 1995
Ronald Baker, PhD

Bristol-Myers Squibb has submitted a supplemental New Drug Application (sNDA) to FDA seeking an expansion of the indication for d4T to include adults with CD4 cell counts between 50 and 500 cells/mm3 who have used AZT for at least 24 weeks. The request for the new indication is based on the results of a multi-center, randomized, double-blind trial of d4T vs continued AZT in 822 HIV positive adults. Participants who switched to d4T (1) had a longer time to treatment failure than those continuing on AZT; (2) experienced slower disease progression (longer time to an AIDS-defining event); (3) had increased survival time. Extensive data from the trial (BMS 019) will be presented at a September 1995 scientific conference in San Francisco -- The Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).

The data from BMS 019 likely will encourage more widespread use of d4T in combination regimens such as d4T plus AZT, d4T plus ddI and d4T plus 3TC. A study of d4T plus Crixivan (the Merck protease inhibitor) is also underway. There are anecdotal reports of clinicians prescribing d4T as part of triple combination regimens. Fortunately, HIV appears to develop only very low-level resistance to d4T, even among people taking the drug as monotherapy for almost 2 years. For more information on d4T see pages 69-70 of the March 1995 issue of BETA.

d4T has been marketed since 1994 under FDA's accelerated approval program for the treatment of adults with advanced HIV disease who are intolerant to or who have failed approved therapies. If approved, the sNDA will significantly broaden patient access to d4T and result in more widespread third party reimbursement for the drug.


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Always watch for outdated information.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.

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This information is designed to support, not replace, the relationship that exists between you and your doctor.
©1995. AEGIS.