FDA approves d4T as alternative to AZT, ddI, or ddC. Food and Drug Administration. Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5023.

Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.

FDA approves d4T as alternative to AZT, ddI, or ddC. Food and Drug Administration. Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5023.

AIDS Clin Care. 1995 Jan;7(1):4, 10. Unique Identifier : AIDSLINE AIDS/95700011
Friedland G

Abstract: Stavudine, 2',3'-didehydro-3'deoxy thymidine (d4T) has been approved by the Food and Drug Administration and is the fourth commercially available drug in the nucleoside analog reverse transcriptase class. d4T is used in the treatment of advanced HIV-1 infection in patients: 1) who are AZT, ddI or ddC intolerant; 2) who have experienced significant clinical or immunologic deterioration or 3) for whom other therapies are contraindicated. It is thought to work like other dideoxynucleoside compounds by inhibiting HIV-1 replication. There is little or no evidence of resistance and it has been demonstrated to work synergistically with ddI and ddC against HIV-1 in vitro. Clinical trials in a total of 272 patients show that doses of 0.5 to 1.0 mg/kg/day provide the best therapeutic/toxicity ratio. Sustained changes in surrogate markers have included increases in CD4 counts, decreases in serum p24 antigen and decrease in virus load measures. Other data show significant weight gain in patients receiving d4T and more favorable quality of life, compared to AZT treatment. The major toxicity is peripheral neuropathy. The recommended dose of d4T for clinical practice is 40 mg orally twice daily and the cost is slightly less than AZT.

Keywords: CD4 Lymphocyte Count Drug Approval Human HIV Infections/*DRUG THERAPY HIV-1/IMMUNOLOGY Stavudine/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE NEWSLETTER ARTICLE
950530
M9551037

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