Rates and risk factors for adverse events associated with didanosine in the expanded access program.
The didanosine Expanded Access Program was the largest AIDS treatment program to prospectively evaluate the safety of an antiretroviral agent among patients with advanced human immunodeficiency virus (HIV) disease in whom therapy with zidovudine was failing.
A total of 21,198 patients who had infections refractory to zidovudine or who were intolerant of the drug received didanosine as a buffered powder for oral solution (sachet), with total daily doses of 6.6-10 mg/kg ; the median CD4 lymphocyte count was 0.04x109/L for this population.
At the currently recommended dose (6.6-8.29 mg/[kg. d]), 6-month estimated rates of pancreatitis ranged from 1.2% for patients with AIDS-related complex (ARC) and CD4 lymphocyte counts of =0.1x109/L to 6.7% for patients with AIDS and CD4 lymphocyte counts of<0.05x109/L.
Mots-clés Pascal : Antiviral, Chimiothérapie, Traitement, SIDA, Virose, Infection, Homme, Programme thérapeutique, Taux risque, Facteur risque, Etats Unis, Amérique du Nord, Amérique, Toxicité, Didanosine, Surveillance, Purine nucléoside, Didésoxynucléoside, Immunopathologie, Immunodéficit
Mots-clés Pascal anglais : Antiviral, Chemotherapy, Treatment, AIDS, Viral disease, Infection, Human, Therapeutic schedule, Risk rate, Risk factor, United States, North America, America, Toxicity, Surveillance, Purine nucleoside, Dideoxynucleoside, Immunopathology, Immune deficiency
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 95-0130111
Code Inist : 002B02S05. Création : 09/06/1995.