Severity of the toxicity associated with combinations that include didanosine plus stavudine in HIV-infected experienced patients.
BACKGROUND: The combination of didanosine (ddI) and stavudine (d4T) is no longer recommended as a first-line treatment because of toxicity, but it may be useful in experienced patients. METHODS: Retrospective chart review of experienced patients on ddI plus d4T was conducted at a single institution, recording the development of adverse events as well as their severity and action taken. The risk of developing severe toxicities was estimated by Kaplan-Meier analysis. RESULTS: A total of 616 patients were on ddI plus d4T for a median time of 12 months (interquartile range: 5.0-24.7 months). Among them, 213 (34.6%) had AIDS, 161 (27.4%) had CD4 counts <200 cells/mm, and 503 (81.2%) had >2 previous treatment failures. Adverse events related to ddI plus d4T were recorded in 136 patients (22.1%), which were mild to moderate in 118 (19.1%) patients and severe in 18 (2.9%) patients. The mean times to development of severe and nonsevere adverse events were 72 (95% confidence interval [CI]: 70 to 75) weeks and 52 (95% CI: 48 to 55) weeks, respectively. The probability of developing severe adverse events was related to the nadir CD4 count, with higher risk in patients with <200 cells/mm (log rank test, P = 0.045). CONCLUSIONS: Multiexperienced patients treated with combinations, including ddI plus d4T, frequently develop drug-related toxicity, but these events are rarely severe. Thus, these drugs can still be considered a valid option for salvage regimens.
Hernández, B; Moreno, S; Pérez-Elías, MJ; Casado, JL; Dronda, F; Moreno, A; Antela, A
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