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
Beatriz
B
Department of Infectious Diseases, Hospital Ramón y Cajal, Ctra. Colmenar, Km. 9.100, 20834 Madrid, Spain. bhernandez@salud.madrid.es
Moreno
Santiago
S
Pérez-Elías
María J
MJ
Casado
José L
JL
Dronda
Fernando
F
Moreno
Ana
A
Antela
Antonio
A
D000328:Adult; D015331:Cohort Studies; D016049:Didanosine / Q000008:administration & dosage* / Q000009:adverse effects* / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D012189:Retrospective Studies; D018119:Stavudine / Q000008:administration & dosage* / Q000009:adverse effects* / Q000627:therapeutic use
D018119:Stavudine; D016049:Didanosine