|
|
Share this Abstract with a Colleague
Background: Expanded access programs are conducted to provide new drugs to HIV infected patients with no other treatment options prior to marketing approval. As of Sept 15, 2000, 4,317 patients (in 18 countries) have documented prestudy and baseline (with Kaletra) antiretroviral use in the Kaletra EAP. Efficacy data are limited, as the collection of CD4and HIV RNA results was optional.
Methods: For these 4,317 patients, the mean baseline CD4was 83 cells/mm3and HIV RNA 5.0 log10copies/ mL, 68% had CDC Class C events. The average numbers of NRTIs, PIs, and NNRTIs taken prior to entry were 5.0, 3.4, and 1.5, respectively. A total of 582 patients have HIV RNA results through 16 wks of treatment.
Results: Plasma viral load response through wk 16 stratified by number of prior PIs is presented below.
| All Pts | Number of Prior PIs | ||||
| <2 | 3 | 4 | 5 | ||
| N | 582 | 88 | 148 | 204 | 142 |
| Baseline (log10 copies/mL) | 5.08 | 4.80 | 5.09 | 5.13 | 5.18 |
| Change (log10 copies/mL) | -1.08 | -1.32 | -1.14 | 1.07* | -0.88* |
| <500 copies/mL | 30% | 50% | 30%* | 29%* | 0%* |
*significantly different from < prior PIs at the 0.05 level.
In addition, baseline viral load (<100,000 copies/mL), baseline CD4(>50 cells/mm3), number of prior NRTIs, and number of prior NNRTIs were found to be significant predictors of viral response.
Conclusion: Response to Kaletra was significantly greater in patients with low baseline viral load, high baseline CD4, and less prior use with NRTIs, PIs, and NNRTIs.
© 2001 Medical Advocates
for Social Justice
225 West Washington Street, Suite 2200, Chicago, IL 60606
Telephone (312) 419-7289 Facsimile: (312) 419-7151
Email: [email protected]
