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Clinical
outcome among HIV-infected patients starting saquinavir hard gel
compared to ritonavir or indinavir [Kirk
O et al. AIDS 2001; 15: 999]:
This is a retrospective analysis of results in 2,708 patients who
started on HAART therapy with regimens that included indinavir,
ritonavir, or hard gel saquinavir as reported by EuroSIDA, an observational
cohort study involving 20 European countries. The results for indinavir
and ritonavir are shown in the table below:
| |
IDV
n = 1342 |
RTV
n = 556 |
| Baseline |
|
CD4 count (median) |
170
cells/mm3 |
136
cells/mm3 |
|
VL (log 10
c/ml) |
4.3 |
4.6 |
|
AIDS |
31% |
36% |
| Response
at 1 year |
|
VL decrease log 10 |
1.5 |
1.5 |
|
VL <500 c/ml |
54% |
47% |
|
CD4 increase (median) |
96
cells/mm3 |
90
cells/mm3 |
|
New AIDS-defining event |
15% |
19% |
| Rate
of regimen modification |
56% |
64% |
The authors concluded that these two PIs were comparable in immunologic
and virologic response.
Comment: This report included hard gel saquinavir (Invirase),
but the reviewer opted to delete these data since the inferior outcome
would be expected, and this drug has been almost totally supplanted
by Fortovase. About 90% of the patients had received NRTIs before
initiating PI-based HAART. Indinavir and ritonavir appeared to be
comparably effective as the first PI, although more than half of participants
in both groups required a regimen change. The authors point out that
randomized trials are obviously better science, but this type of analysis
has the advantage of avoiding the selection bias that limits conclusions
of clinical trials.
posted
6/7/2001
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