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Tipranavir/ritonavir
Demonstrates Superior Response to Lopinavir/ritonavir, Amprenavir/ritonavir
or Saquinavir/ritonavir in PI-experienced Patients
The RESIST
trials
are phase 3, prospective, multicenter, randomized, open-label studies
demonstrating the statistical superiority of tipranavir/ritonavir/
TPV/r (Aptivus)
over optimized standard of care ritonavir-boosted
PIs.
The objective of this planned analysis was
to compare the efficacy of TPV/r to that of lopinavir/ritonavir/LPV/r
(Kaletra),
amprenavir/ritonavir/APV/r and saquinavir/ritonavir
(SQV/r).
Patients with >3-class antiretroviral
experience including >2 PI-based regimens; >1
primary PI mutation and <2 mutations at amino acids 33,
82, 84, 90; and viral load (VL) >1000 copies/mL and any
CD4+ cell count were eligible.
Before randomization, an optimized CPI/r-based
regimen was selected; the selected PI could be new or continued
from the current regimen.
Results
·
1483 patients
with a median baseline VL of 4.8 log10 copies/mL, and
median CD4+ cell count of 162 cells/mm3 were treated.
·
Pre-selected
CPIs were LPV (50%), APV (26%), SQV (20%), or IDV (4%).
·
The median
VL response at 24 weeks with TPV/r and CPI/r respectively was -0.71
and -0.28 log10 in the LPV stratum, -1.01 and -0.20 log10
in the SQV stratum, and -1.01 and -0.16 log10 in the
APV stratum.
·
The VL
response with TPV/r in these strata was -1.79 to -2.20 log10
when enfuvirtide (Fuzeon) was included in the background regimen
compared to -0.56 to -0.63 log10 without enfuvirtide.
·
By contrast, the median VL response
in the CPI strata with enfuvirtide (Fuzeon) was -0.28 to -0.43 log10 and
without was -0.14 to -0.26 log10.
·
TPV/r was
consistently associated with a greater response than CPI/r when
combined with 0 (-0.02 to -0.72 log10), 1 (-0.27 to -0.63
log10), 2 (-0.77 to -1.13 log10), or >3
(-0.49 to -1.42 log10) active drugs.
The
authors conclude, “TPV/r provides a statistically superior VL response
compared with either LPV/r, APV/r or SQV/r in a cohort of 2 PI-regimen-experienced
HIV+ patients.
Fondazione Centro San Raffaele Del Monte
Tabor, Milan, Italy,2Boehringer Ingelheim Pharmaceuticals,
Inc, Ridgefield, United States of America, Hopital Universitaire
St. Pierre, Brussels, United States of America, AIDS Research Initiative,
Darlinghurst, Australia, Therapeutics Concepts, Houston, United
States of America, Clinique Medicale l'Actuel, Montreal, Canada.
08/08/05
Reference
A
Lazzarin and others. Tipranavir/ritonavir (TPV/r) demonstrates superior
treatment response to lopinavir/r (LPV/r), amprenavir/r (APV/r)
or saquinavir/r (SQV/r) in PI-experienced patients from the TPV
RESIST-1 and RESIST-2 trials. Abstract WePe6.3C07. Program and Abstracts of the 3rd IAS Conference
on HIV Pathogenesis and Treatment. July 24-27, 2005. Rio de Janeiro,
Brazil.
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