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Background:
A combination of APV, LPV and RTV could prove effective
in
patients (pts) in whom multiple antiretrovirals have failed, provided that
pharmacokinetic (pk) interactions between LPV and
APV
has no negative effect on virological response.
Methods:
A randomized, open-label, multicentre trial in pts with
CD4+<500/mm3
and plasma HIV viral load (pVL)>10
000 copies/ml after at least 2 PIs and 1 NNRTI. All pts were treated with
LPV/r+APV and were randomized to receive or not an additional boost of 200
mg
RTV/day.
Results:
40 pts were randomized, 37 started treatment. At baseline, median CD4+ was
207/mm3, median pVL 4.7 log10
copies/ml, median number of baseline PI mutations: 7, median phenotypic
resistance index: 9.7 for LPV and 2.6 for APV. Average number of
antiretrovirals taken prior to randomization was 7.7.Median
pVL (log10 copies/ml) changes at wk52 were significantly larger in pts with
the additional boost of RTV (400 mg/d;
n=18):
- 2.0 than in those with 200 mg/d RTV (n=18):
–1.1 (p 0.05). 39%(7/18)
reached a pVL<50 copies/ml vs 11% (2/18), respectively
(P=0.12).
Mean increase in CD4 cell count/mm3 was 156 vs 100, respectively (P=0.5).
Discontinuation of at least one of the two PIs
(APV or
LPV) occurred in 6 and 8 pts respectively. Grade IV adverse
events occurred in 7 and 10 pts, respectively.
Conclusions:
In
pts in
whom multiple antiretroviral regimens
have failed, a combination of APV, LPV/r with an additional boost of RTV
shows a significant and sustained virological response at one year despite a
pk interaction |
