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Indinavir/Ritonavir-based
Therapy in Treatment-naive Patients: Comparison of 800/100 mg and
400/100 mg Twice Daily
To
compare the efficacy and tolerability of indinavir
(IDV)[Crixivan] / ritonavir (RTV)[Norvir] at 800/100 and 400/100 mg
twice daily (bid) in antiretroviral therapy (ART)-naive patients.
An
open comparison of two groups of ART-naive patients treated with
IDV/RTV 800/100 or 400/100 mg bid plus two nucleoside analogues
was carried out. Viral
load, CD4
cell count and tolerability were
measured at baseline and at weeks 4, 12, 24 and 48. IDV plasma concentrations
were measured retrospectively.
A
total of 107 patients were included in the study. Of these, 57 were
treated with 800/100 and 50 with 400/100 mg IDV/RTV bid.
At
week 48, a viral load of <50 HIV-1 RNA copies/mL was achieved
by 77 and 64% of the patients, respectively, and the median CD4
cell count increases were +171 and +164 cells/microliter (intent-to-treat;
P not significant), respectively.
Side
effects leading to protease inhibitor
discontinuation occurred in 61% of subjects in the 800/100 mg
group vs. 20% in the 400/100 mg group (P<0.0001).
Switching
from 800/100 to 400/100 mg dosage improved adverse
events in 16 of 20 patients. IDV concentrations were
above 0.15 mg/L in 89% of the 28 patients tested in the 400/100 mg
group.
The
authors conclude, “Indinavir/ritonavir 400/100 mg bid provided
the same efficacy as 800/100 mg bid at 48 weeks in an ART-naive
population, but safety and tolerance were significantly better for
400/100 mg, while convenience was also improved and cost was
reduced.”
02/09/05
Reference
D
Konopnicki and others. Indinavir/ritonavir-based therapy
in HIV-1-infected antiretroviral therapy-naive patients: comparison
of 800/100 mg and 400/100 mg twice daily. HIV
Medicine 6(1): 1-6. January 2005.
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