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48-week resistance and efficacy
subgroup analysis of once- versus
twice-daily darunavir/ritonavir in ODIN
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Erkki Lathouwers,1 Guy De La Rosa,2
Tom Van de Casteele,1 Piet De Doncker,1
Sabrina Spinosa-Guzman,1 Sandra De Meyer,1
Gaston Picchio2
1Tibotec BVBA, Beerse, Belgium; 2Tibotec, Titusville, NJ, USA
1. PREZISTA US Prescribing Information
2. PREZISTA EMA Summary of Product Characteristics
1. Johnson VA, et al. Top HIV Med 2009;17:138-45
2. De Meyer S, et al. 6th EHDRW 2008. Abstract 54
RAMs = resistance-associated mutations;
OBR = optimized background regimen;
HAART = highly active ARV therapy
ITT = intent-to-treat; TLOVR = time-to-loss of virologic
response; VFs = virologic failures
*Phenotypes were determined by Antivirogram; an ARV was considered susceptible if the fold-change was ὄ the clinical or biologic cut-off; All eight currently available PIs, excluding ritonavir: (fos)amprenavir, atazanavir, indinavir, lopinavir, nelfinavir, saquinavir, tipranavir and DRV; §Data available for 290 patients in the DRV/r qd arm and 287 in the bid arm
M36I; L63P; L63P+V82I; A71T; V77I (n=2);
L10I+K20R+V32I+M36I+M46I+I54V+I62V+A71V+L76V+I84V#;
G16E; M36I; L63P; I64M#
V75I+M184V; M184V; T215F#; T215Y
M184I; M184V#; M41L+T215Y
#Same patient; bold text indicates primary PI mutations; green text indicates DRV RAMs
*One VF lost susceptibility to DRV, amprenavir, atazanavir, indinavir, lopinavir and nelfinavir (patient developed DRV RAMs);
one other VF lost susceptibility to atazanavir and indinavir (patient did not develop PI RAMs)
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