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Table 3 Virologic outcome at Week 24 and 48 according to the FDA Snapshot* analysis in the overall population

From: Cobicistat-boosted darunavir in HIV-1-infected adults: week 48 results of a Phase IIIb, open-label single-arm trial

  Week 24 Week 48
Outcomes, [n (%)]   VL ≤100 K HIV-1 VL >100 K HIV-1   VL ≤100 K HIV-1 VL >100 K HIV-1
Total RNA copies/ml RNA copies/ml Total RNA copies/ml RNA copies/ml
n = 313 n = 182 n = 131 n = 313 n = 182 n = 131
Virologic response 258 (82) 157 (86) 101 (77) 253 (81) 148 (81) 105 (80)
Virologic failure 36 (12) 10 (5) 26 (20) 33 (11) 14 (8) 19 (15)
 VL ≥50 HIV-1 RNA copies/ml 22 (7) 4 (2) 18 (14) 14 (4) 5 (3) 9 (7)
 Discontinued drug due to lack of efficacy 0 0 0 0 0 0
 Discontinued drug due to other reasons and last available VL ≥50 HIV-1 RNA copies/ml 14 (4) 6 (3) 8 (6) 19 (6) 9 (5) 10 (8)
No virologic data in the analysis window 19 (6) 15 (8) 4 (3) 27 (9) 20 (11) 7 (5)
 Discontinued drug to AE 14 (4) 12 (7) 2 (2) 15 (5) 13 (7) 2 (2)
 Discontinued drug for other reason and last VL <50 HIV-1 RNA copies/ml 3 (1) 2 (1) 1 (1) 10 (3) 5 (3) 5 (4)
 Missing data during window but on drug 2 (1) 1 (1) 1 (1) 2 (1) 2 (1) 0
  1. *Proportion of patients with VL <50 HIV-1 RNA copies/ml during Week 24 or Week 48 window; N number of patients; n number of patients with observations; AE adverse event, VL viral load.
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AIDS Research and Therapy

ISSN: 1742-6405

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