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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.