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Journal of the International AIDS Society

Open Access

Influence of demographic and disease parameters on virological response to once- vs twice-daily darunavir/ritonavir (DRV/r) at week 48 in ODIN

  • M Sension1,
  • C Arns Da Cunha2,
  • P Domingo3,
  • K Supparatpinyo4,
  • T Van De Casteele5,
  • P De Doncker5 and
  • F Tomaka6
Journal of the International AIDS Society201013(Suppl 4):P25

https://doi.org/10.1186/1758-2652-13-S4-P25

Published: 8 November 2010

Background

ODIN was a Phase IIIb, randomised, open-label trial showing non-inferiority of DRV/r 800/100mg qd vs 600/100mg bid (+ ≥2 NRTIs) in treatment-experienced HIV-1-infected adults with no DRV resistance-associated mutations at screening. We evaluated the effect of demographic and baseline (BL) disease parameters on virological response (VR) of qd vs bid DRV/r at Week 48.

Methods

Week 48 VR (HIV-1 RNA <50 copies/mL; ITT-TLOVR) was analysed by subgroups including gender, age, race, HIV clade, BL HIV-1 RNA and CD4 count.

Results

Week 48 VR was 72.1% for DRV/r qd vs 70.9% for bid (95% CI = -6.1 to 8.5%). Week 48 VR by gender, age, race, HIV clade, BL CD4 count and HIV-1 RNA is reported (Table 1).
Table 1

% patients with HIV-1 RNA <50 copies/mL at Week 48

 

DRV/r qd

 

DRV/r bid

  

Baseline factor

N

% response

N

% response

Difference in response (95% CI)

HIV-1 RNA (as stratified) (copies/mL)

     

≤50,000

222

78.4

224

76.8

1.6 (-6.2, 9.4)

>50,000

72

52.8

72

52.8

0.0 (-16.4, 16.4)

CD4 count (cells/mm 3 )

     

<50

13

53.8

3

100

-46.2 (-109.6, 17.3)

50-<100

36

58.3

35

57.1

1.2 (-22.2, 24.6)

100-<200

76

77.6

77

67.5

10.1 (-4.1, 24.3)

200-<350

108

72.2

107

74.8

-2.5 (-14.4, 9.3)

≥350

61

77.0

74

74.3

2.7 (-12.0, 17.4)

Gender

     

Female

115

69.6

98

69.4

0.2 (-12.3, 12.7)

Male

179

73.7

198

71.7

2.0 (-7.0, 11.1)

Age (years)

     

≤30

35

71.4

35

60.0

11.4 (-11.0, 33.9)

30-≤45

180

75.6

169

72.8

2.8 (-6.4, 12)

45-≤55

64

60.9

72

72.2

-11.3 (-27.2, 4.6)

55-≤65

14

78.6

18

66.7

11.9 (-20.6, 44.4)

>65

1

100

2

100

0 (0, 0)

Race

     

Black

83

62.7

72

65.3

-2.6 (-17.9, 12.7)

Caucasian

102

71.6

110

69.1

2.5 (-9.9, 14.9)

Hispanic

47

72.3

59

67.8

4.5 (-13.2, 22.3)

Asian

48

89.6

41

87.8

1.8 (-11.6, 15.1)

Other

14

71.4

14

78.6

-7.1 (-40.7, 26.4)

Clade

     

B

179

70.4

199

64.3

6.4 (-3.4, 15.6)

Non-B

115

74.8

97

84.5

-9.8 (-20.7,1.2)

Conclusions

VR was comparable with DRV/r qd and bid regardless of subgroup analysed. As the trial was not powered for treatment comparisons in subgroups, and as numbers were small for some subgroups, these exploratory findings should be interpreted with caution.

Authors’ Affiliations

(1)
Comprehensive Care Center
(2)
Centro Medico Sao Francisco
(3)
Autonomous University of Barcelona
(4)
Chiang Mai University
(5)
Tibotec BVBA
(6)
Tibotec Inc.

Copyright

© Sension et al; licensee BioMed Central Ltd. 2010

This article is published under license to BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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