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Table 1 Characteristics of the included children (N = 225)

From: Off-label use of combined antiretroviral therapy, analysis of data collected by the Italian Register for HIV-1 infection in paediatrics in a large cohort of children

 

Children on label antiretroviral treatment (n)

Children off-label antiretroviral treatment (n)

Total (n)

Total (%)

p value

All children

175 (77.7%)

% on label

% (within category)

50 (22.2%)

% off label

% (within category)

225

100%

 

Sex

 Males

81

46.2%

77.88%

23

46.0%

22.12%

104

100%

 

 Females

94

53.8%

77.69%

27

54.0%

22.31%

121

100%

0.97

Age last controls

 < 1 year

0

0.0%

0.00%

2

4.0%

100.00%

2

100%

 

 1–2 years

7

4.0%

87.50%

1

2.0%

12.50%

8

100%

 

 3–5 years

16

9.1%

84.21%

3

6.0%

15.79%

19

100%

 

 6–11 years

47

26.9%

70.15%

20

40.0%

29.85%

67

100%

 

 ≥ 12 years

105

60.0%

81.40%

24

48.0%

18.60%

129

100%

 

 Median age (months; IQR)

169.13 (106–204.9)

137.08 (98.5–181.5)

159.33 (102.6–201.2)

0.0519

Follow-up

 Followed since birth

52

29.8%

78.79%

14

28.0%

21.21%

66

100%

0.814

Origin (Child/Mother)

 Foreign Country/Missing

22

12.6%

91.67%

2

4.0%

8.33%

24

100%

 

 Foreign Country/Foreign Country

54

30.9%

80.60%

13

26.0%

19.40%

67

100%

 

 Italy/Missing

33

18.9%

80.49%

8

16.0%

19.51%

41

100%

 

 Italy/Foreign Country

42

24.0%

76.36%

13

26.0%

23.64%

55

100%

 

 Italy/Italy

24

13.8%

63.16%

14

28.0%

36.84%

38

100%

 

Age at the beginning of cART

 < 1 year

7

4.0%

58.33%

5

10.0%

41.67%

12

100%

 

 1–2 years

14

8.0%

56.00%

11

22.0%

44.00%

25

100%

 

 3–5 years

23

13.1%

82.14%

5

10.0%

17.86%

28

100%

 

 6–11 years

44

25.1%

72.13%

17

34.0%

27.87%

61

100%

 

 ≥ 12 years

87

49.8%

87.88%

12

24.0%

12.12%

99

100%

 

 Median age (months, IQR)

135 (65.4–184.27)

97.63 (17.7- 136.7)

126.6 (56.3–176.67)

0.001

Number of previous cART regimens

 1 regimen

30

17.1%

66.67%

15

30.0%

33.33%

45

100%

0.045

 2 regimens

43

24.5%

86.00%

7

14.0%

14.00%

50

100%

 

 3 regimens

28

16.0%

71.79%

11

22.0%

28.21%

39

100%

 

 4 regimens

20

11.4%

74.07%

7

14.0%

25.93%

27

100%

 

 5 regimens

22

12.6%

81.48%

5

10.0%

18.52%

27

100%

 

 6 regimens

16

9.1%

94.12%

1

2.0%

5.88%

17

100%

 

 7 regimens

7

4.0%

77.78%

2

4.0%

22.22%

9

100%

 

 8 regimens

5

2.8%

83.33%

1

2.0%

16.67%

6

100%

 

 9 regimens

1

0.6%

100.00%

0

0.0%

0.00%

1

100%

 

 10 regimens

1

0.6%

50.00%

1

2.0%

50.00%

2

100%

 

 11 regimens

2

1.1%

100.00%

0

0.0%

0.00%

2

100%

 

Pre-cART VL

 Detectable

52

29.8%

68.42%

24

48.0%

31.58%

76

100%

0.021

 Undetectable

68

38.9%

83.95%

13

26.0%

16.05%

81

100%

 

 Missing

55

31.4%

80.88%

13

26.0%

19.12%

68

100%

 

VL at last check

 Detectable

29

16.6%

74.36%

10

20.0%

25.64%

39

100%

0.583

 Undetectable

145

82.9%

78.38%

40

80.0%

21.62%

185

100%

 

 Missing

1

0.6%

100.00%

0

0.0%

0.00%

1

100%

 

Pre cART CD4+ lymphocytes count

 < 15%

12

6.9%

85.71%

2

4.0%

14.29%

14

100%

0.472

 15–24%

15

8.6%

75.00%

5

10.0%

25.00%

20

100%

 

 ≥ 25%

91

52.0%

77.78%

26

52.0%

22.22%

117

100%

 

 Missing

57

32.6%

77.03%

17

34.0%

22.97%

74

100%

 

CD4+ lymphocytes count at last check

 < 15%

4

2.3%

50.00%

4

8.0%

50.00%

8

100%

0.0543

 15–24%

15

8.6%

93.75%

1

2.0%

6.25%

16

100%

 

 ≥ 25%

156

89.1%

77.61%

45

90.0%

22.39%

201

100%

 
  1. VL viral load, cART combined antiretroviral therapy