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Table 1 Demographic and baseline characteristics of TPV/r 500/200 mg patients in trials 1182.12, 1182.48, 1182.51, 1182.52 and 1182.17 by risk

From: Hepatic profile analyses of tipranavir in Phase II and III clinical trials

 

All TPV/r1

N = 1299

TPV/r -LD2

N = 1088

TPV/r +LD2

N = 179

TPV/r SAE

N = 14

Age (years):

    

   Median

43

43

42

42

   Range

17-80

17-80

18-72

35-63

Gender [N (%)]:

    

   Male

1124 (86.5)

939 (86.3)

160 (89.4)

13 (92.9)

   Female

175 (13.5)

149 (13.7)

19 (10.6)

1 (7.1)

Baseline HIV RNA (log10 copies/mL):

    

   Median

4.8

4.8

4.7

4.9

   Range

1.7-6.5

1.7-6.5

2.7-6.3

3.6-5.6

Baseline CD4+ cell count (cells/mm3):

    

   Median

156

158

151

70

   Range

1-1893

1-1893

1-702

4-337

Hepatitis co-infection [N (%)]:

    

   HBsAg-/HCV RNA-

1136 (87.5)

1088 (100.0)

37 (20.7)

9 (64.3)

   HBsAg+

55 (4.2)

0 (0.0)

55 (30.7)

2 (14.3)

   HCV RNA+

83 (6.4)

0 (0.0)

83 (46.4)

3 (21.4)

   HBsAg+/HCV RNA+

2 (0.2)

0 (0.0)

2 (1.1)

0 (0.0)

   missing

23 (1.8)

0 (0.0)

2 (1.1)

0 (0.0)

Baseline DAIDS Grade ≥2 ALT/AST3

51 (3.9)

0 (0.0)

51 (28.5)

0 (0.0)

  1. 1Thirty-two patients had missing information and were unable to be classified into one of the two risk groups. These patients were more likely to be female (21.9%) with lower CD4+ counts at baseline (median 121 cells/mm3).
  2. 2+LD: patients with underlying liver disease (baseline evidence of active HBV/HCV infection or ALT/AST Grade > 1); -LD: patients with no apparent liver disease (absence of active HBV/HCV infection and ALT/AST Grade ≤ 1).
  3. 3At baseline, 48 patients had DAIDS Grade 2 ALT/AST, while three patients had DAIDS Grade 3 ALT/AST just prior to first dose of TPV/r.
  4. ALT = alanine aminotransferase; AST = aspartate aminotransferase; DAIDS = Division of AIDS; HBsAg = hepatitis B surface antigen; HBV = hepatitis B virus; HCV = hepatitis C virus; TPV/r = ritonavir-boosted tipranavir 500/200 mg BID