Skip to main content

Advertisement

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