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) |