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
| 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) |
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+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).
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.
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