96 week CR(%)1
| DAIDS2 Grade 3/4 ALT/AST | Hepatic SAE |
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| TPV/r All N = 1299 | TPV/r-LD3
N = 1088 | TPV/r +LD3
N = 179 | TPV/r All N = 1299 | TPV/r-LD4
N = 1088 | TPV/r+LD4
N = 179 |
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Week 24 | 6.1 | 5.4 | 9.4 | 0.5 | 0.5 | 0.6 |
Week 48 | 9.5 | 8.3 | 15.6 | 0.9 | 0.7 | 2.1 |
Week 72 | 11.5 | 10.3 | 17.2 | 1.1 | 0.8 | 3.0 |
Week 96 | 13.7 | 12.5 | 20.6 | 1.4 | 1.0 | 4.3 |
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1Cumulative rate through 96 weeks.
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2DAIDS Grade 3 is defined as ALT/AST = 5.1 to 10 × ULN reference range. DAIDS Grade 4 is defined as ALT/AST >10 × ULN reference range.
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3Log-rank test comparing -LD versus +LD patients: p < 0.05.
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4Log-rank test comparing -LD versus +LD patients: p < 0.05.
- +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); ALT = alanine aminotransferase; AST = aspartate aminotransferase; DAIDS = Division of AIDS; HBV = hepatitis B virus; HCV = hepatitis C virus; SAE = serious adverse event; TPV/r = ritonavir-boosted tipranavir; ULN = upper limit of normal