Table 2.
Kaplan-Meier estimates for time-to-first DAIDS Grade 3/4 ALT and/or AST elevation and time-to-first hepatic serious adverse event (SAE) among TPV/r 500/200 mg patients in trials 1182.12, 1182.48, 1182.51, 1182.52 and 1182.17
| 96 week CR(%)1 | DAIDS2 Grade 3/4 ALT/AST | Hepatic SAE | ||||
|---|---|---|---|---|---|---|
|
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 |
|
| 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 |
1Cumulative rate through 96 weeks.
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.
3Log-rank test comparing -LD versus +LD patients: p < 0.05.
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