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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

From: Hepatic profile analyses of tipranavir in Phase II and III clinical trials

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
  1. 1Cumulative rate through 96 weeks.
  2. 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.
  3. 3Log-rank test comparing -LD versus +LD patients: p < 0.05.
  4. 4Log-rank test comparing -LD versus +LD patients: p < 0.05.
  5. +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