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Table 4 Occurrence of DAIDS Grade 3/4 ALT/AST and hepatic serious adverse events (SAEs) among -LD and +LD TPV/r 500/200 mg BID patients

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

  -LD patients1 +LD patients1
ALT/AST DAIDS >22 Hepatic SAE Hepatic SAE
  Yes No Yes No
Yes 3 107 1 29
No 6 970 4 141
  1. 1Thirty-two patients had missing information and were unable to be classified into one of the two risk groups; none of these patients experienced a hepatic SAE.
  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); ALT = alanine aminotransferase; AST = aspartate aminotransferase; DAIDS = Division of AIDS; HBV = hepatitis B virus; HCV = hepatitis C virus; TPV/r = ritonavir-boosted tipranavir
  3. 2ALT/AST on treatment DAIDS Grade 3/4