title: Combined tipranavir and enfuvirtide use associated with higher plasma tipranavir concentrations but not with increased hepatotoxicity: sub-analysis from RESIST.
abstract: In RESIST, enfuvirtide co-administered with ritonavir-boosted tipranavir was associated with higher plasma tipranavir concentrations, which seldom rose above those associated with an increased risk of grade 3/4 transaminase elevations. Transaminase elevation rates (6.5%) and clinical hepatic event rates (5.9 events/100 person exposure years) were lower in the tipranavir/ritonavir with enfuvirtide group than in the tipranavir/ritonavir without enfuvirtide group. Observed increases in plasma tipranavir concentrations thus had no apparent effect on the risk of hepatotoxicity.
authors.affiliation: University of Nantes, Nantes, France.
authors.forename: François
authors.initials: F
authors.lastname: Raffi
authors.forename: Manuel
authors.initials: M
authors.lastname: Battegay
authors.forename: Stefano
authors.initials: S
authors.lastname: Rusconi
authors.forename: Milos
authors.initials: M
authors.lastname: Opravil
authors.forename: Gary
authors.initials: G
authors.lastname: Blick
authors.forename: Roy T
authors.initials: RT
authors.lastname: Steigbigel
authors.forename: Michael
authors.initials: M
authors.lastname: Kraft
authors.forename: Dietmar
authors.initials: D
authors.lastname: Neubacher
authors.forename: John P
authors.initials: JP
authors.lastname: Sabo
mesh_terms: D000410:Alanine Transaminase / Q000097:blood; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D056486:Chemical and Drug Induced Liver Injury; D004359:Drug Therapy, Combination; D000077560:Enfuvirtide; D015700:HIV Envelope Protein gp41 / Q000627:therapeutic use*; D023581:HIV Fusion Inhibitors / Q000627:therapeutic use; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy* / Q000201:enzymology; D017320:HIV Protease Inhibitors / Q000627:therapeutic use; D015497:HIV-1; D006801:Humans; D008107:Liver Diseases / Q000201:enzymology; D061466:Lopinavir; D010446:Peptide Fragments / Q000627:therapeutic use*; D011725:Pyridines / Q000097:blood / Q000627:therapeutic use*; D011744:Pyrimidinones / Q000627:therapeutic use; D011753:Pyrones / Q000097:blood / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D019438:Ritonavir / Q000627:therapeutic use; D019258:Saquinavir / Q000627:therapeutic use; D013449:Sulfonamides; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D015700:HIV Envelope Protein gp41; D023581:HIV Fusion Inhibitors; D017320:HIV Protease Inhibitors; D010446:Peptide Fragments; D011725:Pyridines; D011744:Pyrimidinones; D011753:Pyrones; D013449:Sulfonamides; D000077560:Enfuvirtide; D061466:Lopinavir; D000410:Alanine Transaminase; D019258:Saquinavir; D019438:Ritonavir; C107201:tipranavir