Effect of tipranavir-ritonavir on pharmacokinetics of raltegravir

Antimicrob Agents Chemother. 2009 Jul;53(7):2752-5. doi: 10.1128/AAC.01486-08. Epub 2009 Apr 27.

Abstract

Raltegravir (RAL) is a novel and potent human immunodeficiency virus type 1 integrase inhibitor that is predominantly metabolized via glucuronidation. The protease inhibitor combination tipranavir (TPV) at 500 mg and ritonavir (RTV) at 200 mg (TPV-RTV) has inhibitory and inductive effects on metabolic enzymes, which includes the potential to induce glucuronosyltransferase. Because RAL may be coadministered with TPV-RTV, there is the potential for the induction of RAL metabolism. Consequently, we assessed the effect of TPV-RTV on the pharmacokinetics of RAL and the safety and tolerability of this combination. Eighteen healthy adults were enrolled in this open-label study. The participants received RAL at 400 mg twice daily for 4 days (period 1) and TPV-RTV twice daily for 7 days (period 2), followed immediately by 400 mg RAL with TPV-RTV twice daily for 4 days (period 3). Under steady-state conditions, the RAL concentration at 12 h (C(12)) was decreased when RAL was administered with TPV-RTV (geometric mean ratio [GMR], 0.45; 90% confidence interval [CI] 0.31, 0.66; P = 0.0021); however, the area under the concentration-time curve from time zero to 12 h (GMR, 0.76; 90% CI, 0.49, 1.19; P = 0.2997) and the maximum concentration in serum (GMR, 0.82; 90% CI, 0.46, 1.46; P = 0.5506) were not substantially affected. There were no serious adverse experiences or discontinuations due to study drug-related adverse experiences, and RAL coadministered with TPV-RTV was generally well tolerated. Although the RAL C(12) was decreased with TPV-RTV in this study, favorable efficacy data collected in phase III studies substantiate that TPV-RTV may be coadministered with RAL without dose adjustment.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Female
  • HIV Protease Inhibitors / pharmacology*
  • Humans
  • Male
  • Middle Aged
  • Pyridines / pharmacology*
  • Pyrones / pharmacology*
  • Pyrrolidinones / blood
  • Pyrrolidinones / pharmacokinetics*
  • Raltegravir Potassium
  • Ritonavir / pharmacology*
  • Sulfonamides
  • Young Adult

Substances

  • HIV Protease Inhibitors
  • Pyridines
  • Pyrones
  • Pyrrolidinones
  • Sulfonamides
  • Raltegravir Potassium
  • Ritonavir
  • tipranavir