Effect of an antiretroviral regimen containing ritonavir boosted lopinavir on intestinal and hepatic CYP3A, CYP2D6 and P-glycoprotein in HIV-infected patients

Clin Pharmacol Ther. 2008 Jul;84(1):75-82. doi: 10.1038/sj.clpt.6100452. Epub 2008 Jan 9.

Abstract

This study aimed to quantify the inhibition of cytochrome P450 (CYP3A), CYP2D6, and P-glycoprotein in human immunodeficiency virus (HIV)-infected patients receiving an antiretroviral therapy (ART) containing ritonavir boosted lopinavir, and to identify factors influencing ritonavir and lopinavir pharmacokinetics. We measured activities of CYP3A, CYP2D6, and P-glycoprotein in 28 patients before and during ART using a cocktail phenotyping approach. Activities, demographics, and genetic polymorphisms in CYP3A, CYP2D6, and P-glycoprotein were tested as covariates. Oral midazolam clearance (overall CYP3A activity) decreased to 0.19-fold (90% confidence interval (CI), 0.15-0.23), hepatic midazolam clearance and intestinal midazolam availability changed to 0.24-fold (0.20-0.29) and 1.12-fold (1.00-1.26), respectively. In CYP2D6 extensive metabolizers, the plasma ratio AUC(dextromethorphan)/AUC(dextrorphan) increased to 2.92-fold (2.31-3.69). Digoxin area under the curve (AUC)(0-12) (P-glycoprotein activity) increased to 1.81-fold (1.56-2.09). Covariates had no major influence on lopinavir and ritonavir pharmacokinetics. In conclusion, CYP3A, CYP2D6, and P-glycoprotein are profoundly inhibited in patients receiving ritonavir boosted lopinavir. The covariates investigated are not useful for a priori dose selection.

Publication types

  • Clinical Trial
  • Comparative Study

MeSH terms

  • ATP Binding Cassette Transporter, Subfamily B, Member 1 / genetics
  • ATP Binding Cassette Transporter, Subfamily B, Member 1 / metabolism*
  • Adult
  • Cytochrome P-450 CYP2D6 / genetics
  • Cytochrome P-450 CYP2D6 / metabolism*
  • Cytochrome P-450 CYP3A / genetics
  • Cytochrome P-450 CYP3A / metabolism*
  • Drug Synergism
  • Female
  • HIV Infections / drug therapy
  • HIV Infections / genetics
  • HIV Infections / metabolism*
  • HIV Protease Inhibitors / administration & dosage*
  • HIV Protease Inhibitors / blood
  • HIV Protease Inhibitors / pharmacokinetics
  • Humans
  • Intestinal Mucosa / metabolism
  • Intestines / drug effects
  • Intestines / enzymology
  • Liver / drug effects
  • Liver / enzymology
  • Liver / metabolism
  • Lopinavir
  • Male
  • Middle Aged
  • Prospective Studies
  • Pyrimidinones / administration & dosage*
  • Pyrimidinones / blood
  • Pyrimidinones / pharmacokinetics
  • Ritonavir / administration & dosage*
  • Ritonavir / blood
  • Ritonavir / pharmacokinetics

Substances

  • ATP Binding Cassette Transporter, Subfamily B, Member 1
  • HIV Protease Inhibitors
  • Pyrimidinones
  • Lopinavir
  • Cytochrome P-450 CYP2D6
  • Cytochrome P-450 CYP3A
  • Ritonavir