Pharmacokinetic enhancement of the hepatitis C virus protease inhibitors VX-950 and SCH 503034 by co-dosing with ritonavir

Antivir Chem Chemother. 2007;18(3):163-7. doi: 10.1177/095632020701800306.

Abstract

Inhibitors of hepatitis C virus (HCV) protease have shown marked antiviral activity in short-term clinical studies in HCV-infected individuals. The interaction of the investigational HCV protease inhibitors VX-950 and SCH 503034 with ritonavir, a potent inhibitor of cytochrome P450 3A, was studied in vitro and in vivo. In rat and human liver microsomes, the metabolism of VX-950 and SCH 503034 was strongly inhibited by the presence of 4 microM ritonavir. Upon co-dosing either VX-950 or SCH 503034 with ritonavir in rats, plasma exposure of the HCV protease inhibitors was increased by > 15-fold, and plasma concentrations 8 h after dosing were increased by > 50-fold. A human pharmacokinetic model of VX-950 co-administered with low-dose ritonavir suggested that improved efficacy and/or dosing convenience may be feasible by pharmacokinetic enhancement with ritonavir.

MeSH terms

  • Animals
  • Antiviral Agents / pharmacokinetics*
  • Antiviral Agents / pharmacology*
  • Hepacivirus / drug effects
  • Humans
  • Male
  • Microsomes, Liver / drug effects
  • Microsomes, Liver / metabolism
  • Models, Animal
  • Oligopeptides / blood
  • Oligopeptides / pharmacokinetics*
  • Plasma / chemistry
  • Proline / analogs & derivatives*
  • Proline / blood
  • Proline / pharmacokinetics
  • Protease Inhibitors / blood
  • Protease Inhibitors / pharmacokinetics*
  • Rats
  • Rats, Sprague-Dawley
  • Ritonavir / administration & dosage
  • Ritonavir / pharmacology*

Substances

  • Antiviral Agents
  • Oligopeptides
  • Protease Inhibitors
  • telaprevir
  • N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide
  • Proline
  • Ritonavir