Pharmacokinetic interaction between nevirapine and darunavir with low-dose ritonavir in HIV-1-infected patients

Br J Clin Pharmacol. 2009 Jul;68(1):116-9. doi: 10.1111/j.1365-2125.2009.03430.x.

Abstract

Aim: To investigate the pharmacokinetic interaction between darunavir/ritonavir (DRV/r) and nevirapine (NVP) in 19 HIV-infected patients.

Methods: An open-label, randomized, crossover study. Patients received Treatment A [NVP 200 mg b.i.d. plus > or =2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)] and Treatment B [A plus DRV/r 300/100 mg b.i.d. (DRV oral solution)] or Treatment B2 [A plus DRV/r 400/100 mg b.i.d. (DRV tablet)] in two 14-day sessions.

Results: Mean NVP AUC(12h) increased by 27% [least square means ratio 1.27 (95% confidence interval 1.02, 1.58)]. Mean DRV and ritonavir exposures were similar to historical data. Co-administration was well tolerated.

Conclusions: DRV/r and NVP have no clinically relevant interaction. No dose adjustments are required.

Publication types

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

MeSH terms

  • Adult
  • Cross-Over Studies
  • Darunavir
  • Drug Interactions
  • Drug Therapy, Combination
  • Female
  • HIV Infections / drug therapy*
  • HIV Protease Inhibitors / administration & dosage*
  • HIV Protease Inhibitors / pharmacokinetics
  • HIV-1 / drug effects
  • Humans
  • Male
  • Middle Aged
  • Nevirapine / administration & dosage*
  • Nevirapine / pharmacokinetics
  • Reverse Transcriptase Inhibitors / administration & dosage*
  • Reverse Transcriptase Inhibitors / pharmacokinetics
  • Ritonavir / administration & dosage*
  • Ritonavir / pharmacokinetics
  • Sulfonamides / administration & dosage*
  • Sulfonamides / pharmacokinetics
  • Treatment Outcome

Substances

  • HIV Protease Inhibitors
  • Reverse Transcriptase Inhibitors
  • Sulfonamides
  • Nevirapine
  • Ritonavir
  • Darunavir