Neither branded nor generic lopinavir/ritonavir produces adequate lopinavir concentrations at a reduced dose of 200/50 mg twice daily

J Acquir Immune Defic Syndr. 2012 Jan 1;59(1):55-8. doi: 10.1097/QAI.0b013e31823ba736.

Abstract

We assessed pharmacokinetic (PK) parameters of reduced dose lopinavir/ritonavir (LPV/r) and compared generic and branded tablets. Twenty HIV-infected patients using protease inhibitors with HIV RNA <50 copies per milliliter were randomized to generic or branded LPV/r 200/50mg twice daily (BID). At week 2, PK-sampling was performed. Patients crossed over to the other arm until week 12, with another PK-sampling at week 4. Subtherapeutic lopinavir concentrations were observed in 10/40 samples. PK parameters were comparable between branded and generic tablets. All patients remained virologically suppressed at week 12. In conclusion, LPV/r 200/50mg BID does not lead to adequate lopinavir plasma concentrations. Generic and branded LPV/r have comparable PK-parameters.

Publication types

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

MeSH terms

  • Adult
  • Anti-HIV Agents / administration & dosage*
  • Anti-HIV Agents / pharmacokinetics
  • Cross-Over Studies
  • Dose-Response Relationship, Drug
  • Female
  • HIV Infections / drug therapy*
  • HIV Protease Inhibitors / administration & dosage*
  • HIV Protease Inhibitors / pharmacokinetics
  • HIV Protease Inhibitors / therapeutic use
  • Humans
  • Lopinavir / administration & dosage*
  • Lopinavir / blood
  • Lopinavir / pharmacokinetics
  • Lopinavir / therapeutic use
  • Male
  • Middle Aged
  • Ritonavir / administration & dosage*
  • Ritonavir / pharmacokinetics
  • Ritonavir / therapeutic use
  • Therapeutic Equivalency

Substances

  • Anti-HIV Agents
  • HIV Protease Inhibitors
  • Lopinavir
  • Ritonavir