Steady-state pharmacokinetics, cord blood concentrations, and safety of ritonavir-boosted fosamprenavir in pregnancy

J Acquir Immune Defic Syndr. 2013 Apr 15;62(5):550-4. doi: 10.1097/QAI.0b013e318285d918.

Abstract

Steady-state pharmacokinetics in pregnant women prescribed ritonavir-boosted fosamprenavir (FPV) to prevent HIV transmission were assessed in the second trimester, third trimester, and postpartum. Compared with postpartum, geometric mean amprenavir (APV, FPVs active metabolite) area under the plasma concentration-time curves were 35% lower in the second trimester and 25% lower in the third trimester. Maternal APV concentrations were 9- to 15-fold above the mean APV protein-adjusted 50% inhibitory concentration for wild-type HIV. Median ratio of cord blood/maternal APV levels was 0.27, and all infants were HIV negative. FPV/ritonavir during pregnancy was well tolerated and led to virologic suppression.

Publication types

  • Clinical Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Area Under Curve
  • Carbamates / administration & dosage
  • Carbamates / pharmacokinetics*
  • Disease Transmission, Infectious / prevention & control
  • Female
  • Fetal Blood
  • Furans
  • HIV / isolation & purification
  • HIV Infections / drug therapy
  • HIV Infections / metabolism*
  • HIV Infections / prevention & control
  • HIV Infections / virology
  • HIV Protease Inhibitors / administration & dosage
  • HIV Protease Inhibitors / pharmacokinetics*
  • Humans
  • Infant, Newborn
  • Organophosphates / administration & dosage
  • Organophosphates / pharmacokinetics*
  • Postpartum Period / blood
  • Postpartum Period / metabolism
  • Pregnancy
  • Pregnancy Complications, Infectious / blood
  • Pregnancy Complications, Infectious / drug therapy*
  • Pregnancy Complications, Infectious / metabolism*
  • Pregnancy Complications, Infectious / virology
  • Ritonavir / administration & dosage
  • Ritonavir / pharmacokinetics*
  • Sulfonamides / administration & dosage
  • Sulfonamides / pharmacokinetics*
  • Young Adult

Substances

  • Carbamates
  • Furans
  • HIV Protease Inhibitors
  • Organophosphates
  • Sulfonamides
  • Ritonavir
  • fosamprenavir