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

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.