Steady-State Pharmacokinetics, Cord Blood Concentrations, and Safety of Ritonavir-Boosted Fosamprenavir in Pregnancy

Cespedes, Michelle S. MD, MS*,†; Castor, Delivette PhD; Ford, Susan L. PharmD§; Lee, Doreen MD; Lou, Yu MS§; Pakes, Gary E. PharmD§; Aberg, Judith A. MD*,†

JAIDS Journal of Acquired Immune Deficiency Syndromes:
doi: 10.1097/QAI.0b013e318285d918
Brief Report: Clinical Science
Abstract

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.

Author Information

*Division of Infectious Diseases and Immunology, Department of Medicine, New York University School of Medicine;

Bellevue Hospital Center, South Manhattan Healthcare Network for New York City Health and Hospital Corporation, New York, NY;

United States Agency for International Development, Washington, DC;

§GlaxoSmithKline, Research Triangle Park, NC; and

Division of Infectious Disease, Department of Medicine, Montifore Medical Center, Bronx, NY.

Correspondence to: Michelle S. Cespedes, MD, New York University School of Medicine, 550 First Avenue, BCD Room 558, New York, NY 10016 (e-mail: Michelle.Cespedes@nyumc.org).

This study was funded by GlaxoSmithKline. This study was also supported in part by NIAID AI069532, NIH 1UL1RR029893 from the National Center for Research Resources, the Grunebaum AIDS Scholarship Award, and NIAID U01 AI068636 through the ACTG MHIMP program.

Presented at the 6th IAS Conference on HIV Pathogenesis, Treatment, and Prevention, July 17–20, 2011, Rome, Italy.

M.S.C. received research support from GSK. S.L.F., Y.L., and G.P. are employed by GSK. J.A.A. has served as a scientific advisor to Merck & Co, Inc., Tibotec/Janssen Therapeutics, and ViiV Healthcare. J.A.A. has received grant support from Kowa. The remaining authors have no conflicts of interest to disclose.

Received August 10, 2012

Accepted January 02, 2013

© 2013 Lippincott Williams & Wilkins, Inc.