Safety and pharmacokinetics of hyperimmune anti-human immunodeficiency virus (HIV) immunoglobulin administered to HIV-infected pregnant women and their newborns

J. S. Lambert, L. M. Mofenson, C. V. Fletcher, Jr Moye J., E. R. Stiehm, W. A. Meyer, G. J. Nemo, B. J. Mathieson, G. Hirsch, C. V. Sapan, L. M. Cummins, E. Jimenez, E. O'Neill, A. Kovacs, A. Stek

Research output: Contribution to journalArticlepeer-review

57 Scopus citations

Abstract

The pharmacokinetics and safety of hyperimmune anti-human immunodeficiency virus (HIV) intravenous immunoglobulin (HIVIG) were evaluated in the first 28 maternal-infant pairs enrolled in a randomized, intravenous immunoglobulin (IVIG)-controlled trial of HIVIG maternal-infant HIV transmission prophylaxis. Using 200 mg/kg, mean half-life and volume of distribution (V(d)) in women were 15 days and 72 mL/kg, respectively, after one and 32 days and 154 mL/kg after three monthly infusions, with stable 4 mL/kg/day clearance. Transplacental passage occurred. Newborn single-dose half-life, V(d), and clearance were 30 days, 143 mL/kg, and 4 mL/kg/day, respectively. HIVIG rapidly cleared maternal serum immune complex-dissociated p24 antigen, and plasma HIV-1 RNA levels were stable. Mild to moderate adverse clinical effects occurred in 2 of 103 maternal and 2 of 25 infant infusions. No adverse hematologic, blood chemistry, or immunologic effects were seen. HIVIG is well-tolerated in HIV-infected pregnant women and their newborns, clears antigenemia, crosses the placenta, and exhibits pharmacokinetics similar to those of other immunoglobulin preparations.

Original languageEnglish (US)
Pages (from-to)283-291
Number of pages9
JournalJournal of Infectious Diseases
Volume175
Issue number2
DOIs
StatePublished - 1997

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

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