SAFETY AND PHARMACOKINETICS OF HYPERIMMUNE ANTI-HUMAN-IMMUNODEFICIENCY-VIRUS (HIV) IMMUNOGLOBULIN ADMINISTERED TO HIV-INFECTED PREGNANT-WOMEN AND THEIR NEWBORNS

The pharmacokinetics and safety of hyperimmune anti-human immunodefici ency virus (HIV) intravenous immunoglobulin (HMG) were evaluated in th e first 28 maternal-infant pairs enrolled in a randomized, intravenous immunoglobulin (IVIG)-controlled trial of HIVIG maternal-infant HIV t ransmission 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, wit h stable 4 mL/kg/day clearance. Transplacental passage occurred. Newbo rn 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 im mune complex-dissociated p24 antigen, and plasma HIV-1 RNA levels were stable. Mild to moderate adverse clinical effects occurred in 2 of 10 3 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.