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Protease Inhibitor Use in 233 Pregnancies

Morris, Anne B MD*; Dobles, Ana Rua RN, ACRN; Cu-Uvin, Susan MD; Zorrilla, Carmen MD§; Anderson, Jean MD; Harwell, Joseph I MD; Keller, Jean PA-C; Garb, Jane MS#

JAIDS Journal of Acquired Immune Deficiency Syndromes: September 1st, 2005 - Volume 40 - Issue 1 - p 30-33
doi: 10.1097/01.qai.0000174651.40782.95
Clinical Science

Background: In the United States, as most highly active antiretroviral therapy (HAART) regimens used during pregnancy in HIV-infected women include a protease inhibitor (PI), it is important to determine the effects of PIs specifically rather than all HAART regimens. Prospective trials employing HAART during pregnancy are ongoing.

Objective: To better understand the effects of PI use during pregnancy on prematurity, maternal and infant adverse events, and infant outcomes.

Results: A total of 233 pregnancies in which PIs were used were reported, including 5 sets of twins and 1 set of triplets. Perinatal transmission is documented in 2 of 221 infants for a rate of 0.9% (95% CI, 0%-2.2%). Both HIV-positive infants were delivered by cesarean section (one elective at 37 1/7 weeks and one unscheduled at 32 6/7 weeks). The prematurity rate (<37 weeks' gestation) was 22.0% (95% CI, 16.9%-28.0%) including 3 twin and 1 triplet pregnancies. In multiple regression analysis no association was noted for individual PIs or the week of gestation that PIs were initiated. Adverse maternal, obstetric, and infant events possibly related to PIs were uncommon.

Conclusions: In this series, PIs during pregnancy appeared generally safe for mothers and infants. Perinatal transmission was low and the prematurity rate is similar to prior data in HIV-positive women not on PIs.

From the *Community Research Initiative of New England, Springfield, MA; †Arnold Palmer Hospital for Children and Women Hug Me Program, Orlando, FL; ‡The Miriam Hospital, Brown University, Providence, RI; §University of Puerto Rico, San Juan, Puerto Rico; ∥Johns Hopkins University, Baltimore, MD; and #Baystate Medical Center, Springfield, MA.

Received for publication February 11, 2005; accepted June 9, 2005.

Supported by an unrestricted educational grant from Agouron Pharmaceuticals, Inc., La Jolla, CA.

Reprints: Anne B. Morris, Community Research Initiative of New England, 780 Chestnut Street, Suite 30, Springfield, MA 01107 (e-mail:

© 2005 Lippincott Williams & Wilkins, Inc.