title: Antiretroviral therapy during pregnancy and the risk of an adverse outcome.
abstract: BACKGROUND
  Some studies suggest that combination antiretroviral therapy in pregnant women with human immunodeficiency virus type 1 (HIV-1) infection increases the risk of premature birth and other adverse outcomes of pregnancy.
  
  
  METHODS
  We studied pregnant women with HIV-1 infection who were enrolled in seven clinical studies and delivered their infants from 1990 through 1998. The cohort comprised 2123 women who received antiretroviral therapy during pregnancy (monotherapy in 1590, combination therapy without protease inhibitors in 396, and combination therapy with protease inhibitors in 137) and 1143 women who did not receive antiretroviral therapy.
  
  
  RESULTS
  After standardization for the CD4+ cell count and use or nonuse of tobacco, alcohol, and illicit drugs, the rate of premature delivery (<37 weeks of gestation) was similar among the women who received antiretroviral therapy and those who did not (16 percent and 17 percent, respectively); the rate of low birth weight (<2500 g) was 16 percent among the infants born to both groups; and the rate of very low birth weight (<1500 g) was 2 percent for the group that received antiretroviral therapy and 1 percent for the group that did not. The rates of low Apgar scores (<7) and stillbirth were also similar or the same in the two groups. After adjustment for multiple risk factors, combination antiretroviral therapy was not associated with an increased risk of premature delivery as compared with monotherapy (odds ratio, 1.08; 95 percent confidence interval, 0.71 to 1.62) or delivery of an infant with low birth weight (odds ratio, 1.03; 95 percent confidence interval, 0.64 to 1.63). Seven of the women who received combination therapy with protease inhibitors (5 percent) had infants with very low birth weight, as compared with nine women who received combination therapy without protease inhibitors (2 percent) (adjusted odds ratio, 3.56; 95 percent confidence interval, 1.04 to 12.19).
  
  
  CONCLUSIONS
  As compared with no antiretroviral therapy or monotherapy, combination therapy for HIV-1 infection in pregnant women is not associated with increased rates of premature delivery or with low birth weight, low Apgar scores, or stillbirth in their infants. The association between combination therapy with protease inhibitors and an increased risk of very low birth weight requires confirmation.
authors.affiliation: Department of Obstetrics and Gynecology, Brigham and Women's Hospital, Boston 02115, USA. rtuomala@partners.org
authors.forename: Ruth E
authors.initials: RE
authors.lastname: Tuomala
authors.forename: David E
authors.initials: DE
authors.lastname: Shapiro
authors.forename: Lynne M
authors.initials: LM
authors.lastname: Mofenson
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Bryson
authors.forename: Mary
authors.initials: M
authors.lastname: Culnane
authors.forename: Michael D
authors.initials: MD
authors.lastname: Hughes
authors.forename: M J
authors.initials: MJ
authors.lastname: O'Sullivan
authors.forename: Gwendolyn
authors.initials: G
authors.lastname: Scott
authors.forename: Alice M
authors.initials: AM
authors.lastname: Stek
authors.forename: Diane
authors.initials: D
authors.lastname: Wara
authors.forename: Marc
authors.initials: M
authors.lastname: Bulterys
mesh_terms: D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001034:Apgar Score; D004359:Drug Therapy, Combination; D005260:Female; D005313:Fetal Death; D015658:HIV Infections / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D007234:Infant, Premature; D008297:Male; D015999:Multivariate Analysis; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D011256:Pregnancy Outcome
chemical_list: D019380:Anti-HIV Agents; D017320:HIV Protease Inhibitors