title: Prenatal protease inhibitor use and risk of preterm birth among HIV-infected women initiating antiretroviral drugs during pregnancy.
abstract: BACKGROUND
  Conflicting results have been reported among studies of protease inhibitor (PI) use during pregnancy and preterm birth. Uncontrolled confounding by indication may explain some of the differences among studies.
  
  
  METHODS
  In total, 777 human immunodeficiency virus (HIV)-infected pregnant women in a prospective cohort who were not receiving antiretroviral (ARV) treatment at conception were studied. Births <37 weeks gestation were reviewed, and deliveries due to spontaneous labor and/or rupture of membranes were identified. Risk of preterm birth and low birth weight (<2500 g) were evaluated by using multivariable logistic regression.
  
  
  RESULTS
  Of the study population, 558 (72%) received combination ARV with PI during pregnancy, and a total of 130 preterm births were observed. In adjusted analyses, combination ARV with PI was not significantly associated with spontaneous preterm birth, compared to ARV without PI (odds ratio [OR], 1.22; 95% confidence interval [CI], 0.70-2.12). Sensitivity analyses that included women who received ARV prior to pregnancy also did not identify a significant association (OR, 1.34; 95% CI, 0.84-2.16). Low birth weight results were similar.
  
  
  CONCLUSIONS
  No evidence of an association between use of combination ARV with PI during pregnancy and preterm birth was found. Our study supports current guidelines that promote consideration of combination ARV for all HIV-infected pregnant women.
authors.affiliation: Department of Epidemiology, Harvard School of Public Health, Boston Massachusetts 02115, USA. kpatel@hsph.harvard.edu
authors.forename: Kunjal
authors.initials: K
authors.lastname: Patel
authors.forename: David E
authors.initials: DE
authors.lastname: Shapiro
authors.forename: Susan B
authors.initials: SB
authors.lastname: Brogly
authors.forename: Elizabeth G
authors.initials: EG
authors.lastname: Livingston
authors.forename: Alice M
authors.initials: AM
authors.lastname: Stek
authors.forename: Arlene D
authors.initials: AD
authors.lastname: Bardeguez
authors.forename: Ruth E
authors.initials: RE
authors.lastname: Tuomala
mesh_terms: D000293:Adolescent; D000328:Adult; D044966:Anti-Retroviral Agents / Q000009:adverse effects* / Q000627:therapeutic use; D016009:Chi-Square Distribution; D015331:Cohort Studies; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D016015:Logistic Models; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy* / Q000821:virology*; D047928:Premature Birth / Q000139:chemically induced / Q000209:etiology* / Q000821:virology; D011295:Prenatal Care / Q000379:methods; D011446:Prospective Studies; D018570:Risk Assessment; D012680:Sensitivity and Specificity
chemical_list: D044966:Anti-Retroviral Agents; D017320:HIV Protease Inhibitors