title: Birth defects in a national cohort of pregnant women with HIV infection in Italy, 2001-2011.
abstract: OBJECTIVE
  We used data from a national study of pregnant women with HIV to evaluate the prevalence of congenital abnormalities in newborns from women with HIV infection.
  
  
  METHODS
  Observational study.
  
  
  METHODS
  University and hospital clinics.
  
  
  METHODS
  Pregnant women with HIV exposed to antiretroviral treatment at any time during pregnancy.
  
  
  METHODS
  The total prevalence of birth defects was assessed on live births, stillbirths, and elective terminations for fetal anomaly. The associations between potentially predictive variables and the occurrence of birth defects were expressed as odds ratios (ORs) with 95% confidence intervals (95% CIs) for exposed versus unexposed cases, calculated in univariate and multivariate logistic regression analyses.
  
  
  METHODS
  Birth defects, defined according to the Antiretroviral Pregnancy Registry criteria.
  
  
  RESULTS
  A total of 1257 pregnancies with exposure at any time to antiretroviral therapy were evaluated. Forty-two cases with major defects were observed. The total prevalence was 3.2% (95% CI 1.9-4.5) for exposure to any antiretroviral drug during the first trimester (23 cases with defects) and 3.4% (95% CI 1.9-4.9) for no antiretroviral exposure during the first trimester (19 cases). No associations were found between major birth defects and first-trimester exposure to any antiretroviral treatment (OR 0.94, 95% CI 0.51-1.75), main drug classes (nucleoside reverse transcriptase inhibitors, OR 0.95, 95% CI 0.51-1.76; non-nucleoside reverse transcriptase inhibitors, OR 1.20, 95% CI 0.56-2.55; protease inhibitors, OR 0.92, 95% CI 0.43-1.95), and individual drugs, including efavirenz (prevalence for efavirenz, 2.5%).
  
  
  CONCLUSIONS
  This study adds further support to the assumption that first-trimester exposure to antiretroviral treatment does not increase the risk of congenital abnormalities.
authors.affiliation: Department of Therapeutic Research and Medicines Evaluation, Istituto Superiore di Sanità, Rome, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Floridia
authors.forename: P
authors.initials: P
authors.lastname: Mastroiacovo
authors.forename: E
authors.initials: E
authors.lastname: Tamburrini
authors.forename: C
authors.initials: C
authors.lastname: Tibaldi
authors.forename: T
authors.initials: T
authors.lastname: Todros
authors.forename: A
authors.initials: A
authors.lastname: Crepaldi
authors.forename: M
authors.initials: M
authors.lastname: Sansone
authors.forename: M
authors.initials: M
authors.lastname: Fiscon
authors.forename: G
authors.initials: G
authors.lastname: Liuzzi
authors.forename: B
authors.initials: B
authors.lastname: Guerra
authors.forename: A
authors.initials: A
authors.lastname: Vimercati
authors.forename: F
authors.initials: F
authors.lastname: Vichi
authors.forename: I
authors.initials: I
authors.lastname: Vicini
authors.forename: C
authors.initials: C
authors.lastname: Pinnetti
authors.forename: A M
authors.initials: AM
authors.lastname: Marconi
authors.forename: M
authors.initials: M
authors.lastname: Ravizza
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000453:epidemiology* / Q000209:etiology; D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects*; D001724:Birth Weight; D015331:Cohort Studies; D060085:Coinfection / Q000453:epidemiology; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology; D019694:Hepatitis B, Chronic / Q000150:complications / Q000453:epidemiology; D019698:Hepatitis C, Chronic / Q000150:complications / Q000453:epidemiology; D006801:Humans; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000706:statistics & numerical data; D007558:Italy / Q000453:epidemiology; D008297:Male; D018811:Maternal Exposure; D008875:Middle Aged; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy* / Q000453:epidemiology; D011261:Pregnancy Trimester, First; D015995:Prevalence; D018894:Reverse Transcriptase Inhibitors / Q000009:adverse effects*; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D018894:Reverse Transcriptase Inhibitors
keywords: Antiretroviral therapy; HIV; birth defects; efavirenz; non-nucleoside reverse transcriptase inhibitors; nucleoside reverse transcriptase inhibitors; pregnancy; protease inhibitors; women