title: Pregnancy outcomes in HIV-infected women receiving long-term isoniazid prophylaxis for tuberculosis and antiretroviral therapy.
abstract: OBJECTIVE
  While 6- to 12-month courses of isoniazid for tuberculosis prevention are considered safe in pregnant women, the effects of longer-term isoniazid prophylaxis or isoniazid in combination with antiretroviral therapy (ART) are not established in human-immunodeficiency-virus-(HIV-) infected women who experience pregnancy during the course of therapy.
  
  
  METHODS
  Nested study of pregnancy outcomes among HIV-infected women participating in a placebo-controlled, TB-prevention trial using 36 months daily isoniazid. Pregnancy outcomes were collected by interview and record review.
  
  
  RESULTS
  Among 196 pregnant women, 103 (52.6%) were exposed to isoniazid during pregnancy; all were exposed to antiretroviral drugs. Prior to pregnancy they had received a median of 341 days (range 1-1095) of isoniazid. We observed no isoniazid-associated hepatitis or other severe isoniazid-associated adverse events in the 103 women. Pregnancy outcomes were 132 term live births, 42 premature births, 11 stillbirths, 8 low birth weight, 6 spontaneous abortions, 4 neonatal deaths, and 1 congenital abnormality. In a multivariable model, neither isoniazid nor ART exposure during pregnancy was significantly associated with adverse pregnancy outcome (adjusted odds ratios 0.6, 95% CI: 0.3-1.1 and 1.8, 95% CI 0.9-3.6, resp.).
  
  
  CONCLUSIONS
  Long-term isoniazid prophylaxis was not associated with adverse pregnancy outcomes, such as preterm delivery, even in the context of ART exposure.
authors.affiliation: Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention (CDC), National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, 1600 Clifton Road, NE MS E-45, Atlanta, GA 30333, USA. ataylor2@cdc.gov
authors.forename: Allan W
authors.initials: AW
authors.lastname: Taylor
authors.forename: Barudi
authors.initials: B
authors.lastname: Mosimaneotsile
authors.forename: Unami
authors.initials: U
authors.lastname: Mathebula
authors.forename: Anikie
authors.initials: A
authors.lastname: Mathoma
authors.forename: Ritah
authors.initials: R
authors.lastname: Moathlodi
authors.forename: Irene
authors.initials: I
authors.lastname: Theebetsile
authors.forename: Taraz
authors.initials: T
authors.lastname: Samandari
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000517:prevention & control*; D000328:Adult; D000704:Analysis of Variance; D019072:Antibiotic Prophylaxis / Q000009:adverse effects; D000995:Antitubercular Agents / Q000009:adverse effects*; D015331:Cohort Studies; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D007538:Isoniazid / Q000009:adverse effects*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000517:prevention & control*; D011256:Pregnancy Outcome; D014376:Tuberculosis / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D000995:Antitubercular Agents; D007538:Isoniazid