Association between in utero zidovudine exposure and nondefect adverse birth outcomes: analysis of prospectively collected data from the Antiretroviral Pregnancy Registry.
OBJECTIVE
To examine the association between nondefect adverse birth outcomes and in utero exposure to zidovudine (ZDV)-containing regimens versus non-ZDV antiretroviral (ARV) regimens.


METHODS
Analysis of prospectively-collected data.


METHODS
Global.


METHODS
HIV-infected pregnant women prenatally exposed to antiretrovirals.


METHODS
Estimation of prevalence of and risk for nondefect adverse birth outcomes among HIV-infected women.


METHODS
Prevalence of and risk for nondefect adverse birth outcomes.


RESULTS
Among 12 780 singleton birth outcomes with in utero ZDV exposure, 96.1% were live births; 3.9% were spontaneous abortions, induced abortions or stillbirths. Among live births, 16.4% were low birthweight (LBW); 12.3% were premature. Among 1904 outcomes with in utero exposure to non-ZDV ARV regimens, 85.8% were live births; 14.2% were spontaneous abortions, induced abortions or stillbirths. Among live births, 14.1% were LBW; 12.4% were premature. Relative risk comparing exposure to ZDV-containing ARV regimens to non-ZDV ARV regimens for spontaneous abortions was 0.18 (95% confidence interval [95% CI] 0.14-0.22); induced abortions 0.28 (95% CI 0.22-0.36); stillbirths 0.76 (95% CI 0.51-1.12); premature births 1.00 (95% CI 0.87-1.15) and LBW 1.17 (95% CI 1.02-1.33).


CONCLUSIONS
Prevalence of nondefect adverse birth outcomes is lower among outcomes with in utero ZDV exposure versus in utero non-ZDV ARV exposure. The risks for spontaneous and induced abortions were no different for ZDV-containing regimens versus non-ZDV ARV regimens. For premature births and stillbirths, there was no significant difference in risk between the two regimens. The risk of LBW was statistically significantly higher among ZDV-containing regimens versus non-ZDV ARV regimens.


CONCLUSIONS
ZDV-containing regimens do not increase the risk for nondefect adverse birth outcomes.
Epidemiology and Real World Evidence, ViiV Healthcare, Research Triangle Park, Raleigh, NC, USA.|Gillings School of Global Public Health, University of North Carolina-Chapel Hill, Chapel Hill, NC, USA.
V
V
Vannappagari
Worldwide Epidemiology, GlaxoSmithKline, Research Triangle Park, Raleigh, NC, USA.
N
N
Koram
INC Research, Post Approval & Strategic Services, Raleigh, NC, USA.
J
J
Albano
Gillings School of Global Public Health, University of North Carolina-Chapel Hill, Chapel Hill, NC, USA.
H
H
Tilson
INC Research, Biostatistics, Wilmington, NC, USA.
C
C
Gee
D000028:Abortion, Induced / Q000706:statistics & numerical data; D000022:Abortion, Spontaneous / Q000453:epidemiology*; D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D007230:Infant, Low Birth Weight; D050498:Live Birth; D008875:Middle Aged; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D047928:Premature Birth / Q000453:epidemiology; D011297:Prenatal Exposure Delayed Effects / Q000453:epidemiology*; D015995:Prevalence; D012042:Registries; D012307:Risk Factors; D050497:Stillbirth / Q000453:epidemiology*; D055815:Young Adult; D015215:Zidovudine / Q000008:administration & dosage* / Q000009:adverse effects
D019380:Anti-HIV Agents; D015215:Zidovudine
Epidemiology HIV; pregnancy outcomes; zidovudine