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Clin Infect Dis. 2019 Jan 7;68(2):273-279. doi: 10.1093/cid/ciy471.

Adverse Pregnancy Outcomes Among Women Who Conceive on Antiretroviral Therapy.

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Division of Infectious Diseases, David Geffen School of Medicine at the University of California, Los Angeles.
Harvard T. H. Chan School of Public Health, Boston, Massachusetts.
Oswaldo Cruz Foundation/Fiocruz and Hospital Geral de Nova Iguacu, Rio de Janeiro, Brazil.
Botswana Harvard AIDS Institute Partnership, Gaborone.
Research Institute for Health Sciences, Chiang Mai University, Thailand.
Infectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil.
Division of Pediatric Infectious Diseases, Bronx-Lebanon Hospital Center, Icahn School of Medicine at Mount Sinai, New York, New York.
Texas Children's Hospital, Houston.
Haitian Study Group for Kaposi's Sarcoma and Opportunistic Infections Centers, Port-au-Prince.
Family Health International 360, Durham, North Carolina.
National Institute of Child Health and Human Development.
Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.



Adverse pregnancy outcomes for women who conceive on antiretroviral therapy (ART) may be increased, but data are conflicting.


Human immunodeficiency virus-infected, nonbreastfeeding women with pre-ART CD4 counts ≥400 cells/μL who started ART during pregnancy were randomized after delivery to continue ART (CTART) or discontinue ART (DCART). Women randomized to DCART were recommended to restart if a subsequent pregnancy occurred or for clinical indications. Using both intent-to-treat and as-treated approaches, we performed Fisher exact tests to compare subsequent pregnancy outcomes by randomized arm.


Subsequent pregnancies occurred in 277 of 1652 (17%) women (CTART: 144/827; DCART: 133/825). A pregnancy outcome was recorded for 266 (96%) women with a median age of 27 years (interquartile range [IQR], 24-31 years) and median CD4+ T-cell count 638 cells/μL (IQR, 492-833 cells/μL). When spontaneous abortions and stillbirths were combined, there was a significant difference in events, with 33 of 140 (23.6%) in the CTART arm and 15 of 126 (11.9%) in the DCART arm (relative risk [RR], 2.0 [95% confidence interval {CI}, 1.1-3.5]; P = .02). In the as-treated analysis, the RR was reduced and no longer statistically significant (RR, 1.4 [95% CI, .8-2.4]).


Women randomized to continue ART who subsequently conceived were more likely to have spontaneous abortion or stillbirth, compared with women randomized to stop ART; however, the findings did not remain significant in the as-treated analysis. More data are needed on pregnancy outcomes among women conceiving on ART, particularly with newer regimens.

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