@article{9a3c8f4f9b554b4eabca0bcd26008772,
title = "Adverse Pregnancy Outcomes among Women Who Conceive on Antiretroviral Therapy",
abstract = "Background. Adverse pregnancy outcomes for women who conceive on antiretroviral therapy (ART) may be increased, but data are conflicting. Methods. Human immunodeficiency virus-infected, nonbreastfeeding women with pre-ART CD4 counts ?400 cells/?L 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 intentto- treat and as-treated approaches, we performed Fisher exact tests to compare subsequent pregnancy outcomes by randomized arm. Results. 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/?L (IQR, 492-833 cells/?L). 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]). Conclusions. 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.",
keywords = "Antiretroviral therapy, Conception, HIV/AIDS, Pregnancy, Pregnancy outcomes",
author = "{PROMISE (Promoting Maternal and Infant Safety Everywhere) 1077HS Team} and Hoffman, {Risa M.} and Brummel, {Sean S.} and Paula Britto and Pilotto, {Jose H.} and Gaerolwe Masheto and Linda Aurpibul and Esau Joao and Purswani, {Murli U.} and Shelley Buschur and Pierre, {Marie Flore} and Anne Coletti and Nahida Chakhtoura and Klingman, {Karin L.} and Currier, {Judith S.} and M. Losso and E. Machado and {De Menezes}, J. and G. Duarte and R. Sperhacke and J. Pinto and R. Kreitchman and B. Santos and L. Wei and Pape, {J. W.} and J. Sanchez and E. Sandoval and K. Chokephaibulkit and J. Achalapong and G. Halue and P. Yuthavisuthi and S. Prommas and C. Bowonwatanuwong and V. Sirisanthana and S. Riddler and P. Kumar and W. Shearer and R. Yogev and G. Scott and S. Spector and C. Cunningham and M. Bamji and E. Cooper and A. Wiznia and J. Hitti and P. Emmanuel and R. Scott and M. Acevedo and S. Nachman and T. Jones and S. Rana",
note = "Funding Information: Financial support. Overall support for the IMPAACT Network was provided by the National Institute of Allergy and Infectious Diseases (NIAID) of the NIH under award numbers UM1AI068632 (IMPAACT Leadership and Operations Center), UM1AI068616 (IMPAACT Statistical and Data Management Center), and UM1AI106716 (IMPAACT Laboratory Center), with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Institute of Mental Health. Overall support for the ACTG was provided under NIAID award number 5UM1AI068636. The study products were provided free of charge by AbbVie, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline/ViiV, and Merck and Co. Funding Information: Potential conflicts of interest. A. C. has received a grant from FHI360. J. S. C. has received grants from Theratechnologies. S. S. B. has received grants from the NIH. M. U. P. has received grants from the NICHD. All other authors report no potential conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.",
year = "2019",
month = jan,
day = "7",
doi = "10.1093/cid/ciy471",
language = "English (US)",
volume = "68",
pages = "273--279",
journal = "Clinical Infectious Diseases",
issn = "1058-4838",
publisher = "Oxford University Press",
number = "2",
}