Birth outcomes following bictegravir exposure during pregnancy

Pediatric HIV; AIDS Cohort Study; HOPE study

doi:10.1097/QAD.0000000000004041

Birth outcomes following bictegravir exposure during pregnancy

Pediatric HIV, AIDS Cohort Study, HOPE study

Research output: Contribution to journal › Article › peer-review

2 Scopus citations

Abstract

Objective: Bictegravir is increasingly prescribed as a co-formulated tablet with tenofovir alafenamide and emtricitabine to pregnant persons with HIV (PWH) despite limited pregnancy and birth outcome data. We sought to provide birth outcome data following exposure to bictegravir during pregnancy. Design: We conducted a descriptive analysis of infants born to pregnant PWH 18-45 years of age enrolled in at least one Pediatric HIV/AIDS Cohort Study (PHACS)-affiliated study who received bictegravir for ≥7 days during pregnancy and completed follow-up through delivery. Methods: The outcomes of interest were gestational age at birth, preterm birth (<37 weeks' gestation), gestational-age adjusted birth weight (BWZ) and length (BLZ) Z-scores, small for gestational age (SGA, birthweight <10th percentile), congenital anomalies, neonatal deaths in the first 28 days of life, and infant HIV status. Results: A total of 177 infants born to 170 unique PWH were exposed to bictegravir for ≥7 days during gestation; 55% were exposed to bictegravir from the time of conception. Median gestational age at birth was 38.1 weeks. The prevalence of preterm birth was 15.8% and SGA was 9.3%. Mean BWZ and BLZ were -0.48 and 0.03. No neonatal deaths or perinatal HIV transmissions were reported. Among 126 infants exposed to first-trimester bictegravir, 7 (5.6%) had major congenital anomalies with no specific pattern suggestive of a syndrome. Conclusions: These findings provide preliminary data without significant safety concerns for fetal bictegravir exposure in this United States cohort. Comparative data and continued surveillance of outcomes among infants exposed to bictegravir during gestation are warranted.

Original language	English (US)
Pages (from-to)	381-386
Number of pages	6
Journal	AIDS
Volume	39
Issue number	4
DOIs	https://doi.org/10.1097/QAD.0000000000004041
State	Published - Mar 15 2025

Funding

We thank the participants and families for their participation in PHACS and HOPE, and the individuals and institutions involved in the conduct of the PHACS and HOPE studies. The Pediatric HIV/AIDS Cohort Study (PHACS) network was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Office of The Director, National Institutes of Health (OD), National Institute of Dental and Craniofacial Research (NIDCR), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Neurological Disorders and Stroke (NINDS), National Institute on Deafness and Other Communication Disorders (NIDCD), National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA), National Cancer Institute (NCI), National Institute on Alcohol Abuse and Alcoholism (NIAAA), and the National Heart, Lung, and Blood Institute (NHLBI) through grants to the Harvard T.H. Chan School of Public Health (P01HD103133, Principal Investigators: Ellen Chadwick, Sonia Hernandez-Diaz, Jennifer Jao, Paige Williams; Program Director: Liz Salomon). The HOPE study was supported by the Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD), through award R01HD101351 to the Harvard T.H. Chan School of Public Health (Principal Investigators: Paige Williams, Ellen Chadwick, Deborah Kacanek, Kathleen Powis; Protocol Co-Chairs: Deborah Kacanek, Kathleen Powis, Lynn Yee). Data management services for the PHACS network studies and HOPE were provided by Frontier Science (Data Management Center Director: Suzanne Siminski), and regulatory services and logistical support were provided by Westat, Inc. (Project Director: Tracy Wolbach). Funded by the Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD) through grants to the Harvard T.H. Chan School of Public Health (P01HD103133 and HD052102) and with Tulane University School of Medicine (HD052104) for the Pediatric HIV/AIDS Cohort Study (PHACS) network, and by grant HD101351 to Harvard T.H. Chan School of Public Health for the HOPE study.

Keywords

HIV-exposed
antiretroviral
congenital anomalies
infants
pregnancy
safety

ASJC Scopus subject areas

Immunology and Allergy
Immunology
Infectious Diseases

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1097/QAD.0000000000004041

Cite this

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title = "Birth outcomes following bictegravir exposure during pregnancy",

abstract = "Objective: Bictegravir is increasingly prescribed as a co-formulated tablet with tenofovir alafenamide and emtricitabine to pregnant persons with HIV (PWH) despite limited pregnancy and birth outcome data. We sought to provide birth outcome data following exposure to bictegravir during pregnancy. Design: We conducted a descriptive analysis of infants born to pregnant PWH 18-45 years of age enrolled in at least one Pediatric HIV/AIDS Cohort Study (PHACS)-affiliated study who received bictegravir for ≥7 days during pregnancy and completed follow-up through delivery. Methods: The outcomes of interest were gestational age at birth, preterm birth (<37 weeks' gestation), gestational-age adjusted birth weight (BWZ) and length (BLZ) Z-scores, small for gestational age (SGA, birthweight <10th percentile), congenital anomalies, neonatal deaths in the first 28 days of life, and infant HIV status. Results: A total of 177 infants born to 170 unique PWH were exposed to bictegravir for ≥7 days during gestation; 55% were exposed to bictegravir from the time of conception. Median gestational age at birth was 38.1 weeks. The prevalence of preterm birth was 15.8% and SGA was 9.3%. Mean BWZ and BLZ were -0.48 and 0.03. No neonatal deaths or perinatal HIV transmissions were reported. Among 126 infants exposed to first-trimester bictegravir, 7 (5.6%) had major congenital anomalies with no specific pattern suggestive of a syndrome. Conclusions: These findings provide preliminary data without significant safety concerns for fetal bictegravir exposure in this United States cohort. Comparative data and continued surveillance of outcomes among infants exposed to bictegravir during gestation are warranted.",

keywords = "HIV-exposed, antiretroviral, congenital anomalies, infants, pregnancy, safety",

author = "{Pediatric HIV} and {AIDS Cohort Study} and {HOPE study} and Rosemary Olivero and Williams, {Paige L.} and George Sawyer and Yee, {Lynn M.} and Kunjal Patel and Sonia Hernandez-Diaz and Kathleen Powis and Mary Paul and Chadwick, {Ellen G.}",

year = "2025",

month = mar,

day = "15",

doi = "10.1097/QAD.0000000000004041",

language = "English (US)",

volume = "39",

pages = "381--386",

journal = "AIDS",

issn = "0269-9370",

publisher = "Lippincott Williams and Wilkins",

number = "4",

}

TY - JOUR

T1 - Birth outcomes following bictegravir exposure during pregnancy

AU - Pediatric HIV

AU - AIDS Cohort Study

AU - HOPE study

AU - Olivero, Rosemary

AU - Williams, Paige L.

AU - Sawyer, George

AU - Yee, Lynn M.

AU - Patel, Kunjal

AU - Hernandez-Diaz, Sonia

AU - Powis, Kathleen

AU - Paul, Mary

AU - Chadwick, Ellen G.

PY - 2025/3/15

Y1 - 2025/3/15

N2 - Objective: Bictegravir is increasingly prescribed as a co-formulated tablet with tenofovir alafenamide and emtricitabine to pregnant persons with HIV (PWH) despite limited pregnancy and birth outcome data. We sought to provide birth outcome data following exposure to bictegravir during pregnancy. Design: We conducted a descriptive analysis of infants born to pregnant PWH 18-45 years of age enrolled in at least one Pediatric HIV/AIDS Cohort Study (PHACS)-affiliated study who received bictegravir for ≥7 days during pregnancy and completed follow-up through delivery. Methods: The outcomes of interest were gestational age at birth, preterm birth (<37 weeks' gestation), gestational-age adjusted birth weight (BWZ) and length (BLZ) Z-scores, small for gestational age (SGA, birthweight <10th percentile), congenital anomalies, neonatal deaths in the first 28 days of life, and infant HIV status. Results: A total of 177 infants born to 170 unique PWH were exposed to bictegravir for ≥7 days during gestation; 55% were exposed to bictegravir from the time of conception. Median gestational age at birth was 38.1 weeks. The prevalence of preterm birth was 15.8% and SGA was 9.3%. Mean BWZ and BLZ were -0.48 and 0.03. No neonatal deaths or perinatal HIV transmissions were reported. Among 126 infants exposed to first-trimester bictegravir, 7 (5.6%) had major congenital anomalies with no specific pattern suggestive of a syndrome. Conclusions: These findings provide preliminary data without significant safety concerns for fetal bictegravir exposure in this United States cohort. Comparative data and continued surveillance of outcomes among infants exposed to bictegravir during gestation are warranted.

AB - Objective: Bictegravir is increasingly prescribed as a co-formulated tablet with tenofovir alafenamide and emtricitabine to pregnant persons with HIV (PWH) despite limited pregnancy and birth outcome data. We sought to provide birth outcome data following exposure to bictegravir during pregnancy. Design: We conducted a descriptive analysis of infants born to pregnant PWH 18-45 years of age enrolled in at least one Pediatric HIV/AIDS Cohort Study (PHACS)-affiliated study who received bictegravir for ≥7 days during pregnancy and completed follow-up through delivery. Methods: The outcomes of interest were gestational age at birth, preterm birth (<37 weeks' gestation), gestational-age adjusted birth weight (BWZ) and length (BLZ) Z-scores, small for gestational age (SGA, birthweight <10th percentile), congenital anomalies, neonatal deaths in the first 28 days of life, and infant HIV status. Results: A total of 177 infants born to 170 unique PWH were exposed to bictegravir for ≥7 days during gestation; 55% were exposed to bictegravir from the time of conception. Median gestational age at birth was 38.1 weeks. The prevalence of preterm birth was 15.8% and SGA was 9.3%. Mean BWZ and BLZ were -0.48 and 0.03. No neonatal deaths or perinatal HIV transmissions were reported. Among 126 infants exposed to first-trimester bictegravir, 7 (5.6%) had major congenital anomalies with no specific pattern suggestive of a syndrome. Conclusions: These findings provide preliminary data without significant safety concerns for fetal bictegravir exposure in this United States cohort. Comparative data and continued surveillance of outcomes among infants exposed to bictegravir during gestation are warranted.

KW - HIV-exposed

KW - antiretroviral

KW - congenital anomalies

KW - infants

KW - pregnancy

KW - safety

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U2 - 10.1097/QAD.0000000000004041

DO - 10.1097/QAD.0000000000004041

M3 - Article

C2 - 39411892

AN - SCOPUS:85207327618

SN - 0269-9370

VL - 39

SP - 381

EP - 386

JO - AIDS

JF - AIDS

IS - 4

ER -

Birth outcomes following bictegravir exposure during pregnancy

Abstract

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

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