Infant Growth Outcomes After Maternal Tenofovir Disoproxil Fumarate Use During Pregnancy

Ransom, Carla E. MD*; Huo, Yanling MS; Patel, Kunjal DSc, MPH†,‡; Scott, Gwendolyn B. MD§; Watts, Heather D. MD; Williams, Paige PhD; Siberry, George K. MD, MPH; Livingston, Elizabeth G. MD; for the P1025 Team of the International Maternal Pediatric Adolescent AIDS Clinical Trials Group

JAIDS Journal of Acquired Immune Deficiency Syndromes: 1 December 2013 - Volume 64 - Issue 4 - p 374–381
doi: 10.1097/QAI.0b013e3182a7adb2
Clinical Science

Objective: To determine whether maternal use of tenofovir disoproxil fumarate for treatment of HIV in pregnancy predicts fetal and infant growth.

Methods: The study population included HIV-uninfected live-born singleton infants of mothers enrolled in the International Maternal Pediatric Adolescent AIDS Clinical Trials Group protocol P1025 (born 2002–2011) in the United States and exposed in utero to a combined (triple or more) antiretroviral regimen. Infant weight at birth and 6 months was compared between infants exposed and unexposed to tenofovir in utero using 2-sample t test, χ2 test, and multivariable linear and logistic regression models, including demographic and maternal characteristics.

Results: Among 2025 infants with measured birth weight, there was no difference between those exposed (N = 630, 31%) versus unexposed to tenofovir in mean birth weight (2.75 vs. 2.77 kg, P = 0.64) or mean gestational age- and sex-adjusted birth weight z-score (WASZ) (0.14 vs. 0.14, P = 0.90). Among 1496 infants followed for 6 months, there was no difference in mean weight at 6 months between tenofovir-exposed (N = 457, 31%) and tenofovir-unexposed infants (7.64 vs. 7.59 kg, P = 0.52) or in mean WASZ (0.29 vs. 0.26, P = 0.61). Tenofovir exposure during the second/third trimester, relative to no exposure, significantly predicted underweight (WASZ < 5%) at age 6 months [odds ratio (95% confidence interval): 2.06 (1.01 to 3.95), P = 0.04]. Duration of tenofovir exposure did not predict neonatal or infant growth.

Conclusions: By most measures, in utero exposure to tenofovir did not significantly predict infant birth weight or growth through 6 months of age.

*Department of Obstetrics and Gynecology, Vanderbilt University, Nashville, TN;

Center for Biostatistics in AIDS Research and

Department of Epidemiology, Harvard School of Public Health, Boston, MA;

§Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL;

Maternal and Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institutes of Child Health and Human Development, National Institutes of Health, Bethesda, MD; and

Department of Obstetrics and Gynecology, Duke University Medical School, Durham, NC.

Correspondence to: Carla E. Ransom, MD, Department of Obstetrics and Gynecology, B-1100 Medical Center North, Vanderbilt University, Nashville, TN 37232-2519 (e-mail:

Overall support for the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Group was provided by the National Institute of Allergy and Infectious Diseases (NIAID) Grant U01 AI068632, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and the National Institute of Mental Health Grant AI068632. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. This work was supported by the Statistical and Data Analysis Center at Harvard School of Public Health, under the National Institute of Allergy and Infectious Diseases cooperative agreement 5 U01 AI41110 with the Pediatric AIDS Clinical Trials Group and 1 U01 AI068616 with the IMPAACT Group. Support of the sites was provided by NIAID and NICHD, International and Domestic Pediatric and Maternal HIV Clinical Trials Network funded by NICHD Contract N01-DK-9-001/HHSN267200800001C.

Presented at the International AIDS Society 2012 Meeting, July 22–27, 2012, Washington, DC.

The authors have no conflicts of interest to disclose.

Received April 30, 2013

Accepted July 29, 2013

© 2013 by Lippincott Williams & Wilkins