Safety of tenofovir use during pregnancy: early growth outcomes in HIV-exposed uninfected infants

George K Siberry, Paige L Williams, Hermann Mendez, George R Seage 3rd, Denise L Jacobson, Rohan Hazra, Kenneth C Rich, Raymond Griner, Katherine Tassiopoulos, Deborah Kacanek, Lynne M Mofenson, Tracie Miller, Linda A DiMeglio, D Heather Watts, Pediatric HIV/AIDS Cohort Study (PHACS), Suzanne Siminski, Mercy Swatson, William Shearer, Norma Cooper, Lynette Harris, Murli Purswani, Emma Stuard, Anna Cintron, Ana Puga, Dia Cooley, Doyle Patton, Richard Rutstein, Carol Vincent, Nancy Silverman, Ram Yogev, Kathleen Malee, Scott Hunter, Eric Cagwin, Andrew Wiznia, Marlene Burey, Molly Nozyce, William Borkowsky, Sandra Deygoo, Helen Rozelman, Katherine Knapp, Kim Allison, Patricia Garvie, Midnela Acevedo-Flores, Lourdes Angeli-Nieves, Vivian Olivera, Ava Dennie, Susan Bewley, Sharon Nachman, Margaret Oliver, Helen Rozelman, Russell Van Dyke, Karen Craig, Patricia Sirois, Marilyn Crain, Newana Beatty, Dan Marullo, Stephen Spector, Jean Manning, Sharon Nichols, Elizabeth McFarland, Emily Barr, Robin McEvoy, Mobeen Rathore, Kathleen Thoma, Ann Usitalo, K C R, Delmyra Turpin, Renee Smith, Douglas Watson, LaToya Stubbs, Rose Belanger, Arry Dieudonne, Linda Bettica, Susan Adubato, Gwendolyn Scott, Erika Lopez, Elizabeth Willen, Toinette Frederick, Marian Davtyan, Maribel Mejia, Zoe Rodriguez, Ibet Heyer, Nydia Scalley Trifilio, George K Siberry, Paige L Williams, Hermann Mendez, George R Seage 3rd, Denise L Jacobson, Rohan Hazra, Kenneth C Rich, Raymond Griner, Katherine Tassiopoulos, Deborah Kacanek, Lynne M Mofenson, Tracie Miller, Linda A DiMeglio, D Heather Watts, Pediatric HIV/AIDS Cohort Study (PHACS), Suzanne Siminski, Mercy Swatson, William Shearer, Norma Cooper, Lynette Harris, Murli Purswani, Emma Stuard, Anna Cintron, Ana Puga, Dia Cooley, Doyle Patton, Richard Rutstein, Carol Vincent, Nancy Silverman, Ram Yogev, Kathleen Malee, Scott Hunter, Eric Cagwin, Andrew Wiznia, Marlene Burey, Molly Nozyce, William Borkowsky, Sandra Deygoo, Helen Rozelman, Katherine Knapp, Kim Allison, Patricia Garvie, Midnela Acevedo-Flores, Lourdes Angeli-Nieves, Vivian Olivera, Ava Dennie, Susan Bewley, Sharon Nachman, Margaret Oliver, Helen Rozelman, Russell Van Dyke, Karen Craig, Patricia Sirois, Marilyn Crain, Newana Beatty, Dan Marullo, Stephen Spector, Jean Manning, Sharon Nichols, Elizabeth McFarland, Emily Barr, Robin McEvoy, Mobeen Rathore, Kathleen Thoma, Ann Usitalo, K C R, Delmyra Turpin, Renee Smith, Douglas Watson, LaToya Stubbs, Rose Belanger, Arry Dieudonne, Linda Bettica, Susan Adubato, Gwendolyn Scott, Erika Lopez, Elizabeth Willen, Toinette Frederick, Marian Davtyan, Maribel Mejia, Zoe Rodriguez, Ibet Heyer, Nydia Scalley Trifilio

Abstract

Objective: To evaluate the association of tenofovir disoproxil fumarate (TDF) use during pregnancy with early growth parameters in HIV-exposed, uninfected (HEU) infants.

Design: US-based prospective cohort study of HEU children to examine potential adverse effects of prenatal TDF exposure.

Methods: We evaluated the association of maternal TDF use during pregnancy with small for gestational age (SGA); low birth weight (LBW, <2.5 kg); weight-for-age z-scores (WAZ), length-for-age z-scores (LAZ), and head circumference-for-age (HCAZ) z-scores at newborn visit; and LAZ, HCAZ, and WAZ at age 1 year. Logistic regression models for LBW and SGA were fit, adjusting for maternal and sociodemographic factors. Adjusted linear regression models were used to evaluate LAZ, WAZ, and HCAZ by TDF exposure.

Results: Of 2029 enrolled children with maternal antiretroviral information, TDF was used by 449 (21%) HIV-infected mothers, increasing from 14% in 2003 to 43% in 2010. There was no difference between those exposed to combination regimens with vs. without TDF for SGA, LBW, and newborn LAZ and HCAZ. However, at age 1 year, infants exposed to combination regimens with TDF had significantly lower adjusted mean LAZ and HCAZ than those without TDF (LAZ: -0.17 vs. -0.03, P=0.04; HCAZ: 0.17 vs. 0.42, P=0.02).

Conclusion: TDF use during pregnancy was not associated with increased risk for LBW or SGA. The slightly lower mean LAZ and HCAZ observed at age 1 year in TDF-exposed infants are of uncertain significance but underscore the need for additional studies of growth outcomes after TDF use during pregnancy.

Conflict of interest statement

All authors declare no conflict of interest.

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Source: PubMed

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