1. Pregnancy outcomes and infant growth among babies with in-utero exposure to tenofovir-based preexposure prophylaxis for HIV prevention
- Author
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Mark A. Marzinke, Connie Celum, Kenneth Ngure, Stephen Asiimwe, Jared M. Baeten, Nelly Mugo, Ting Hong, Renee Heffron, Josephine Odoyo, Elizabeth A. Bukusi, Tindimwebwa E, Nulu Bulya, and Elly Katabira
- Subjects
Adult ,0301 basic medicine ,medicine.medical_specialty ,Drug-Related Side Effects and Adverse Reactions ,Anti-HIV Agents ,Immunology ,Human immunodeficiency virus (HIV) ,HIV Infections ,Placebo ,medicine.disease_cause ,Article ,03 medical and health sciences ,Child Development ,0302 clinical medicine ,Pregnancy ,medicine ,Humans ,Immunology and Allergy ,Uganda ,Longitudinal Studies ,030212 general & internal medicine ,Tenofovir ,Pregnancy outcomes ,Maternal-Fetal Exchange ,Obstetrics ,business.industry ,Infant, Newborn ,Pregnancy Outcome ,Odds ratio ,medicine.disease ,Kenya ,030112 virology ,Child development ,Infectious Diseases ,In utero ,Serodiscordant ,Female ,Pre-Exposure Prophylaxis ,business - Abstract
BACKGROUND Global guidelines recommend preexposure prophylaxis (PrEP) use by women at risk for HIV, including during pregnancy, a period with heightened HIV risk. However, data to support safety of PrEP use during pregnancy are limited, particularly from women using PrEP throughout pregnancy. METHODS In an open-label delivery study of PrEP integrated with ART for high-risk HIV serodiscordant couples in Kenya and Uganda (the Partners Demonstration Project), women who became pregnant while using PrEP were offered the option to continue PrEP throughout pregnancy. We compared pregnancy outcomes and 1-year infant growth from pregnancies with exposure to PrEP throughout pregnancy to those without any exposure, with data from the placebo arm of a prior efficacy trial of PrEP conducted in the same setting. RESULTS Outcomes from 30 women who elected to continue PrEP throughout pregnancy were compared with those from 96 pregnancies among PrEP-unexposed women. There were small nonsignificant decreases in the frequency of pregnancy loss [16.7% PrEP-exposed versus 23.5% PrEP-unexposed, adjusted odds ratio (aOR) = 0.59, P = 0.4] and preterm delivery [0 versus 7.7%, (aOR) = 0.54, exact P = 0.6]. No congenital anomalies occurred among PrEP-exposed infants. PrEP-exposed infants had slightly lower adjusted mean z-scores for length (-1.73 versus -0.79, P = 0.05) and head circumference (0.24 versus 1.07, P = 0.04) 1 month after birth but were comparable to PrEP-unexposed infants in these measurements 1 year after birth. CONCLUSION This first evaluation among women using PrEP throughout pregnancy indicates no greater frequency of adverse pregnancy outcomes or restricted infant growth; these findings support recommendations permitting PrEP use during pregnancy.
- Published
- 2018
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