Tenofovir disoproxil fumarate safety for women and their infants during pregnancy and breastfeeding

AIDS. 2017 Jan 14;31(2):213-232. doi: 10.1097/QAD.0000000000001313.


Objectives: Pregnant/lactating women in some sub-Saharan Africa settings are at substantial risk of HIV acquisition and could benefit from preexposure prophylaxis (PrEP) with tenofovir disoproxil fumarate (TDF), but safety data in pregnancy/lactation are limited.

Design: Systematic data review through August 2016.

Methods: We reviewed research reports/conference abstracts with maternal/child adverse outcome data in HIV-infected and HIV-uninfected pregnant/lactating women receiving TDF alone or in combination with other drugs compared with non-TDF regimens.

Results: In total, 26 articles in HIV-infected and seven in HIV-uninfected women were identified. No statistically significant differences were observed between TDF and comparison non-TDF regimens in pregnancy incidence, stillbirth/pregnancy loss, preterm delivery less than 37 weeks, low birth weight <2500/<1500 g, small for gestational age, birth defects, or infant (>14 days) or maternal mortality. One study reported significantly higher very preterm delivery (<34 weeks) and neonatal mortality with TDF versus non-TDF antiretroviral therapy (ART), but no significant difference between TDF ART and zidovudine/single-dose nevirapine. Most studies report normal infant linear growth; one study showed slightly lower, and one higher 1-year length-for-age z-score in TDF ART-exposed infants. No significant differences were reported in abnormal laboratory values or bone markers between TDF and non-TDF-exposed infants in four studies. Lower maternal bone mineral density was observed at 74 weeks postpartum in breastfeeding women on TDF ART compared with no ART in one study.

Conclusion: Given available safety data, there does not appear to be a safety-related rationale for prohibiting PrEP during pregnancy/lactation or for discontinuing PrEP in HIV-uninfected women receiving PrEP who become pregnant and are at continuing risk of HIV acquisition.

Publication types

  • Review
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Africa South of the Sahara
  • Anti-HIV Agents / administration & dosage
  • Anti-HIV Agents / adverse effects*
  • Breast Feeding*
  • Disease Transmission, Infectious / prevention & control*
  • Drug-Related Side Effects and Adverse Reactions / epidemiology*
  • Female
  • HIV Infections / prevention & control*
  • HIV Infections / transmission
  • Humans
  • Infant
  • Infant, Newborn
  • Pre-Exposure Prophylaxis / methods*
  • Pregnancy
  • Tenofovir / administration & dosage
  • Tenofovir / adverse effects*


  • Anti-HIV Agents
  • Tenofovir