Maternal Tenofovir Disoproxil Fumarate Use During Pregnancy Is Not Associated With Adverse Perinatal Outcomes Among HIV-infected East African Women: A Prospective Study

J Infect Dis. 2017 Dec 19;216(12):1561-1568. doi: 10.1093/infdis/jix542.

Abstract

Background: Tenofovir disoproxil fumarate (TDF) is commonly used in antiretroviral treatment (ART) and pre-exposure prophylaxis regimens. We evaluated the relationship between adverse perinatal outcomes and prenatal TDF use.

Methods: Longitudinal data were analyzed from human immunodeficiency virus (HIV)-infected women who became pregnant during 2 HIV prevention studies conducted among HIV-serodiscordant couples in Kenya and Uganda. Pregnancies included were singleton, not terminated by an induced abortion, and had documented 3-drug ART use. Multivariate generalized estimating equation models were used to determine the association of prenatal TDF and perinatal outcomes.

Results: The most frequent ART regimens were TDF/3TC/EFV (39%) and AZT/3TC/NVP (34%); 49% of pregnancies had prenatal TDF exposure and 6% used a protease inhibitor. Neonatal death, preterm birth, and pregnancy loss occurred in 2%, 8%, and 12% of pregnancies, respectively. No differences were observed between pregnancies with and without exposure to TDF in the frequency of pregnancy loss (adjusted prevalence rate ratio [aPRR] 1.19, P = .8) or neonatal death (aPRR 0.68, P = .6). Preterm birth occurred less frequently among pregnancies exposed to TDF (aPRR, 0.34, P = .02).

Conclusion: Maternal TDF use did not adversely affect perinatal outcomes.

Keywords: antiretroviral therapy; pre-exposure prophylaxis; pregnancy loss; preterm birth; tenofovir.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-HIV Agents / adverse effects*
  • Anti-HIV Agents / therapeutic use*
  • Female
  • HIV Infections / complications*
  • HIV Infections / drug therapy*
  • Humans
  • Kenya / epidemiology
  • Longitudinal Studies
  • Pregnancy
  • Pregnancy Complications / epidemiology*
  • Prevalence
  • Prospective Studies
  • Tenofovir / adverse effects*
  • Tenofovir / therapeutic use*
  • Treatment Outcome
  • Uganda / epidemiology
  • Young Adult

Substances

  • Anti-HIV Agents
  • Tenofovir