First-line ART for pregnant and breastfeeding women and ARV drugs for their infants

Consolidated ARV guidelines, June 2013

Rationale and supporting evidence: Safety of TDF in pregnancy and during breastfeeding

Potential concerns about the safety of TDF include renal toxicity (see section 7.4.3), adverse birth outcomes and effects on bone density. A systematic review assessed the toxicity of fetal exposure to TDF in pregnancy (Web Annex).

In the Antiretroviral Pregnancy Registry, the prevalence of overall birth defects with exposure to TDF in the first trimester was 2.4% of 1612 live births and did not differ from the background rate in the USA. A limited number of studies showed no difference in fetal growth between infants exposed or not exposed to TDF (144,145). TDF has limited penetration into breast-milk, which would limit potential toxicity for the breastfeeding infant. However, there have been no studies of TDF among lactating women, who normally have bone loss during breastfeeding that stabilizes after lactation. More extensive studies are ongoing of TDF bone and renal safety in pregnancy and breastfeeding for both the mother and child.

The once-daily TDF + 3TC (or FTC) + EFV fixed-dose regimen is simple and convenient, and harmonizing the recommendations for pregnant and non-pregnant women simplifies supply chain management. Based on available data and experience, the Guidelines Development Group felt that the clear benefits of this regimen for pregnant and breastfeeding women (and women of childbearing potential) outweigh the potential risks (see section 7.5.2).