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

Consolidated ARV guidelines, June 2013

Rationale and supporting evidence

The 2013 guidelines emphasize simplifying and harmonizing first-line therapy. A once-daily fixed-dose combination regimen is recommended, with TDF as the preferred NRTI and EFV as the preferred NNRTI, in combination with 3TC or FTC for all adults – including pregnant and breastfeeding women – as the preferred regimen to improve health outcomes and facilitate adherence and drug procurement (see section 7.2.1 and Web Annex)

The ideal first-line regimen for pregnant and breastfeeding women with HIV has low cost; is available as a fixed-dose combination; is safe for both pregnant and breastfeeding women and their infants; is well tolerated; has low monitoring requirements and a low drug-resistance profile; is compatible with other drugs used in clinical care; and is harmonized with the recommendations for non-pregnant adults.

The regimen of TDF + 3TC (or FTC) + EFV is available as a once-daily fixed-dose combination and is the recommended first-line regimen for adults because of simplicity, affordability (the cost has declined significantly since 2010) and efficacy against HBV.

Safety is a critical issue for pregnant and breastfeeding women and their infants as well as women who might become pregnant. Although data on EFV and TDF use in pregnant women remain limited, more data have become available since 2010 and provide increased reassurance for recommending TDF + 3TC (or FTC) + EFV as the first-line ARV regimen for pregnant and breastfeeding women (122 139 140). Sections 7.3.1 and 7.5.2 provide more detail on the overall rationale for the recommended first-line regimen, including toxicity and monitoring issues.