Safety of antiretroviral drugs in pregnancy and breastfeeding for mother and child

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Purpose of review

The introduction of combination ART to prevent mother-to-child-transmission (MTCT) has substantially decreased MTCT rates. However, there are concerns regarding safety of ART exposure for the mother, pregnancy outcome and infant. Changing MTCT prevention guidelines, with expanded eligibility, have led to a rapid increase of ART-treated women and exposed infants in high prevalence regions.

Recent findings

Recent studies confirm that ART in HIV-infected mothers decreases disease progression and mortality, also after delivery. However extended duration of ART, especially HAART, during pregnancy has also been associated with premature delivery, small-for-gestational age (SGA) infants and pregnancy complications including hypertension. In the uninfected infant, ART exposure was associated with levels of hematologic and immunological markers, which, in high microbial regions, may be clinically relevant, especially in combination with premature birth and SGA. Altered mitochondrial functioning is reported in ART-exposed children although clinical implications remain difficult to discern.


The benefit of ART in the prevention of MTCT is beyond doubt, but there are reports on adverse effects on pregnancy outcome and infant currently also from high prevalence regions. Further research regarding safety is urgently required, as the number of pregnant women on ART and exposed uninfected infants is rapidly increasing.

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