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Article Dolutegravir – A review of the pharmacology, efficacy, and s...

Placental and Breast Milk Passage Placental transfer of dolutegravir in an ex vivo perfusion model was high, with a fetal-to-maternal ratio of 60%.8 High placental transfer of dolutegravir has been confirmed in several of the case reports.2,5,6 In a report from one breast feeding mother receiving dolutegravir and her infant, the dolutegravir breast milk-to-maternal-plasma-concentration ratio was 0.02 and the plasma dolutegravir concentration in the infant was 0.10 mg/L, equal to the dolutegravir target trough plasma concentration in treatment-naive patients.9

Teratogenicity Data As of January 31, 2017, the overall birth defect rate was 3.0% (4 infants) in 133 live births from 142 pregnancies with exposure to dolutegravir reported to the Antiretroviral Pregnancy Registry.10 In the larger PK study in pregnant women, discussed above, birth abnormalities were reported in 4 of 18 infants: total anomalous pulmonary venous return; cystic fibrosis and polycystic right kidney; congenital chin tremor; sacral dimple with filum terminale fibrolipoma.11 In 2 reviews of clinical experience with pregnant women receiving dolutegravir, birth defects were noted in 3 infants born to 42 European women and in no infants born to 116 women from Botswana receiving dolutegravir during the first trimester.12,13

https://aidsinfo.nih.gov/guidelines/html/3/perinatal/447/dolutegravir--tivicay--dtg-

http://gtt-vih.org/actualizate/la_noticia_del_dia/11-10-16

Maternal antiretroviral therapy may increase the risk of preterm delivery, although available information is conflicting possibly due to variability of maternal factors (disease severity; initiation of therapy); however, maternal antiretroviral medication should not be withheld due to concerns of preterm birth. Information related to stillbirth, low birth weight, and small for gestational age infants is limited. Long-term follow-up is recommended for all infants exposed to antiretroviral medications .

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