Background: Dolutegravir (DTG) is an integrase strand inhibitor approved for the treatment of HIV in adults and adolescents since 2013. There is minimal information on use of DTG in pregnant women. Our aim was to assess maternal and fetal outcomes following DTG use during pregnancy in real-world European settings.
Methods: A retrospective analysis of individual patient data prospectively collected in observational studies of pregnant women living with HIV and their infants within the European Pregnancy and Paediatric HIV Cohort Collaboration was conducted. All women with any prenatal exposure to DTG and reported to studies by September 2016 were included.
Results: A total of 81 pregnancies in 81 women were identified. Median maternal age at conception was 33.1 years (interquartile range [IQR], 26.7-37.1 years), and 44/81 (54.3%) born in sub-Saharan Africa. Most (62/74, 83.8%, 7 unknown acquisition) women had heterosexual acquisition of HIV, 9 women were vertically infected and 3 had injecting drug use acquisition. Most women had been diagnosed with HIV before conception (70/75, 6 unknown), 48 conceived whilst on any ART and 28 conceived on a DTG-based regimen. There were two twin pregnancies (all live births). Pregnancy outcomes were known for 64 pregnancies (1 moved to another country before delivery, 16 continuing): 61 ended in live births (29 with 1st trimester DTG exposure), 1 in stillbirth (without 1st trimester DTG exposure), 1 in termination (with 1st trimester DTG exposure) and 1 in spontaneous abortion (with 1st trimester DTG exposure). Birth outcomes for the 63 delivered liveborn infants (including 2 twin pairs) and 1 stillborn infant (62 pregnancies) are in the Table. The congenital abnormalities with 1st trimester DTG exposure were: patent foramen ovale; bilateral hexadactyly of hands (familial) and hypospadias (both in 1 child); in 2nd trimester: ankyloglossia.

 1st trimester earliest DTG exposure2nd / 3rd trimester earliest DTG exposure
First prenatal CD4 count (median, IQR)#525 cells/mm3 (323-660)338 cells/mm3 (218-591)
Preterm delivery (<37 weeks)*2/27 (7.4%)9/33 (27.3%)
Low birth weight (<2500g)*8/25 (32.0%)13/33 (39.4%)
Very low birth weight (<1500g)*0/25 (0.0%)0/33 (0.0%)
Congenital abnormality (livebirths)2/29 (6.9%) (2 missing)1/32 (3.1%) (0 missing)
# available for 58 of 62 pregnancies* calculated for the 60 singleton deliveries (59 livebirths, 1 stillbirth) only 
[Characteristics by trimester of DTG exposure]

Conclusions: Although this is the largest study to date, small numbers preclude firm conclusions regarding safety of DTG in pregnancy and further prospective monitoring is required.

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