(P7) Use of integrase inhibitors during pregnancy in Women Living With HIV in Denmark

Författare/Medförfattare

Ellen Moseholm [1], Terese L Katzenstein [2], Merete Storgaard [3], Gitte Pedersen [4], Isik S. Johansen [5], Nina Weis [1,6]

Affiliates

Department of Infectious Diseases, Copenhagen University Hospital, Hvidovre, Denmark [1] Department of Infectious Diseases, Copenhagen University Hospital, Rigshospitalet, Denmark [2] Department of Infectious Diseases, Aarhus University Hospital, Denmark [3] Department of Infectious Diseases, Aalborg University Hospital, Denmark [4] Department of Infectious Diseases, Odense University Hospital, Denmark [5] Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark [6]

Abstract

Background
Integrase inhibitors (InST) are increasingly prescribed as first-line treatment including by Women Living With HIV (WLWH) of childbearing potential. The safety and efficacy of InSTs are not well established in pregnancy and concerns have been raised especially regarding the use of dolutegravir in early pregnancy. The aim of this nationwide cohort study is to assess maternal and infant outcomes of mother-infant pairs using InSTs during pregnancy in Denmark.

Methods
The Danish HIV Birth Cohort (DHBC) is a prospective, nationwide, population-based cohort study including all WLWH giving birth to one or more children in Denmark after 31 December 1999, with consecutive ongoing enrollment. All women giving birth to one or more children between 2014 – 2018 and treated with InST prior to or during pregnancy were identified. Maternal outcomes included CD4 count and viral suppression (viral load of <20 copies/ml prior to delivery), and tolerability to InsT. Infant outcomes included preterm delivery (birth at <37 weeks), low birth weight (<2500 g), infant HIV status at birth, birth defect(s), infant hemoglobin (HgB) level at birth and Appearance, Pulse, Grimace, Activity, Respiration (APGAR) scores at 10 minutes.

Results
A total of 172 children were born to 138 WLWH during the study period. In total, 23 (16.7%) women received treatment with InST at any time during pregnancy (Raltegravir n=12, Dolutegravir n=9 and Eltegravir n=2), of whom 15 (65.2%) were receiving InST at conception (Raltegravir n=4, Dolutegravir n=9 and Eltegravir n=2). The WLWH were well treated at the time of delivery; 91% (n=21) had a CD4 count >350 cells/μL and 78% (n=18) had an undetectable viral load. There were no reported side effects during pregnancy. There was no significant difference in CD4 count and HIV RNA at delivery between WLWH treated with InST and WLWH not receiving InST. Infants exposed to InST had a mean APGAR score of 9 (SD 0.7) at 10 min, 13% (n=3) were born prematurely, 17% (n=4) had a low birth weight, and 9% (n=2) had a low Hgb level (<7.8). None of the infants had a birth defect and no cases of HIV transmission occurred. There was no significant difference in any of the infant outcomes (preterm birth, low birthweight, APGAR score and HgB level) between infants exposed to InST and infants born to WLWH not exposed to InST.

Conclusion
Treatment with integrase inhibitors, including Dolutegravir, in pregnancy seems to be well tolerated and effective among women living with HIV and their infants in Denmark. Infant outcomes (preterm deliveries and birth defects) needs to be investigated in larger studies.