CROI 2024 Abstract eBook

Abstract eBook

Poster Abstracts

933

Birth Outcomes Following Bictegravir Use During Pregnancy Rosemary M Olivero 1 , Paige L. Williams 2 , George Sawyer 2 , Lynn Yee 3 , Kunjal Patel 4 , Sonia Hernandez-Diaz 2 , Kathleen M. Powis 2 , Mary Paul 5 , Ellen G. Chadwick 3 , for the Pediatric HIV/AIDS Cohort Study (PHACS) 1 Corewell Health Helen DeVos Children's Hospital, Grand Rapids, MI, USA, 2 Harvard University, Boston, MA, USA, 3 Northwestern University, Chicago, IL, USA, 4 Harvard University, Cambridge, MA, USA, 5 Baylor College of Medicine, Houston, TX, USA Background: Bictegravir (BIC), co-formulated in a tablet with tenofovir alafenamide and emtricitabine, is being increasingly prescribed to pregnant persons with HIV (PWH), yet limited birth outcome data have been reported. Methods: We conducted a descriptive analysis of PWH 18-45 years of age enrolled in at least one Pediatric HIV/AIDS Cohort Study (PHACS)-affiliated protocol who received BIC for at least 7 days during pregnancy and completed follow-up through delivery. The outcomes of interest were gestational age at birth, preterm birth (<37 weeks' gestation), gestational-age adjusted birth weight (BWZ) and length (BLZ) z-scores (CDC 2000 growth standards), small for gestational age (SGA, birthweight <10th percentile), congenital anomalies, neonatal deaths in the first 28 days of life, and infant HIV status. The prevalence [with Clopper-Pearson 95% Confidence Intervals (CIs)] of each outcome was calculated among infants exposed to BIC during gestation and, for the outcome of anomalies, in infants exposed during the first trimester. Maternal CD4 count and HIV viral load (VL) nearest and prior to delivery were reported if available. Results: A total of 144 infants were born to 134 unique PWH (including 2 twin sets) who received BIC for at least 7 days during pregnancy. Infants were born between September 2018 and October 2023. Median maternal age at delivery was 29.7 years (interquartile range (IQR): 26.1, 33.9), 71% reported their race/ ethnicity as Black or African American, and 52% had an annual household income ≤$20,000; all US census regions were represented. Fifty-three percent initiated BIC prior to conception. The mean gestational age was 38.2 weeks [standard deviation (SD)=1.5], the prevalence of preterm birth was 14.0% (95% CI: 8.8%, 20.8%) and SGA was 10.6% (95% CI 6.0%, 16.8%). Mean BWZ and BLZ were -0.49 (SD 0.93) and 0.08 (SD 1.13), respectively (Table). No neonatal deaths or perinatal HIV transmissions were reported. Among 99 infants exposed to BIC in the first trimester, 5 (5.1%, 95% CI 1.7%, 11.4%) had at least one congenital anomaly reported (Table). Maternal VL was <50 copies/mL in 82.0% and median CD4 count was 466.5 (IQR: 309.0, 744.0) cells/mm 3 nearest to delivery of exposed infants. Conclusion: In this US cohort, BIC use during pregnancy was frequent. These findings provide initial reassuring observations about the potential safety of BIC use during pregnancy, although comparative data and continued surveillance of outcomes of antiretroviral therapy among PWH is warranted.

932

Outcomes Following Prenatal Exposure to Raltegravir: A Multi-Cohort European Study Rebecca Sconza 1 , Georgina Fernandes 1 , Karoline Aebi-Popp 2 , Luminita Ene 3 , Antoinette Frick 4 , Anna Gamell 5 , Marta Illán Ramos 6 , Christian Kahlert 7 , Helen Peters 1 , Luis M. Prieto Tato 8 , Anna Samarina 9 , Carlo Giaquinto 10 , Claire Thorne 1 , for the EPPICC Pregnancy Study Group 1 UCL Great Ormond Street Institute of Child Health, London, United Kingdom, 2 University Hospital of Bern, Bern, Switzerland, 3 Dr Victor Babeș Timișoara Infectious Diseases and Pneumophysiology Clinical Hospital, Bucharest, Romania, 4 Hospital Universitario de la Vall d’Hebron, Barcelona, Spain, 5 Hospital Sant Joan de Déu Barcelona, Barcelona, Spain, 6 Hospital Universitario Clí¬nico San Carlos, Madrid, Spain, 7 Children's Hospital of Eastern Switzerland St. Gallen, St Gallen, Switzerland, 8 Hospital Universitario 12 de Octubre, Madrid, Spain, 9 St. Petersburg Center for Prevention and Control of AIDS and Infectious Diseases, St Petersburg, Russian Federation, 10 University of Padova, Padova, Italy Background: Real world data on safety of antiretroviral drugs (ARVs) in pregnancy informs decision-making, but accumulating sufficiently large samples with specific periconception ARV exposure to rule out increased risk of rare birth defects, such as neural tube defects (NTDs), can take many years. Methods: We assessed risk of birth defects and other adverse outcomes following prenatal exposure to raltegravir (RAL) using pooled prospectively collected individual patient data from studies in the European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC). Pregnancies with any documented prenatal exposure to RAL and with outcomes in 2008-2020 were included. Earliest prenatal RAL exposure timing was classified as periconception (PC) (exposure at ≤6 completed gestational weeks [GWs]), later first trimester (later T1) (exposure in T1 at >6 completed GWs), and second/third trimester (T2/T3) (exposure at >12 completed GWs). Results: A total of 1499 pregnancies across 9 cohorts were included (1194, 79.7% from the UK). Most pregnancies were in women of Black (898/1480, 60.7%) or white (466/1480, 31.5%) ethnicity. Median age at conception was 32 years (IQR: 27-36). Half (763/1487, 51.3%) of RAL-exposed pregnancies were conceived on ARVs. There were 1429 live births (1466 live-born infants), 10 stillbirths, 41 spontaneous abortions, and 19 terminations. Among stillbirths, earliest RAL exposure was PC in 3, later T1 in 1, and T2/T3 in 6, with no defects reported. Birth outcomes of live-born singleton infants (1393) by timing of earliest RAL exposure are in the Table. Among all live-born infants (1466), earliest RAL exposure was PC in 466 (31.8%), later T1 in 62 (4.2%), T2/T3 in 892 (60.9%), and unknown in 46 (3.1%). Where data were available (1443/1466), 56 (3.9%, 95% CI 2.9, 5.0) live-born infants had a reported birth defect (9 had 2 defects), including 23/461 (5.0%, 95% CI 3.2, 7.4) of those with PC exposure; 38 (2.6%, 95% CI 1.9, 3.6) infants had defects per EUROCAT classification. Defects were in the following systems: heart (20), limb (16), CNS (5), genitourinary (4), gastrointestinal (2), oral facial cleft (2), ear, face and neck (1), respiratory (1), musculoskeletal (1), and other (13). One NTD was observed (spina bifida with PC exposure). Of the 5 neonatal deaths (2 with PC, 3 with T2/T3 exposure), 2 had defects. Conclusion: The birth defect rate in EPPICC is consistent with and contributes to the current evidence-base on safety of periconception RAL use.

Poster Abstracts

CROI 2024 294