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Outcomes After Prenatal Exposure to Raltegravir-Containing Antiretroviral Therapy: A Multicohort European Study
Rebecca Sconza1, Georgina Fernandes1, Heather Bailey2
1UCL Great Ormond Street Institute of Child Health, London, United Kingdom.
Journal of Acquired Immune Deficiency Syndromes (1999)
|February 25, 2025
Summary
Prenatal exposure to raltegravir, an HIV medication, showed no increased risk of birth defects or adverse outcomes in infants. Safety monitoring for rare events is still recommended.
Area of Science:
- Reproductive Health
- Pharmacovigilance
- Infectious Diseases
Background:
- Raltegravir is an HIV integrase strand transfer inhibitor.
- It is recommended for use during pregnancy.
- The study assessed risks associated with prenatal raltegravir exposure.
Purpose of the Study:
- To evaluate the risk of birth defects after prenatal exposure to raltegravir.
- To assess other suboptimal infant outcomes following in utero raltegravir exposure.
- To analyze outcomes based on the timing of raltegravir exposure during pregnancy.
Main Methods:
- Pooled individual patient data from the European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC).
- Included pregnancies with raltegravir exposure between 2008-2020.
- Classified birth defects using ICD and EUROCAT criteria; exposure timing categorized as periconception, first trimester, and second/third trimester.
Main Results:
- 1499 pregnancies were analyzed; 3.9% of live-born infants had birth defects.
- No increased risk of birth defects was observed with periconception raltegravir exposure.
- Preterm birth, low birthweight, and small for gestational age rates were similar across all exposure timing groups.
Conclusions:
- Raltegravir use in pregnancy appears safe regarding major birth defects and other adverse outcomes.
- Findings contribute to the safety evidence for raltegravir during gestation.
- Continued safety monitoring is advised to detect potential rare adverse events.
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