Outcomes after prenatal exposure to raltegravir-containing antiretroviral therapy
Integrase inhibitors such as raltegravir are increasingly used during pregnancy due to their rapid viral suppression and good tolerability, but data on their safety during early pregnancy remain limited.
Sconza et al and the European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC) analyzed 1,499 pregnancies with raltegravir exposure across nine European cohorts (including MOCHIV) between 2008 and 2020. Of these, 34.8% were exposed at conception, 4.5% later in the first trimester, and 60.7% in the second or third trimester.
Among 1,466 live-born infants, the overall prevalence of birth defects was 3.9% (95% CI: 2.9–5.0)—within the range observed in the general population—with no increased risk for periconception exposure. Only one neural tube defect (spina bifida) was reported (0.07%). Other outcomes were also reassuring: 11.9% of infants were born preterm, 11.3% had low birthweight, and 8.6% were small for gestational age, with no variation by timing of exposure. Viral suppression at delivery (<50 copies/mL) was achieved in 73% of pregnancies with available data.
In summary, this large multicohort European study provides further reassurance on the safety of raltegravir use during pregnancy, including conception exposure. Ongoing pharmacovigilance remains essential to detect rare outcomes, but these findings support raltegravir as a safe alternative integrase inhibitor for use when dolutegravir is unavailable or contraindicated.