Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Randomized Against Valaciclovir - CYMEVALIII STEP1

Summary

In the model of the perfused cotyledon, Letermovir crosses the placenta to reach appropriate fetal concentration. The cotyledon model can only be performed in the third trimester placenta. Although it is probable that the transplacental passage in the second trimester is in the same range than the one found in the 2th trimester, it needs to be confirmed. The study will be divided in 2 steps: step 1 will study the Letermovir transplacental transfer in the second trimester and step 2 will test the efficacy of letermovir to inhibit replication in infected fetuses. Main objective To measure the Letermovir transplacental transfer in the second trimester and its accumulation in the amniotic fluid and the placenta in the second trimester Primary end point: Concentrations reached in fetal blood relative to EC50 of letermovir.

Timeline

Start

2021-06-11

Primary completion

2021-11-05

Completion

2021-11-12

Publications

• Background Faure Bardon V, Peytavin G, Le MP, Guilleminot T, Elefant E, Stirnemann J, Leruez-Ville M, Ville Y. Placental transfer of Letermovir & Maribavir in the ex vivo human cotyledon perfusion model. New perspectives for in utero treatment of congenital cytomegalovirus infection. PLoS One. 2020 Apr 30;15(4):e0232140. doi: 10.1371/journal.pone.0232140. eCollection 2020.
• Faure Bardon V, Bouazza N, Peytavin G, Patrick Le M, Benaboud S, Foissac F, Lui G, Froelicher-Bournaud L, Urien S, Bessieres B, Guilleminot T, Bussieres L, Treluyer JM, Leruez-Ville M, Ville Y. Maternal-Fetal Letermovir Exposure In Vivo and Physiologically Based Pharmacokinetic Modeling: A Rationale for Congenital Cytomegalovirus Therapy. J Infect Dis. 2026 May 15;233(5):848-857. doi: 10.1093/infdis/jiaf619.

Drugs

Indications

No indication recorded.