In utero treatment of congenital cytomegalovirus infection with valacyclovir in a multicenter, open-label, phase II study - INRAE - Institut national de recherche pour l’agriculture, l’alimentation et l’environnement
Journal Articles American Journal of Obstetrics and Gynecology Year : 2016

In utero treatment of congenital cytomegalovirus infection with valacyclovir in a multicenter, open-label, phase II study

Guillaume Benoist
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Abstract

Congenital infection with human cytomegalovirus is a major cause of morbidity and mortality. A randomized controlled trial showed that high-dosage valacyclovir prevents cytomegalovirus disease in transplant recipients. Fetuses showing ultrasound features of infection are at high risk of being symptomatic at or before birth. In a pilot study, oral administration of high-dosage valacyclovir to mothers significantly decreased viral load and produced therapeutic concentrations in the blood of infected fetuses. A randomized controlled trial comparing prenatal treatment with valacyclovir against placebo in infected fetuses failed to recruit because women declined randomization. Randomized controlled trials in fetal medicine have often proven unacceptable by women who decline termination of pregnancy and are not prepared to resign themselves to the odds of the natural history of the disease.
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hal-02641581 , version 1 (07-06-2023)

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Marianne Leruez-Ville, Idir Ghout, Laurence Bussières, Julien Stirnemann, Jean-François Magny, et al.. In utero treatment of congenital cytomegalovirus infection with valacyclovir in a multicenter, open-label, phase II study. American Journal of Obstetrics and Gynecology, 2016, 215 (4), pp.462.e1-462.e10. ⟨10.1016/j.ajog.2016.04.003⟩. ⟨hal-02641581⟩
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