Asma Khalil1, Chrissie Jones, Yves Ville. 1. aFetal Medicine Unit, St George's University NHS Foundation Trust, University of London, London bFaculty of Medicine, Institute for Life Sciences, University Hospital Southampton NHS Foundation Trust, University of Southampton, Southampton, UK cUnité de Médecine Fœtale, Necker-Enfants Malades Hospital, Paris, France.
Abstract
PURPOSE OF REVIEW: Until recently, management options in congenital cytomegalovirus (cCMV) infection have been either conservative or termination of pregnancy. However, medical therapies aimed at reducing the risk of infection and/or its severity have recently been investigated. RECENT FINDINGS: In a phase 2 open label, nonrandomized trial, valaciclovir (ValACV) was given to women carrying a CMV-infected fetus. ValACV was associated with a greater proportion of asymptomatic neonates when compared with a historical cohort (82 vs. 43%). However, the study design and the small number of treated women limit its applicability. Even though initial observational data suggested that hyperimmune globulin (HIG) therapy in pregnancy was associated with a significantly lower risk of cCMV, its efficacy has not been borne out in a subsequent phase 2 randomized, placebo controlled, double-blind study [cCMV 30% in the HIG group, 44% in the placebo group (P = 0.13)]. Furthermore, 11% of fetuses in the HIG group had transient or permanent abnormalities, compared with 16% in the placebo group. SUMMARY:ValACV might have a promising role in the antenatal treatment of cCMV infection, but definitive recommendations require further research. The use of HIG should currently be limited to the research setting.Video abstract http://links.lww.com/COID/A18.
RCT Entities:
PURPOSE OF REVIEW: Until recently, management options in congenital cytomegalovirus (cCMV) infection have been either conservative or termination of pregnancy. However, medical therapies aimed at reducing the risk of infection and/or its severity have recently been investigated. RECENT FINDINGS: In a phase 2 open label, nonrandomized trial, valaciclovir (ValACV) was given to women carrying a CMV-infected fetus. ValACV was associated with a greater proportion of asymptomatic neonates when compared with a historical cohort (82 vs. 43%). However, the study design and the small number of treated women limit its applicability. Even though initial observational data suggested that hyperimmune globulin (HIG) therapy in pregnancy was associated with a significantly lower risk of cCMV, its efficacy has not been borne out in a subsequent phase 2 randomized, placebo controlled, double-blind study [cCMV 30% in the HIG group, 44% in the placebo group (P = 0.13)]. Furthermore, 11% of fetuses in the HIG group had transient or permanent abnormalities, compared with 16% in the placebo group. SUMMARY:ValACV might have a promising role in the antenatal treatment of cCMV infection, but definitive recommendations require further research. The use of HIG should currently be limited to the research setting.Video abstract http://links.lww.com/COID/A18.