The effect of valacyclovir on secondary prevention of congenital cytomegalovirus infection, following primary maternal infection acquired periconceptionally or in the first trimester of pregnancy. An individual patient data meta-analysis

Christos Chatzakis, Karen Shahar-Nissan, Valentine Faure-Bardon, Olivier Picone, Eran Hadar, Jacob Amir, Charles Egloff, Alexandre Vivanti, Alexandros Sotiriadis, Marianne Leruez-Ville, Yves Ville*

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

9 Scopus citations

Abstract

Objective: Recent studies have shown that a dosage of 8 g/d of oral valacyclovir reduces substantially the vertical transmission rate of cytomegalovirus in women with primary cytomegalovirus infection acquired periconceptionally or during the first trimester of pregnancy. This individual patient data meta-analysis aimed to assess the effectiveness and safety of valacyclovir treatment in the secondary prevention of congenital cytomegalovirus infection. Data Sources: MEDLINE, Scopus, Cochrane Central Register of Controlled Trials, the US registry of clinical trials (www.clinicaltrials.gov), and gray literature sources were searched from inception to March 2023. Study Eligibility Criteria: Randomized controlled trials and quasi-randomized studies administering 8 g/d of oral valacyclovir in pregnant women with primary cytomegalovirus infection acquired periconceptionally or during the first trimester of pregnancy were included. Methods: All corresponding authors of the eligible studies were contacted. Cochrane's Risk of Bias 2 and Risk Of Bias In Non-randomised Studies - of Interventions tools were used for the risk of bias assessment. The result of amniocentesis was the primary outcome of interest. A 1-stage individual patient data meta-analysis was performed, using a generalized linear mixed model, clustered by the different trials. A subgroup analysis was performed, assessing separately the effect of valacyclovir in the periconceptional period and first trimester of pregnancy. Results: Overall, 3 studies were included in the analysis (n=527 women). Valacyclovir reduced the vertical transmission rate of cytomegalovirus (adjusted odds ratio, 0.34; 95% confidence interval, 0.18–0.61). This reduction was apparent for both periconceptional period (adjusted odds ratio, 0.34; 95% confidence interval, 0.12–0.96) and first-trimester (adjusted odds ratio, 0.35; 95% confidence interval, 0.16–0.76) infections. Moreover, valacyclovir reduced the rate of neonatal infection (adjusted odds ratio, 0.30; 95% confidence interval, 0.19–0.47), in both periconceptional period (adjusted odds ratio, 0.30; 95% confidence interval, 0.14–0.61) and first-trimester (adjusted odds ratio, 0.30; 95% confidence interval, 0.17–0.54) infections. Furthermore, valacyclovir reduced the rate of termination of pregnancy because of cytomegalovirus-associated severe fetal findings (adjusted odds ratio, 0.23; 95% confidence interval, 0.22–0.24). The gestational age at the initiation of treatment has a positive correlation with all outcomes. The overall prevalence of severe side effects was 2.1%. Conclusion: A dosage of 8 g/d of oral valacyclovir reduced the vertical transmission rates of cytomegalovirus following primary maternal infection acquired periconceptionally or in the first trimester of pregnancy, with a low incidence of side effects.

Original languageEnglish
Pages (from-to)109-117.e2
JournalAmerican Journal of Obstetrics and Gynecology
Volume230
Issue number2
DOIs
StatePublished - Feb 2024

Keywords

  • amniocentesis
  • congenital cytomegalovirus infection
  • first trimester
  • neonates
  • periconceptional period
  • prevention
  • primary infection
  • side effects
  • valacyclovir
  • vertical transmission

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