Valaciclovir to prevent vertical transmission of cytomegalovirus after maternal primary infection during pregnancy: a randomised, double-blind, placebo-controlled trial

Is it time to adopt routine cytomegalovirus screening in pregnancy? No!

“…(https://clinicaltrials.gov/ct2/show/NCT03511274) Although, tertiary prevention with treatment of symptomatic newborns has been shown to improve childhood outcomes, 19,20 universal screening and follow up of asymptomatic newborns is not currently performed. In this clinical opinion, we address secondary prevention of cCMV with maternal serological screening, in light of new data on therapeutic options after maternal primary infection in pregnancy 21 and subsequent calls to action. 22,23 Screening and anti-viral therapy as a secondary prevention strategy Serological screening during pregnancy with CMV-specific IgM and IgG and IgG avidity is a strategy that has been advocated for early detection of maternal primary infection, and prevention of cCMV.…”

“…27 The recent publication of a double-blinded RCT demonstrating a significant reduction in fetal infection with high-dose oral valaciclovir therapy has re-ignited interest in offering universal CMV serological screening for pregnant women. 21 In this trial by Shahar-Nissan and colleagues, women with evidence of primary infection in first trimester or periconception were randomised to valaciclovir 8g daily or placebo, commencing as soon as possible after infection, and continuing through until amniocentesis. The rate of fetal infection, defined as a positive amniocentesis at 21-22 weeks gestation, was 11% in the treatment group compared with 30% in the placebo group (p=0•027; odds ratio [OR] 0•29, 95% CI 0•09-0•90).…”

“…This was the case in 2 patients in the study by Shahar-Nissan et al, where primary infection was ruled out after randomisation. 21 The difficulties of making a diagnosis in a fetal medicine centre specialised in infection, gives us reason to pause in rolling out a screening program without coordinated laboratory expertise, as both laboratory variation and issues with interpretation may be a problem in a nonspecialised setting, especially when irrevocable management such as termination of pregnancy (TOP) is undertaken. Previous studies have shown that the maternity workforce may not have the knowledge in management of CMV and may require upskilling to prepare for a new screening program.…”

40 years of prenatal diagnosis in 2020

“…We asked experts to give us their approach to counseling couples at risk of cCMV, 15 and routine serological screening for CMV, 16 which become even more topical in light of new data on antiviral therapy. 17 We also publish the latest on congenital toxoplasmosis, including a large case series gathered from 30 fetal medicine centers across France, 18 and a review of pharmacotherapy from Mandelbrot. 19 We conclude the issue with reviews on other important infections in pregnancy, including HIV, 20 syphilis, 21 and parvovirus B19.…”

“…We also include two articles on congenital cytomegalovirus (cCMV), the most common perinatal infection and the potentially most preventable cause of sensorineural deafness and cerebral palsy. We asked experts to give us their approach to counseling couples at risk of cCMV, 15 and routine serological screening for CMV, 16 which become even more topical in light of new data on antiviral therapy 17 . We also publish the latest on congenital toxoplasmosis, including a large case series gathered from 30 fetal medicine centers across France, 18 and a review of pharmacotherapy from Mandelbrot 19 .…”