Valacyclovir treatment for preventing fetal cytomegalovirus (CMV) infection after primary infection of the mother – a wonderful study!
Let me tell you a story – a few years ago, Dr. Keren Shahar-Nissan, back then an intern at Schneider’s children medical center of Israel, was following up on a friend with cytomegalovirus (CMV) maternal infection in the early stage of the pregnancy. At that time, besides a meticulous follow-up, there were no options for treatment, in order to prevent fetal infection.
Dr. Keren did not gave up, and with her own two hands formed a well-constructed study, offering treatment with Valacyclovir to women with early CMV infection during pregnancy. The study was published on September 2020 in the very prestigious journal – The Lancet (PMID 32919517).
Introduction – CMV is the most common congenital infection, with a high morbidity rate in cases of maternal infection in the early stages of the pregnancy. So far, there was no effective way to prevent fetal infection after maternal infection. The purpose of the study was to examine the efficacy of the drug (Valacyclovir) in preventing fetal infection with CMV, when given to pregnant women who contracted CMV in the early stages of the pregnancy.
Methods – women who contracted CMV in the early stages of the pregnancy were recruited to this study. They were randomly assigned to one of two groups- a group treated with Valacyclovir and a group who was given placebo. Treatment began the moment CMV infection was identified, and ended at the day of amniocentesis (around week 22).
Results – The study included 100 women. Both groups (treatment and placebo), were similar. 10 women were excluded from the study due to various reasons (false diagnosis, termination of pregnancy not related to the virus, etc.). At the end in the analysis there were 45 women in each group.
The rate of CMV positive amniotic fluid (representing fetuses infected with CMV), was 11% amongst women treated with the drug, and 30% in women treated with placebo. This rate was even more significant amongst women contracting the infection on the first trimester – 11% from those treated with Valacyclovir were positive, while the rate for the placebo group was 48%.
Practically, this study showed that treatment with Valacyclovir lowered fetal infection rate by 71%. Another important finding is the safety profile of the drug – there were no major side effects requiring ceasing of treatment or dose reduction.
Discussion – It’s important to understand that this is a groundbraking study, designed and executed as a randomized, double blinded, placebo controlled trial. This is why it’s findings were published not only by one of the most major medical journals, but it is also a hot topic in many centers and medical professions, following the field of congenital CMV infection.
If until now there were no interventional options in cases of infection during pregnancy, now when there is a treatment option, countries would start testing women in the beginning of pregnancy for the virus.
I must mention to all CMV negative women – there is an excellent way for preventing CMV infection – which is following the four steps mentioned in another post – see in this link. But if there ןד an early pregnancy infection, this is an important treatment option.
And most importantly – Dr. Keren Shahar Nissan proved that even an intern can make an important major study like this happen. Kudos!
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