Interview by Weronika Kolczyńska with Prof. Tadeusz Issat, Head of the Department of Gynecology and Obstetrics at the Mother and Child Institute.
For years, cytomegalovirus infection in pregnancy has remained an area filled with uncertainty and difficult decisions. Today, there is a real chance for change. At the Mother and Child Institute in Warsaw, a clinical trial is underway to evaluate the use of antiviral treatment in pregnant women infected with CMV. According to Prof. Tadeusz Issat, MD, PhD, the project may lead to a reduction in the number of newborns with congenital cytomegaly and its most severe neurological complications.
Weronika Kolczyńska: Cytomegaly is a very common virus, yet still little known. How would you explain to patients, in the simplest terms, what CMV is, when the infection becomes a real threat to the baby, and in which situations physicians should order testing?
Prof. Tadeusz Issat: Cytomegaly is a viral infection that up to 80-90% of adults encounter at some point in their lives, most often without any symptoms. For a healthy adult, CMV usually poses no threat. The situation changes dramatically when a primary infection occurs during pregnancy.
The greatest risk for the baby arises when a woman acquires CMV for the first time in the first or second trimester. In such cases, the risk of transmitting the virus to the fetus is around 50%, and the infection may lead to congenital cytomegaly. This condition can result in severe neurological complications, including developmental disorders, hearing loss, or damage to the central nervous system.
Testing should be considered for pregnant women showing flu‑like symptoms, when fetal ultrasound shows abnormalities, and for patients from higher‑risk groups – for example, those who have frequent contact with small children attending daycare or preschool, as infection most often occurs in the household environment.
From a clinical perspective – what question or concern most often arises among patients with suspected CMV, and what do they find most difficult about this diagnosis?
The most common question patients ask is whether anything can still be done, followed immediately by: “Does this infection mean the baby will definitely be sick?” The most difficult aspect is the sense of uncertainty and the lack of clear answers, especially when patients receive conflicting information from different doctors.
Another burden is the fact that CMV is still not widely discussed in prenatal care, meaning many women hear about it for the first time only in a crisis situation.
In Poland, around 2,500 newborns are born each year with congenital cytomegaly, and about 10% experience serious, permanent complications. Why was it possible to launch this clinical trial in Poland now, and why was the Mother and Child Institute chosen to lead it?
For many years, there was insufficient data to meaningfully change clinical practice. A breakthrough came with recent publications, including studies showing that antiviral treatment with valacyclovir – when administered early enough, up to around the 22nd week of pregnancy – can reduce the risk of fetal transmission by as much as 90%.
The Mother and Child Institute has long been involved in diagnosing and treating the most severe pregnancy pathologies and congenital disorders. We have the clinical infrastructure, interdisciplinary teams, and facilities necessary for conducting non‑commercial clinical trials. That is why we submitted the POL PRENATAL CMV project to the Medical Research Agency competition and received funding. It was a natural setting for such an initiative.
Clinical trials in pregnant women are among the most challenging from an ethical and regulatory standpoint. What were the biggest challenges in this project, and how were they overcome?
The main challenge was ensuring maximum safety for both the mother and the child while still obtaining reliable scientific data. The project had to meet very strict ethical and regulatory requirements.
A key element was thoroughly informing patients about the nature of the study, potential benefits, and risks, and ensuring their complete voluntary participation. The entire process was supervised by bioethics committees and built on previously available clinical data.
In the study, you compare the standard dose of valacyclovir with a dose reduced by half. Why could this dose reduction be so significant not only clinically but also systemically?
The standard prophylactic dose of valacyclovir for CMV is 8 grams per day, which means taking up to 16 tablets daily for several weeks. This is a significant burden for patients and carries a potential risk of side effects, including rare but reported cases of nephrotoxicity.
If it turns out that a half‑dose is equally effective, it could mean better treatment tolerance, greater adherence among patients, and a significant reduction in costs. From a system perspective, this is crucial, as this treatment could be used much more broadly if integrated into care standards.
The POL PRENATAL CMV project also aims to provide epidemiological and economic data. How important are such data today in discussions with policymakers about changes to the healthcare benefits package?
They are absolutely essential. Clinical effectiveness alone is no longer enough. Reimbursement decisions also rely on cost analyses and long‑term consequences for the healthcare system.
We want to show the real costs of caring for a child with complications from congenital cytomegaly – rehabilitation, treatment, social support – and compare them with the costs of early diagnostics and treatment. Data from other countries show that CMV screening in pregnancy is cost‑effective. We want to provide such data for the Polish population.
If the results confirm the effectiveness of the lower dose, what would an ideal care pathway for a pregnant patient with CMV in Poland look like in a few years?
An ideal pathway would ensure early detection of infection, rapid referral to a specialized center, clear diagnostic and therapeutic standards, and immediate access to treatment without unnecessary delays.
The patient should receive consistent information, psychological support, and care from a team of specialists – rather than being left alone with uncertainty and conflicting opinions.
In your opinion, is Poland organizationally and financially ready to introduce CMV screening in pregnancy if the scientific evidence becomes definitive?
Organizationally, we are increasingly approaching readiness. Financially, everything depends on system‑level decisions and national health priorities. If the trial results clearly confirm the effectiveness of this approach, postponing the decision will become increasingly difficult to justify.
Interviewed:
Prof. Tadeusz Issat, MD, PhD – Head of the Department of Gynecology and Obstetrics at the Mother and Child Institute. A graduate of the Medical University of Warsaw, specialist in obstetrics and gynecology as well as gynecological endocrinology and reproductive medicine. In 2017, he received the habilitation degree awarded by the Scientific Council of IMiD for his scientific achievements. A year later, he obtained the title of Associate Professor at IMiD. Author and co‑author of innovative therapies in gynecology and obstetrics, speaker and participant at numerous international conferences and symposia.
Weronika Kolczyńska – Innovation Manager at the Mother and Child Institute, one of the coordinators of MCSC Hospital Leadership Innovation. An experienced communication and health innovation specialist working at the intersection of medicine, technology, and the public sector. She has collaborated with the Medical Research Agency and the e‑Health Center, where she was responsible for communication of MedTech and AI‑in‑medicine initiatives. She is currently expanding her knowledge as a student of the Innovation in Medicine and Healthcare program at the Medical University of Warsaw.