VIROPREG: expanding our knowledge of viral infections in mother-child pairs

Understanding viral infections during pregnancy and their impact on pregnancy outcomes

The ANRS 0288s VIROPREG study is a prospective national cohort study whose objective is to assess the impact of various viral infections contracted during pregnancy on the pregnant woman, the outcome of the pregnancy and the child’s early years.

This study, scheduled to launch on 9 March 2026, will be multicentre and will run for a period of ten years. The first three years will be devoted to patient recruitment: pregnant women who wish to carry their pregnancy to term and who have one of the targeted viral infections (HIV, hepatitis or arboviruses) diagnosed before or during pregnancy. In total, the VIROPREG team plans to include 2,380 mother-child pairs.

The study will continue until the children born during the pregnancy reach the age of four or seven. The researchers will then have six years, until 2042, to analyse the data and publish the results.

Four cohorts in one

The VIROPREG cohort will be divided into four ‘modules’. The first will assess the impact of exposure to HIV-1 or HIV-2 in the mother and the effect of antiretroviral (ARV) treatments received during pregnancy and the neonatal period on the children’s gross and fine motor skills and their socio-emotional development in the medium term, up to the age of four.

The aim here is to broaden the scope of analysis to include the pharmacological dimension and mental health of patients, both mothers and children, two issues that have been underestimated in the historical cohorts of the French Perinatal Survey (EPF). The EPF was launched in 1986 by Inserm and ANRS MIE and has involved more than 18,000 mother-child pairs to date.

Two other modules will focus on the rates of mother-to-foetus transmission of two viral hepatitis infections: hepatitis B virus (and possible co-infections with hepatitis D virus) on the one hand, and hepatitis C on the other. Children born to infected mothers will be monitored until they are nine months old in the HBV module and eighteen to twenty-four months old in the HCV module.

Finally, in order to enrich our knowledge of the impact of emerging infectious diseases on pregnant women and their children, VIROPREG will include a fourth and final module targeting arboviruses, such as dengue or Oropouche virus disease. Depending on the type of arbovirus, investigators will estimate the prevalence of adverse pregnancy outcomes in women with biologically confirmed symptomatic arbovirus infection. The analysis will focus in particular on transmission of the virus at birth or, possibly, through breastfeeding.

Three questions to Jeanne Sibiude, professor of obstetrics and gynaecology and principal investigator for VIROPREG

Why did you decide to focus on the health of the mother-child pair?

The health of the mother-child dyad is often understudied. In particular, there are very few drug trials that include pregnant women. However, the effect of an infection or a drug is not the same when it affects two people at the same time. It can have a positive or negative effect on one, the other, or both at the same time. And that is something we cannot control.

Successive cohorts of the EPF, launched in 1986 by Inserm and then supported by ANRS on the impact of HIV-1 and HIV-2 on the mother-child couple, have served to demonstrate the effectiveness of a prevention strategy for this population group. However, they did not provide sufficient answers on the effects of medication and did not address mental health or literacy issues at all. Yet women living with HIV/AIDS or hepatitis are among the most socially vulnerable.

Together with my scientific supervisor, Pierre Frange, professor of paediatrics and co-chair of the ANRS MIE’s Coordinated Action ‘Mother, Child and Adolescent Health’ (AC Sameado), we wanted to explore these issues in greater depth.

How does VIROPREG plan to take emerging infectious diseases into account?

In addition to the three cohorts targeting HIV-1, HIV-2, hepatitis B and C, we will also set up a fourth cohort focusing on arboviruses.

The Covid-19 pandemic has shown that medical research is not necessarily well equipped to respond quickly and in a coordinated manner to a new epidemic, particularly with regard to its effects on pregnant women, pregnancy and children. At the same time, a dozen cases of Oropouche virus have recently involved pregnant women, raising concerns about the outcome of their pregnancies. Until now, we had no scientific basis for estimating the effects of this infection in this specific case. Similarly, we know little about other arboviruses such as dengue or chikungunya, particularly regarding the spread of the virus in maternal and foetal tissues.

With VIROPREG, we want to go beyond the observational data obtained by centres that have worked on this subject in the most exposed areas. In particular, we will investigate viral damage to the placenta and amniotic fluid.

What makes the inclusion criteria for this study unique?

The originality of VIROPREG lies in its consideration of a number of social determinants on the course of pregnancy and its outcome. For example, VIROPREG will be able to include women who have no social protection. Social science research clearly shows that a significant number of pregnant women living with HIV are recent migrants, who therefore do not benefit from state medical aid (AME). It is therefore very important to take this group of patients into consideration.

In addition, we are working to offer questionnaires in the future that are accessible to non-French-speaking patient groups living in overseas departments and regions (DROM), particularly in Haitian Creole, in order to be as inclusive and representative as possible. Finally, the questionnaires will be administered by research staff, either in person or by telephone, so that even women who cannot read or write, or who have difficulty doing so, will be able to respond to the assessments that will be submitted to them four and then seven years after the end of their pregnancy.