2021 Summary of valganciclovir toddler trial

     

Would toddlers with CMV benefit from anti viral treatment?

The headline results of this trial have been discussed with the paediatric infectious diseases doctors in the UK who were responsible for recruiting eligible children with congenital CMV infection. They, in turn, have given the results to the families who volunteered for the study. We would now like to share the main results with other parents through the CMV Action website.

Valganciclovir has previously been shown in a randomised clinical trial to help stabilise the hearing of children who were under one month of age when treatment started. The valganciclovir toddler trial aimed to see if the same benefit was found for older children.

The trial recruited children aged from one month of age up to their fourth birthday who had congenital CMV infection and sensorineural hearing loss. They were randomised to receive either valganciclovir or a matching placebo for six weeks. Hearing was measured at the start of the study and again 6 months later.

The results showed that valganciclovir did not produce any unexpected side effects. The drug reduced the quantity of CMV (the viral load) found in urine or saliva samples. However, the drug did not have any effect on hearing. We conclude that this drug offers no benefit to children of this age and so cannot be recommended.

It is not clear why this drug works in young babies but not older children. One possible explanation is that the drug may gain access in babies to the inner ear structures where CMV is replicating, but not in older children. Another possibility is that the damage to the hearing of babies may be caused by the virus directly whereas, in older children, it may be caused by their ability to cause inflammation in the ear as their immune system matures. The doctors will now discuss how another clinical trial could be designed to address these possibilities and keep CMV Action informed.

We will update with the full trial results when they are published.

CMV Action continue to highlight the importance of timely follow-up and treatment as necessary for any babies who fail their newborn hearing tests.

 

 

     

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