Cytomegalovirus (CMV) is a common virus that can cause serious health problems, especially in newborns with congenital CMV disease. Congenital CMV disease is a condition where the virus is passed from mother to baby during pregnancy, and it can lead to a range of complications, including hearing loss, intellectual disability, and developmental delay.
Clinical trial
A clinical trial aimed to evaluate the efficacy of oral valganciclovir (VGCV) therapy in infants aged two months or younger with congenital CMV disease. The study enrolled 25 infants with CMV disease involving the central nervous system and treated them with VGCV for six months.
The primary endpoint of the study was to assess the change in the whole blood CMV load before and after VGCV treatment. The secondary endpoint was to evaluate the change in auditory brainstem response (ABR) before and after VGCV treatment. The study also compared the changes in ABR between younger and older age groups, which were defined as those ≤30 days old at the start of treatment and those >30 days old.
Results
The study found that oral VGCV therapy had a potential therapeutic benefit for treating infants with congenital CMV disease. The median change in CMV DNA level in whole blood was -246.0 IU/mL after six months of VGCV treatment. The best ear and total ear assessments based on ABR were categorized as improved or unchanged after treatment for 100% and 93.8% of patients, respectively. There were no significant differences in hearing efficacy between the younger and older age groups.