Efficacy and Tolerability of Valganciclovir 6 Months vs 6 Weeks in Symptomatic Cytomegalovirus Infection in Infants: An Open Level Randomized Controlled Trial

Abstract

Congenital cytomegalovirus (CMV) infection is the most common transplacental infection affecting neurodevelopment in infant, commonly hearing and cognitive impairment. This study aimed to compare 6 weeks with 6 months duration of oral valganciclovir in respect of efficacy and tolerability. This randomized controlled trial was conducted in both outpatient and inpatient pediatrics department of a tertiary hospital, on123 infants aged 0-12 months with polymerase chain reaction proven congenital CMV infection over a period of 18 months. The children were divided into two groups, according to the treatment group they belonged to, one is 6 weeks group and other is 6 months group. The children were followed up for 12 months at 3-month interval to compare the virological clearance, psychological, visual, and hearing status, and side effects of drug. The viral load assessment was done at 6 weeks, 6 months, and 12 months of the initial treatment. Mean age of the infants of 6 weeks group is 7.33±1.74months and that of 6 months group is 6.70±2.23 months. Primary outcome is the clearance of virus, exhibited in both groups significantly at 12 weeks of follow up but 100% clearance of virus observed in 6 months group at 6 months of follow up. Whereas 5 patients at 12 weeks and 3 patients at 6 months have shown non clearance of virus among the 6 weeks treatment group. Total 50(80.6%) patients hearing return to normal at 12 months follow up in 6 months treatment group compared to 31(50.8%) in 6 weeks group (p=0.001). Visual improvement also observed among 58(93.5%) patients of 6 months group and 48(78.7%) in 6 weeks group and this difference is statistically significant (p=0.01). At 12 months of follow up 6 months group had shown better neurodevelopmental outcome (p=0.00). Both groups exhibit good tolerance to drug. Conclusion: 6 months duration treatment of valganciclovir in symptomatic CMV infection have shown better neurodevelopmental outcome and visual, auditory improvement compared to 6 weeks duration.