Efficacy of Valganciclovir Versus Ganciclovir in Treatment of Symptomatic Cytomegalovirus Infection in Infants: An Open- Labeled Randomized Controlled Trial

Abstract

Introduction: Congenital cytomegalovirus (CMV) infection is the most common viral infection transmitted via the placenta, causing significant neurodevelopmental impairment in infants and children. Gancyclovir and Valgancyclovir are two drugs used in the treatment of symptomatic CMV infected case which have limited comparative study. This study compared the efficacy and tolerability of these two drugs on symptomatic CMV infected infants.Methodology: This was an open-label randomized controlled trial done to compare oral valganciclovir(VGCV) with injectable ganciclovir (GCV) in the treatment of symptomatic congenital CMV infected infants. A total of 72 patients were included; 12 patients discontinued the treatment due to noncompliance or side effects. Pre and post-treatment CMV virus levels and adverse effects were monitored. Psychological, visual, and hearing assessments were performed at baseline and six months post-treatment.Results: The mean age of the infants in VGCV and GCV group was 7.10±3.58 and 7.50±3.99 months, respectively. Nineteen infants presented with developmental delay, 13 with seizure, 4 with a movement disorder. Twenty-one percent of the infants were preterm, and 38% were low birth weight. Eighteen infants had a neonatal seizure. Twenty-eight infants of VGCV and 24 infants of the GCV group showed clearance of the virus after six weeks of treatment. No statistical difference was found in virus clearance. Regarding ophthalmological assessment, infants had chorioretinitis, optic atrophy, squint, and cortical blindness. On hearing assessment, none of the infants deteriorated after drug administration, while some showed improved hearing. None of the infants showed deterioration of cognition, while some of the infants showedimprovement in cognitive assessment, but there was no significant difference in two groups. The side effects of GCV were significantly greater than VGCV (P<0.05). Conclusion: In symptomatic congenital CMV infection in infants, VGCV is as efficient as GCV, and the former has fewer side effects.