| Symptomatic congenital cytomegalovirus disease: A randomised controlled trial (RCT) in infants ≥ 32 weeks GA of 6 weeks IV ganciclovir 6 mg/kg every 12 hours demonstrated more infants had improved hearing or maintained normal hearing between baseline and 6 months in the IV ganciclovir group versus placebo (84% vs 59%, p=0.06) and fewer infants had worsening hearing (0% vs 41%, p < 0.01).1 This effect is sustained at 1 year of age, when 21% infants in the treatment group had worsening hearing versus 68% in the placebo group (p < 0.01).1 Two-thirds of the treatment group developed significant neutropenia1. At 12 months infants treated with 6 weeks IV ganciclovir had fewer developmental delays.2 [Ganciclovir: LOE II GORR B]
An RCT of oral valganciclovir 16 mg/kg 12 hourly for 6 months versus 6 weeks in neonates ≥ 32 weeks and ≤ 30 days of age and weighing at least 1800 g at the initiation of therapy reported better total-ear hearing at 12 months in patients treated for 6 months compared to 6 weeks (73% vs. 57%, P = 0.01), which is modestly maintained at 24 months (77% vs. 64%, P = 0.04), without an increase in neutropenia. The 6-month group had better neurodevelopment scores at 24 months.3 Valganciclovir treatment was associated with neutropenia,3 although the incidence was markedly lower than previously observed with intravenous ganciclovir.1, 2 [LOE II GOR B]
There are case reports of the use of oral valganciclovir in extreme preterm infants.9-12
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