Choice of initial antiviral therapy in infants with virologically confirmed congenital cytomegalovirus infection

	Suggested initial antiviral agent
	Ganciclovir*	Valganciclovir^¶	Antiviral therapy not indicated
CMV-specific symptoms	Life-threatening symptoms Any of the following: Viral sepsis-like syndrome Pneumonitis Myocarditis Severe hepatitis Enterocolitis Severe and refractory thrombocytopenia Sight-threatening retinitis	Non-life-threatening symptoms Examples include: Microcephaly or intracranial calcifications without seizures or encephalopathy Jaundice or hepatosplenomegaly without severe hepatitis or refractory thrombocytopenia Isolated hearing loss^Δ Severe symptoms Infants with 1 or more of the conditions listed to the left may be candidates for oral valganciclovir if they meet all of the general medical condition criteria listed below	Asymptomatic (including passed newborn hearing screen)
General medical condition	Any of the following: Seriously or critically ill, requiring NICU care Requiring mechanical ventilation, CPAP, or supplemental oxygen NPO Unable to tolerate oral feeds Malabsorption	All of the following: Well appearing or mildly ill, being managed in newborn unit or at home On room air or low supplemental oxygen Able to tolerate oral feeds Stable and gaining weight	Stable and well appearing
Immune status	Primary immunodeficiency (eg, SCID)	Immunocompetent	Immunocompetent

CMV: cytomegalovirus; NICU: neonatal intensive care unit; CPAP: continuous positive airway pressure; NPO: nothing by mouth; SCID: severe combined immunodeficiency; IV: intravenous.
* Ganciclovir dosing is 6 mg/kg per dose administered IV every 12 hours. Treatment with IV ganciclovir should be for a maximum of 6 weeks. Ganciclovir is dependent on renal function for clearance. The dose listed is for infant swith normal renal function. Infants initially treated with IV ganciclovir may transition to oral valganciclovir when their condition improves and oral feedings are tolerated.
¶ Valganciclovir dosing is 16 mg/kg per dose of commercially available suspension administered orally every 12 hours. Treatment with oral valganciclovir should be continued for a total of 6 months for most newborns with symptomatic congenital CMV infection. The dose listed is for infants with normal renal function.
Δ Evidence is lacking and expert opinion varies as to whether the benefits of antiviral therapy outweigh the risks in infants with isolated hearing loss.

References:

Harrison GJ. Cytomegalovirus. In: Feigin and Cherry's Textbook of Pediatric Infectious Diseases, 7th ed, Cherry JD, Harrison GJ, Kaplan SL, et al (Eds), Elsevier Saunders, Philadelphia 2014. p.1969.
Kimberlin DW, Lin CY, Sánchez PJ, et al. Effect of ganciclovir therapy on hearing in symptomatic congenital cytomegalovirus disease involving the central nervous system: a randomized, controlled trial. J Pediatr 2003; 143:16.
Kimberlin DW, Jester PM, Sánchez PJ, et al. Valganciclovir for symptomatic congenital cytomegalovirus disease. N Engl J Med 2015; 372:933.

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Choice of initial antiviral therapy in infants with virologically confirmed congenital cytomegalovirus infection