Valganciclovir for Symptomatic Congenital Cytomegalovirus Disease

Hiral Patel, PharmD Candidate 2015, Mercer University College of Pharmacy

The leading cause of nongenetic sensorineural hearing loss is congenital cytomegalovirus (CMV) infection. Although the infection is rare, it accounts for 21% of children with hearing loss at birth and 24% of those with hearing loss at 4 years of age.1 The National Institute of Allergy and Infectious Diseases (NIAID) Collaborative Antiviral Study Group (CASG) found that among neonates with symptomatic congenital CMV disease involving the central nervous system (CNS), ganciclovir administered intravenously over a period of 6 weeks was associated with improved audiologic outcomes at 6 months of life.2

Title: Valganciclovir for Symptomatic Congenital Cytomegalovirus Disease 3
Design Randomized, placebo-controlled trial; 96 participants
Objective To compare six weeks or six months of valganciclovir therapy in the treatment of neonates with symptomatic congenital CMV disease
Study groups Valganciclovir therapy for six months versus six weeks
Methods A total of 96 neonates with symptomatic congenital CMV disease were randomized to receive blinded study medication after receiving 6 weeks of valganciclovir (16 mg/kg of body weight, orally twice daily)
Duration June 2008 – May 2011
Primary Outcome Measure Change in hearing in the better ear from baseline to six months (best-ear hearing)
(Hearing thresholds were defined as follows: 0 to 20 dB for normal hearing, 21 to 45 dB for mild hearing loss, 46 to 70 dB for moderate hearing loss, and 71 dB or higher for severe hearing loss).
Baseline Characteristics Neonates with symptomatic congenital CMV disease with or without CNS involvement were eligible.
Results Among 43 participants in the six-month group, the change in best-ear hearing indicated improvement in two patients, no change in 36 patients, and worsened hearing in five patients. Among 43 patients in the six-week group, three had improved hearing, 37 had unchanged hearing, and three had worsened hearing (p= 0.41).
Adverse Events Common Adverse Events: None reported
Serious Adverse Events: Grade 3 or 4 neutropenia (19%)
Percentage that Discontinued due to Adverse Evens: 0%
Study Author Conclusions Treating symptomatic congenital CMV disease with valganciclovir for six months, as compared with six weeks, did not improve hearing in the short term.

The results of this study suggest that there is no benefit for treating symptomatic congenital CMV disease for six months as opposed to six weeks. However, these results cannot be applied to patients that have asymptomatic congenital CMV infections. Overall, this study does not show improvement in “best-ear” hearing when treated with six months over six weeks of valganciclovir for patients with symptomatic congenital CMV disease.

References:

1. Fowler KB, McCollister FP, Dahle AJ, Boppana S, Britt WJ, Pass RF. Progressive and fluctuating sensorineural hearing loss in children with asymptomatic con- genital cytomegalovirus infection. J Pedi- atr 1997;130:624-30.
2. Kimberlin DW, Lin CY, Sánchez PJ, et al. Effect of ganciclovir therapy on hearing in symptomatic congenital cytomegalovi- rus disease involving the central nervous system: a randomized, controlled trial. J Pediatr 2003;143:16-25.
3. Kimberlin DW, Jester PM, Sánchez PJ, et al. Valganciclovir for symptomatic congenital cytomegalovirus disease. N Engl J Med. 2015;372(10):933-43.

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