Oral valganciclovir initiated beyond one month of age as treatment of sensorineural hearing loss caused by congenital cytomegalovirus infection: a randomized clinical trial
Oral valganciclovir initiated beyond one month of age as treatment of sensorineural hearing loss caused by congenital cytomegalovirus infection: a randomized clinical trial
Objective: The objective of this study was to determine if valganciclovir initiated after 1 month of age improves congenital cytomegalovirus–associated sensorineural hearing loss. Study design: We conducted a randomized, double-blind, placebo-controlled phase 2 trial of 6 weeks of oral valganciclovir at US (n = 12) and UK (n = 9) sites. Patients of ages 1 month through 3 years with baseline sensorineural hearing loss were enrolled. The primary outcome was change in total ear hearing between baseline and study month 6. Secondary outcome measures included change in best ear hearing and reduction in cytomegalovirus viral load in blood, saliva, and urine. Results: Of 54 participants enrolled, 35 were documented to have congenital cytomegalovirus infection and were randomized (active group: 17; placebo group: 18). Mean age at enrollment was 17.8 ± 15.8 months (valganciclovir) vs 19.5 ± 13.1 months (placebo). Twenty (76.9%) of the 26 ears from subjects in the active treatment group did not have worsening of hearing, compared with 27 (96.4%) of 28 ears from subjects in the placebo group (P = .09). All other comparisons of total ear or best ear hearing outcomes were also not statistically significant. Saliva and urine viral loads decreased significantly in the valganciclovir group but did not correlate with change in hearing outcome. Conclusions: In this randomized controlled trial, initiation of antiviral therapy beyond the first month of age did not improve hearing outcomes in children with congenital cytomegalovirus–associated sensorineural hearing loss. Clinical Trial Registration: ClinicalTrials.gov identifier NCT01649869.
antiviral therapy, congenital infection, cytomegalovirus, hearing loss
Kimberlin, David W.
19c1840c-d3db-4073-b597-e1ee435de95a
Aban, Inmaculada
b1010767-c13a-4dbb-93c3-e3d9ab367095
Peri, Kalyani
136f3d69-da99-48e9-8e9b-e36229ec0c20
Faust, Saul
f97df780-9f9b-418e-b349-7adf63e150c1
Jones, Christine E .
48229079-8b58-4dcb-8374-d9481fe7b426
Collaborative Antiviral Study Group (CASG)
May 2024
Kimberlin, David W.
19c1840c-d3db-4073-b597-e1ee435de95a
Aban, Inmaculada
b1010767-c13a-4dbb-93c3-e3d9ab367095
Peri, Kalyani
136f3d69-da99-48e9-8e9b-e36229ec0c20
Faust, Saul
f97df780-9f9b-418e-b349-7adf63e150c1
Jones, Christine E .
48229079-8b58-4dcb-8374-d9481fe7b426
Kimberlin, David W., Aban, Inmaculada and Peri, Kalyani
,
et al. and Collaborative Antiviral Study Group (CASG)
(2024)
Oral valganciclovir initiated beyond one month of age as treatment of sensorineural hearing loss caused by congenital cytomegalovirus infection: a randomized clinical trial.
The Journal of Pediatrics, 268, [113934].
(doi:10.1016/j.jpeds.2024.113934).
Abstract
Objective: The objective of this study was to determine if valganciclovir initiated after 1 month of age improves congenital cytomegalovirus–associated sensorineural hearing loss. Study design: We conducted a randomized, double-blind, placebo-controlled phase 2 trial of 6 weeks of oral valganciclovir at US (n = 12) and UK (n = 9) sites. Patients of ages 1 month through 3 years with baseline sensorineural hearing loss were enrolled. The primary outcome was change in total ear hearing between baseline and study month 6. Secondary outcome measures included change in best ear hearing and reduction in cytomegalovirus viral load in blood, saliva, and urine. Results: Of 54 participants enrolled, 35 were documented to have congenital cytomegalovirus infection and were randomized (active group: 17; placebo group: 18). Mean age at enrollment was 17.8 ± 15.8 months (valganciclovir) vs 19.5 ± 13.1 months (placebo). Twenty (76.9%) of the 26 ears from subjects in the active treatment group did not have worsening of hearing, compared with 27 (96.4%) of 28 ears from subjects in the placebo group (P = .09). All other comparisons of total ear or best ear hearing outcomes were also not statistically significant. Saliva and urine viral loads decreased significantly in the valganciclovir group but did not correlate with change in hearing outcome. Conclusions: In this randomized controlled trial, initiation of antiviral therapy beyond the first month of age did not improve hearing outcomes in children with congenital cytomegalovirus–associated sensorineural hearing loss. Clinical Trial Registration: ClinicalTrials.gov identifier NCT01649869.
Other
Edited MS 20232623R1 RCT Valgan older cCMV
- Accepted Manuscript
Restricted to Repository staff only until 1 February 2025.
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Accepted/In Press date: 29 January 2024
e-pub ahead of print date: 1 February 2024
Published date: May 2024
Additional Information:
Funding Information:
Funding was provided under contract HHSN272201100035C by the National Institute of Allergy and Infectious Diseases (NIAID) Division of Microbiology and Infectious Diseases (DMID). Participation of study sites in the UK was supported by the National Institute for Health Research Clinical Research Network (NIHR CRN).
Publisher Copyright:
© 2024 Elsevier Inc.
Keywords:
antiviral therapy, congenital infection, cytomegalovirus, hearing loss
Identifiers
Local EPrints ID: 487889
URI: http://eprints.soton.ac.uk/id/eprint/487889
ISSN: 0022-3476
PURE UUID: de423a24-5c16-46cb-8073-d3d78be57e21
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Date deposited: 08 Mar 2024 17:50
Last modified: 18 Mar 2024 03:39
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Contributors
Author:
David W. Kimberlin
Author:
Inmaculada Aban
Author:
Kalyani Peri
Corporate Author: et al.
Corporate Author: Collaborative Antiviral Study Group (CASG)
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