International Congenital Cytomegalovirus Recommendations Group

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International Congenital Cytomegalovirus Recommendations Group
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bet | 607/654 | Sana | 03.01.2022 | Hajmi | 1,5 Mb. | | #14803 |
International Congenital Cytomegalovirus Recommendations Group: Ganciclovir is now available as an oral prodrug, valganciclovir. A recent RCT now recommends valganciclovir treatment for congenitally-infected neonates ≥ 32 weeks of life, with moderate to severe symptomatic disease, to be commenced within the first month of life and for 6 months. Antiviral therapy should not be administered to neonates with asymptomatic congenital cytomegalovirus infections. Antiviral therapy is not routinely recommended for asymptomatic congenital cytomegalovirus infection with isolated sensorineural hearing loss, or for neonates with mildly symptomatic congenital cytomegalovirus infection.4 [LOE II, GOR B]
Pharmacokinetics:
A pharmacokinetic study showed that oral valganciclovir 16 mg/kg every 12 hours achieved similar concentrations to IV ganciclovir 6 mg/kg every 12 hours. Only a marginal decrease in AUC12 over time was noted after administration of the valganciclovir oral solution despite increased clearance, due to increased bioavailability, by 32% over the same period. The oral bioavailability of valganciclovir averaged 41.1% (95% CI, 30.8%–51.4%).5 [LOE III, GOR B]
References
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Kimberlin DW, Lin CY, Sanchez PJ, Demmler GJ, Dankner W, Shelton M, Jacobs RF, Vaudry W, Pass RF, Kiell JM, Soong SJ, Whitley RJ. Effect of ganciclovir therapy on hearing in symptomatic congenital cytomegalovirus disease involving the central nervous system: A randomized, controlled trial. Journal of Pediatrics. 2003;143:16-25.
Oliver SE, Cloud GA, Sanchez PJ, Demmler GJ, Dankner W, Shelton M, Jacobs RF, Vaudry W, Pass RF, Soong Sj, Whitley RJ, Kimberlin DW. Neurodevelopmental outcomes following ganciclovir therapy in symptomatic congenital cytomegalovirus infections involving the central nervous system. Journal of Clinical Virology. 2009;46:S22-S6.
Kimberlin DW, Jester PM, Sanchez PJ, Ahmed A, Arav-Boger R, Michaels MG, Ashouri N, Englund JA, Estrada B, Jacobs RF, Romero JR, Sood SK, Whitworth MS, Abzug MJ, Caserta MT, Fowler S, Lujan-Zilbermann J, Storch GA, DeBiasi RL, Han JY, Palmer A, Weiner LB, Bocchini JA, Dennehy PH, Finn A, Griffiths PD, Luck S, Gutierrez K, Halasa N, Homans J, Shane AL, Sharland M, Simonsen K, Vanchiere JA, Woods CR, Sabo DL, Aban I, Kuo H, James SH, Prichard MN, Griffin J, Giles D, Acosta EP, Whitley RJ. Valganciclovir for symptomatic congenital cytomegalovirus disease. New England Journal of Medicine. 2015;372:933-43.
Rawlinson WD, Boppana SB, Fowler KB, Kimberlin DW, Lazzarotto T, Alain S, Daly K, Doutre S, Gibson L, Giles ML, Greenlee J, Hamilton ST, Harrison GJ, Hui L, Jones CA, Palasanthiran P, Schleiss MR, Shand AW, van Zuylen WJ. Congenital cytomegalovirus infection in pregnancy and the neonate: consensus recommendations for prevention, diagnosis, and therapy. The Lancet Infectious Diseases. 2017;17:e177-e88.
Kimberlin DW, Acosta EP, Sanchez PJ, Sood S, Agrawal V, Homans J, Jacobs RF, Lang D, Romero JR, Griffin J, Cloud GA, Lakeman FD, Whitley RJ, National Institute of A, Infectious Diseases Collaborative Antiviral Study G. Pharmacokinetic and pharmacodynamic assessment of oral valganciclovir in the treatment of symptomatic congenital cytomegalovirus disease. J Infect Dis. 2008;197:836-45.5. SHPA, Ganciclovir monograph, Australian Injectable Handbook 7th Ed, 2017.
Roche, Valcyte monograph, MIMs, 2017.
Roche, Cymevene monograph, MIMs, 2017.
Trissel's 2 Clinical Pharmaceutics Database (Parenteral Compatibility), Ganciclovir monograph, accessed via Micromedex, 26/07/2017.
El-Sayed MF, Goldfarb DM, Fulford M, Pernica JM. Severe late-onset multisystem cytomegalovirus infection in a premature neonate previously treated for congenital infection. BMC Pediatr. 2013;13:142.
Fischer C, Meylan P, Bickle Graz M, Gudinchet F, Vaudaux B, Berger C, Roth-Kleiner M. Severe postnatally acquired cytomegalovirus infection presenting with colitis, pneumonitis and sepsis-like syndrome in an extremely low birthweight infant. Neonatology. 2010;97:339-45.
Mehler K, Oberthuer A, Lang-Roth R, Kribs A. High rate of symptomatic cytomegalovirus infection in extremely low gestational age preterm infants of 22-24 weeks' gestation after transmission via breast milk. Neonatology. 2014;105:27-32.
Muller A, Eis-Hubinger AM, Brandhorst G, Heep A, Bartmann P, Franz AR. Oral valganciclovir for symptomatic congenital cytomegalovirus infection in an extremely low birth weight infant. J Perinatol. 2008;28:74-6.
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Original version Date: 18/09/2017
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Author: Jing Xiao
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Current Version number: 1.0
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Current Version Date: 24/9/2019
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Risk Rating: Medium
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Due for Review: 24/09/2022
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Approval by: DTC
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Approval Date: October 2019
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