Ganciclovir Treatment of Symptomatic Congenital Cytomegalovirus Infection: Results of a Phase II Study

Congenital cytomegalovirus (CMV) infection occurs in ∼1% of newborns in the United States. A phase II evaluation was done of ganciclovir for the treatment of symptomatic congenital CMV infection. Daily doses of 8 or 12 mg/kg were administered in divided doses at 12-h intervals for 6 weeks. Clinical...

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Bibliographic Details
Published in:The Journal of infectious diseases 1997-05, Vol.175 (5), p.1080-1086
Main Authors: Whitley, Richard J., Cloud, Gretchen, Gruber, William, Storch, Gregory A., Demmler, Gail J., Jacobs, Richard F., Dankner, Wayne, Spector, Stephen A., Starr, Stuart, Pass, Robert F., Stagno, Sergio, Britt, William J., Alford, Charles, Soong, Seng-jaw, Zhou, Xiao-Jian, Sherrill, Lanette, FitzGerald, Jan M., Sommadossi, Jean-Pierre
Format: Article
Language:English
Subjects:
Antibiotics. Antiinfectious agents. Antiparasitic agents
Antiviral agents
Biological and medical sciences
Children
Cytomegalovirus
Cytomegalovirus infections
Dosage
Health care administration
Infants
Infections
Major Articles
Medical sciences
Pharmacokinetics
Pharmacology. Drug treatments
Platelets
Urine
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Summary:Congenital cytomegalovirus (CMV) infection occurs in ∼1% of newborns in the United States. A phase II evaluation was done of ganciclovir for the treatment of symptomatic congenital CMV infection. Daily doses of 8 or 12 mg/kg were administered in divided doses at 12-h intervals for 6 weeks. Clinical and laboratory evaluations sought evidence of toxicity, quantitative virologic responses in urine, plasma drug concentrations, and clinical outcome. A total of 14 and 28 babies received 8 and 12 mg/kg/day, respectively. Five additional babies received ganciclovir on a compassionate plea basis. Significant laboratory abnormalities included thrombocytopenia (≤50,000/mm3) in 37 babies and absolute neutropenia (≤500 mm3) in 29 babies. Quantitative excretion of CMV in the urine decreased; however, after cessation of therapy, viruria returned to near pretreatment levels. Hearing improvement or stabilization occurred in 5 (16%) of 30 babies at 6 months or later, indicating efficacy.
ISSN:0022-1899
1537-6613
DOI:10.1086/516445