Ganciclovir treatment of symptomatic congenital cytomegalovirus infection: Results of a phase II study

Richard J. Whitley, Gretchen Cloud, William Gruber, Gregory A. Storch, Gail J. Demmler, Richard F. Jacobs, Wayne Dankner, Stephen A. Spector, Stuart Starr, Robert F. Pass, Sergio Stagno, William J. Britt, Charles Alford, Seng Jaw Soong, Xiao Jian Zhou, Lanette Sherrill, Jan M. FitzGerald, Jean Pierre Sommadossi

Research output: Contribution to journalArticlepeer-review

234 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)1080-1086
Number of pages7
JournalJournal of Infectious Diseases
Volume175
Issue number5
DOIs
StatePublished - Jan 1 1997
Externally publishedYes

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