Ganciclovir Treatment of Symptomatic Congenital Cytomegalovirus Infection: Results of a Phase II Study.
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 Jr.; Soong, Seng-jaw; Zhou, Xiao-Jian; Sherrill, Lanette; FitzGerald, Jan M.; Sommadossi, Jean-Pierre; National Institute of Allergy; Infectious Diseases Collaborative Antiviral Study Group
[Article] Journal of Infectious Diseases. 175(5):1080-1086, May 1997.

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: 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.

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