• R J Whitley, G Cloud, W Gruber, G A Storch, G J Demmler, R F Jacobs, W Dankner, S A Spector, S Starr, R F Pass, S Stagno, W J Britt, C Alford, S Soong, X J Zhou, L Sherrill, J M FitzGerald, and J P Sommadossi.
• Department of Pediatrics, University of Alabama at Birmingham, 35233, USA.
• J. Infect. Dis. 1997 May 1;175(5):1080-6.

AbstractCongenital cytomegalovirus (CMV) infection occurs in approximately 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 (< or = 50,000/mm3) in 37 babies and absolute neutropenia (< or = 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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