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

Academic Article


  • 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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    Author List

  • Whitley RJ; Cloud G; Gruber W; Storch GA; Demmler GJ; Jacobs RF; Dankner W; Spector SA; Starr S; Pass RF
  • Start Page

  • 1080
  • End Page

  • 1086
  • Volume

  • 175
  • Issue

  • 5