GANCICLOVIR TREATMENT OF SYMPTOMATIC CONGENITAL CYTOMEGALOVIRUS-INFECTION - RESULTS OF A PHASE-II STUDY

Congenital cytomegalovirus (CMV) infection occurs in similar to 1% of newborns in the United Stales. A phase II evaluation was done of ganci clovir for the treatment of symptomatic congenital CMV infection. Dail y doses of 8 or 12 mg/kg were administered in divided doses at 12-h in tervals for 6 weeks. Clinical and laboratory evaluations sought eviden ce of toxicity, quantitative virologic responses in urine, plasma drug concentrations, and clinical outcome. A total of 14 and 28 babies rec eived 8 and 12 mg/kg/day, respectively, Five additional babies receive d ganciclovir on a compassionate plea basis. Significant laboratory ab normalities included thrombocytopenia (less than or equal to 50,000/mm (3)) in 37 babies and absolute neutropenia (less than or equal to 500 mm(3)) in 29 babies. Quantitative excretion of CMV in the urine decrea sed; however, after cessation of therapy, viruria returned to near pre treatment levels. Hearing improvement or stabilization occurred in 5 ( 16%) of 30 babies at 6 months or later, indicating efficacy.