CYTOMEGALOVIRUS PP65 ANTIGENEMIA-GUIDED EARLY TREATMENT WITH GANCICLOVIR VERSUS GANCICLOVIR AT ENGRAFTMENT AFTER ALLOGENEIC MARROW TRANSPLANTATION - A RANDOMIZED DOUBLE-BLIND-STUDY

To determine whether cytomegalovirus (CMV) antigenemia-guided ganciclo vir treatment may be as effective, may require less treatment, and thu s may cause less marrow toxicity than ganciclovir administered at engr aftment, 226 marrow transplant recipients were randomized at engraftme nt to receive placebo (antigenemia-ganciclovir group) or ganciclovir ( ganciclovir group) until day 100 in a double-blind study. In patients with antigenemia of 3 or more positive cells in 2 slides and/or viremi a, study drug was discontinued and ganciclovir was started for at leas t 3 weeks or until negative CMV antigenemia and resumed only if antige nemia recurred. More patients in the antigenemia-ganciclovir group dev eloped CMV disease before day 100 after transplantation compared with the ganciclovir group (14% v 2.7%, P =.002). Of the 16 patients with C MV disease before day 100 in the antigenemia-ganciclovir group, 10 (8. 8%) had disease before or during the first episode of antigenemia and 6 (5.3%) developed disease after discontinuation of ganciclovir. Untre ated low-grade antigenemia progressed to CMV disease in 19% of patient s with grade 3-4 compared with 0% of patients with grade 0-2 acute gra ft-versus-host disease (P=.04). There was no significant difference in CMV disease by day 180 after transplantation and thereafter. CMV-rela ted death, transplant survival, and neutropenia were not significantly different between the groups. In the ganciclovir group, more invasive fungal infections occurred (P =.03) and more ganciclovir was used (P <.0001). Thus, delaying the start of ganciclovir until high-grade anti genemia and discontinuing ganciclovir based on negative antigenemia re sults in more CMV disease by day 100 than ganciclovir administered at engraftment. However, ganciclovir at engraftment is associated with mo re early invasive fungal infections and more late CMV disease resultin g in similar survival rates. (C) 1996 by The American Society of Hemat ology.