Death from CMV disease was adjudicated by the EC in one patient www.selleckchem.com
with CMV pneumonia. For the secondary endpoints of the combination of CMV infection (pp65, PCR, or either) or EC-confirmed CMV disease, the ganciclovir group had a significantly lower incidence of either compared with the maribavir group at both 100 days after transplantation (all p < 0.0001) and at 6 months after transplantation (p = 0.0283, 0.0024 and 0.0053; Table 2). For initiation of anti-CMV therapy, significantly fewer ganciclovir patients than maribavir patients had EC-confirmed disease or received additional anti-CMV therapy at 100 days post-transplantation (4% vs. 33%, p < 0.0001), but not at 6 months post-transplantation (33% vs. 41%, p = 0.2339). The treatment difference was statistically significant in time to onset of CMV selleckchem
infection (by pp65 or PCR) or EC-confirmed CMV disease, in favor of ganciclovir group with longer time to onset compared to the maribavir group, at both 100 days and at 6 months post-transplantation (p < 0.0001; Figures 2 and 3). Only 3 CMV isolates were available for antiviral susceptibility testing. Two CMV isolates were obtained after maribavir dosing, and one CMV isolate was obtained after ganciclovir dosing. All 3 CMV isolates were sensitive to maribavir (range of mean IC50��M, 0.19�C0.77 ��M). Nine subjects in the ITT-S analysis had one or more non-CMV herpesvirus infections documented within 6 months after transplantation (4 ganciclovir, 5 maribavir). Four of the subjects had documented Epstein-Barr virus infection (3 ganciclovir, 1 maribavir), three subjects had documented herpes zoster infection (1 ganciclovir, 2 maribavir) and two subjects had oral herpes simplex infection (both maribavir). The incidences of invasive bacterial and fungal infections at both 100 days after transplantation (11% of ganciclovir patients, 10% of maribavir patients) and at 6 months after transplantation (15% of ganciclovir patients, 12% of maribavir patients) were similar in both study groups. As expected in this study population, AEs were common. Ninety-seven percent of Ponatinib
ganciclovir patients and 95 percent of maribavir patients had one or more treatment-emergent AEs during the study (first day of study drug through 7 days after last dose of study drug). Table 3 summarizes treatment-emergent AEs reported by investigators in 10 percent or more of patients in either therapy group. Generally, the incidences and types of most AEs were similar for the two study groups. Diarrhea was the most frequently reported AE in both study groups. The incidence of dysgeusia or taste disturbance, an AE commonly associated with maribavir in previous clinical studies, was similar for ganciclovir and maribavir patients. On the other hand, nausea, leukopenia, and anemia were more frequent in the ganciclovir patients.