The anti-cytomegalovirus (CMV) activity and safety of oral
maribavir in CMV-seropositive allogeneic stem-cell transplant recipients were evaluated in a randomized, double-blind, placebo-controlled, dose-ranging study. After engraftment, 111 patients were randomized to receive CMV prophylaxis with
maribavir (100 mg twice daily, 400 mg once daily, or 400 mg twice daily) or placebo. Within the first 100 days after
transplantation, the incidence of CMV
infection based on CMV pp65 antigenemia was lower in each of the respective
maribavir groups (15%, P = .046; 19%, P = .116; 15%, P = .053) compared with placebo (39%). Similarly, the incidence of CMV
infection based on plasma CMV
DNA was lower in each of the respective
maribavir groups (7%, P = .001; 11%, P = .007; 19%, P = .038) compared with placebo (46%). Anti-CMV
therapy was also used less often in patients receiving each respective dose of
maribavir (15%, P = .001; 30%, P = .051; 15%, P = .002) compared with placebo (57%). There were 3 cases of CMV disease in placebo patients but none in the
maribavir patients. Adverse events, mostly taste disturbance,
nausea, and
vomiting, were more frequent with
maribavir.
Maribavir had no adverse effect on neutrophil or platelet counts. These results show that
maribavir can reduce the incidence of CMV
infection and, unlike
ganciclovir, does not cause myelosuppression.