TY - JOUR
T1 - Maribavir prophylaxis for prevention of cytomegalovirus infection in allogeneic stem cell transplant recipients
T2 - A multicenter, randomized, double-blind, placebo-controlled, dose-ranging study
AU - Winston, Drew J.
AU - Young, Jo Anne H.
AU - Pullarkat, Vinod
AU - Papanicolaou, Genovefa A.
AU - Vij, Ravi
AU - Vance, Estil
AU - Alangaden, George J.
AU - Chemaly, Roy R.
AU - Petersen, Finn
AU - Chao, Nelson
AU - Klein, Jared
AU - Sprague, Kellie
AU - Villano, Stephen A.
AU - Boeckh, Michael
PY - 2008/6/1
Y1 - 2008/6/1
N2 - 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 en-graftment, 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 myelosup-pression. This trial is registered at www. ClinicalTrials.gov as #NCT00223925.
AB - 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 en-graftment, 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 myelosup-pression. This trial is registered at www. ClinicalTrials.gov as #NCT00223925.
UR - http://www.scopus.com/inward/record.url?scp=44049085618&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=44049085618&partnerID=8YFLogxK
U2 - 10.1182/blood-2007-11-121558
DO - 10.1182/blood-2007-11-121558
M3 - Article
C2 - 18285548
AN - SCOPUS:44049085618
SN - 0006-4971
VL - 111
SP - 5403
EP - 5410
JO - Blood
JF - Blood
IS - 11
ER -