Maribavir prophylaxis for prevention of cytomegalovirus infection in allogeneic stem cell transplant recipients: A multicenter, randomized, double-blind, placebo-controlled, dose-ranging study Journal Article
| Authors: | Winston, D. J.; Young, J. A. H.; Pullarkat, V.; Papanicolaou, G. A.; Vij, R.; Vance, E.; Alangaden, G. J.; Chemaly, R. R.; Petersen, F.; Chao, N.; Klein, J.; Sprague, K.; Villano, S. A.; Boeckh, M. |
| Article Title: | Maribavir prophylaxis for prevention of cytomegalovirus infection in allogeneic stem cell transplant recipients: A multicenter, randomized, double-blind, placebo-controlled, dose-ranging study |
| Abstract: | 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. © 2008 by The American Society of Hematology. |
| Keywords: | adult; controlled study; treatment response; middle aged; transplantation, homologous; major clinical study; allogeneic stem cell transplantation; clinical trial; fatigue; mortality; neutropenia; placebo; diarrhea; dose response; drug dose comparison; drug safety; drug withdrawal; nonhuman; polymerase chain reaction; low drug dose; controlled clinical trial; bone marrow suppression; nausea; randomized controlled trial; vomiting; relapse; aciclovir; stem cell transplantation; dose-response relationship, drug; abdominal pain; arthralgia; chill; dizziness; pruritus; rash; cause of death; drug fatality; dysphagia; blood; acute leukemia; myelodysplastic syndrome; dosage schedule comparison; multicenter study; chemically induced disorder; lymphoma; graft versus host reaction; taste disorder; xerostomia; hyperpigmentation; antivirus agent; virus infection; headache; kaplan meier method; hypercholesterolemia; double blind procedure; double-blind method; serology; cytomegalovirus infection; benzimidazole derivative; benzimidazoles; allotransplantation; virus detection; hypesthesia; antiviral agents; virus dna; dose time effect relation; chronic leukemia; famciclovir; herpes virus infection; benzimidavir; valaciclovir; ribonucleoside; cytomegalovirus infections; ribonucleosides; taste disorders |
| Journal Title: | Blood |
| Volume: | 111 |
| Issue: | 11 |
| ISSN: | 0006-4971 |
| Publisher: | American Society of Hematology |
| Date Published: | 2008-06-01 |
| Start Page: | 5403 |
| End Page: | 5410 |
| Language: | English |
| DOI: | 10.1182/blood-2007-11-121558 |
| PUBMED: | 18285548 |
| PROVIDER: | scopus |
| PMCID: | PMC5726327 |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 63" - "Export Date: 17 November 2011" - "CODEN: BLOOA" - "Source: Scopus" |
