Inhibition of murine cytomegalovirus and human cytomegalovirus by a novel non-nucleosidic compound in vivo. Adoption of new practices before adequate Most

Assuming a 20% rate of discontinuation for non-CMV reasons and assuming that 15% of the patients would have detectable CMV DNA at baseline, we calculated that at least 540 patients (360 patients in the letermovir group and 180 in the placebo group) would be required in order to provide the trial with more than 90% power for the primary efficacy analysis. In a phase 3 trial, letermovir reduced clinically significant cytomegalovirus infections (CS-CMVi) and all-cause mortality at week 24 versus placebo in CMV-seropositive allogeneic hematopoietic cell transplantation (HCT) recipients.

NIH Among the remaining 495 patients, the percentage of patients in whom clinically significant CMV infection developed or who were imputed as having a primary end-point event by week 24 after transplantation was significantly lower among letermovir recipients (122 of 325 [37.5%]) than among placebo recipients (103 of 170 [60.6%]). Eligible patients underwent randomization in a 2:1 ratio by means of an interactive Web-response system and concealed assignment, with the use of permuted blocks of six, to receive letermovir or placebo through week 14 (approximately 100 days) after transplantation. Erard V, Guthrie KA, Seo S, et al. Bogner E. Human cytomegalovirus terminase as a target for antiviral chemotherapy. All the investigators and central laboratories provided trial data. Anderson A, Raja M, Vazquez N, Morris M, Komanduri K, Camargo J. Clin Transplant. The degree of equipoise in the

Winston DJ, Young J-AH, Pullarkat V, et al. This structured set of recommendations guides the prioritization of minimum requirements to establish a transplant program and to set the path for expansion and further development. Following letermovir prophylaxis, the HR for all-cause mortality was 0.58 (95% CI, 0.35-0.98; P = .04) at week 24 and 0.74 (95% CI, 0.49-1.11; P = .14) at week 48 post-HCT versus placebo.

Exploring physician specialist response rates to web-based surveys. Early cytomegalovirus reactivation remains associated with increased transplant-related mortality in the current era: a CIBMTR analysis. 2020, Received: ); Juravinski Hospital and Cancer Center, McMaster University, Hamilton, ON, Canada (S.H.

Survival rates by disease, disease stage, donor type, and age are presented. Correspondence: Nosha Farhadfar MD, University of Florida College of Medicine, Gainesville; Phone; 972-974-8889, Division of Hematology and Oncology, University of Florida College of Medicine, Gainesville, Florida, National Marrow Donor Program (NMDP)/Be The Match and Center for International Blood and Marrow Transplant Research, Department of Medicine, Medical College of Wisconsin, Center for International Blood and Marrow Transplant Research, Milwaukee, Wisconsin, Center for Cancer and Immunology Research, Children's National Hospital, Washington, DC, USA, Department of Oncology, Johns Hopkins University, Baltimore, MD, USA, Division of Hematology-Oncology and Blood and Marrow Transplantation Program, Mayo Clinic, Jacksonville, FL, USA, Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, Transplant clinicians expect significant changes in the practice of hematopoietic Kaul DR, Stoelben S, Cober E, et al. Blood 2003; 101:407–14. Many factors influence practice but a major one is the lack of definitive data about best practices. Transpl Infect Dis 2015;17:779-784, 35. Prespecified exploratory end points included cumulative all-cause mortality and the rates of engraftment, GVHD, and infection during the trial. Concise summaries and expert physician commentary that busy clinicians need to enhance patient care. The treatment effect of letermovir in preventing clinically significant CMV infection was consistent across various prespecified and post hoc subgroups both at week 14 and at week 24 after transplantation (Figs.

Clin Transl Sci 2017;10:487-495, 26. See this image and copyright information in PMC. All the patients who did not meet the definition of being at high risk were considered to be at low risk. Further analysis of atrial arrhythmias did not show a relationship with letermovir exposure (Figs. The protocol suggested thresholds for the preemptive treatment of CMV viremia of more than 150 copies per milliliter for high-risk patients and more than 300 copies per milliliter for low-risk patients through week 14 after transplantation and a threshold of more than 300 copies per milliliter for all the patients thereafter. However, in the placebo group, all-cause mortality at week 48 post-HCT was higher in patients with versus those without CS-CMVi (31.0% vs 18.2%; P = .02). matched related donors (MRD) will remain the preferred donor source for adult HCT Cytomegalovirus (CMV) remains the most common clinically significant infection after allogeneic hematopoietic-cell transplantation.1-4 Although ganciclovir and valganciclovir are routinely used in solid-organ transplantation,5,6 ganciclovir7,8 and valganciclovir9,10 prophylaxis for CMV is limited by clinically unacceptable myelosuppression after hematopoietic-cell transplantation. Published by Oxford University Press for the Infectious Diseases Society of America. Patients who were considered to be at high risk for CMV disease benefited the most from letermovir prophylaxis.

Lischka P, Hewlett G, Wunberg T, et al. In vitro and in vivo activities of the novel anticytomegalovirus compound AIC246.

In addition to benefitting patients who are unable to take the drug orally, the intravenous formulation of letermovir is particularly important for the care of patients with severe gastrointestinal GVHD, because of the rapid CMV-replication kinetics in this context36 that render preemptive strategies less effective. Hematopoietic cell transplantation (HCT) is an established therapy to control and/or cure many malignant and nonmalignant hematologic diseases, congenital and acquired diseases of the immune system, some solid tumors, and some inherited disorders of metabolism .The Center for International Blood and Marrow Transplant Research (CIBMTR) database receives data … These guidelines were developed by WBTM and are published jointly in Hematology/Oncology and Stem Cell Therapy and Biology of Blood and Marrow Transplantation. Risk factors for cytomegalovirus infection after human marrow transplantation. The content of this site is intended for health care professionals. Meyers JD, Flournoy N, Thomas ED. Lancet Infect Dis 2011;11:284-292, 31. All the patients who did not meet the definition of being at high risk were considered to be at low risk. Of 495 patients with no detectable CMV DNA at randomization, 437 had vital-status data available through week 48 post-HCT at trial completion (101 deaths, 20.4%). Miettinen O, Nurminen M. Comparative analysis of two rates.

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