scholarly journals A multicenter, longitudinal, interventional, double blind randomized clinical trial in hematopoietic cell transplant recipients residing in remote areas: Lessons learned from the late cytomegalovirus prevention trial

2016 ◽  
Vol 4 ◽  
pp. 84-89 ◽  
Author(s):  
Louise E. Kimball ◽  
Terry Stevens-Ayers ◽  
Margaret L. Green ◽  
Hu Xie ◽  
Mary E.D. Flowers ◽  
...  
Blood ◽  
2006 ◽  
Vol 107 (5) ◽  
pp. 1800-1805 ◽  
Author(s):  
Michael Boeckh ◽  
Hyung W. Kim ◽  
Mary E. D. Flowers ◽  
Joel D. Meyers ◽  
Raleigh A. Bowden

Varicella-zoster virus (VZV) disease occurs in 30% of allogeneic hematopoietic cell transplant recipients who had a history of VZV infection. A safe and effective prevention strategy has not been established. In a double-blind controlled trial, 77 hematopoietic cell transplant recipients at risk for VZV reactivation were randomized to acyclovir 800 mg twice daily or placebo given from 1 to 2 months until 1 year after transplantation. VZV disease at 1 year was the primary end point; VZV disease after discontinuation of prophylaxis, VZV-specific T-cell immunity, herpes simplex virus (HSV) infection, cytomegalovirus (CMV) disease, survival, and safety were secondary end points. Acyclovir significantly reduced VZV infections at 1 year after transplantation (HR, 0.16; 95% CI, 0.035-0.74; P = .006). In the postintervention observation period, this difference was not statistically significant (2 years: HR, 0.52; 95% CI, 0.21-1.3; 5 years: HR, 0.76; 95% CI, 0.36-1.6). There was no statistically significant difference in reconstitution of VZV-specific T-helper cell responses, HSV infections, CMV disease, chronic graft-versus-host disease, and overall survival between the groups. Acyclovir was well tolerated. Post-study VZV disease predominantly occurred in patients with continued need for systemic immunosuppression. In conclusion, acyclovir effectively and safely prevents VZV disease during the first year after hematopoietic cell transplantation. Periods of prophylaxis longer than 12 months may be beneficial for those hematopoietic cell transplant recipients on continued immune suppression.


2020 ◽  
Vol 11 ◽  
pp. 204062072093715
Author(s):  
Terri Lynn Shigle ◽  
Victoria Wehr Handy ◽  
Roy F. Chemaly

Cytomegalovirus (CMV) reactivation is one of the most common infections affecting allogeneic hematopoietic cell transplant recipients. Although available anti-CMV therapies have been evaluated for the prevention of CMV reactivation, their toxicity profile makes them unfavorable for use as primary prophylaxis; thus, they are routinely reserved for the treatment of CMV viremia or CMV end-organ disease. Pre-emptive CMV monitoring strategies have been widely accepted, and although they have been helpful in early detection, they have not affected the overall morbidity and mortality associated with CMV. Letermovir is a novel agent that was approved for primary prophylaxis in CMV-seropositive adult allogeneic hematopoietic cell transplant recipients. This review focuses on letermovir’s novel mechanism; clinical trials supporting its United States Food and Drug Administration (FDA) approval and subsequent follow-up analyses; clinical considerations, with an emphasis on pharmacology; and lessons learned from solid organ transplant recipients, as well as potential future directions.


2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S266-S267 ◽  
Author(s):  
Christopher Kovacs ◽  
Vasilios Athans ◽  
David Lang ◽  
Ronald Sobecks ◽  
Lisa Rybicki ◽  
...  

2021 ◽  
Vol 27 (3) ◽  
pp. S124
Author(s):  
Issam S. Hamadeh ◽  
Michael R. Grunwald ◽  
Allison Martin ◽  
Jai N. Patel ◽  
Alexandra Wolff ◽  
...  

2021 ◽  
Author(s):  
Erica J. Roelofs ◽  
Donald R. Dengel ◽  
Qi Wang ◽  
James S. Hodges ◽  
Julia Steinberger ◽  
...  

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