scholarly journals Brincidofovir for Prevention of Cytomegalovirus (CMV) after Allogeneic Hematopoietic Cell Transplantation (HCT) in CMV-Seropositive Patients: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Trial

2016 ◽  
Vol 22 (3) ◽  
pp. S23 ◽  
Author(s):  
Francisco M. Marty ◽  
Drew J. Winston ◽  
Roy F. Chemaly ◽  
Michael J. Boeckh ◽  
Kathlene M. Mullane ◽  
...  
Keyword(s):  
Cell Transplantation ◽  
Hematopoietic Cell Transplantation ◽  
Hematopoietic Cell ◽  
Allogeneic Hematopoietic Cell Transplantation ◽  
Phase 3 ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Parallel Group

scholarly journals A Mortality Analysis of Letermovir Prophylaxis for Cytomegalovirus (CMV) in CMV-seropositive Recipients of Allogeneic Hematopoietic Cell Transplantation

2019 ◽  
Vol 70 (8) ◽  
pp. 1525-1533 ◽  
Author(s):  
Per Ljungman ◽  
Michael Schmitt ◽  
Francisco M Marty ◽  
Johan Maertens ◽  
Roy F Chemaly ◽  
...  
Keyword(s):  
Cell Transplantation ◽  
Hematopoietic Cell Transplantation ◽  
Hematopoietic Cell ◽  
Allogeneic Hematopoietic Cell Transplantation ◽  
Phase 3 ◽  
Kaplan Meier ◽  
Hazard Ratios ◽  
All Cause Mortality ◽  
Clinically Significant ◽  
Status Data

Abstract Background 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. This post hoc analysis of phase 3 data further investigated the effects of letermovir on all-cause mortality. Methods Kaplan-Meier survival curves were generated by treatment group for all-cause mortality. Observations were censored at trial discontinuation for reasons other than death or at trial completion. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated using Cox modeling, adjusting for risk factors associated with mortality. Results 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%). 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. Incidence of all-cause mortality through week 48 post-HCT in the letermovir group was similar in patients with or without CS-CMVi (15.8 vs 19.4%; P = .71). 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). The HR for all-cause mortality in patients with CS-CMVi was 0.45 (95% CI, 0.21–1.00; P = .05) at week 48 for letermovir versus placebo. Conclusions Letermovir may reduce mortality by preventing or delaying CS-CMVi in HCT recipients. Clinical Trials Registration clinicaltrials.gov, NCT02137772.

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