A Mortality Analysis of Letermovir Prophylaxis for Cytomegalovirus (CMV) in CMV-seropositive Recipients of Allogeneic Hematopoietic Cell Transplantation.
In: Clinical Infectious Diseases, Jg. 70 (2020-04-15), Heft 8, S. 1525-1533
academicJournal
Zugriff:
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. [ABSTRACT FROM AUTHOR]
Titel: |
A Mortality Analysis of Letermovir Prophylaxis for Cytomegalovirus (CMV) in CMV-seropositive Recipients of Allogeneic Hematopoietic Cell Transplantation.
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Autor/in / Beteiligte Person: | Ljungman, Per ; Schmitt, Michael ; Marty, Francisco M ; Maertens, Johan ; Chemaly, Roy F ; Kartsonis, Nicholas A ; Butterton, Joan R ; Wan, Hong ; Teal, Valerie L ; Sarratt, Kendra ; Murata, Yoshihiko ; Leavitt, Randi Y ; Badshah, Cyrus |
Zeitschrift: | Clinical Infectious Diseases, Jg. 70 (2020-04-15), Heft 8, S. 1525-1533 |
Veröffentlichung: | 2020 |
Medientyp: | academicJournal |
ISSN: | 1058-4838 (print) |
DOI: | 10.1093/cid/ciz490 |
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